Cleared Special

K220494 - BreathID Hp Lab System, BreathID Smart System (FDA 510(k) Clearance)

Class I Microbiology device.

K220494 · Meridian Bioscience Israel , Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
121d
Days
Class 1
Risk

K220494 is an FDA 510(k) clearance for the BreathID Hp Lab System, BreathID Smart System. Classified as Test, Urea (breath Or Blood) (product code MSQ), Class I - General Controls.

Submitted by Meridian Bioscience Israel , Ltd. (Modiin, IL). The FDA issued a Cleared decision on June 23, 2022 after a review of 121 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Meridian Bioscience Israel , Ltd. devices

Submission Details

510(k) Number K220494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2022
Decision Date June 23, 2022
Days to Decision 121 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
19d slower than avg
Panel avg: 102d · This submission: 121d
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.