# K152408: Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack

- Pathway: 510(k) (Special)
- Applicant: Focus Diagnostics, Inc.
- Decided: Sep 21, 2015 after 27 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN070013 (2008). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142365: Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack, Focus Diagnostics (2014) Summary page 4.

## Recalls of this device
- Feb 10, 2016 · Class II · Z-1273-2016: Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kit

## Indications for use
Simplexa™ Flu A/B & RSV Direct REF MOL2650 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. Simplexa™ Flu A/B & RSV Positive Control Pack REF MOL2660 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/K152408
Methodology: https://510kreport.com/methodology