Cleared Traditional

K162911 - Sofia RSV FIA on Sofia 2 analyzer

K162911 is the FDA 510(k) clearance for Sofia RSV FIA on Sofia 2 analyzer by Quidel Corporation. It is a Class 1 Microbiology device (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

Submission Details

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.

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 20
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