Cleared Traditional

K021789 - QUICKLAB RSV

K021789 is an FDA 510(k) clearance for QUICKLAB RSV, manufactured by Integrated Biotechnology Corp.. The device is a Class 1 Microbiology device with product code GQG cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K021789 · Integrated Biotechnology Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
173d
Days
Class 1
Risk

K021789 is an FDA 510(k) clearance for the QUICKLAB RSV. Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Integrated Biotechnology Corp. (Carmel, US). The FDA issued a Cleared decision on November 20, 2002 after a review of 173 days - an extended review 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: 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 Integrated Biotechnology Corp. devices

FDA 510(k) Submission Details - K021789

510(k) Number K021789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2002
Decision Date November 20, 2002
Days to Decision 173 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
71d slower than avg
Panel avg: 102d · This submission: 173d
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 K021789.
BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065
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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
VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY
K896097 · Vitek Systems, Inc. · Feb 1990