# K132237: Prodesse Profast+ Assay

- Pathway: 510(k) (Special)
- Applicant: Gen-Probe Prodesse, Inc.
- Decided: Aug 26, 2013 after 39 days
- Product code: OQW (2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification)
- Device class: 2
- Regulation: 21 CFR 866.3332
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN070013 (2008). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101855: Profast+ Assay, Gen-Probe Prodesse, Inc. (2010) Summary page 1.

## Indications for use
The ProdesseJProFASr®O+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the qualitative detection and discrimination of seasonal Influenza A/HI1, seasonal Influenza AIH3 and 2009 H IN I Influenza viral nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. This Assay targets conserved regions of the Hemagglutinin (HA) gene for seasonal Influenza A/I-l, seasonal Influenza A/H3 and 2009 HINI Influenza Virus, respectively. This Assay is not intended to detect Influenza B or Influenza C Viruses. A negative ProFAST+ Assay result is a presumptive negative result for Influenza A. These results should be confirmed by an FDA cleared nucleic acid-based test (NAT) detecting Influenza A. Negative results do not preclude Influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Source page: https://510kreport.com/device/K132237
Methodology: https://510kreport.com/methodology