# K120413: Simplexa Flu a/B & RSV Direct, Simplexa Flu a/B & RSV Positive Control Pack

- Pathway: 510(k) (Traditional)
- Applicant: Focus Diagnostics, Inc.
- Decided: Jul 13, 2012 after 154 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN070013 (2008). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092500: Modification to Proflu+ Assay, Prodesse, Inc. (2009) Summary page 1.
- K081030: Modification to Proflu+ Assay, Prodesse, Inc. (2008) Summary page 1.
- K073029: Proflu+ Assay, Prodesse, Inc. (2008) Summary page 1.

## Most influential descendants
- K142365: Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack (2014), 1 descendant of its own
- K161220: ARIES® Flu A/B & RSV Assay (2016), 0 descendants of its own
- K152408: Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack (2015), 0 descendants of its own

## Recalls of this device
- May 15, 2014 · Class II · Z-1958-2014: Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa" Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer complaints of Simplexa Fl
- Jan 10, 2014 · Class II · Z-0846-2014: Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received some customer complaints of Simplexa Flu A/B

## Indications for use
The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an 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 virus or RSV infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established with clinical specimens collected during the 2010/2011 influenza season when 2009 H1N1 influenza and H3N2 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 the 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. Focus Diagnostics' Simplexa Flu A/B & RSV Positive Control Pack is intended to be used as a control with the Simplexa Flu A/B & RSV Direct kit. This control is not intended for use with other assays or systems.

Source page: https://510kreport.com/device/K120413
Methodology: https://510kreport.com/methodology