510(k) · Cleared
Recalled · Class II · 2019BD Max Staphsr Assay, Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geneohm Sciences Canada, Inc. (Bd Diagnostics) · NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Cleared on Nov 26, 2013 as substantially equivalent to K071026 (Bd Diagnostics (Geneohm Sciences Canada, Inc), 2007) and 1 other predicate after a 78-day review. Its family tree reaches back 5 generations to 1985. It has been recalled 2 times.
- Decided
- Nov 26, 2013
- Review
- 78 days
- Class
- Class II
- Product code
- NQX
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to K850291 (1985). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK850291 Mueller Hinton Agar W/4% Nacl W/AntibioticsRemel Co. · 1985 · Recalled
- 4 generations backK033415 Idi-MrsaInfectio Diagnostic (I.D.I.), Inc. · 2004 · Recalled
- 3 generations backK070462 Xpert MrsaCepheid · 2007 · Recalled
- 2 generations backK093346 BD Geneohm Mrsa Acp AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2009 · Recalled
- 1 generation backK120138 BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc) · 2012 · Recalled
- This deviceK132822 BD Max Staphsr Assay, InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K850291 | Mueller Hinton Agar W/4% Nacl W/Antibiotics | Remel Co. | 1985 | 2 |
| −4 | K033415 | Idi-Mrsa | Infectio Diagnostic (I.D.I.), Inc. | 2004 | 1 |
| −3 | K070462 | Xpert Mrsa | Cepheid | 2007 | 1 |
| −2 | K093346 | BD Geneohm Mrsa Acp Assay | Bd Diagnostics (Geneohm Sciences, Inc.) | 2009 | 2 |
| −1 | K120138 | BD Max Mrsa Assay, BD Max Instrument | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2012 | 4 |
| 0 (this device) | K132822 | BD Max Staphsr Assay, Instrument | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 2002 | 5 | 0 |
| 2004 | 1 | 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 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? (2)
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 1…001 Panel: Microbiology (83) Predicate Devices: 60D MAX TM MRSA and BID Gene~hm TM StaphSR Assay Predicate 510(k) Numbers: K120138 and K071026 Intended Use: The 80D MAXIM StaphSR assay performed on the BID MAXTM System is an automated qualitative in vitro diagnostic test… | 2007 |
| * | K120138 | BD Max Mrsa Assay, BD Max InstrumentSummary page 1…NQX, 001 Panel: Microbiology (83) Predicate Devices: 60D MAX TM MRSA and BID Gene~hm TM StaphSR Assay Predicate 510(k) Numbers: K120138 and K071026 Intended Use: The 80D MAXIM StaphSR assay performed on the BID MAXTM System is an automated qualitative in vitro dia… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 17, 2019 | Class II | Z-2333-2019 | Process control | The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. |
| Jul 17, 2019 | Class II | Z-2332-2019 | Process control | The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 9 of the 14 ancestors have a recall of any class.
- 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. 2013, 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 StaphSR assay performed on the BD MAX System is an automated qualitative in vitro diagnostic test for the direct detection and differentiation of Staphylococcus aureus (SA) and 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/SA DNA and fluorogenic target-specific hybridization probes for…
Read the full statement (134 words)
The BD MAX StaphSR assay performed on the BD MAX System is an automated qualitative in vitro diagnostic test for the direct detection and differentiation of Staphylococcus aureus (SA) and 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/SA DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. The BD MAX StaphSR assay is intended to aid in the prevention and control of MRSA and SA infections in healthcare settings. It is not intended to diagnose MRSA or SA infections nor guide or monitor treatment for MRSA/SA 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/K132822 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132822: BD Max Staphsr Assay, Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132822
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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