# K220494: BreathID Hp Lab System, BreathID Smart System

- Pathway: 510(k) (Special)
- Applicant: Meridian Bioscience Israel, Ltd.
- Decided: Jun 23, 2022 after 121 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: 7 generations back to K952220 (1996). 7 ancestors in all.
1 later device descends 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)
- K173777: BreathID Hp Lab System, Exalenz Bioscience, Ltd. (2018) Summary page 4.
- K193610: BreathID Smart System, Exalenz Bioscience, Ltd. (2020) Summary page 4.

## Most influential descendants
- K223185: BreathID®  Smart System (2022), 0 descendants of its own

## Indications for use
The BreathlD Hp Lab System or BreathlD Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathlD Hp Lab System or BreathlD Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathlD Hp Lab System consists of the appropriate IDkit Hp kit, and the BreathlD Hp device, Auto Sampler and Lab Application. The BreathlD Smart System consists of the appropriate IDkit Hp kit and the BreathlD Smart device. To be administered by trained personnel as ordered by a licensed healthcare practitioner.

Source page: https://510kreport.com/device/K220494
Methodology: https://510kreport.com/methodology