IDkit HP ONE citric acid anhydrous and 13C urea 75 mg; 4 g Solution
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| IDkit HP ONE 75 mg/1; 4 gthis 50402-0100-13 | Meridian | 1 solution | — | — | FDA listed | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 50402-0100-13 You're viewing this | 25 BAG in 1 BOX (50402-100-13) / 1 SOLUTION in 1 BAG | 2013-05-01 | Active |
| 50402-0100-14 | 5 BOX in 1 CASE (50402-100-14) / 1 SOLUTION in 1 BOX | 2017-01-01 | Active |
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What quantity is in NDC 50402-0100-13?
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE IDkit Hp ® One and IDkit Hp ® Two are indicated for use as a diagnostic aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori (H. pylori) infection in adults and pediatric patients 3 years of age and older. IDkit Hp One and IDkit Hp Two are to be administered only by trained personnel as ordered by a licensed healthcare practitioner using the BreathID ® system device as identified in the BreathID ® system device labeling. IDkit Hp One and IDkit Hp Two are indicated for use as a diagnostic aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori (H. pylori) infection in adults and pediatric patients 3 years of age and older.
( 1 ) IDkit Hp One and IDkit Hp Two are to be administered only by trained personnel as ordered by a licensed healthcare practitioner using the BreathID ® system device as identified in the BreathID ® system device labeling. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION IDkit Hp One and IDkit Hp Two each contain a 75 mg 13 C-urea tablet for oral solution, and 4 g Citrica (citric acid) for oral solution along with other materials for use with the BreathID system device ( 2.1 , 16 ) o IDkit Hp One is co-packaged with a nasal canula to be used with the BreathID system device as identified in the BreathID system device labeling. ( 2.1 ) o IDkit Hp Two is co-packaged with breath sample bags to be used with the BreathID system device as identified in the BreathID system device labeling.
( 2.1 ) To prepare the oral solution for either kit, dissolve the 13 C-urea tablet and the Citrica (citric acid) for oral solution in 150 to 200 mL of water to provide a clear, colorless solution for oral administration. The resulting solution is ingested by the patient. ( 2.3 ) See full prescribing information for detailed important instructions concerning preparation, administration, and disposal of IDkit Hp One and IDkit Hp Two.
( 2.3 - 2.6 ) See BreathID ® system device manual for additional details for use of IDkit Hp One and IDkit Hp Two with the BreathID system device, including troubleshooting device malfunction. ( 2.2 )
2.1Dosage and Administration Overview IDkit Hp One or IDkit Hp Two contain the same drug product, 75 mg 13 C-urea tablet and 4 g Citrica (citric acid) for oral solution and follow the same drug preparation and administration instructions. IDkit Hp One and IDkit Hp Two are to be administered only by trained personnel as ordered by a licensed healthcare practitioner, using the BreathID system device that as identified in the BreathID system device labeling, is intended for use with IDkit Hp One and IDkit Hp Two. For in vitro diagnostic use only.
Inform the patient that each 4 g packet of Citrica (citric acid) for oral solution contains 84 mg of phenylalanine per dose. Phenylketonurics restrict dietary phenylalanine [see Warnings and Precautions ( 5.2 )] . The patient should have fasted for at least one hour before administering the test drink.
The patient should not have taken antimicrobials, proton pump inhibitors (PPI), or bismuth preparations within two weeks prior to administering the test. If PPIs are used within two weeks of breath testing, false negative test results may occur, and the test should be repeated two weeks after discontinuation of PPI treatment. A positive result for a patient on PPI could be considered as indicative of the presence of urease enzyme associated with H. pylori .
Before opening the kit (IDkit Hp One or IDkit Hp Two), verify that the entire package is intact [see How Supplied/Storage and Handling ( 16 )] .
