Cleared Special

BIOSIGN FLU A + B, STATUS FLU A & B

K132465 · Princeton BioMeditech Corp. · Microbiology

Sep 2013

Decision

33d

Days

Class 2

Risk

About This 510(k) Submission

K132465 is an FDA 510(k) clearance for the BIOSIGN FLU A + B, STATUS 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 September 9, 2013, 33 days after receiving the submission on August 7, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3328.

Submission Details

510(k) Number	K132465 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 07, 2013
Decision Date	September 09, 2013
Days to Decision	33 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Statement

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.