Cleared Traditional

K112177 - SOFIA ANALYZER AND INFLUENZA A+B FIA

K112177 is the FDA 510(k) clearance for SOFIA ANALYZER AND INFLUENZA A+B FIA by Quidel Corp.. It is a Class 2 Microbiology device (product code PSZ) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K112177 · Quidel Corp. · Microbiology device
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Oct 2011
Decision
88d
Days
Class 2
Risk

K112177 is an FDA 510(k) clearance for the SOFIA ANALYZER AND INFLUENZA A+B FIA. Classified as Devices Detecting Influenza A, B, And C Virus Antigens (product code PSZ), Class II - Special Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on October 24, 2011 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3328 - 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 K112177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2011
Decision Date October 24, 2011
Days to Decision 88 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
14d faster than avg
Panel avg: 102d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3328
Definition An Influenza Virus Antigen Detection Test System Is A Device Intended For The Qualitative Detection Of Influenza Viral Antigens Directly From Clinical Specimens In Patients With Signs And Symptoms Of Respiratory Infection.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - PSZ Devices Detecting Influenza A, B, And C Virus Antigens

All 43
Devices cleared under the same product code (PSZ) and FDA review panel - the closest regulatory comparables to K112177.
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
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BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
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BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
K112277 · Becton, Dickinson and Company · Oct 2011
BIOSIGN FLU A+B
K083746 · Princeton BioMeditech Corp. · Nov 2010
BD DIRECTIGEN EX FLU A+B
K101461 · Becton, Dickinson and Company · Jun 2010
BD DIRECTIGEN EZ FLU A+B ASSAY
K101529 · Becton, Dickinson & CO · Jun 2010