2.2Recommended Dosage for Adults and Pediatric Patients 3 Years of Age and Older IDkit Hp One Single-use Kit or IDkit Hp Two Single-use Kit A 75 mg 13 C-urea tablet for oral solution and 4 g Citrica (citric acid) for oral solution are dissolved in 150 to 200 mL of water for oral consumption, and the resulting solution is ingested by the patient.
2.3Preparation of IDkit Hp One Single-use kit or IDkit Hp Two Single-use Kit Preparation Instructions with IDkit Hp One single-use kit or IDkit Hp Two single-use kit Dissolve the 13 C-urea tablet and Citrica (citric acid) for oral solution in 150 mL to 200 mL of tap water in a single drinking cup of at least eight ounces (236 mL) in capacity. In the IDkit Hp Two kit a drinking cup is provided. Stir thoroughly with the provided straw until the 13 C-urea tablet and Citrica (citric acid) for oral solution are completely dissolved.
Tiny particles may remain visible after thorough mixing. However, if more substantial particulate matter is still present after five minutes of stirring, discard the solution and repeat the procedure with a new kit. Use the test drink within two hours of preparation, as this is the maximal time for maintaining solution stability.
2.4IDkit Hp One Single-use Kit: Instruction for Performing the BreathID H. pylori Test Preparing the BreathID System Device Refer to th…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS IDkit Hp One and IDkit Hp Two consists of a 13 C-urea tablet for oral solution co-packaged with Citrica (citric acid) for oral solution along with other materials for use with the BreathID system device [see How Supplied/Storage and Handling ( 16 )] . 13 C-urea tablet for oral solution is supplied as a white, biconvex round tablet with “U” debossed on one side. Each tablet contains 75 mg 13 C-urea.
Citrica (citric acid) for oral solution is supplied as a white to off-white powder. Each pouch contains 4 grams of citric acid. 75 mg 13 C-urea tablet for oral solution co-packaged with 4g Citrica (citric acid) for oral solution.
( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS IDkit Hp One and IDkit Hp Two are contraindicated in patients with a known hypersensitivity to the 13 C-urea, Citrica (citric acid) or to any of the excipients [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.2 )] . Hypersensitivity to the 13 C-urea, Citrica (citric acid) or to any of the excipients in the drug. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, have been reported in patients using IDkit Hp. Institute appropriate supportive measures if an allergic reaction occurs. ( 5.1 ) Phenylketonuria: Citrica (citric acid) for oral solution, a component in the IDkit Hp, contains phenylalanine which can be harmful to patients with phenylketonuria. ( 5.2 )
5.1Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, have been reported in patients who have used the IDkit Hp One and IDkit Hp Two for H. pylori diagnostic testing [see Adverse Reactions ( 6.2 )] . The IDkit Hp One and IDkit Hp Two are contraindicated in patients with known history of hypersensitivity to 13 C-urea, Citrica (citric acid) or the excipients [see Contraindications ( 4 )] . Before administering the IDkit Hp One or IDkit Hp Two, carefully inquire about previous hypersensitivity reactions.
5.2Risks in Patients with Phenylketonuria Phenylalanine can be harmful to patients with phenylketonuria (PKU). In IDkit Hp One and IDkit Hp Two, the Citrica (citric acid) for oral solution contains phenylalanine, a component of aspartame. Each 4 g packet of Citrica (citric acid) for oral solution contains 84 mg of phenylalanine.
Before prescribing IDkit Hp One or IDkit Hp Two to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including IDkit Hp One or IDkit Hp Two.
5.1Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, have been reported in patients who have used the IDkit Hp One and IDkit Hp Two for H. pylori diagnostic testing [see Adverse Reactions ( 6.2 )] . The IDkit Hp One and IDkit Hp Two are contraindicated in patients with known history of hypersensitivity to 13 C-urea, Citrica (citric acid) or the excipients [see Contraindications ( 4 )] . Before administering the IDkit Hp One or IDkit Hp Two, carefully inquire about previous hypersensitivity reactions.
