510(k) K132465

BIOSIGN FLU A + B, STATUS FLU A & B by Princeton BioMeditech Corp. — Product Code PSZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 9, 2013
Date Received: August 7, 2013
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Devices Detecting Influenza A, B, And C Virus Antigens
Device Class: Class II
Regulation Number: 866.3328
Review Panel: MI
Submission Type

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.

Other clearances by Princeton BioMeditech Corp.

K251538 — Status COVID-19/Flu A&B (November 14, 2025)
K182157 — BioSign Flu A+B (September 18, 2018)
K130650 — STATUS DS OXY (February 26, 2014)
K133474 — BIOSIGN FLU A + B, STATUS FLU A & B (December 10, 2013)
K083746 — BIOSIGN FLU A+B (November 10, 2010)
K100817 — BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST (July 1, 2010)
K100341 — SPERMCHECK FERTILITY (May 4, 2010)
K082661 — BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A (October 6, 2008)
K073039 — SPERMCHECK VASECTOMY (January 24, 2008)
K062575 — MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP (November 26, 2007)

Other clearances for product code PSZ

K252283 — Nano-Check Influenza A+B Test (January 15, 2026)
K250398 — Innovita Flu A/B Antigen Rapid Test (July 3, 2025)
K241188 — Acucy® Influenza A&B Test with the Acucy® 2 System (April 18, 2025)
K232434 — BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit (December 5, 2023)
K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (January 27, 2023)
K192719 — Osom Ultra Plus Flu A&B Test Kit (April 3, 2020)
K191514 — CareStart Flu A&B Plus (February 18, 2020)
K182001 — Acucy Influenza A&B Test with the Acucy System (December 17, 2018)
K182157 — BioSign Flu A+B (September 18, 2018)
K181853 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader (August 8, 2018)