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510(k) K101564

CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL by Centers for Disease Control and Prevention — Product Code OQW

K101564 is an FDA 510(k) premarket notification submitted by Centers for Disease Control and Prevention for the device "CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL". The FDA issued a decision of Substantially Equivalent on June 22, 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. Centers for Disease Control and Prevention has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2010
Date Received
June 4, 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 Centers for Disease Control and Prevention

  • K260812 — Francisella tularensis Real-time PCR Assay (March 30, 2026)
  • K252072 — Francisella tularensis Real-time PCR assay (September 30, 2025)
  • K243274 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typin (July 11, 2025)
  • K243931 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typin (March 14, 2025)
  • K241110 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtypi (May 21, 2024)
  • K222558 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (August 30, 2022)
  • K221834 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (June 24, 2022)
  • K221658 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (June 10, 2022)
  • K200370 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin (March 10, 2020)
  • K192871 — B. anthracis Real-time PCR Assay (November 7, 2019)

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)
  • K100148 — SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 (May 24, 2010)

FDA data resources