510(k) K100148

SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 by Focus Diagnostics, Inc. — Product Code OQW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 24, 2010
Date Received: January 19, 2010
Clearance Type: Traditional
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

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K143651 — Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack (March 18, 2015)
K142365 — Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack (December 5, 2014)
K141458 — SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK (July 1, 2014)
DEN130049 — SIMPLEXA HSV 1&2 DIRECT (March 21, 2014)
K120986 — STRATIFY JCV DXSELECT (August 16, 2012)
K120413 — SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK (July 13, 2012)
K113433 — SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT (April 4, 2012)
DEN120008 — STRATIFY JCV(TM) ANTIBODY (January 20, 2012)

Other clearances for product code OQW

K132237 — PRODESSE PROFAST+ ASSAY (August 26, 2013)
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)