510(k) K132237

PRODESSE PROFAST+ ASSAY by Gen-Probe Prodesse, Inc. — Product Code OQW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 26, 2013
Date Received: July 18, 2013
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Device Class: Class II
Regulation Number: 866.3332
Review Panel: MI
Submission Type

2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens

Other clearances by Gen-Probe Prodesse, Inc.

K132238 — PROPARAFLU+ ASSAY (August 26, 2013)
K132159 — PROADENO+ ASSAY (August 14, 2013)
K132200 — PRO HMPV+ ASSAY (August 14, 2013)
K132129 — PRODESSE PROFLU+ ASSAY (August 9, 2013)
K123838 — PRO HMPV+ ASSAY (January 16, 2013)
K123274 — PROGASTRO SSCS ASSAY (January 16, 2013)
K110968 — PROFLU+ ASSAY (June 27, 2011)
K102952 — PRODESSE PROADENO (December 3, 2010)
K101855 — PROFAST+ ASSAY (July 23, 2010)

Other clearances for product code OQW

K130551 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (May 22, 2013)
K123905 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (January 14, 2013)
K120911 — XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) (May 18, 2012)
K111778 — JBAIDS INFLUENZA A SUBTYPING KIT (September 13, 2011)
K111507 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (August 23, 2011)
K103766 — XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOF (April 21, 2011)
K101855 — PROFAST+ ASSAY (July 23, 2010)
K101564 — CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL (June 22, 2010)
K100148 — SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 (May 24, 2010)