# K162150: BreathID Hp Lab System

- Pathway: 510(k) (Traditional)
- Applicant: Exalenz Bioscience, Ltd.
- Decided: Oct 31, 2016 after 90 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: 4 generations back to K952220 (1996). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130524: Breathid HP System, Exalenz Bioscience, Ltd. (2013) Summary page 5.

## Most influential descendants
- K173777: BreathID Hp Lab System (2018), 3 descendants of its own
- K193610: BreathID Smart System (2020), 2 descendants of its own
- K220494: BreathID Hp Lab System, BreathID Smart System (2022), 1 descendant of its own
- K223185: BreathID®  Smart System (2022), 0 descendants of its own

## Indications for use
The Exalenz BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13C02/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The Exalenz BreathID® Hp Lab System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. The Exalenz BreathID® Hp Lab System consists of the IDkit: Hp™ kits, and the BreathID® Hp device, Auto Sampler and Lab Application. To be administered by trained personnel as ordered by a licensed healthcare practitioner.

Source page: https://510kreport.com/device/K162150
Methodology: https://510kreport.com/methodology