Cleared Special

K133411 - ALERE BINAXNOW INFLUENZA A & B CARD

K133411 is an FDA 510(k) clearance for ALERE BINAXNOW INFLUENZA A & B CARD, manufactured by Alere Scarborough, Inc D/B/A Binax, Inc.. The device is a Class 1 Microbiology device with product code GNX cleared through the Special 510(k) pathway after a 28-day FDA review.

K133411 · Alere Scarborough, Inc D/B/A Binax, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
28d
Days
Class 1
Risk

K133411 is an FDA 510(k) clearance for the ALERE BINAXNOW INFLUENZA A & B CARD. Classified as Antigens, Cf (including Cf Control), Influenza Virus A, B, C (product code GNX), Class I - General Controls.

Submitted by Alere Scarborough, Inc D/B/A Binax, Inc. (Scarborough, US). The FDA issued a Cleared decision on December 5, 2013 after a review of 28 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 - K133411

510(k) Number K133411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2013
Decision Date December 05, 2013
Days to Decision 28 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
74d faster than avg
Panel avg: 102d · This submission: 28d
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 17
Devices cleared under the same product code (GNX) and FDA review panel - the closest regulatory comparables to K133411.
SAS FLUALERT A & B, SAS INFLUENZA A TEST
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K131599 · Quidel Corporation · Jul 2013
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K131606 · Quidel Corp. · Jul 2013
QUICKVUE INFLUENZA A+B
K131619 · Quidel Corp. · Jun 2013
OSOM INFLUENZA A&B TEST MODEL 190
K123182 · SEKISUI Diagnostics, LLC · Nov 2012
K133411 · ALERE BINAXNOW INFLUENZA A & B CARD
Download PDF FDA Summary Alere Scarborough, In…