510(k) · Cleared
ClearedXpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
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 Apr 25, 2019 as substantially equivalent to K130894 (Cepheid, 2013) after a 30-day review. Its family tree reaches back 6 generations to 2002.
- Decided
- Apr 25, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- NQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K020322 (2002). 12 ancestors in all, the oldest K851949 (1985). No later device cites it as a predicate yet.
- Root · 6 generations backK020322 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
- 5 generations backK023301 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002 · Recalled
- 4 generations backK071026 BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 2007
- 3 generations backK082140 Xpert Mrsa/SA Blood Culture AssayCepheid · 2008 · Recalled
- 2 generations backK101879 Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10Cepheid · 2010 · Recalled
- 1 generation backK130894 Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I…Cepheid · 2013
- This deviceK190771 Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert…Cepheid · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K020322 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | — |
| −5 | K023301 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | 2 |
| −4 | K071026 | BD Geneohm Staphsr Assay | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2007 | — |
| −3 | K082140 | Xpert Mrsa/SA Blood Culture Assay | Cepheid | 2008 | 2 |
| −2 | K101879 | Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10 | Cepheid | 2010 | 1 |
| −1 | K130894 | Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV… | Cepheid | 2013 | — |
| 0 (this device) | K190771 | Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s… | Cepheid | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 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? (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 |
|---|---|---|---|
| * | K130894 | Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV, GX-Xvi)…Summary page 4…Microbiology (83) Panel Prescription Use Yes Predicate Device Assay: Cepheid Xpert MRSA/SA Blood Culture [510(k) #K130894] DEVICE DESCRIPTION The Cepheid Xpert® MRSA/SA Blood Culture test is a rapid, automated DNA test for the simultaneous qualitativ… | 2013 |
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 17 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 6 of the 12 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. 2019, 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® MRSA/SA Blood Culture 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 (MRSA) DNA directly from positive blood cultures. The assay utilizes automated real-time polymerase chain reaction (PCR) for the amplification of MRSA/SA specific DNA targets and fluorogenic target-specific…
Read the full statement (188 words)
The Cepheid® Xpert® MRSA/SA Blood Culture 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 (MRSA) DNA directly from positive blood cultures. The assay utilizes automated real-time polymerase chain reaction (PCR) for the amplification of MRSA/SA specific DNA targets and fluorogenic target-specific hybridization probes for the real-time detection of the amplified DNA. The assay is performed directly on positive blood culture samples using BD BACTEC™ Plus Aerobic/F, BacT/ALERT® SA (Standard Aerobic) or VersaTREK REDOX 1® (aerobic) blood culture bottles that are determined as Gram Positive Cocci in Clusters (GPCC) or as Gram Positive Cocci in singles (GPC) by Gram stain. The Xpert MRSA/SA Blood Culture test is indicated for use in conjunction with other laboratory tests, such as culture, and clinical data available to the clinician as an aid in the detection of MRSA/SA from positive blood cultures. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing or for epidemiological typing. The Cepheid Xpert MRSA/SA Blood Culture test is not intended to monitor treatment for MRSA/SA infections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190771 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190771: Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190771
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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