# K223185: BreathID®  Smart System

- Pathway: 510(k) (Special)
- Applicant: Meridian Bioscience Israel, Ltd.
- Decided: Nov 10, 2022 after 29 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: 8 generations back to K952220 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220494: BreathID Hp Lab System, BreathID Smart System, Meridian Bioscience Israel, Ltd. (2022) Summary page 4.

## Indications for use
The BreathID Hp Lab System or BreathID 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 BreathID Hp Lab System or BreathID 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 BreathID Hp Lab System consists of the appropriate IDkit Hp kit, and the BreathID Hp device, Auto Sampler and Lab Application. The BreathID Smart System consists of the appropriate IDkit Hp kit and the BreathID Smart device. To be administered by trained personnel as ordered by a licensed healthcare practitioner.

Source page: https://510kreport.com/device/K223185
Methodology: https://510kreport.com/methodology