510(k) · Cleared
Recalled · 2011Xpert Mrsa/SA Blood Culture 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 29, 2008 as substantially equivalent to K071026 (Bd Diagnostics (Geneohm Sciences Canada, Inc), 2007) and 5 other predicates after a 61-day review. Its family tree reaches back 3 generations to 2002. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 29, 2008
- Review
- 61 days
- Class
- Class II
- Product code
- NQX
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 3 generations to K020322 (2002). 9 ancestors in all, the oldest K851949 (1985). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK020322 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
- 2 generations backK023301 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002 · Recalled
- 1 generation backK071026 BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 2007
- This deviceK082140 Xpert Mrsa/SA Blood Culture AssayCepheid · 2008
- Descendant · cites it directly · 2 of its ownK101879 Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10Cepheid · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK130894 Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I…Cepheid · 2013
- Descendant · 3 generations on · 0 of its ownK190771 Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert…Cepheid · 2019
Most influential descendants
Showing 3 of 3 · See all- K101879Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10Cepheid · 2010 · cites it directly2descendants
- K130894Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV, GX-Xvi)…Cepheid · 2013 · 2 generations on1descendant
- K190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System…Cepheid · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K020322 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | — |
| −2 | K023301 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | 2 |
| −1 | K071026 | BD Geneohm Staphsr Assay | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2007 | — |
| 0 (this device) | K082140 | Xpert Mrsa/SA Blood Culture Assay | Cepheid | 2008 | — |
| +1 | K101879 | Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10 | Cepheid | 2010 | 1 |
| +2 | K130894 | Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV… | Cepheid | 2013 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 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? (6)
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 |
|---|---|---|---|
| * | K071026 | BD Geneohm Staphsr AssaySummary page 3…require independent validation. Substantial Equivalence: The Xpert MRSA/SA Blood Culture Assay is substantially equivalent to the BD GeneOhm TM StaphSR Assay (5 10(k) #k071026). Both assays detect SA and MRSA from positive blood cultures and determine the presence of the target organisms through real-tim… | 2007 |
| * | K851949 | Staphaurex ZL30Summary page 1…M TM StaphSR Assay (5 10(k) 1107 1026), Remel Staphaurex Latex Agglutination Test (5 10(k) #k851949), BBL (BD) Oxacillin Screen Agar (510(k) #k863 82 1),… | 1985 |
| * | K863821 | Mueller Hinton Agar W/4%Nacl and OxacillinSummary page 1…haurex Latex Agglutination Test (5 10(k) #k851949), BBL (BD) Oxacillin Screen Agar (510(k) #k863 82 1), BD BBL CHROMagar MRSA (5 10(k) #k042812 BD Phoeni… | 1986 |
| * | K042812 | Bblchromagar MrsaSummary page 1…51949), BBL (BD) Oxacillin Screen Agar (510(k) #k863 82 1), BD BBL CHROMagar MRSA (5 10(k) #k042812 BD Phoenix Automated Microbiology ID/AST System (5… | 2004 |
| * | K020322 | BD Phoenix Automated Microbiology SystemSummary page 1…CHROMagar MRSA (5 10(k) #k042812 BD Phoenix Automated Microbiology ID/AST System (5 10(k) #k020322 and #k02330 1). Device Description: The Cepheid XpertTm MRSA/SA Blood Culture Assay (Xpert MRSA/SA Blood Culture Assay) is a r… | 2002 |
| * | K023301 | BD Phoenix Automated Microbiology SystemSummary page 1…SA (5 10(k) #k042812 BD Phoenix Automated Microbiology ID/AST System (5 10(k) #k020322 and #k02330 1). Device Description: The Cepheid XpertTm MRSA/SA Blood Culture Assay (Xpert MRSA/SA Blood Culture Assay) is a rapid, automate… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101879 | Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10 | 2010 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 17, 2011 | Not classified | Z-0453-2012 | Nonconforming Material/Component | Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the Xpert MRSA/SA BC (blood culture) product. |
| Apr 5, 2010 | Not classified | Z-1898-2010 | Nonconforming Material/Component | The firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill patients. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K101879 (Cepheid, 2010) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K071026.
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 TM MRSA/SA Blood Culture Assay performed on the GeneXpert® Dx SystemTM is a qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA directly from patient 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 (144 words)
The Cepheid Xpert TM MRSA/SA Blood Culture Assay performed on the GeneXpert® Dx SystemTM is a qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA directly from patient 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 specimens using BD BACTECTM Plus Aerobic/F 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 Cepheid Xpert TM MRSA/SA Blood Culture Assay is not intended to monitor treatment for MRSA/SA infections. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing or for epidemiological typing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082140: Xpert Mrsa/SA Blood Culture Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082140
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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