5.2Risks in Patients with Phenylketonuria Phenylalanine can be harmful to patients with phenylketonuria (PKU). In IDkit Hp One and IDkit Hp Two, the Citrica (citric acid) for oral solution contains phenylalanine, a component of aspartame. Each 4 g packet of Citrica (citric acid) for oral solution contains 84 mg of phenylalanine.
Before prescribing IDkit Hp One or IDkit Hp Two to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including IDkit Hp One or IDkit Hp Two.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in the Warning and Precautions section of the labeling: Hypersensitivity Reactions [see Warning and Precautions ( 5.1 )] Adult Patients: The most common adverse reactions (incidence >0.3%) using the IDkit Hp included nausea, throat burning, and lightheadedness. ( 6.1 ) Pediatric Patients: The most common adverse reactions (incidence >1.5%) using the IDkit Hp included vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meridian Bioscience Corporation at 1-800-543-1980 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Experience and Adverse Reactions in Adult Patients The safety of the IDkit Hp was evaluated in 465 adult patients who participated in two clinical trials (Trial 1 and Trial 2). All patients used the IDkit Hp Two kit for initial diagnosis and post-treatment monitoring of H. pylori infection.
The most commonly observed adverse reactions associated with the use of the IDkit Hp were nausea (0.6%), throat burning (0.4%), and lightheadedness (0.4%). Clinical Trials Experience and Adverse Reactions in Pediatric Patients The safety of the IDkit Hp was evaluated in one multi-center, non-randomized, open-label study (Trial 3). A total of 53 pediatric patients, 3 to less than 18 years of age, were enrolled in the study and used the IDkit Hp Two.
The only adverse reaction reported was vomiting (2%).
6.2Post-marketing Experience In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during post-marketing use of the IDkit Hp One and IDkit Hp Two based on patient and test administrator reports. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal: Nausea, vomiting, abdominal pain, diarrhea General: Sweating, throat pain, malaise Immune: Anaphylactic reaction Neurologic: Dizziness, headache
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Experience and Adverse Reactions in Adult Patients The safety of the IDkit Hp was evaluated in 465 adult patients who participated in two clinical trials (Trial 1 and Trial 2). All patients used the IDkit Hp Two kit for initial diagnosis and post-treatment monitoring of H. pylori infection.
The most commonly observed adverse reactions associated with the use of the IDkit Hp were nausea (0.6%), throat burning (0.4%), and lightheadedness (0.4%). Clinical Trials Experience and Adverse Reactions in Pediatric Patients The safety of the IDkit Hp was evaluated in one multi-center, non-randomized, open-label study (Trial 3). A total of 53 pediatric patients, 3 to less than 18 years of age, were enrolled in the study and used the IDkit Hp Two.
The only adverse reaction reported was vomiting (2%).
6.2Post-marketing Experience In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during post-marketing use of the IDkit Hp One and IDkit Hp Two based on patient and test administrator reports. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal: Nausea, vomiting, abdominal pain, diarrhea General: Swe…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No formal drug interaction studies were conducted. Information on drugs that may interfere with test results are listed in the Table 1. Table 1: Drugs That Interfere with Test Results Interfering Drug Clinical Effect Prevention or Management Antimicrobials, bismuth-containing preparations May suppress H. pylori or urease activity, leading to false negative results Avoid use within 2 weeks prior to testing.
If used within 2 weeks, postpone testing until at least 2 weeks after discontinuation. Proton pump inhibitors (PPIs) May reduce urease activity or alter gastric conditions, potentially causing false negative results. A positive result during PPI use may still indicate H. pylori presence.
Avoid use within 2 weeks prior to testing. If a negative result is obtained during PPI use, repeat the test 2 weeks after PPI discontinuation. Antimicrobials, Bismuth-containing preparations: Avoid use within 2 weeks prior to testing.
