← Product Code [MSQ](/submissions/MI/subpart-d%E2%80%94serological-reagents/MSQ) · K221896

# BreathID Hp System (K221896)

_Meridian Bioscience Israel , Ltd. · MSQ · Dec 19, 2022 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MSQ/K221896

## Device Facts

- **Applicant:** Meridian Bioscience Israel , Ltd.
- **Product Code:** [MSQ](/submissions/MI/subpart-d%E2%80%94serological-reagents/MSQ.md)
- **Decision Date:** Dec 19, 2022
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.3110
- **Device Class:** Class 1
- **Review Panel:** Microbiology
- **Attributes:** Pediatric

## Indications for Use

The BreathID® Hp System is intended for use to continually and 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 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 System consists of the appropriate IDkit Hp® kit and the BreathID® Hp test device. The device is for use by trained health care professionals. To be administered under a physician's supervision.

## Device Story

BreathID Hp System is a non-invasive point-of-care diagnostic device for H. pylori detection. System components include an electro-optical device, software, and IDkit Hp One (containing 13C-enriched urea tablet, citric acid powder, nasal cannula, and straw). Operation: patient ingests 13C-urea; device uses nasal cannula to collect exhaled breath; Molecular Correlation Spectroscopy (MCS) measures 13CO2/12CO2 ratio changes before and after ingestion. Software computes Delta over Baseline (DOB) to identify urease activity. Used by trained healthcare professionals under physician supervision. Output informs clinicians of active H. pylori infection status, aiding diagnosis and monitoring. Labeling update clarifies that while PPI use may cause false negatives, positive results in patients on PPIs remain indicative of H. pylori-associated urease.

## Clinical Evidence

No clinical data provided; substantial equivalence based on design control activities and labeling modifications regarding PPI usage limitations.

## Technological Characteristics

Electro-optical device using Molecular Correlation Spectroscopy (MCS) based on optical absorption of CO2 discharge lamp radiation. Measures 13CO2/12CO2 ratio. Includes nasal cannula for breath collection. Software-based computation of Delta over Baseline (DOB).

## Regulatory 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.

## Predicate Devices

- BreathID® Hp System ([K173772](/device/K173772.md))

## 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

K221896

B Applicant

Meridian Bioscience Israel Ltd.

C Proprietary and Established Names

BreathID Hp System

D Regulatory Information

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

## II Review Summary:

This 510(k) submission contains information/data modifications made to the Meridian's own Class I 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 are provided.
2. Meridian'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.
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 device has not changed. This change was for the removal of a limitation. The sponsor wanted to remove a limitation stating, all test subjects need to refrain PPI drugs for two

Food and Drug Administration

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Silver Spring, MD 20993-0002

www.fda.gov

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weeks prior to testing. The new limitation will state, subjects who get a positive result while on PPIs should be considered positive and a positive result is an actionable result, while a negative result is not actionable and subjects suspected of $H.$ pylori infection should be retested after PPI have been ceased for at least two weeks, prior to re-testing.

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

5. A Design Control Activities Summary includes:

a) The risk associated with the removal of a limitation form the package insert was mitigated by the addition of another limitation stating, "If a negative result is obtained from a patient ingesting a PPI within two weeks prior to the breath test, the results cannot be considered indicative of the absence of urease associated with $H.$ pylori and the test should be repeated two weeks after discontinuing the PPI treatment."

b) Following modifications were included in sections of the package insert as follows:

Section 5.2 Warnings and Precautions, item 7 is revised to remove the following statement:

"Antimicrobials, proton pump inhibitors, and bismuth preparations are known to suppress $H.$ pylori. Ingesting these medications within two weeks prior to performing the breath test may produce false negative test results"

The following statements replaced the removed warning:

7. False negative test results may be caused by:

- Ingestion of antimicrobials or bismuth preparations within two weeks prior to performing the breath test.
- Ingestion of proton pump inhibitors (PPIs) within two weeks prior to performing the breath test.

Note: If a negative result is obtained from a patient ingesting a PPI within two weeks prior to the breath test, the results cannot be considered indicative of the absence of urease associated with $H.$ pylori and the test should be repeated two weeks after discontinuing the PPI treatment. A positive result for a patient on a PPI could be considered as indicative of the presence of urease associated with $H.$ pylori.

Section 7.7 Operational Precautions and Limitations, item 4-6 is revised to accept positive breath test results in patients using PPIs as noted in the following statements:

4. The patient should not have taken antimicrobials, proton pump inhibitors (PPI), or bismuth preparations within two weeks prior to administering the breath test.

K221896 - Page 2 of 3

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5. If the test is negative and it is determined that the subject has used PPIs within two weeks prior to taking the breath test, the test may provide a false negative result. The test needs to be repeated two weeks post discontinuation of PPI treatment.

6. A positive result for a patient on PPI could be considered as indicative of the presence of urease enzyme associated with *H. pylori*.

Section 8.1 Patient Preparation is revised to accept positive breath test results in patients using PPIs as in the following statement:

The patient should have fasted at least one hour before administering the solution. The patient should not have taken antimicrobials, proton pump inhibitors (PPI) or bismuth preparations within two weeks prior to administering the test. If PPIs are used within two weeks of breath testing, false negative test results may occur, and the test should be repeated two weeks after discontinuation of PPI treatment. A positive result for a patient on PPI could be considered as indicative of the presence of urease enzyme associated with *H. pylori*.

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 special 510(k) submission and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MSQ/K221896](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MSQ/K221896)

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