510(k) · Cleared
Recalled · Class II · 2025BD Max Mrsa Assay, BD Max Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Diagnostics (Geneohm Sciences Canada, Inc) · NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Cleared on Jul 5, 2012 as substantially equivalent to K093346 (Bd Diagnostics (Geneohm Sciences, Inc.), 2009) after a 170-day review. Its family tree reaches back 4 generations to 1985. 4 later devices descend from it. It has been recalled 4 times.
- Decided
- Jul 5, 2012
- Review
- 170 days
- Class
- Class II
- Product code
- NQX
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 4 generations to K850291 (1985). 6 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- 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 backK093346 BD Geneohm Mrsa Acp AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2009 · Recalled
- This deviceK120138 BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc) · 2012
- Descendant · cites it directly · 2 of its ownK133605 BD Max Mrsa XT, BD Max InstrumentGeneohm Sciences Canada, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK191742 ARIES MRSA AssayLuminex Corporation · 2019
- Descendant · 2 generations on · 0 of its ownK162444 Xpert MRSA NxGCepheid · 2016
- Descendant · cites it directly · 0 of its ownK132822 BD Max Staphsr Assay, InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2013 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K133605BD Max Mrsa XT, BD Max InstrumentGeneohm Sciences Canada, Inc. · 2013 · cites it directly2descendants
- K191742ARIES MRSA AssayLuminex Corporation · 2019 · 2 generations on0descendants
- K162444Xpert MRSA NxGCepheid · 2016 · 2 generations on0descendants
- K132822BD Max Staphsr Assay, InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2013 · cites it directly0descendants
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 | K093346 | BD Geneohm Mrsa Acp Assay | Bd Diagnostics (Geneohm Sciences, Inc.) | 2009 | 2 |
| 0 (this device) | K120138 | BD Max Mrsa Assay, BD Max Instrument | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2012 | — |
| +1 | K133605 | BD Max Mrsa XT, BD Max Instrument | Geneohm Sciences Canada, Inc. | 2013 | 1 |
| +2 | K191742 | ARIES MRSA Assay | Luminex Corporation | 2019 | — |
| +2 | K162444 | Xpert MRSA NxG | Cepheid | 2016 | — |
| +1 | K132822 | BD Max Staphsr Assay, Instrument | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | K093346 | BD Geneohm Mrsa Acp AssaySummary page 1…d non- resistant markers, Staphylococcus colonies Predicate Device: Performance/ Technology BID GeneOhmTM MRSA ACP Assay (K093346) Device Description: Intended Use: The BD MAXTM MRSA Assay performed on the BID MAXTM System is an automated qualitative in vitr… | 2009 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2025 | Class II | Z-0238-2026 | Software design | Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may… |
| Oct 31, 2024 | Class II | Z-0590-2025 | Software design | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of… |
| Jul 17, 2019 | Class II | Z-2328-2019 | Process control | The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. |
| Jul 23, 2014 | Class II | Z-2618-2014 | Under Investigation by firm | The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains tested at extremely high concentrations (> 106 CFU/swab)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 5 of the 6 ancestors have a recall of any class.
- Of its descendants, K133605 (Geneohm Sciences Canada, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K093346.
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. 2012, 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 BD MAX™ MRSA Assay performed on the BD MAX™ System is an automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. The BD MAX™ MRSA…
Read the full statement (119 words)
The BD MAX™ MRSA Assay performed on the BD MAX™ System is an automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. The BD MAX™ MRSA Assay is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose, guide or monitor MRSA infections. A negative result does not preclude nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120138: BD Max Mrsa Assay, BD Max Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120138
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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