Cleared Traditional

K130524 - BREATHID HP SYSTEM

K130524 is an FDA 510(k) clearance for BREATHID HP SYSTEM, manufactured by Exalenz Bioscience , Ltd.. The device is a Class 1 Microbiology device with product code MSQ cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K130524 · Exalenz Bioscience , Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
83d
Days
Class 1
Risk

K130524 is an FDA 510(k) clearance for the BREATHID HP SYSTEM. Classified as Test, Urea (breath Or Blood) (product code MSQ), Class I - General Controls.

Submitted by Exalenz Bioscience , Ltd. (Wheat Ridge, US). The FDA issued a Cleared decision on May 22, 2013 after a review of 83 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

FDA 510(k) Submission Details - K130524

510(k) Number K130524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2013
Decision Date May 22, 2013
Days to Decision 83 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
19d faster than avg
Panel avg: 102d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

MSQ Device Classification - Class 1, General Controls

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.

Clinical Evidence

ClinicalTrials.gov
NCT01650831 Completed Interventional Industry-sponsored

Show Equivalence of the Modified BreathID Compared to Currently Approved BreathID in H.Pylori Detection

Clinical Study to Evaluate the Equivalence of the Modified BreathID Compared to Currently Approved BreathID System in Detection of H.Pylori Infection

113
Patients (actual)
1
Site
Diagnostic
Purpose
Single blind
Masking
Condition studied Suspicion of Being Infected With H.Pylori
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Jenny Liu, MD
Sponsor Meridian Bioscience, Inc. (industry)
Started 2012-10-01 → Primary completion 2012-11-01 → Completed 2013-01-01
Primary outcome
Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori
View full study on ClinicalTrials.gov

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

All 12
Devices cleared under the same product code (MSQ) and FDA review panel - the closest regulatory comparables to K130524.
BreathID Hp System
K173772 · Exalenz Bioscience , Ltd. · Mar 2018
BreathID Hp Lab System
K173777 · Exalenz Bioscience , Ltd. · Mar 2018
BreathID Hp Lab System
K162150 · Exalenz Bioscience , Ltd. · Oct 2016
POCONE INFRARED SPECTROPHOTOMETER
K041148 · Otsuka Pharmaceutical Co., Ltd. · Jul 2004
VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI
K011668 · Oridion Medical 1987 , Ltd. · Jul 2001
EZ-HBT HELICOBACTER BLOOD TEST
K990931 · Metabolic Solutions, Inc. · Sep 1999