Cleared Traditional

Sofia Influenza A+B FIA

K153012 · Quidel Corporation · Microbiology

Jan 2016

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K153012 is an FDA 510(k) clearance for the Sofia Influenza A+B FIA, a Devices Detecting Influenza A, B, And C Virus Antigens (Class II — Special Controls, product code PSZ), submitted by Quidel Corporation (San Diego,, US). The FDA issued a Cleared decision on January 12, 2016, 90 days after receiving the submission on October 14, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3328.

Submission Details

510(k) Number	K153012 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	PSZ — Devices Detecting Influenza A, B, And C Virus Antigens
Device Class	Class II — 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.