( 7 ) Proton pump inhibitors (PPIs): Avoid use within 2 weeks prior to testing. ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pediatric Use: The safety and effectiveness of IDkit Hp One and IDkit Hp Two has not been established in pediatric patients less than 3 years of age. ( 8.4 )
8.1Pregnancy Risk Summary Published data from other single oral dose 13 C-urea breath test kits containing urea and citric acid have not demonstrated a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are no available data on the use of IDkit Hp One or IDkit Hp Two use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are no animal data that meet current standards for nonclinical developmental toxicity studies.
Based on available literature, no significant developmental or reproductive toxicities were observed in nonclinical studies with urea or citric acid. A single oral dose of 13 C-urea and citric acid at the maximum recommended human dose (MRHD) are unlikely to pose a significant developmental or reproductive risk, since humans typically have higher circulating levels of urea, and citric acid exposure from the test is within the range of normal dietary intake. The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
8.2Lactation Risk Summary There are no data on the presence of the components of IDkit Hp One or IDkit Hp Two in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. A single oral dose of 13 C-urea and citric acid at the MRHD is unlikely to pose a risk in breastfed infants since humans typically have higher circulating levels of urea, and citric acid exposure from the test is within the range of normal dietary intake. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for IDkit Hp One or IDkit Hp Two and any potential adverse effects on the breastfed infant from IDkit Hp One or IDkit Hp Two or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of IDkit Hp One and IDkit Hp Two have been established in pediatric patients 3 years of age and older. Use of IDkit Hp One and IDkit Hp Two in pediatric patients is supported by two trials demonstrating clinical performance in adults along with a multi-center, non-randomized, open label study confirming the safety of the 13 C-urea substrate and the performance of the BreathID system device in pediatric patients [see Adverse Reaction ( 6.1 ) and Clinical Studies ( 14.1 )] .
The safety and effectiveness of IDkit Hp One and IDkit Hp Two have not been established in pediatric patients less than 3 years of age.
8.5Geriatric Use Of the total number of IDkit Hp One and IDkit Hp Two patients in clinical studies for detection of H. pylori , 74 (12%) were 65 to 74 years of age, and 38 (6%) were 75 years of age and older [see Clinical Studies ( 14 )] . No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients, and other reported clinical experience has not identified differences in responses between the elderly and younger adult patients.
8.6Gastrectomy Data is insufficient for recommending the use of IDkit Hp One and IDkit Hp Two on patients with total or partial gastrectomy [see Clinical Pharmacology ( 12.3 )] .
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Published data from other single oral dose 13 C-urea breath test kits containing urea and citric acid have not demonstrated a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are no available data on the use of IDkit Hp One or IDkit Hp Two use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are no animal data that meet current standards for nonclinical developmental toxicity studies.
Based on available literature, no significant developmental or reproductive toxicities were observed in nonclinical studies with urea or citric acid. A single oral dose of 13 C-urea and citric acid at the maximum recommended human dose (MRHD) are unlikely to pose a significant developmental or reproductive risk, since humans typically have higher circulating levels of urea, and citric acid exposure from the test is within the range of normal dietary intake. The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of IDkit Hp One and IDkit Hp Two have been established in pediatric patients 3 years of age and older. Use of IDkit Hp One and IDkit Hp Two in pediatric patients is supported by two trials demonstrating clinical performance in adults along with a multi-center, non-randomized, open label study confirming the safety of the 13 C-urea substrate and the performance of the BreathID system device in pediatric patients [see Adverse Reaction ( 6.1 ) and Clinical Studies ( 14.1 )] .
