# K092500: Modification to Proflu+ Assay

- Pathway: 510(k) (Special)
- Applicant: Prodesse, Inc.
- Decided: Aug 20, 2009 after 6 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN070013 (2008). 5 ancestors in all.
41 later devices descend from it; 10 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081030: Modification to Proflu+ Assay, Prodesse, Inc. (2008) Summary page 1.
- K091667: Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116, Luminex Molecular Diagnostics, Inc. (2009) Summary page 1.

## Most influential descendants
- K110968: Proflu+ Assay (2011), 15 descendants of its own
- K132129: Prodesse Proflu+ Assay (2013), 13 descendants of its own
- K131813: Quidel Molecular RSV + HMPV Assay (2013), 7 descendants of its own
- K142045: Xpert Flu/RSV XC Assay (2014), 5 descendants of its own
- K101855: Profast+ Assay (2010), 5 descendants of its own

## Indications for use
The ProFlu+™ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the rapid and qualitative detection and discrimination of Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from symptomatic patients. This test is intended for use to aid in the differential diagnosis of Influenza A, Influenza B and RSV viral infections in humans and is not intended to detect Influenza C. Negative results do not preclude influenza or RSV virus infection and should not be used as the sole basis for treatment or other management decisions. It is recommended that negative RSV results be confirmed by culture. Performance characteristics for Influenza A Virus were established when Influenza A/H3 and A/H1 were the predominant Influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. 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/K092500
Methodology: https://510kreport.com/methodology