Cleared Traditional

K032166 - BINAX NOW RSV TEST

K032166 is the FDA 510(k) clearance for BINAX NOW RSV TEST by Binax, Inc.. It is a Class 1 Microbiology device (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

Submission Details

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
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 102d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 18
Devices cleared under the same product code (GQG) and FDA review panel - the closest regulatory comparables to K032166.
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DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT
K882629 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988