Cleared Special

K131606 - SOFIA INFLUENZA A+B FIA

K131606 is an FDA 510(k) clearance for SOFIA INFLUENZA A+B FIA, manufactured by Quidel Corp.. The device is a Class 1 Microbiology device with product code GNX cleared through the Special 510(k) pathway after a 32-day FDA review.

K131606 · Quidel Corp. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
32d
Days
Class 1
Risk

K131606 is an FDA 510(k) clearance for the SOFIA INFLUENZA A+B FIA. Classified as Antigens, Cf (including Cf Control), Influenza Virus A, B, C (product code GNX), Class I - General Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on July 5, 2013 after a review of 32 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.

FDA 510(k) Submission Details - K131606

510(k) Number K131606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2013
Decision Date July 05, 2013
Days to Decision 32 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
70d faster than avg
Panel avg: 102d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

GNX Device Classification - Class 1, General Controls

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.

Regulatory Peers - GNX Antigens, Cf (including Cf Control), Influenza Virus A, B, C

All 13
Devices cleared under the same product code (GNX) and FDA review panel - the closest regulatory comparables to K131606.
SAS FLUALERT A & B, SAS INFLUENZA A TEST
K132352 · Sa Scientific , Ltd. · Aug 2013
REMEL XPECT FLU A&B
K131804 · Remel, Inc. · Jul 2013
QUICK VUE INFLUENZA
K131599 · Quidel Corporation · Jul 2013
QUICKVUE INFLUENZA A+B
K131619 · Quidel Corp. · Jun 2013
OSOM INFLUENZA A&B TEST MODEL 190
K123182 · SEKISUI Diagnostics, LLC · Nov 2012
VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES
K971494 · Zymetx, Inc. · Sep 1997
K131606 · SOFIA INFLUENZA A+B FIA
Download PDF FDA Summary Quidel Corp.