510(k) · Cleared
Recalled · Class I · 2016Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focus Diagnostics, Inc. · PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Cleared on Mar 18, 2015 as substantially equivalent to DEN140005 (Quidel Corporation, 2014) after an 85-day review. Its family tree reaches back 1 generation to 2014. 1 of the 3 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once, including a Class I recall.
- Decided
- Mar 18, 2015
- Review
- 85 days
- Class
- Class II
- Product code
- PGX
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN140005 (2014). 1 later device descends from it, 1 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backDEN140005 Lyra Direct Strep AssayQuidel Corporation · 2014
- This deviceK143651 Simplexa Group A Strep Direct, Simplexa Group A Strep Positive…Focus Diagnostics, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK260333 LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab KitDiasorin Molecular, LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K260333LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab KitDiasorin Molecular, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN140005 | Lyra Direct Strep Assay | Quidel Corporation | 2014 | — |
| 0 (this device) | K143651 | Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack | Focus Diagnostics, Inc. | 2015 | — |
| +1 | K260333 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | Diasorin Molecular, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PGX device
- #1 K260047 cobas Strep A Nucleic acid test for use on the…score 14.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN140005 | Lyra Direct Strep Assay 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. | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260333 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | 2026 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 10, 2016 | Class I | Z-1274-2016 | Under Investigation by firm | 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 kits (MOL2850) because it may result in a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All PGX devicesPGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PGX
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PGX
85in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGX
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PGX
1in 2022
MAUDE reports naming product code PGX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | — | 0 | 0 |
| 2015 | 3 | 85 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 2 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (129 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143651: Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143651
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026