IDkit HP One

1. For in vitro diagnostic use only. The 13C-urea tablet and Citrica Powder are dissolved in a glass of water and the resulting solution is taken orally as part of the diagnostic procedure.
2. Phenylketonurics: Contains Phenylalanine, 84 mg per dosage unit of Citrica Powder.
3. In the case of accidental overdose – drink water and call the physician.
4. A negative result does not rule out the possibility of H. pylori infection.  False negative results can occur with this procedure. If clinical signs suggest H. pylori infection, retest with a new sample or an alternate method.
5. A false positive test may (rarely) occur due to urease associated with other gastric spiral organisms observed in humans such as Helicobacter heilmanni.
6. A false positive test could occur in patients who have achlorhydria.
7. Antimicrobials, proton pump inhibitors, and bismuth preparations are known to suppress H. pylori. Ingesting these medications within two weeks prior to performing the breath test may produce false negative test results.
8. Tiny particles may remain visible in the reconstituted 13C-urea and Citrica solution after thorough mixing for up to five minutes. However, if more substantial particulate matter is still present after five minutes of mixing, the solution should not be used, and a new kit should be opened.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. The following components of the test kits have expiration dates: the 13C-urea tablet and the Citrica Powder. Do not use either of these components beyond the expiration date stated on the respective labels.

The calibration stability of the BreathID® system is ensured by the Exalenz proprietary 12CO2 and 13CO2 Isotope Specific InfraRed (ISIR) lamps. The physical process underlying gas discharge emissions supports this stability. The emissions are caused by molecular rotation-vibration transitions, each generating a spectral line at a specific wavelength, uniquely defined to an accuracy of better than 0.01 Å (Angstrom). Five gas samples of known concentration and isotope ratio are used to adjust the absorption cell calibration curves, aiming to attain identical isotope ratios over the collection range of CO2 concentrations.  This will ensure accurate readings in both negative and positive samples.In addition, quality checks as described above in the Quality Control section are performed by the BreathID® device after every 25 tests in order to ensure that the BreathID® System performs within established limits, and calibration is performed if required. Refer to the BreathID® Operator’s Manual for a complete description of the SystemCheck and calibration procedure.

1. Post treatment monitoring of H. pylori should be performed after at least four weeks of treatment for H. pylori infection. Earlier assessment may give false results.
2. Safety and effectiveness in patients under the age of 18 years have not yet been established.
3. Data is insufficient for recommending the use of this test on patients with total or partial gastrectomy.
4. Data is insufficient to recommend the use of this test on pregnant and lactating women.
5. A correlation between the number of H. pylori organisms in the stomach and the BreathID® results has not been established.

Delta Over Baseline values for the BreathID® test were determined in a controlled clinical study of 186 adult asymptomatic and symptomatic patients (101 infected and 85 uninfected) in Israel, using a known reference standard called the Isotope Ratio Mass Spectrometer (IRMS) and performed in a local Israeli laboratory. The range of Delta Over Baseline values for the uninfected patients was determined to be between 1 and 8. A histogram of the distribution of Delta Over Baseline values from uninfected patients is shown in Figure 5 below.


Delta Over Baseline values, as determined by the BreathID®  in a pivotal clinical study, were used to confirm the initial clinical data. In the pre-therapy phase, there were 47 infected and 253 uninfected patients. Congruent results obtained by rapid urease test and histological examinations of biopsy tissue were used as the reference standard and were confirmed by the BreathID®  in the 47 infected patients. In the post therapy phase, 22 patients were infected and 50 were uninfected. The reference standard in this phase was at least one positive finding from either an endoscopic test (rapid urease or histology) or by the Meretek UBT®.

The following values were obtained for the data from the pivotal study:
Upper 97.5% percentile of the Negative patients: 2.245
Lower 2.5% percentile of the Positive patients: 7.212

A histogram of the distribution of Delta Over Baseline values from pre-therapy uninfected (first phase) patients is shown in Figure 6 below.

1. Marshall BJ, Warren JR. Unidentified curved bacilli on gastric epithelium in active chronic gastritis.  Lancet 1983;1:1273–5.
2. Suerbaum S, Michetti P. Helicobacter pylori infection. N Engl J Med 2002;347:1175-86.
3. Dominguez-Munoz JE, Leodolter A, Sauerbruch T, et al. A citric acid solution is an optimal test drink in the 13C-urea breath test for the diagnosis of Helicobacter pylori infection. Gut 1997;40:459–62.
4. Leodolter A, Dominguez-Munoz JE, Von Armim U, et al. 13C-urea breath test for the diagnosis of Helicobacter pylori infection. A further simplification for clinical practice. Scand J Gastroenterol 1998;33:267–70.
5. Graham DY, Runke D, Anderson S, et al. Citric acid as the test meal for the 13C-urea breath test. Am J Gastroenterol 1999;94:1214–7.
6. Borriello SP, Reed PJ, Dolby JM, et al. Microbial and metabolic profile of achlorhydric stomach: comparison of pernicious anaemia and hypogammaglobulinaemia. J Clin Pathol 1985;38:946-53.

REPRESENTATIVE PACKAGING

See How Supplied section for a complete list of available
packages of the IDkit:Hp™ for the Exalenz BreathID® System.

Case containing 25 kits of IDkit:Hp™ ONE

Kit label for IDkit:Hp™ ONE

Box containing 5 kits of IDkit:Hp™ TWO

Kit label for IDkit:Hp™ TWO

Citrica pouch

Urea blister pack

IDkit HP One  citric acid anhydrous and 13c urea kit

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50402-100

Packaging # Item Code Package Description 1 NDC:50402-100-11 25 BAG (BAG) in 1 CASE 1 NDC:50402-100-01 1 KIT (KIT) in 1 BAG 2 NDC:50402-100-22 5 BOX (BOX) in 1 CASE 2 NDC:50402-100-02 1 KIT (KIT) in 1 BOX

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKET 1  Part 2 1

Part 1 of 2 CITRICA  citric acid anhydrous powder, for solution

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength citric acid (citric acid) citric acid 4 g

Product Characteristics Color      Score      Shape Size Flavor TUTTI FRUTTI (Tutti Frutti Flavor) Imprint Code Contains

Packaging # Item Code Package Description 1 1 POWDER, FOR SOLUTION (PACKET) in 1 PACKET

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021314 12/28/2009

Part 2 of 2 UREA C-13  urea c-13 tablet, for solution

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength urea c-13 (urea c-13) urea c-13 75 mg

Product Characteristics Color white (White) Score no score Shape ROUND (bi-convex) Size 6mm Flavor Imprint Code U Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021314 12/28/2009

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021314 12/28/2009

Labeler - Exalenz Bioscience Ltd. (514832786)

Establishment
Name	Address	ID/FEI	Operations
Exalenz Bioscience Ltd.		514832786	manufacture

Revised: 09/2011   Exalenz Bioscience Ltd.