Cleared Traditional

BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 (K032166) - FDA 510(k) Clearance

Class I Microbiology device.

K032166 · Binax, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 31
Devices cleared under the same product code (GQG) and FDA review panel - the closest regulatory comparables to K032166.
Clungene RSV Antigen Rapid Test
K253318 · Hangzhou Clongene Biotech Co., Ltd. · Jan 2026
Nano-Check™ RSV Test
K240280 · Nano-Ditech Corporation · Jul 2024
DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT
K882629 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988
ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL
K882277 · Abbott Laboratories · Jun 1988
ABBOTT TESTPACK RSV
K874127 · Abbott Laboratories · May 1988
ABBOTT RSV EIA
K862429 · Abbott Laboratories · Sep 1986