510(k) · Cleared
ClearedAlere PBP2A 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 Jul 26, 2012 as substantially equivalent to K091766 (Binax, Inc., 2010) after a 27-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Jul 26, 2012
- Review
- 27 days
- Class
- Class II
- Product code
- MYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K850291 (1985). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850291 | Mueller Hinton Agar W/4% Nacl W/Antibiotics | Remel Co. | 1985 | 2 |
| −1 | K091766 | Clearview Exact PBP2A Test, Model 891-000 | Binax, Inc. | 2010 | — |
| 0 (this device) | K121905 | Alere PBP2A Test | Alere Scarborough, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 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 |
|---|---|---|---|
| * | K091766 | Clearview Exact PBP2A Test, Model 891-000Summary page 1…, Resistant Markers, Staphylococcus Colonies (per 21 CER 866.1640) CLASSIFICATION Class 11 PRODUCT CODE MY1 PANEL Microbiology PREDICATE DEVICES Alere' M PBP2a Test, K09 1766 Alere PBP2a Test Page 16 Special 510(k)… | 2010 |
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 24.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K091766.
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. 2012, 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 M PBP2a Test is a qualitative, in vitro immunochromatographic assay for the detection of penicillin-binding protein 2a (PBP2a) in isolates identified as Staphylococcus aureus, as an aid in detecting methicillin-resistant Staphylococcus aureus (MRSA). The Alere M PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121905: Alere PBP2A Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121905
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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