Cleared Traditional

K023779 - RSV OIA

K023779 is an FDA 510(k) clearance for RSV OIA, manufactured by Thermo Biostar, Inc.. The device is a Class 1 Microbiology device with product code GQG cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K023779 · Thermo Biostar, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
63d
Days
Class 1
Risk

K023779 is an FDA 510(k) clearance for the RSV OIA. Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Thermo Biostar, Inc. (Louisville, US). The FDA issued a Cleared decision on January 14, 2003 after a review of 63 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Thermo Biostar, Inc. devices

FDA 510(k) Submission Details - K023779

510(k) Number K023779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2002
Decision Date January 14, 2003
Days to Decision 63 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
39d faster than avg
Panel avg: 102d · This submission: 63d
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 28
Devices cleared under the same product code (GQG) and FDA review panel - the closest regulatory comparables to K023779.
IMMUNOCARD STAT! RSV MODEL #750630
K041445 · Meridian Bioscience, Inc. · Aug 2004
BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065
K032166 · Binax, Inc. · Oct 2003
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
RSV ANTIGEN CONTROL SLIDES
K964870 · Viral Antigens, Inc. · Mar 1997