# K972352: The Meretek Ubt Breath Test for H.Pylori

- Pathway: 510(k) (Traditional)
- Applicant: Meretek Diagnostics, Inc.
- Decided: Oct 29, 1997 after 127 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 K952220 (1996). 1 ancestor in all.
9 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952220: Meretek Breath Test for H.Pylori Collection Kit, Meretek Diagnostics, Inc. (1996) Summary page 1.

## Most influential descendants
- K011668: Validation of the Breathid System, for the Detection of Helicbactor Pylori (2001), 8 descendants of its own
- K130524: Breathid HP System (2013), 7 descendants of its own
- K162150: BreathID Hp Lab System (2016), 4 descendants of its own
- K173777: BreathID Hp Lab System (2018), 3 descendants of its own
- K193610: BreathID Smart System (2020), 2 descendants of its own

## Indications for use
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. For this purpose, the system utilizes a Gas Isotope Ratio Mass Spectrometer ("GIRMS") for the measurement of the ratio of 13CO, to *CO, in breath samples. For administrationn by health care professionals. To be administered under a physician’s supervision.

Source page: https://510kreport.com/device/K972352
Methodology: https://510kreport.com/methodology