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The BreathTek™ - UBT for H. pylori collection kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and 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 weeks following completion of therapy. For these purposes, the test utilizes the UBiT IR spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2content in breath gas. For administration by health care professionals. To be administered under a physician's supervision.

The scientific basis underlying the BreathTek™ UBT and the BreathTek™ -UBiT® UBT kit is identical. Both kits contain a pouch of Pranactin-Citric drug product, a reconstitution cup, sample collection containers, sample identification labels and a package insert. The parts lists of the two kits differ for types of sample collection containers, the configuration of the barcode labels and the quantity of straws provided. The UBiT version of the kit directly collects breath samples into two 300cc breath bags each fitted with a mouthpiece containing a check valve and the original kit collects breath samples via a straw into glass test tubes. The glass test tubes must be quickly sealed with screw-on caps to contain the breath; the check valve incorporated in the breath bags eliminates this concern. The original kit contains a back-up set of sample collection tubes to compensate for the fragility of the tubes' glass structure. Use of barcode labels will be mandatory for the original kit and optional for the UBiT version. The two kits will coexist on the market and share the same package insert. The package insert will be modified to include the UBiT version's component list and step-by-step procedure for collecting samples. The package insert will instruct the health care provider to analyze the tube samples using a GIRMS spectrometer and the bag samples using an UBiT IR spectrophotometer.

The MERETEK UBT® Breath Test Collection Kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and 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 weeks following completion of therapy. For these purposes, the system utilizes a Gas Isotope Ratio Mass Spectrometer ("GIRMS") for the measurement of the ratio of 13CO2 to 12CO2 in breath samples. For administration by health care professionals. To be administered under a physician's supervision.

The device is a combination kit diagnostic drug/device composed of the following principle components: Test Meal (of approximately 220 calories), Pranactin Diagnostic Drug Dosage, Sterile Water, Breath Bag, Evacuated Breath Specimen Collection Tubes. In the MERETEK UBT® Breath Test for H. pylori, 125 mg of reconstituted 13C-urea is ingested by the patient. In the presence of urease associated with gastric H. pylori, 13Curea is decomposed to 13CO2 and NH4+. The 13CO2 is absorbed in the blood, then exhaled in the breath. This results in an increase in the ratio of 13CO2 to 12CO2 in a TEST breath sample compared to a BASELINE sample taken before the Pranactin® solution was consumed. Analysis of the breath samples is performed by Gas Isotope Ratio Mass Spectrometry ("GIRMS").

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