# K973000: Alimenterics Lara (TM) Breath Test System

- Pathway: 510(k) (Traditional)
- Applicant: Alimenterics, Inc.
- Decided: Feb 26, 1998 after 198 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CLOtest®: named in the summary without a submission number

## Indications for use
The Pylori-Chek Test System is intended for use with the LARA Laser Assisted Ratio Analyzer for the qualitative detection of urease associated with Helicobacter pylori infection in the human stomach and as an aid in the diagnosis of H. pylori infection in symptomatic adult patients. The Pylori-Chek Test system consists of a Pylori-Chek test kit for the collection of breath samples and a LARA Laser Assisted Ratio Analyzer for the measurement of the ratio of *CO, to ?CO, in the breath sample. For use by healthcare professionals. To be administered under a physician’s supervision.

Source page: https://510kreport.com/device/K973000
Methodology: https://510kreport.com/methodology