Cleared Traditional

BreathID Hp Lab System (K173777) - FDA 510(k) Clearance

Class I Microbiology device.

K173777 · Exalenz Bioscience , Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
86d
Days
Class 1
Risk

K173777 is an FDA 510(k) clearance for the BreathID Hp Lab System. Classified as Test, Urea (breath Or Blood) (product code MSQ), Class I - General Controls.

Submitted by Exalenz Bioscience , Ltd. (Modiin, IL). The FDA issued a Cleared decision on March 8, 2018 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Exalenz Bioscience , Ltd. devices

Submission Details

510(k) Number K173777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2017
Decision Date March 08, 2018
Days to Decision 86 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 102d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MSQ Test, Urea (breath Or Blood)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3110
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Medicsense USA
George Hattub

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02905825 Completed Interventional Industry-sponsored

Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics

Clinical Confirmation Study to Confirm Safety and Presence of H. Pylori With 13C-Urea Breath Test Using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population

54
Patients (actual)
6
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Helicobacter Pylori Infection
Study design Single group
Eligibility All sexes · 3 Years+
Sponsor Meridian Bioscience, Inc. (industry)
Started 2017-05-18 → Primary completion 2017-10-30 → Completed 2017-11-05
Primary outcome
Number of Participants With Reported Adverse Events
Secondary outcome
Percentage of Agreement
View full study on ClinicalTrials.gov

Regulatory Peers - MSQ Test, Urea (breath Or Blood)

All 16
Devices cleared under the same product code (MSQ) and FDA review panel - the closest regulatory comparables to K173777.
BreathID Hp System
K221896 · Meridian Bioscience Israel , Ltd. · Dec 2022
BreathID® Smart System
K223185 · Meridian Bioscience Israel , Ltd. · Nov 2022
BreathID Hp Lab System, BreathID Smart System
K220494 · Meridian Bioscience Israel , Ltd. · Jun 2022
BreathID Smart System
K193610 · Exalenz Bioscience , Ltd. · Feb 2020
BreathID Hp System
K173772 · Exalenz Bioscience , Ltd. · Mar 2018