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ProFlu+ Assay

by Gen-Probe Prodesse, Inc.

510(k) K110968

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK110968 Date27 Jun 2011ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OCC
Device Class
Class II
Regulation
21 CFR Part 866.3980
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ProFlu+ Assay is a Respiratory Virus Panel Nucleic Acid Assay System, designed for the rapid, qualitative detection and discrimination of Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV) nucleic acids. It employs multiplex real-time PCR technology to simultaneously identify these pathogens from clinical specimens, enabling precise and efficient diagnostic differentiation in microbiology settings.

This in vitro diagnostic device is supplied as a single-use assay kit and is intended for use in clinical laboratories. It requires no additional sterilization or reprocessing, adhering to standard molecular diagnostics workflows. The assay is classified under FDA 510(k) clearance (K110968) and falls under Device Class II (866.3980) for microbiology applications. Storage and handling follow standard molecular assay protocols, with no noted MRI safety concerns or special environmental requirements.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What pathogens does the ProFlu+ Assay detect?

    The ProFlu+ Assay is designed to detect and differentiate Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV) from clinical specimens. It uses multiplex real-time PCR technology to simultaneously identify these three respiratory pathogens, enabling accurate and efficient diagnostic results in microbiology settings.

  • How is the ProFlu+ Assay supplied, and is it reusable?

    The ProFlu+ Assay is supplied as a single-use assay kit, meaning each kit is intended for one use only. This eliminates the need for sterilization or reprocessing, aligning with standard molecular diagnostics workflows and ensuring consistent performance without cross-contamination risks.

  • What are the storage and handling requirements for the ProFlu+ Assay?

    The ProFlu+ Assay follows standard molecular assay protocols for storage and handling. There are no special environmental requirements or MRI safety concerns noted. Adherence to typical molecular diagnostics practices ensures proper functionality and reliability.

  • Is the ProFlu+ Assay approved for use in clinical laboratories?

    Yes, the ProFlu+ Assay holds FDA 510(k) clearance (K110968) and is classified under Device Class II for microbiology applications. This authorization confirms its suitability for use in clinical laboratories for the rapid detection of Influenza A, B, and RSV.

  • What regulatory pathway was followed for the ProFlu+ Assay?

    The ProFlu+ Assay was submitted through the traditional 510(k) pathway, reviewed by the FDA’s Microbiology Advisory Committee. The decision was based on a determination of substantial equivalence to a predicate device, ensuring compliance with regulatory standards for molecular diagnostics.