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ProFlu+ Assay Modification

by Prodesse, Inc. 2 variants

510(k) K081030

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 · Special NumberK081030 Date2 May 2008ClearedStatusActive

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  • Withdrawn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)

Full name
Modification to Proflu+ Assay
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, 19 Sep 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 Modification is a multiplex Real-Time RT-PCR in vitro diagnostic test designed for the rapid qualitative detection and differentiation of Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV) nucleic acids extracted from nasopharyngeal swab specimens. It falls under the classification of a Respiratory Virus Panel Nucleic Acid Assay System and is intended for use in microbiology diagnostics.

This device is supplied as a single-use diagnostic kit and is regulated under FDA 510(k) clearance (K092500) with a Special Substantial Equivalence (SESE) determination. It is intended for use in clinical microbiology laboratories and requires compliance with standard molecular testing protocols. The modification does not alter the intended use or labeling, maintaining the original indication for symptomatic patient testing via nasopharyngeal swabs.

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