# K101855: Profast+ Assay

- Pathway: 510(k) (Traditional)
- Applicant: Gen-Probe Prodesse, Inc.
- Decided: Jul 23, 2010 after 22 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: 4 generations back to DEN070013 (2008). 9 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 15 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.
- K091667: Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116, Luminex Molecular Diagnostics, Inc. (2009). Our reading of the summary gave K091677, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ID Tag Respiratory Virus Panel”.
- K080570: CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel, Centers for Disease Control and Prevention (2008) Summary page 1.
- K100148: Simplexa Influenza a H1N1 (2009) Model MOL2500, Focus Diagnostics, Inc. (2010) Summary page 1.
- 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
- K103209: Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+) (2011), 2 descendants of its own
- K163628: Idylla Respiratory (IFV-RSV) Panel (2017), 0 descendants of its own
- K132237: Prodesse Profast+ Assay (2013), 0 descendants of its own
- K131584: Imdx Flu a/B and RSV for Abbott M2000 (2013), 0 descendants of its own
- K121003: Abbott Plex-ID Flu Assay (2012), 0 descendants of its own

## Indications for use
The ProFASTTm+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the qualitative detection and discrimination of seasonal Influenza A/HI, seasonal Influenza A/H3 and 2009 H1N1 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 ilemagglutinin (HA) gene for seasonal Influenza A/HI, seasonal Influenza A/H-3 and 2009 H1N1 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/K101855
Methodology: https://510kreport.com/methodology