510(k) · Cleared
ClearedXpert Mrsa/SA Ssti Assay
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 Sep 24, 2008 as substantially equivalent to K070462 (Cepheid, 2007) and 6 other predicates after a 183-day review. Its family tree reaches back 3 generations to 1985. 1 later device descends from it.
- Decided
- Sep 24, 2008
- Review
- 183 days
- Class
- Class II
- Product code
- NQX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K850291 (1985). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK850291 Mueller Hinton Agar W/4% Nacl W/AntibioticsRemel Co. · 1985 · Recalled
- 2 generations backK033415 Idi-MrsaInfectio Diagnostic (I.D.I.), Inc. · 2004 · Recalled
- 1 generation backK070462 Xpert MrsaCepheid · 2007 · Recalled
- This deviceK080837 Xpert Mrsa/SA Ssti AssayCepheid · 2008
- Descendant · cites it directly · 0 of its ownK243625 Xpert MRSA/SA SSTICepheid® · 2024
Most influential descendants
Showing 1 of 1 · See all- K243625Xpert MRSA/SA SSTICepheid® · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K850291 | Mueller Hinton Agar W/4% Nacl W/Antibiotics | Remel Co. | 1985 | 2 |
| −2 | K033415 | Idi-Mrsa | Infectio Diagnostic (I.D.I.), Inc. | 2004 | 1 |
| −1 | K070462 | Xpert Mrsa | Cepheid | 2007 | 1 |
| 0 (this device) | K080837 | Xpert Mrsa/SA Ssti Assay | Cepheid | 2008 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 K243625 Xpert MRSA/SA SSTIscore 9.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K070462 | Xpert MrsaSummary page 1…QX Classification Microbiology Advisory Committee: Panel: 83 Predicate Device: Cepheid Xpert MRSA Assay [5 10(k) no. K070462] Device Description: The Cepheid Xpert MRSA/SA Skin and Soft Tissue Infection Assay (Xpert MRSA/SA SSTI Assay) is a rapid, autom… | 2007 |
| * | K071026 | BD Geneohm Staphsr AssaySummary page 2…he Xpert MRSA/SA SSTI Assay is substantially equivalent to two molecular-based MRSA and SA assays, Cepheid XpertTM MRSA Assay (K070462) and the BD GeneOhm StaphSR Assay (K071026). All three assays detect MRSA and the Xpert MRSA/SA and the BD GeneOhm StaphSR Assay detect both SA and MRSA; all three assays d… | 2007 |
| * | K851949 | Staphaurex ZL30Summary page 3…including swabbed specimens of skin and soft tissue infections. These conventional microbiology-based predicates are: · Remel Staphaurex Latex Agglutination Test (K851949), · BBL (BD) Oxacillin Screen Agar (K863821), : BD BBL CHROMagar MRSA (K042812 * BD Phoenix Automated Microb… | 1985 |
| * | K863821 | Mueller Hinton Agar W/4%Nacl and OxacillinSummary page 3…infections. These conventional microbiology-based predicates are: · Remel Staphaurex Latex Agglutination Test (K851949), · BBL (BD) Oxacillin Screen Agar (K863821), : BD BBL CHROMagar MRSA (K042812 * BD Phoenix Automated Microbiology ID/AST System (K020322 and K023301). Table… | 1986 |
| * | K042812 | Bblchromagar MrsaSummary page 3…gy-based predicates are: · Remel Staphaurex Latex Agglutination Test (K851949), · BBL (BD) Oxacillin Screen Agar (K863821), : BD BBL CHROMagar MRSA (K042812 * BD Phoenix Automated Microbiology ID/AST System (K020322 and K023301). Table 5.2 compares the new device with the conve… | 2004 |
| * | K020322 | BD Phoenix Automated Microbiology SystemSummary page 3…tion Test (K851949), · BBL (BD) Oxacillin Screen Agar (K863821), : BD BBL CHROMagar MRSA (K042812 * BD Phoenix Automated Microbiology ID/AST System (K020322 and K023301). Table 5.2 compares the new device with the conventional microbiology-based assays for SA. Table 5.3 compares the n… | 2002 |
| * | K023301 | BD Phoenix Automated Microbiology SystemSummary page 3…851949), · BBL (BD) Oxacillin Screen Agar (K863821), : BD BBL CHROMagar MRSA (K042812 * BD Phoenix Automated Microbiology ID/AST System (K020322 and K023301). Table 5.2 compares the new device with the conventional microbiology-based assays for SA. Table 5.3 compares the new device wi… | 2002 |
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 |
|---|---|---|---|
| K243625 | Xpert MRSA/SA SSTI | 2024 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 7 of the 13 ancestors have a recall of any class.
- Of its descendants, K243625 (Cepheid®, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K070462.
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. 2008, 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 Cepheid Xpert MIRSA/SA Skin and Soft Tissues Infection Assay (Xpert MRSA/SA SSTI Assay) performed in the GeneXpert® Dx System is a qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) from skin and soft tissue infection swabs. The test utilizes automated real-time polymerase chain reaction (PCR) to detect MRSA/SA DNA. The Xpert MRSA/SA SSTI Assay is…
Read the full statement (173 words)
The Cepheid Xpert MIRSA/SA Skin and Soft Tissues Infection Assay (Xpert MRSA/SA SSTI Assay) performed in the GeneXpert® Dx System is a qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) from skin and soft tissue infection swabs. The test utilizes automated real-time polymerase chain reaction (PCR) to detect MRSA/SA DNA. The Xpert MRSA/SA SSTI Assay 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 MRSA/SA from skin and soft tissue infections. The Xpert MRSA/SA SSTI Assay is not intended to monitor treatment for MRSA/SA infections. Concomitant cultures for SA and MRSA are necessary to recover organisms for susceptibility testing or epidemiological typing. In a mixed culture containing MRSA/SA and other organisms (e.g. Gram negative bacilli, yeast), results can be false negative or variable depending on the concentration of MRSA/SA present, particularly if the concentration of MRSA/SA is close to the LoD of the assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080837 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080837: Xpert Mrsa/SA Ssti Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080837
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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