Cleared Traditional

K162150 - BreathID Hp Lab System

K162150 is the FDA 510(k) clearance for BreathID Hp Lab System by Exalenz Bioscience , Ltd.. It is a Class 1 Microbiology device (product code MSQ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K162150 · Exalenz Bioscience , Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
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.