# K110968: Proflu+ Assay

- Pathway: 510(k) (Traditional)
- Applicant: Gen-Probe Prodesse, Inc.
- Decided: Jun 27, 2011 after 82 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: 4 generations back to DEN070013 (2008). 7 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN070013: ID-Tag Respiratory Viral Panel, Luminex Molecular Diagnostics, Inc. (2008). Our reading of the summary gave K063765, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN070013, ID-Tag Respiratory Viral Panel (Luminex Molecular Diagnostics, Inc.), granted Jan 3, 2008; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K081483: Xtag Respiratory Viral Panel, Luminex Molecular Diagnostics, Inc. (2008) Summary page 1.
- DEN110001: Norovirus Serological Reagent. Our reading of the summary gave K091677, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN110001, Norovirus Serological Reagent (), granted —; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K073029: Proflu+ Assay, Prodesse, Inc. (2008) Summary page 1.
- K081030: Modification to Proflu+ Assay, Prodesse, Inc. (2008) Summary page 1.
- K092500: Modification to Proflu+ Assay, Prodesse, Inc. (2009) Summary page 1.

## Most influential descendants
- K132129: Prodesse Proflu+ Assay (2013), 13 descendants of its own
- K142045: Xpert Flu/RSV XC Assay (2014), 5 descendants of its own
- K153544: cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System (2016), 4 descendants of its own
- K151226: Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) (2015), 4 descendants of its own
- K200065: cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System (2020), 3 descendants of its own

## Indications for use
The ProFluTM+ Assay is a multiplex Real-Time PCR (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. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for Influenza A Virus were established when Influenza A/H and A/H I were the predominant Influenza A viruses in circulation (2006 - 2007 respiratory season). Performance characteristics for Influenza A were confirmed when Influenza AMHi, Influenza A/1-13, and Influenza A/2009 H IN I were the predominant Influenza A viruses in circulation (2008 and 2009). 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/K110968
Methodology: https://510kreport.com/methodology