CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K132508 ↗

FDA Product Code

OZE

Device Class

Class II

Regulation

21 CFR Part 866.3980

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• B. anthracis Real-time PCR Assay

  Class II

  FDA 510(k) K262368 Active Cleared 7 Oct 2026

• CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit

  Class II

  FDA 510(k) K263035 Active Cleared 30 Sep 2026

• Rickettsia Real-time PCR Assay

  Class II

  FDA 510(k) K170940 Active Cleared 29 Jun 2017

• Sera for Antinuclear Antibodies

  Class II

  FDA 510(k) K820945 Active Cleared 26 Oct 1982

• Anthracis Real-Time Pcr Assay

  Class II

  FDA 510(k) K140426 Active Cleared 22 May 2014

• CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit

  Class II

  FDA 510(k) K190302 Active Cleared 27 Mar 2019

See all devices from Centers for Disease Control and Prevention →

• What clinical setting is this diagnostic panel designed for, and why is it not sterile?

  The CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel is designed exclusively for use in clinical microbiology laboratories, where trained personnel can handle non-sterile reagents under controlled conditions. Since it requires processing in a regulated lab setting with biosafety measures—such as PCR instrumentation and specialized workflows—sterility is unnecessary and impractical for a single-use reagent kit. The device is not intended for point-of-care or non-laboratory use.

• How is this assay different from traditional influenza tests, and what viruses does it detect?

  Unlike rapid antigen tests or viral culture methods, this multiplex real-time RT-PCR assay detects and differentiates human influenza A and B viruses simultaneously by amplifying viral RNA in a single test. Traditional methods often require separate tests for each virus type or lack the sensitivity of PCR. The multiplex approach enables faster, more accurate identification of the specific influenza strain causing infection, improving clinical decision-making.

• Is this panel reusable, and if not, how should unused portions be handled?

  The CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel is intended for single-use only per kit. Since it is not sterile and contains reagents designed for one diagnostic run, unused components should be discarded according to laboratory biosafety protocols to prevent cross-contamination. Always follow CDC guidelines for molecular diagnostic waste disposal, as residual specimens or reagents may pose biohazard risks.

• What storage requirements apply to this diagnostic panel, and why are they important?

  Storage must comply with CDC guidelines for molecular diagnostic assays, though specific conditions (e.g., temperature, light exposure) are not detailed in the data. The panel’s reagents are sensitive to degradation, so adherence to manufacturer-provided instructions is critical to maintain assay performance. Improper storage could lead to false negatives or unreliable results, compromising diagnostic accuracy. Always verify the included storage instructions or contact CDC support for details.

• What regulatory pathway was followed for FDA clearance, and how does this affect its use?

  The device received FDA 510(k) clearance (K132508) under the Microbiology advisory committee (MI) via a *Traditional* review process, demonstrating it is substantially equivalent to a predicate device. This clearance confirms the panel meets U.S. safety and effectiveness standards for in vitro diagnostic use in clinical microbiology labs. While clearance is granted, clinicians should ensure their lab adheres to CLIA regulations and CDC protocols for molecular diagnostics to maintain compliance and accuracy.