Cleared Traditional

K032166 - BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065

K032166 is an FDA 510(k) clearance for BINAX NOW RSV TEST, manufactured by Binax, Inc.. The device is a Class 1 Microbiology device with product code GQG cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K032166 · Binax, Inc. · Microbiology device
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Oct 2003
Decision
97d
Days
Class 1
Risk

K032166 is an FDA 510(k) clearance for the BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY.... Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Binax, Inc. (Portland, US). The FDA issued a Cleared decision on October 21, 2003 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3480 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Binax, Inc. devices

FDA 510(k) Submission Details - K032166

510(k) Number K032166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2003
Decision Date October 21, 2003
Days to Decision 97 days
Submission Type Traditional
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
5d faster than avg
Panel avg: 102d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

GQG Device Classification - Class 1, General Controls

Product Code GQG Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3480
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 - GQG Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus

All 27
Devices cleared under the same product code (GQG) and FDA review panel - the closest regulatory comparables to K032166.
BD DIRECTIGEN EZ RSV
K101514 · Becton, Dickinson & CO · Jul 2010
QUICK VUE RSV TEST, MODELS 20193, 20199
K070747 · Quidel Corp. · Apr 2007
IMMUNOCARD STAT! RSV MODEL #750630
K041445 · Meridian Bioscience, Inc. · Aug 2004
SAS RSV TEST
K022845 · Sa Scientific, Inc. · Jan 2003
BD DIRECTIGEN EZ RSV KIT
K022133 · Becton, Dickinson & CO · Dec 2002
BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK
K021687 · Binax, Inc. · Sep 2002