Cleared Special

K123182 - OSOM INFLUENZA A&B TEST MODEL 190 (FDA 510(k) Clearance)

Class I Microbiology device.

K123182 · SEKISUI Diagnostics, LLC · Microbiology device
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Nov 2012
Decision
26d
Days
Class 1
Risk

K123182 is an FDA 510(k) clearance for the OSOM INFLUENZA A&B TEST MODEL 190. Classified as Antigens, Cf (including Cf Control), Influenza Virus A, B, C (product code GNX), Class I - General Controls.

Submitted by SEKISUI Diagnostics, LLC (San Diego, US). The FDA issued a Cleared decision on November 5, 2012 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3330 - 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 SEKISUI Diagnostics, LLC devices

Submission Details

510(k) Number K123182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2012
Decision Date November 05, 2012
Days to Decision 26 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 102d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GNX Antigens, Cf (including Cf Control), Influenza Virus A, B, C
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3330
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.