510(k) · Cleared
ClearedAlere PBP2A SA/Cons Culture Colony Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alere Scarborough, Inc. · MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Cleared on Sep 3, 2014 as substantially equivalent to K011710 (Oxoid, Ltd., 2002) after a 258-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Sep 3, 2014
- Review
- 258 days
- Class
- Class II
- Product code
- MYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011710 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK011710 Oxoid PBP2 1 Latex Agglutination TestOxoid, Ltd. · 2002
- This deviceK133851 Alere PBP2A SA/Cons Culture Colony TestAlere Scarborough, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011710 | Oxoid PBP2 1 Latex Agglutination Test | Oxoid, Ltd. | 2002 | — |
| 0 (this device) | K133851 | Alere PBP2A SA/Cons Culture Colony Test | Alere Scarborough, Inc. | 2014 | — |
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 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? (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 |
|---|---|---|---|
| * | K011710 | Oxoid PBP2 1 Latex Agglutination TestSummary page 4…taphylococcus Colonies (per 21 CFR 866.1640) CLASSIFICATION Class II PRODUCT CODE MYI PANEL Microbiology (83) PREDICATE DEVICE Oxoid PBP2’ Latex Agglutination Test (#K011710) Alere™ PBP2a SA Culture Colony Test Page 1 of 5 510k k133851 === Page… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K011710.
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. 2014, this device’s year, is highlighted.
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?
The Alere™ PBP2a SA Culture Colony Test is a qualitative, in vitro immunochromatographic assay for the rapid
detection of penicillin-binding protein 2a (PBP2a) in isolates identified as Staphylococcus aureus as an aid in identifying
methicillin-resistant Staphylococcus aureus (MRSA).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133851: Alere PBP2A SA/Cons Culture Colony Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133851
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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