510(k) · Cleared
ClearedOxoid PBP2 1 Latex Agglutination Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxoid, Ltd. · MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Cleared on Apr 2, 2002 after a 302-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 25 later devices descend from it.
- Decided
- Apr 2, 2002
- Review
- 302 days
- Class
- Class II
- Product code
- MYI
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 5 citing it directly.
- This deviceK011710 Oxoid PBP2 1 Latex Agglutination TestOxoid, Ltd. · 2002
- Descendant · cites it directly · 14 of its ownK033415 Idi-MrsaInfectio Diagnostic (I.D.I.), Inc. · 2004 · Recalled
- Descendant · 2 generations on · 10 of its ownK070462 Xpert MrsaCepheid · 2007 · Recalled
- Descendant · 3 generations on · 7 of its ownK093346 BD Geneohm Mrsa Acp AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2009 · Recalled
- Descendant · 4 generations on · 4 of its ownK120138 BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc) · 2012 · Recalled
- Descendant · cites it directly · 4 of its ownK091766 Clearview Exact PBP2A Test, Model 891-000Binax, Inc. · 2010
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K033415Idi-MrsaInfectio Diagnostic (I.D.I.), Inc. · 2004 · cites it directly14descendants
- K070462Xpert MrsaCepheid · 2007 · 2 generations on10descendants
- K093346BD Geneohm Mrsa Acp AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2009 · 3 generations on7descendants
- K120138BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc) · 2012 · 4 generations on4descendants
- K091766Clearview Exact PBP2A Test, Model 891-000Binax, Inc. · 2010 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011710 | Oxoid PBP2 1 Latex Agglutination Test | Oxoid, Ltd. | 2002 | — |
| +1 | K033415 | Idi-Mrsa | Infectio Diagnostic (I.D.I.), Inc. | 2004 | 1 |
| +2 | K070462 | Xpert Mrsa | Cepheid | 2007 | 1 |
| +3 | K093346 | BD Geneohm Mrsa Acp Assay | Bd Diagnostics (Geneohm Sciences, Inc.) | 2009 | 2 |
| +4 | K120138 | BD Max Mrsa Assay, BD Max Instrument | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2012 | 4 |
| +1 | K091766 | Clearview Exact PBP2A Test, Model 891-000 | Binax, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MYI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (25)
See all 255 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033415 (Infectio Diagnostic (I.D.I.), Inc., 2004) has gone furthest, with 14 descendants of its own.
How does its category compare?
All MYI devicesMYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MYI
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · MYI
Too few MYI 510(k)s in any year since 2007 to give a median.
Recalls per year · MYI
No recall names MYI since 2007.
Adverse event reports per year · MYI
2in 2023
MAUDE reports naming product code MYI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This Kit detects penicillin binding protein 2' in isolates of Staphylococcus as an aid in identifying
Methicillin Resistant Staphylococcus aureus (MRSA) and methicillin resistant coagulase-negative staphylococci.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011710: Oxoid PBP2 1 Latex Agglutination Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011710
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026