Cleared Traditional

K101918 - QUICKVUE RSV 10

K101918 is the FDA 510(k) clearance for QUICKVUE RSV 10 by Quidel Corp.. It is a Class 1 Microbiology device (product code GQG) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K101918 · Quidel Corp. · Microbiology device
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Sep 2010
Decision
77d
Days
Class 1
Risk

K101918 is an FDA 510(k) clearance for the QUICKVUE RSV 10. Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on September 24, 2010 after a review of 77 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 Quidel Corp. devices

Submission Details

510(k) Number K101918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2010
Decision Date September 24, 2010
Days to Decision 77 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 102d · This submission: 77d
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 15
Devices cleared under the same product code (GQG) and FDA review panel - the closest regulatory comparables to K101918.
BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV
K132456 · Becton, Dickinson and Company · Nov 2013
SOFIA(R) RSV FIA
K130398 · Quidel Corp. · Aug 2013
BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV
K121633 · Becton, Dickinson and Company · Sep 2012
BD DIRECTIGEN EZ RSV
K101514 · Becton, Dickinson & CO · Jul 2010
QUICK VUE RSV TEST, MODELS 20193, 20199
K070747 · Quidel Corp. · Apr 2007
SAS RSV TEST
K022845 · Sa Scientific, Inc. · Jan 2003