510(k) · Cleared
ClearedXpert MRSA/SA SSTI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid® · NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Cleared on Dec 18, 2024 as substantially equivalent to K080837 (Cepheid, 2008) after a 23-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Dec 18, 2024
- Review
- 23 days
- Class
- Class II
- Product code
- NQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K850291 (1985). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK850291 Mueller Hinton Agar W/4% Nacl W/AntibioticsRemel Co. · 1985 · Recalled
- 3 generations backK033415 Idi-MrsaInfectio Diagnostic (I.D.I.), Inc. · 2004 · Recalled
- 2 generations backK070462 Xpert MrsaCepheid · 2007 · Recalled
- 1 generation backK080837 Xpert Mrsa/SA Ssti AssayCepheid · 2008
- This deviceK243625 Xpert MRSA/SA SSTICepheid® · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K850291 | Mueller Hinton Agar W/4% Nacl W/Antibiotics | Remel Co. | 1985 | 2 |
| −3 | K033415 | Idi-Mrsa | Infectio Diagnostic (I.D.I.), Inc. | 2004 | 1 |
| −2 | K070462 | Xpert Mrsa | Cepheid | 2007 | 1 |
| −1 | K080837 | Xpert Mrsa/SA Ssti Assay | Cepheid | 2008 | — |
| 0 (this device) | K243625 | Xpert MRSA/SA SSTI | Cepheid® | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 2002 | 5 | 0 |
| 2004 | 2 | 0 |
| 2007 | 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.
Planning a device in NQX? 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 NQX device
- #1 K243070 Xpert® SA Nasal Completescore 6.2 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K080837 | Xpert Mrsa/SA Ssti AssaySummary page 6…t code: NQX, OOI Classification Microbiology (83) Advisory Panel Prescription Use Yes Predicate Device Xpert MRSA/SA SSTI (K080837) Assay: 510(k) Summary Attachment 50 Page 3 of 8 === Page 7 ==… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 39 years and passes through 4 companies; a new generation was cleared every 16.2 years on median.
- 7 of the 14 ancestors have a recall of any class.
How does its category compare?
All NQX devicesNQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · NQX
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NQX
75in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQX
15in 2025
MAUDE reports naming product code NQX, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 3 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 70 | 1 | 1 |
| 2011 | 2 | — | 6 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 4 | 75 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 2 | — | 0 | 8 |
| 2025 | 0 | — | 1 | 15 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Xpert® MR.SA/SA Skin and Soft Tissue Infection test (Xpert MR.SA/SA SSTI test) performed on the GeneXpert® Instrument Systems is a qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MR.SA) from skin and soft tissue infection swabs. The test utilizes automated real-time polymerase chain reaction (PCR) to detect MR.SA/SA DNA. The Xpert MR.SA/SA SSTI test is…
Read the full statement (174 words)
The Xpert® MR.SA/SA Skin and Soft Tissue Infection test (Xpert MR.SA/SA SSTI test) performed on the GeneXpert® Instrument Systems is a qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MR.SA) from skin and soft tissue infection swabs. The test utilizes automated real-time polymerase chain reaction (PCR) to detect MR.SA/SA DNA. The Xpert MR.SA/SA SSTI test is indicated for use in conjunction with other laboratory tests, such as microbiology culture, and clinical data available to the clinician as an aid in the detection of MR.SA/SA from skin and soft tissue infections. The Xpert MR.SA/SA SSTI test is not intended to monitor treatment for MR.SA/SA infections. Concomitant cultures for SA and MR.SA are necessary to recover organisms for susceptibility testing or epidemiological typing. In a mixed culture containing MR.SA/SA and other organisms (e.g., Gram-negative bacilli, yeast), results can be false negative or variable depending on the concentration of MR.SA/SA present, particularly if the concentration of MR.SA/SA is close to the limit of detection (LoD) of the test.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243625: Xpert MRSA/SA SSTI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243625
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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