# K143651: Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack

- Pathway: 510(k) (Traditional)
- Applicant: Focus Diagnostics, Inc.
- Decided: Mar 18, 2015 after 85 days
- Product code: PGX (Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System)
- Device class: 2
- Regulation: 21 CFR 866.2680
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN140005 (2014). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN140005: Lyra Direct Strep Assay, Quidel Corporation (2014). Our reading of the summary gave K133883, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN140005, Lyra Direct Strep Assay (Quidel Corporation), granted Apr 16, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K260333: LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit (2026), 0 descendants of its own

## Recalls of this device
- Feb 10, 2016 · Class I · Z-1274-2016: 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™ Group A Strep Direct The Focus Diagnostics Simplexa™ Group A Strep Direct assay is intended for use on the 3M Integrated Cycler for the in vitro qualitative detection of Group A Streptococcus (GAS) from throat swabs collected from human patients with signs and symptoms of pharyngitis, such as sore throat. This test is intended for use as an aid in the diagnosis of GAS infection. The assay is intended for use in hospital, reference, or state laboratory settings. The device is not intended for point-of-care use. Simplexa™ Group A Strep Positive Control Pack Focus Diagnostics’ Simplexa™ Group A Strep Positive Control Pack is intended to be used as a control with Simplexa™ Group A Strep Direct. This control is not intended for use with other assays or systems.

Source page: https://510kreport.com/device/K143651
Methodology: https://510kreport.com/methodology