# K100148: Simplexa Influenza a H1N1 (2009) Model MOL2500

- Pathway: 510(k) (Traditional)
- Applicant: Focus Diagnostics, Inc.
- Decided: May 24, 2010 after 125 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: 3 generations back to DEN070013 (2008). 6 ancestors in all.
34 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091667: Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116, Luminex Molecular Diagnostics, Inc. (2009) Summary page 1.
- K081483: Xtag Respiratory Viral Panel, Luminex Molecular Diagnostics, Inc. (2008) Summary page 1.
- 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.
- K080570: CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel, Centers for Disease Control and Prevention (2008) Summary page 1.

## Most influential descendants
- K103766: Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software Verisions 2.1 and 4.0 (2011), 27 descendants of its own
- K111387: Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer (2011), 18 descendants of its own
- K141520: Alere I Influenza a & B (2014), 11 descendants of its own
- K151464: Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit (2015), 8 descendants of its own
- K163266: Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument (2016), 7 descendants of its own

## Indications for use
The Focus Diagnostics SimpleXaTM Influenza A HiN1 (2009) assay is intended for use on the 3M Integrated Cycler as part of the Microfluidlic Molecular System for the in vitro qualitative detection and differentiation of influenza A and 2009 Hi1Ni influenza viral RNA in nasopharyngeal swabs (NPS), nasal swabs (NS), and nasopharyngeal aspirates (NPA) from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2009-2010 influenza season when 2009 HiN1 influenza was the predominant influenza A virus 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/K100148
Methodology: https://510kreport.com/methodology