Home / 510(k) Clearances / K140851

510(k) K140851

INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL by Centers For Disease Control and Prevention — Product Code OEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2014
Date Received
April 3, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Influenza A Virus Subtype Differentiation Nucleic Acid Assay
Device Class
Class II
Regulation Number
866.3980
Review Panel
MI
Submission Type

A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture. Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses. Also, it aids in the presumptive laboratory identification of influenza a virus subtypes to provide epidemiological information on influenza.

Other clearances by Centers For Disease Control and Prevention

  • 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)
  • K190302 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin (March 27, 2019)