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TaqPath COVID-19, Flu A, Flu B, RSV Select Panel

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K241806

by Life Technologies Corporation

Identifiers

510(k) Number
K241806 FDA 510(k)
FDA Product Code
QOF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3981 FDA 510(k)
Regulation Number
866.3981 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TaqPath COVID-19, Flu A, Flu B, RSV Select Panel is a Multi-Target Respiratory Specimen Nucleic Acid Test designed for the qualitative detection and differentiation of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) from RNA extracted specimens. This multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) assay enables simultaneous identification of multiple respiratory pathogens in a single test run, supporting rapid diagnostic workflows in clinical microbiology settings.

This in vitro diagnostic device is intended for use in clinical laboratories and requires RNA extracted from nasopharyngeal swab or anterior nasal specimens. Supplied as a single-use kit, it complies with FDA 510(k) clearance under the In Vitro Diagnostic Regulation (IVDR) and is classified as a Class II device (Regulation Number 866.3981). The panel includes assay reagents, master mix, and controls, with no additional preparation required beyond standard RT-PCR instrumentation. Storage and handling follow manufacturer guidelines for nucleic acid tests.

Frequently asked questions

What types of respiratory specimens are required for this test, and how are they processed before use?

This panel requires RNA extracted from nasopharyngeal swab or anterior nasal specimens. The test is designed for use in clinical laboratories and does not include specimen processing—only the extracted RNA is compatible with the assay. The kit itself contains reagents, master mix, and controls, so no additional preparation beyond standard RT-PCR instrumentation is needed.

Is this a single-use or reusable device, and how should it be stored?

The TaqPath COVID-19, Flu A, Flu B, RSV Select Panel is supplied as a single-use kit, meaning each kit is intended for one test run. Storage and handling must follow manufacturer guidelines for nucleic acid tests, which typically include refrigeration or freezing (as specified in the accompanying documentation) to maintain reagent integrity.

What pathogens does this test detect simultaneously, and why is this useful in clinical settings?

The panel detects SARS-CoV-2 (COVID-19), influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) in a single multiplex RT-PCR run. This is clinically valuable because it enables rapid identification of multiple respiratory pathogens from a single specimen, reducing turnaround time and streamlining diagnostic workflows—especially during overlapping outbreaks.

How is this device classified, and what regulatory pathways does it follow?

This device is classified as a Class II in vitro diagnostic under FDA regulation (866.3981) and has received FDA 510(k) clearance as well as IVDR compliance in the EU. The clearance was determined through a traditional 510(k) review process, with a decision described as *Substantially Equivalent* to a predicate device, filed under the Microbiology product code (QOF).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel, TaqPath COVID-19, Flu A, Flu B, RSV Select Panel, Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Life Technologies Corporation

Sources (2)

  • FDA 510(k) K241806 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026