Cleared Special

BreathID Smart System (K193610) - FDA 510(k) Clearance

Class I Microbiology device.

K193610 · Exalenz Bioscience , Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
42d
Days
Class 1
Risk

K193610 is an FDA 510(k) clearance for the BreathID Smart 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 February 6, 2020 after a review of 42 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Exalenz Bioscience , Ltd. devices

Submission Details

510(k) Number K193610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2019
Decision Date February 06, 2020
Days to Decision 42 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 102d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

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 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 K193610.
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 Hp System
K173772 · Exalenz Bioscience , Ltd. · Mar 2018
BreathID Hp Lab System
K173777 · Exalenz Bioscience , Ltd. · Mar 2018