Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
MYI — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
252 daysmedian FDA review time
432 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140619 | MECA XPRESSFISH | Advandx, Inc. | 2014-10-10 | 213 | 0 |
| K133851 | ALERE PBP2A SA/CONS CULTURE COLONY TEST | Alere Scarborough, Inc. | 2014-09-03 | 258 | 0 |
| K121905 | ALERE PBP2A TEST | Alere Scarborough, Inc. | 2012-07-26 | 27 | 0 |
| K090301 | BINAXNOW PBP2A TEST, MODEL 890-000 | Binax, Inc. | 2010-04-14 | 432 | 0 |
| K091766 | CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 | Binax, Inc. | 2010-02-24 | 252 | 0 |
| K062864 | MASTALEX -MRSA, MODEL RST501 | Mast Group , Ltd. | 2006-10-18 | 23 | 0 |
| K011710 | OXOID PBP2 1 LATEX AGGLUTINATION TEST | Oxoid , Ltd. | 2002-04-02 | 302 | 0 |
| K011400 | MRSA-SCREEN | Denka Seiken'S | 2002-03-27 | 324 | 0 |
| K010858 | VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP | Id Biomedical Corp. | 2001-05-24 | 63 | 0 |
| K990640 | VELOGENE RAPID MRSA IDENTIFICATION ASSAY | Id Biomedical Corp. | 1999-07-09 | 133 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda