Cleared Traditional

BIOSIGN FLU A+B

K083746 · Princeton BioMeditech Corp. · Microbiology

Nov 2010

Decision

693d

Days

Class 2

Risk

About This 510(k) Submission

K083746 is an FDA 510(k) clearance for the BIOSIGN FLU A+B, a Devices Detecting Influenza A, B, And C Virus Antigens (Class II — Special Controls, product code PSZ), submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on November 10, 2010, 693 days after receiving the submission on December 17, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3328.

Submission Details

510(k) Number	K083746 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 2008
Decision Date	November 10, 2010
Days to Decision	693 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.