510(k) · Cleared
ClearedClearview Exact PBP2A Test, Model 891-000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Binax, Inc. · MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Cleared on Feb 24, 2010 as substantially equivalent to K850291 (Remel Co., 1985) and 1 other predicate after a 252-day review. Its family tree reaches back 1 generation to 1985. 4 later devices descend from it.
- Decided
- Feb 24, 2010
- Review
- 252 days
- Class
- Class II
- Product code
- MYI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K850291 (1985). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK850291 Mueller Hinton Agar W/4% Nacl W/AntibioticsRemel Co. · 1985 · Recalled
- This deviceK091766 Clearview Exact PBP2A Test, Model 891-000Binax, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK162385 Rapidec Carba NPBiomerieux S.A. · 2017
- Descendant · 2 generations on · 1 of its ownK191889 NG-Test CARBA 5Ng Biotech · 2019
- Descendant · 3 generations on · 0 of its ownK243499 NG-Test® CTX-M MULTINg Biotech · 2025
- Descendant · cites it directly · 0 of its ownK121905 Alere PBP2A TestAlere Scarborough, Inc. · 2012
Most influential descendants
Showing 4 of 4 · See all- K162385Rapidec Carba NPBiomerieux S.A. · 2017 · cites it directly2descendants
- K191889NG-Test CARBA 5Ng Biotech · 2019 · 2 generations on1descendant
- K243499NG-Test® CTX-M MULTINg Biotech · 2025 · 3 generations on0descendants
- K121905Alere PBP2A TestAlere Scarborough, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K850291 | Mueller Hinton Agar W/4% Nacl W/Antibiotics | Remel Co. | 1985 | 2 |
| 0 (this device) | K091766 | Clearview Exact PBP2A Test, Model 891-000 | Binax, Inc. | 2010 | — |
| +1 | K162385 | Rapidec Carba NP | Biomerieux S.A. | 2017 | — |
| +2 | K191889 | NG-Test CARBA 5 | Ng Biotech | 2019 | — |
| +3 | K243499 | NG-Test® CTX-M MULTI | Ng Biotech | 2025 | — |
| +1 | K121905 | Alere PBP2A Test | Alere Scarborough, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K850291 | Mueller Hinton Agar W/4% Nacl W/AntibioticsSummary page 1…Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies (MYI) (per 21 CFR 866.1640) PREDICATE DEVICES Mueller Hinton Agar w/4% NaCI w/Antibiotics (Remel) K850291 PBP2' Latex Agglutination Test (Oxoid) K01 171 0 DEVICE DESCRIPTION The Clearview® Exact PBP2a Test is a rapid immunochromatogra… | 1985 |
| * | K011710 | Oxoid PBP2 1 Latex Agglutination TestSummary page 1…Staphylococcus Colonies (MYI) (per 21 CFR 866.1640) PREDICATE DEVICES Mueller Hinton Agar w/4% NaCI w/Antibiotics (Remel) K850291 PBP2' Latex Agglutination Test (Oxoid) K01 171 0 DEVICE DESCRIPTION The Clearview® Exact PBP2a Test is a rapid immunochromatographic membrane assay that uses highly sensitive mo… | 2002 |
What descends from it? (4)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2010, 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 Clearview® Exact PBP2a Test is a qualitative, in vitro immunochromatographic assay for the detection of penicillin-binding protein 2a (FBP2a) in isolates identified as Staphylococcus aureus, as an aid in detecting methicillin-resistant Staphylococcus aureus (MRA) The Clearview® Exact 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/K091766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091766: Clearview Exact PBP2A Test, Model 891-000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091766
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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