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510(k) K100148

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

K100148 is an FDA 510(k) premarket notification submitted by Focus Diagnostics, Inc. for the device "SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500". The FDA issued a decision of Substantially Equivalent on May 24, 2010. The device falls under product code OQW (2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification), a Class II device regulated under 21 CFR 866.3332. Focus Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Focus Diagnostics, Inc.

  • K152408 — Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack (September 21, 2015)
  • K150962 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (August 28, 2015)
  • 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)

FDA data resources