BreathID Hp Lab System, BreathID Smart System

K220494 · Meridian Bioscience Israel , Ltd. · MSQ · Jun 23, 2022 · Microbiology

Device Facts

• Record ID: K220494
• Device Name: BreathID Hp Lab System, BreathID Smart System
• Applicant: Meridian Bioscience Israel , Ltd.
• Product Code: MSQ · Microbiology
• Decision Date: Jun 23, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3110
• Device Class: Class 1
• Attributes: Pediatric

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.

Device Story

Non-invasive breath test system for H. pylori detection; utilizes Molecular Correlation Spectroscopy (MCS) to measure 13CO2/12CO2 ratio in exhaled breath. Patient ingests 13C-urea tablet and citric acid; breath samples collected in bags before and after ingestion. Device measures optical absorption of radiation from CO2 discharge lamps to compute Delta over Baseline (DOB). Used in clinical settings by trained personnel; results aid clinicians in diagnosing active infection or monitoring treatment efficacy. Labeling update clarifies that positive results in patients taking proton pump inhibitors (PPIs) are considered indicative of H. pylori, while negative results in PPI users may be false negatives requiring re-testing after two-week washout.

Clinical Evidence

No clinical data provided; this is a labeling modification submission. Performance characteristics remain unchanged from previously cleared predicate devices.

Technological Characteristics

Electro-optical medical device; utilizes Molecular Correlation Spectroscopy (MCS) based on optical absorption of specific radiation from CO2 discharge lamps. Includes Auto Sampler, software, and IDkit Hp Two (13C-urea tablet, citric acid, breath collection bags). Connectivity/platform details not specified. No changes to materials or hardware.

Indications for Use

Indicated for initial diagnosis and post-treatment monitoring of H. pylori infection in adults and pediatric patients ages 3-17 years.

Regulatory Classification

Identification

Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases. Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K220494

B Applicant

Meridian Bioscience Israel Ltd.

C Proprietary and Established Names

BreathID Hp Lab System, BreathID Smart System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| MSQ | Class I, Reserved | 21 CFR 866.3110 - Campylobacter Fetus Serological Reagents | MI - Microbiology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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device has not changed. The modifications include changes to cartridge reagents to increase shelf life and changes to Assay Definition File commands to accommodate reagent changes.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

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