Cleared Traditional

RSV OIA (K023779) - FDA 510(k) Clearance

Class I Microbiology device.

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

Submission Details

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.

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 K023779.
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