# K073029: Proflu+ Assay

- Pathway: 510(k) (Traditional)
- Applicant: Prodesse, Inc.
- Decided: Jan 4, 2008 after 67 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
No predicates in its family tree.
85 later devices descend from it; 10 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) xTAG Respiratory Viral Panel Luminex Molecular Diagnostics: named in the summary without a submission number

## Most influential descendants
- K080570: CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel (2008), 59 descendants of its own
- K081030: Modification to Proflu+ Assay (2008), 45 descendants of its own
- K092500: Modification to Proflu+ Assay (2009), 41 descendants of its own
- K100148: Simplexa Influenza a H1N1 (2009) Model MOL2500 (2010), 34 descendants of its own
- K103766: Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software Verisions 2.1 and 4.0 (2011), 27 descendants of its own

## Indications for use
The ProFlu+TM 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. A negative test is presumptive and it is recommended these results be confirmed by cell culture. 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. Performance characteristics for Influenza A Virus were established when Influenza A/H3 and A/HI were the predominant Influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infections with a novel Influenza A virus are 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/K073029
Methodology: https://510kreport.com/methodology