# K990931: EZ-HBT Helicobacter Blood Test

- Pathway: 510(k) (Traditional)
- Applicant: Metabolic Solutions, Inc.
- Decided: Sep 24, 1999 after 189 days
- Product code: MSQ (Test, Urea (Breath Or Blood))
- Device class: 1
- Regulation: 21 CFR 866.3110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953632 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953632: Serim Pyloritek Test Kit, Serim Research Corp. (1995) Summary page 2.
- K952220: Meretek Breath Test for H.Pylori Collection Kit, Meretek Diagnostics, Inc. (1996) Summary page 2.

## Indications for use
The Ez-HBT™ Helicobacter Blood Test is intended for use in the qualitative detection of '>CO, in whole blood specimens, collected after the ingestion of *C-urea. Helicobacter pylori (H. pylori) organisms colonizing the lining of the human stomach, produce urease which converts BC-urea into *CO, and ammonia (NH,"). The device is indicated as an aid in the diagnosis of H. pylori infection in symptomatic adult subjects, 18 years or older. For use by health care professionals. Administer test under a physician’s supervision. Metabolic Solutions, Inc. or a qualified laboratory using Gas Isotope Ratio Mass Spectrometry or equivalent instrumentation must analyze the test samples.

Source page: https://510kreport.com/device/K990931
Methodology: https://510kreport.com/methodology