510(k) · Cleared
ClearedLIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diasorin Molecular, LLC · PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Cleared on Jun 15, 2026 as substantially equivalent to K143651 (Focus Diagnostics, Inc., 2015) after a 133-day review. Its family tree reaches back 2 generations to 2014. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 15, 2026
- Review
- 133 days
- Class
- Class II
- Product code
- PGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN140005 (2014). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backDEN140005 Lyra Direct Strep AssayQuidel Corporation · 2014
- 1 generation backK143651 Simplexa Group A Strep Direct, Simplexa Group A Strep Positive…Focus Diagnostics, Inc. · 2015 · Recalled (Class I)
- This deviceK260333 LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab KitDiasorin Molecular, LLC · 2026
Class I recalls in this family
- K143651 Simplexa Group A Strep Direct, Simplexa Group A…direct predicate · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN140005 | Lyra Direct Strep Assay | Quidel Corporation | 2014 | — |
| −1 | K143651 | Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack | Focus Diagnostics, Inc. | 2015 | Class I |
| 0 (this device) | K260333 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | Diasorin Molecular, LLC | 2026 | — |
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
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 |
|---|---|---|---|
| * | K143651 | Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control PackSummary page 7…ailures and/or inhibition. J. Substanial Equivalence Information: 1. Predicate device name(s): Simplexa™ Group A Strep Direct 2. Predicate 510(k) number(s): K143651 3. Comparison with predicate: The following table compares the similarities and differences between the LIAISON® NES Group… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K143651Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control PackFocus Diagnostics, Inc. · 2015 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 11.2 years on median.
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
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. 2026, 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?
LIAISON NES Group A Strep is a real-time PCR assay intended for use on the LIAISON NES instrument for the in vitro qualitative detection of Streptococcus pyogenes, Group A Streptococcus (GAS) bacterial nucleic acid in throat swab specimens freshly collected from human patients with signs and symptoms of pharyngitis. This test is intended for use as an aid in the rapid diagnosis of Group A Streptococcus bacterial infections.
The LIAISON NES Group A Strep Control Swab Kit is intended to be used as positive and negative controls with the LIAISON NES Group A Strep assay for use on the LIAISON NES instrument. These controls are 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/K260333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260333: LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260333
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026