Cleared Special

CLEARVIEW EXACT II INFLUENZA A & B TEST

K103610 · Alere Scarborough, Inc D/B/A Binax, Inc. · Microbiology

Jan 2011

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K103610 is an FDA 510(k) clearance for the CLEARVIEW EXACT II INFLUENZA A & B TEST, a Devices Detecting Influenza A, B, And C Virus Antigens (Class II — Special Controls, product code PSZ), submitted by Alere Scarborough, Inc D/B/A Binax, Inc. (Scarborough, US). The FDA issued a Cleared decision on January 6, 2011, 28 days after receiving the submission on December 9, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3328.

Submission Details

510(k) Number	K103610 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 09, 2010
Decision Date	January 06, 2011
Days to Decision	28 days
Submission Type	Special
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.