DESCRIPTION SECTION.

Introduction and Test Instructions. Note: This Introduction and Test Instructions contains information for:Test Collection KitBreath Test InstrumentBreathTek(TM)UBT for H. pylori 1. UBiT(R)-IR 300 Infrared Spectrophotometer2. POCone(TM) Infrared Spectrophotometer.

CONTROLLED SUBSTANCE SECTION.

X. Limitations of the Test. The BreathTek(TM) UBT should not be used until four (4) weeks or more after the end of treatment for the eradication of H. pylori as earlier post-treatment assessment may give false negative results.The performance characteristics for persons under the age of eighteen (18) have not been established for this test.The specimen integrity of breath samples and reference gases stored in breath bags under ambient conditions has not been determined beyond seven (7) days.A correlation between the number of H. pylori organisms in the stomach and the BreathTek(TM) UBT result has not been established.The predicate device (Meretek UBT(R)) was standardized in asymptomatic healthy volunteers and subsequently validated in clinical trials limited to patients with documented duodenal ulcer disease.. The BreathTek(TM) UBT should not be used until four (4) weeks or more after the end of treatment for the eradication of H. pylori as earlier post-treatment assessment may give false negative results.. The performance characteristics for persons under the age of eighteen (18) have not been established for this test.. The specimen integrity of breath samples and reference gases stored in breath bags under ambient conditions has not been determined beyond seven (7) days.. correlation between the number of H. pylori organisms in the stomach and the BreathTek(TM) UBT result has not been established.. The predicate device (Meretek UBT(R)) was standardized in asymptomatic healthy volunteers and subsequently validated in clinical trials limited to patients with documented duodenal ulcer disease.

OVERDOSAGE SECTION.

XI. Expected Values. Delta Over Baseline values for the BreathTek(TM) UBT were determinedin controlled clinical study of twenty-six (26) infected and twenty-three(23) uninfected adult volunteers. The Meretek UBT(R) BreathTest was used as the reference method in the diagnosis of infection. The rangeof BreathTek(TM) UBT Delta Over Baseline values for the uninfected group wasdetermined to be 0.0 to 1.0. histogram for the distribution of Delta OverBaseline values from the uninfected subjects is shown in Figure 2a.Values for the Meretek UBT(R) Breath Test weredetermined in controlled clinical study of sixty-six (66) infected and fifty-three(53) uninfected asymptomatic, apparently healthy volunteers. Histologicalexamination of biopsy tissue was used as the reference method in the determinationof infection in this study. The range of Meretek UBT(R) DeltaOver Baseline values for the uninfected group was determined to be 0.0 to2.2. histogram for the distribution of Delta Over Baseline values from theuninfected subjects is shown in Figure 2b.. Expected Values: Figure 2a. BreathTek(TM) UBT -- Figure 2b. Meretek UBT(R).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Directions For Use:The PranactinR-Citric in this containeris intended for use only as componet of BreathTekTM UBT for H. pylori. See package insert for instructions on how to prepare the solution and directions for use. Phenylketonurics: ContainsPhenylalanine, 84 mg Per Pouch Part No. 002201AAPrint Code: 0508L-0155US PATENT 4,830,010 NDC 59148-023-33 PranactinR-Citric Contains: 13C-Urea, 75mg For in vitro diagnostic use only.The PranactinR-Citric drug is taken orally as part of the BreathTekTM UBT for H. pylori. Store at 15o-30oC (59o-86oF) Manufactured for Otsuka America Pharmaceutical, Inc. Rockville, MD 20850 002204AA Pranactin Poach.

SPL PATIENT PACKAGE INSERT SECTION.

XIV. Name and Place of Business. The BreathTek(TM) UBT for H. pylori Collection Kitis manufactured for Meretek Diagnostics Group of Otsuka America Pharmaceutical,Inc., 2440 Research Boulevard, Rockville, MD 20850.

SPL UNCLASSIFIED SECTION.

I. Intended Use. The BreathTek(TM) UBT Collection Kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomachand as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. The test may be used for monitoring treatment if used at least four (4) weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples.For administration by health care professionals. To be administered under physicians supervision.

STORAGE AND HANDLING SECTION.

V. Shelf Life and Storage. The BreathTek(TM) UBTCollection Kit should be stored at 15-30C (59-86F). Pranactin(R)-Citrichas an expiration date. Do not use beyond the expiration date stated on thelabel.

WARNINGS AND PRECAUTIONS SECTION.

IV. Warnings and Precautions. For in vitro diagnostic use only. The Pranactin(R)-Citricdrug solution is taken orally as part of the diagnostic procedure.Phenylketonurics: Contains Phenylalanine (one of the protein componentsof Aspartame), 84 mg per dosage unit. (For reference, 12 ounces of typicaldiet cola soft drinks contain approximately 80 mg of Phenylalanine.)A negative result does not rule out the possibility of Helicobacterpylori infection. False negative results do occur with this procedure.If clinical signs are suggestive of H. pylori infection,retest with new sample or an alternate method.Antimicrobials, proton pump inhibitors, and bismuth preparationsare known to suppress H. pylori. Ingestion of these withintwo (2) weeks prior to performing the BreathTek(TM) UBT may give false negativeresults.A false positive test may occur due to urease associated with othergastric spiral organisms observed in humans such as Helicobacter heilmannii.Premature POST-DOSE breath collection time can lead to false negativediagnosis for patient with marginally positive BreathTek(TM) UBT result.A false positive test could occur in patients who have achlorhydria.8 If particulate matter is visible in the reconstituted Pranactin(R)-Citricsolution after thorough mixing, the solution should not be used.. For in vitro diagnostic use only. The Pranactin(R)-Citricdrug solution is taken orally as part of the diagnostic procedure.. Phenylketonurics: Contains Phenylalanine (one of the protein componentsof Aspartame), 84 mg per dosage unit. (For reference, 12 ounces of typicaldiet cola soft drinks contain approximately 80 mg of Phenylalanine.). negative result does not rule out the possibility of Helicobacterpylori infection. False negative results do occur with this procedure.If clinical signs are suggestive of H. pylori infection,retest with new sample or an alternate method.. Antimicrobials, proton pump inhibitors, and bismuth preparationsare known to suppress H. pylori. Ingestion of these withintwo (2) weeks prior to performing the BreathTek(TM) UBT may give false negativeresults.. false positive test may occur due to urease associated with othergastric spiral organisms observed in humans such as Helicobacter heilmannii.. Premature POST-DOSE breath collection time can lead to false negativediagnosis for patient with marginally positive BreathTek(TM) UBT result.. false positive test could occur in patients who have achlorhydria.8 If particulate matter is visible in the reconstituted Pranactin(R)-Citricsolution after thorough mixing, the solution should not be used.