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510(k) K051244

GENZYME OSOM INFLUENZA A & B TEST by Genzyme Corp. — Product Code PSZ

K051244 is an FDA 510(k) premarket notification submitted by Genzyme Corp. for the device "GENZYME OSOM INFLUENZA A & B TEST". The FDA issued a decision of Substantially Equivalent on February 21, 2006. 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. Genzyme Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2006
Date Received
May 16, 2005
Clearance Type
Traditional
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 Genzyme Corp.

  • K061508 — OSOM INFLUENZA A&B TEST (June 12, 2006)
  • K040241 — N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET (June 25, 2004)
  • K040868 — SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH (June 4, 2004)
  • K033864 — GENZYME OSOM TRICHOMONAS RAPID TEST (April 2, 2004)
  • K023544 — GENZYME CONTRAST II HCG URINE/SERUM TEST (January 16, 2003)
  • K021316 — ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTR (July 25, 2002)
  • K021019 — COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE (June 18, 2002)
  • K012532 — SEPRAGEL SINUS (October 30, 2001)
  • K011843 — GENZYME DIRECT-AMYLASE TEST REAGENT (August 10, 2001)
  • K000239 — GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL (March 21, 2000)

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