Cleared Traditional

K121633 - BD VERITOR(TM) SYSTEM FOR THE RAPID DET...

K121633 is an FDA 510(k) clearance for BD VERITOR(TM) SYSTEM FOR THE RAPID DET..., manufactured by Becton, Dickinson and Company. The device is a Class 1 Microbiology device with product code GQG cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K121633 · Becton, Dickinson and Company · Microbiology device
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Sep 2012
Decision
106d
Days
Class 1
Risk

K121633 is an FDA 510(k) clearance for the BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV. Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Becton, Dickinson and Company (San Diego, US). The FDA issued a Cleared decision on September 18, 2012 after a review of 106 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 Becton, Dickinson and Company devices

FDA 510(k) Submission Details - K121633

510(k) Number K121633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2012
Decision Date September 18, 2012
Days to Decision 106 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
4d slower than avg
Panel avg: 102d · This submission: 106d
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 25
Devices cleared under the same product code (GQG) and FDA review panel - the closest regulatory comparables to K121633.
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
K133140 · Becton, Dickinson & CO · Nov 2013
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
QUICKVUE RSV 10
K101918 · Quidel Corp. · Sep 2010
BD DIRECTIGEN EZ RSV
K101514 · Becton, Dickinson & CO · Jul 2010
QUICK VUE RSV TEST, MODELS 20193, 20199
K070747 · Quidel Corp. · Apr 2007