Cleared Traditional

K162911 - Sofia RSV FIA on Sofia 2 analyzer

K162911 is an FDA 510(k) clearance for Sofia RSV FIA on Sofia 2 analyzer, manufactured by Quidel Corporation. The device is a Class 1 Microbiology device with product code GQG cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K162911 · Quidel Corporation · Microbiology device
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Feb 2017
Decision
128d
Days
Class 1
Risk

K162911 is an FDA 510(k) clearance for the Sofia RSV FIA on Sofia 2 analyzer. Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Quidel Corporation (San Diego,, US). The FDA issued a Cleared decision on February 22, 2017 after a review of 128 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 Quidel Corporation devices

FDA 510(k) Submission Details - K162911

510(k) Number K162911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2016
Decision Date February 22, 2017
Days to Decision 128 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
26d slower than avg
Panel avg: 102d · This submission: 128d
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 27
Devices cleared under the same product code (GQG) and FDA review panel - the closest regulatory comparables to K162911.
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SOFIA(R) RSV FIA
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BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV
K121633 · Becton, Dickinson and Company · Sep 2012