Cleared Traditional

K162150 - BreathID Hp Lab System

K162150 is an FDA 510(k) clearance for BreathID Hp Lab 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 90-day FDA review.

K162150 · Exalenz Bioscience , Ltd. · Microbiology device
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Oct 2016
Decision
90d
Days
Class 1
Risk

K162150 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 October 31, 2016 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Exalenz Bioscience , Ltd. devices

FDA 510(k) Submission Details - K162150

510(k) Number K162150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2016
Decision Date October 31, 2016
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
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.

Regulatory Consultant

Biomedical Strategy , Ltd.
Orna Oz

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.

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 K162150.
BreathID Smart System
K193610 · Exalenz Bioscience , Ltd. · Feb 2020
BreathID Hp System
K173772 · Exalenz Bioscience , Ltd. · Mar 2018
BreathID Hp Lab System
K173777 · Exalenz Bioscience , Ltd. · Mar 2018
BREATHID HP SYSTEM
K130524 · Exalenz Bioscience , Ltd. · May 2013
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