Cleared Traditional

K153012 - Sofia Influenza A+B FIA

K153012 is the FDA 510(k) clearance for Sofia Influenza A+B FIA by Quidel Corporation. It is a Class 2 Microbiology device (product code PSZ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K153012 · Quidel Corporation · Microbiology device
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Jan 2016
Decision
90d
Days
Class 2
Risk

K153012 is an FDA 510(k) clearance for the Sofia 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 Corporation (San Diego,, US). The FDA issued a Cleared decision on January 12, 2016 after a review of 90 days - within the typical 510(k) review window.

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: 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 K153012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2015
Decision Date January 12, 2016
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01309568 Completed Observational Industry-sponsored

"Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"

2500
Patients (actual)
16
Sites
Condition studied Influenza
Eligibility All sexes
Principal investigator John D Tamerius, PhD
Sponsor Quidel Corporation (industry)
Started 2011-02-01 → Primary completion 2011-04-01
Primary outcome
Diagnosis of infection with influenza
Study completed - no results published. This trial concluded in 2011 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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

All 49
Devices cleared under the same product code (PSZ) and FDA review panel - the closest regulatory comparables to K153012.
Sofia Influenza A+B FIA on Sofia 2
K162438 · Quidel Corporation · Apr 2017
BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
K160164 · Becton, Dickinson & CO · Feb 2016
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
K160161 · Becton, Dickinson & CO · Feb 2016
BD Veritor (TM) System for the Rapid Detection of Flu A+B
K151291 · Becton, Dickinson and Company · Jun 2015
BD Veritor™ System Flu A+B Assay
K151301 · Becton, Dickinson and Company · Jun 2015
TRU FLU
K133714 · Meridian Bioscience, Inc. · Jan 2014