510(k) · Cleared
ClearedBD Geneohm Staphsr Assay
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 Dec 20, 2007 as substantially equivalent to K851949 (Wellcome Diagnostics, 1985) and 4 other predicates after a 253-day review. Its family tree reaches back 2 generations to 2002. 9 later devices descend from it.
- Decided
- Dec 20, 2007
- Review
- 253 days
- Class
- Class II
- Product code
- NQX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K020322 (2002). 7 ancestors in all, the oldest K851949 (1985). 9 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK020322 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
- 1 generation backK023301 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002 · Recalled
- This deviceK071026 BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 2007
- Descendant · cites it directly · 3 of its ownK082140 Xpert Mrsa/SA Blood Culture AssayCepheid · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK101879 Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10Cepheid · 2010 · Recalled
- Descendant · cites it directly · 1 of its ownK130894 Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I…Cepheid · 2013
- Descendant · cites it directly · 1 of its ownK102342 Keypath (TM) Mrsa/Mssa Blood Culture Test- BTMicrophage, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK080837 Xpert Mrsa/SA Ssti AssayCepheid · 2008
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K082140Xpert Mrsa/SA Blood Culture AssayCepheid · 2008 · cites it directly3descendants
- K101879Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10Cepheid · 2010 · 2 generations on2descendants
- K130894Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV, GX-Xvi)…Cepheid · 2013 · cites it directly1descendant
- K102342Keypath (TM) Mrsa/Mssa Blood Culture Test- BTMicrophage, Inc. · 2011 · cites it directly1descendant
- K080837Xpert Mrsa/SA Ssti AssayCepheid · 2008 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020322 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | — |
| −1 | K023301 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | 2 |
| 0 (this device) | K071026 | BD Geneohm Staphsr Assay | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2007 | — |
| +1 | 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 | — |
| +1 | K102342 | Keypath (TM) Mrsa/Mssa Blood Culture Test- BT | Microphage, Inc. | 2011 | — |
| +1 | K080837 | Xpert Mrsa/SA Ssti Assay | Cepheid | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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? (5)
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 |
|---|---|---|---|
| * | K851949 | Staphaurex ZL30Summary page 1…resistant markers, Staphylococcus colonies Predicate Device: Performance: Remel Staphaurex Latex Agglutination Test (K851949) BBL (BD) Oxacillin Screen Agar (K(863821) BO Phoenix A… | 1985 |
| * | K863821 | Mueller Hinton Agar W/4%Nacl and OxacillinSummary page 2…lent in performance to the Remel Staphaurex Latex Agglutination Test (K851949) for detection of Staphylococcus aureus; the culture medium BBL (BD) Oxacillin Screen Agar (K863821) for detection of methicillin-resistant Staphylococcus aureus; and the BD Phoenix Automated ID/AST System (K020322, K023301) for… | 1986 |
| * | K020322 | BD Phoenix Automated Microbiology SystemSummary page 2…us; the culture medium BBL (BD) Oxacillin Screen Agar (K863821) for detection of methicillin-resistant Staphylococcus aureus; and the BD Phoenix Automated ID/AST System (K020322, K023301) for detection of both Staphylococcus aureus and methicillin-resistant Staphylococcus aureus. These methods were used as… | 2002 |
| * | K023301 | BD Phoenix Automated Microbiology SystemSummary page 1…BBL (BD) Oxacillin Screen Agar (K(863821) BO Phoenix Automated ID/AST System (1(020322, K023301) Technology: Gene~hm Sciences Canada BID Geneoh MTM MRSA Assa… | 2002 |
| * | K042357 | Idi-Mrsa AssaySummary page 1…) Technology: Gene~hm Sciences Canada BID Geneoh MTM MRSA Assay (K042357) Device Description: Intended Use: The BID GeneohM TM StaphSR Assay is a qualitative in vitro diagnostic test for the rapid det… | 2004 |
What descends from it? (9)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082140 | Xpert Mrsa/SA Blood Culture Assay | 2008 | 3 |
| K130894 | Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV, GX-Xvi)… | 2013 | 1 |
| K102342 | Keypath (TM) Mrsa/Mssa Blood Culture Test- BT | 2011 | 1 |
| K080837 | Xpert Mrsa/SA Ssti Assay | 2008 | 1 |
| K132822 | BD Max Staphsr Assay, Instrument | 2013 | 0 |
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 5 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K082140 (Cepheid, 2008) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K851949.
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. 2007, 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 GeneOhmTM StaphSR Assay is a qualitative in vitro diagnostic test for the rapid detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) directly from positive blood culture. The assay utilizes polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the real-time detection of the amplified DNA. The assay is performed on Gram positive cocci, identified by Gram stain, from positive blood cultures. The BD GeneOhmTM StaphSR Assay is not intended to monitor treatment for MRSA/SA infections. Subculturing of positive blood cultures is necessary for further susceptibility testing.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K071026 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071026: BD Geneohm Staphsr Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071026
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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