510(k) · Cleared
Recalled · Class II · 2012BD Geneohm Mrsa Acp Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Diagnostics (Geneohm Sciences, Inc.) · NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Cleared on Dec 15, 2009 as substantially equivalent to K042357 (Infectio Diagnostic (I.D.I.), Inc., 2004) and 1 other predicate after a 50-day review. Its family tree reaches back 3 generations to 1985. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 15, 2009
- Review
- 50 days
- Class
- Class II
- Product code
- NQX
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K850291 (1985). 5 ancestors in all. 7 later devices descend from it, 2 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 deviceK093346 BD Geneohm Mrsa Acp AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2009
- Descendant · cites it directly · 4 of its ownK120138 BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc) · 2012 · Recalled
- Descendant · 2 generations on · 2 of its ownK133605 BD Max Mrsa XT, BD Max InstrumentGeneohm Sciences Canada, Inc. · 2013 · Recalled
- Descendant · cites it directly · 1 of its ownK112937 Mrsa/SA Elite MGBElitech · 2012
- Descendant · 3 generations on · 0 of its ownK191742 ARIES MRSA AssayLuminex Corporation · 2019
- Descendant · 3 generations on · 0 of its ownK162444 Xpert MRSA NxGCepheid · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K120138BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc) · 2012 · cites it directly4descendants
- K133605BD Max Mrsa XT, BD Max InstrumentGeneohm Sciences Canada, Inc. · 2013 · 2 generations on2descendants
- K112937Mrsa/SA Elite MGBElitech · 2012 · cites it directly1descendant
- K191742ARIES MRSA AssayLuminex Corporation · 2019 · 3 generations on0descendants
- K162444Xpert MRSA NxGCepheid · 2016 · 3 generations on0descendants
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) | K093346 | BD Geneohm Mrsa Acp Assay | Bd Diagnostics (Geneohm Sciences, Inc.) | 2009 | — |
| +1 | K120138 | BD Max Mrsa Assay, BD Max Instrument | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2012 | 4 |
| +2 | K133605 | BD Max Mrsa XT, BD Max Instrument | Geneohm Sciences Canada, Inc. | 2013 | 1 |
| +1 | K112937 | Mrsa/SA Elite MGB | Elitech | 2012 | — |
| +3 | K191742 | ARIES MRSA Assay | Luminex Corporation | 2019 | — |
| +3 | K162444 | Xpert MRSA NxG | Cepheid | 2016 | — |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 3 | 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? (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 |
|---|---|---|---|
| * | K042357 | Idi-Mrsa AssaySummary page 1…866.1640 Product Code: NQX Classification advisory committee: Microbiology Predicate Devices: BID Gene~hM T M MRSA Assay (K042357) Cepheid Xpert MRSA Assay (K070462) Device Description: Intended Use: The BD Gene~hmT MRS… | 2004 |
| * | K070462 | Xpert MrsaSummary page 1…isory committee: Microbiology Predicate Devices: BID Gene~hM T M MRSA Assay (K042357) Cepheid Xpert MRSA Assay (K070462) Device Description: Intended Use: The BD Gene~hmT MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct det… | 2007 |
What descends from it? (7)
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 |
|---|---|---|---|---|
| May 22, 2012 | Class II | Z-2316-2012 | Nonconforming Material/Component | Leakage in Cepheid SmartCycler reaction tubes. |
| May 22, 2012 | Class II | Z-2317-2012 | Nonconforming Material/Component | Leakage in Cepheid SmartCycler reaction tubes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K120138 (Bd Diagnostics (Geneohm Sciences Canada, Inc), 2012) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K042357.
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. 2009, 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 BID GeneOh M TM MRSA ACP Assay is a 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 polymerase chain reaction (POR) for the amplification of MRSA DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. The BID GeneOh M TM MRSA ACP Assay is intended to aid in the…
Read the full statement (116 words)
The BID GeneOh M TM MRSA ACP Assay is a 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 polymerase chain reaction (POR) for the amplification of MRSA DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. The BID GeneOh M TM MRSA ACP Assay is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections.
Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093346 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093346: BD Geneohm Mrsa Acp Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093346
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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