The safety and effectiveness of IDkit Hp One and IDkit Hp Two have not been established in pediatric patients less than 3 years of age.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of IDkit Hp One and IDkit Hp Two patients in clinical studies for detection of H. pylori , 74 (12%) were 65 to 74 years of age, and 38 (6%) were 75 years of age and older [see Clinical Studies ( 14 )] . No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients, and other reported clinical experience has not identified differences in responses between the elderly and younger adult patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action IDkit Hp One and IDkit Hp Two are administered using the BreathID system device, a non-invasive breath test that analyzes a breath sample before and after ingestion of 13 C- urea and citric acid. 75 mg 13 C-urea and 4. g citric acid is dissolved in water and administered orally to the patient. The presence of citric acid creates an acidic environment in the stomach and delays the gastric emptying of the ingested solution to the duodenum.
These two characteristics facilitate the decomposition of the urea by H. pylori , if present. Thus, in the presence of urease produced by gastric H. pylori , 13 C-urea is decomposed to 13 CO 2 and NH 3 according to the following equation: The 13 CO 2 formed is absorbed into the blood and then exhaled in breath, enabling detection of elevated 13 CO 2 in H. pylori-positive patients. In H. pylori-negative patients, no significant production of 13 CO 2 occurs in the stomach, as there are no human enzymes capable of hydrolyzing urea under gastric conditions. equ2
12.2Pharmacodynamics IDkit Hp One and IDkit Hp Two ( 13 C-urea and citric acid) have no therapeutic pharmacodynamic effects. It contains diagnostic agents 13 C-urea and citric acid that detects the presence of H. pylori based on bacterial urease activity in the gastric mucosa.
12.3Pharmacokinetics Absorption Following oral administration of 13 C-urea 100 mg to 400 mg (1.33 to 4 times the highest approved recommended dosage) in 3 healthy subjects, the Tmax of 13 C-urea was around 30 minutes [see Dosage and Administration ( 2.1 )] . Elimination Metabolism In H. pylori -positive subjects, 13 C-urea is hydrolysed in the stomach by bacterial urease to 13 CO 2 and ammonia. Excretion Urea is eliminated predominantly by renal excretion.
Specific Populations The pharmacokinetics of 13 C-urea are not expected to have clinically meaningful differences based on age (including geriatric and pediatric patients), sex, race, or ethnicity with respect to its activity as diagnostic agent. Gastrectomy Patients The performance and reliability of the test in gastrectomy patients have not been established. Drug Interaction Studies No formal drug interaction studies have been conducted.
Antimicrobials, proton pump inhibitors, and bismuth preparations may affect H. pylori status or urease activity and interfere with test results [see Drug Interactions ( 7 )] . In vitro studies demonstrated that mouthwash, chewing gum, carbonated beverages, cigarette smoke, acetone, and alcohol had no clinically relevant effect on test results.
🧬 Mechanism of Action ▾
12.1Mechanism of Action IDkit Hp One and IDkit Hp Two are administered using the BreathID system device, a non-invasive breath test that analyzes a breath sample before and after ingestion of 13 C- urea and citric acid. 75 mg 13 C-urea and 4. g citric acid is dissolved in water and administered orally to the patient. The presence of citric acid creates an acidic environment in the stomach and delays the gastric emptying of the ingested solution to the duodenum.
These two characteristics facilitate the decomposition of the urea by H. pylori , if present. Thus, in the presence of urease produced by gastric H. pylori , 13 C-urea is decomposed to 13 CO 2 and NH 3 according to the following equation: The 13 CO 2 formed is absorbed into the blood and then exhaled in breath, enabling detection of elevated 13 CO 2 in H. pylori-positive patients. In H. pylori-negative patients, no significant production of 13 CO 2 occurs in the stomach, as there are no human enzymes capable of hydrolyzing urea under gastric conditions. equ2
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied IDkit Hp One and IDkit Hp Two each contain a 75 mg 13 C-urea tablet for oral solution and 4 g Citrica (citric acid) for oral solution along with other materials for use with the BreathID system device. IDkit Hp ® One NDC 50402-100-13 A single IDkit Hp One is provided to perform the Breath Test. Each IDkit Hp One contains: One 13 C-urea tablet for oral solution One packet of Citrica (citric acid) for oral solution One IDcircuit ® nasal cannula One straw for stirring and drinking Materials Needed but Not Provided: A drinking cup with a capacity of eight ounces (236 mL) or greater.
