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510(k) K152870

BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit by Becton, Dickinson and Co. — Product Code PSZ

K152870 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Co. for the device "BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit". The FDA issued a decision of Substantially Equivalent on October 27, 2015. The device falls under product code PSZ (Devices Detecting Influenza A, B, And C Virus Antigens), a Class II device regulated under 21 CFR 866.3328. Becton, Dickinson and Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2015
Date Received
September 30, 2015
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.

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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)

FDA data resources