Cleared Traditional

Sofia Influenza A+B FIA on Sofia 2

K162438 · Quidel Corporation · Microbiology

Apr 2017

Decision

226d

Days

Class 2

Risk

About This 510(k) Submission

K162438 is an FDA 510(k) clearance for the Sofia Influenza A+B FIA on Sofia 2, 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 April 14, 2017, 226 days after receiving the submission on August 31, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3328.

Submission Details

510(k) Number	K162438 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 2016
Decision Date	April 14, 2017
Days to Decision	226 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.