Tap water IDkit Hp ® Two NDC 50402-100-14 A single IDkit Hp Two is provided to perform the Breath Test. Each IDkit Hp Two contains: One 13 C-urea tablet for oral solution One packet of Citrica (citric acid) for oral solution One straw for drinking One drinking cup One blue BASELINE Breath Sample Bag for BASELINE breath collection prior to ingestion of the test substrate One gray POST INGESTION Breath Sample Bag for 15 minutes POST INGESTION breath collection One large sample transport bag provided to store/ship both Breath Sample Bags Four barcode labels (one for each Breath Sample Bag and two for the requisition form) One Quick User Guide showing the basic steps of administering the test (printed on the inside of the box) Materials Needed but Not Provided: Tap water Timer
16.2Storage and Handling Store at 20°C to 25°C (68°F-77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. The following components of the test kit have expiration dates: the 13 C-urea tablet and the Citrica Powder. Do not use either of these components beyond the expiration date stated on the respective labels. The earlier of the two expiry dates appears on the IDkit Hp box.
16.1How Supplied IDkit Hp One and IDkit Hp Two each contain a 75 mg 13 C-urea tablet for oral solution and 4 g Citrica (citric acid) for oral solution along with other materials for use with the BreathID system device. IDkit Hp ® One NDC 50402-100-13 A single IDkit Hp One is provided to perform the Breath Test. Each IDkit Hp One contains: One 13 C-urea tablet for oral solution One packet of Citrica (citric acid) for oral solution One IDcircuit ® nasal cannula One straw for stirring and drinking Materials Needed but Not Provided: A drinking cup with a capacity of eight ounces (236 mL) or greater.
Tap water IDkit Hp ® Two NDC 50402-100-14 A single IDkit Hp Two is provided to perform the Breath Test. Each IDkit Hp Two contains: One 13 C-urea tablet for oral solution One packet of Citrica (citric acid) for oral solution One straw for drinking One drinking cup One blue BASELINE Breath Sample Bag for BASELINE breath collection prior to ingestion of the test substrate One gray POST INGESTION Breath Sample Bag for 15 minutes POST INGESTION breath collection One large sample transport bag provided to store/ship both Breath Sample Bags Four barcode labels (one for each Breath Sample Bag and two for the requisition form) One Quick User Guide showing the basic steps of administering the test (printed on the inside of the box) Materials Needed but Not Provided: Tap water Timer
📦 Storage and Handling ▾
16.2Storage and Handling Store at 20°C to 25°C (68°F-77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. The following components of the test kit have expiration dates: the 13 C-urea tablet and the Citrica Powder. Do not use either of these components beyond the expiration date stated on the respective labels. The earlier of the two expiry dates appears on the IDkit Hp box.
📋 Description ▾
11 DESCRIPTION IDkit Hp One and IDkit Hp Two are a diagnostic aid that analyzes a breath sample before and after ingestion of 13 C-urea and citric acid; it is used to identify those patients with a H. pylori infection. The kit consists of a 13 C-urea tablet for oral solution and Citrica (citric acid) for oral solution along with other materials for use with the BreathID system device [see How Supplied/Storage and Handling ( 16 )] . 13 C-Urea Tablet for Oral Solution 13 C-urea has a molecular weight of 61.06 g/mol and the molecular formula 13 CH 4 N 2 O and the following structure: 13 C-urea tablet for oral solution contains 75 mg 13 C-urea and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, povidone, and sodium benzoate.
Citrica (citric acid) for Oral Solution Citric acid has a molecular weight of 210.14 g/mol and the molecular formula C 6 H 8 O 7 . Each pouch contains 4 g of citric acid and the following inactive ingredients: aspartame and tutti frutti flavoring. structure