Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LOJ — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
272 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220176 | Elecsys AFP | Roche Diagnostics | 2022-09-15 | 237 | 0 |
| K213626 | VITROS AFP | Ortho Clinical Diagnostics | 2022-06-15 | 210 | 0 |
| K090236 | DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 | Siemens Healthcare Diagnostics | 2009-04-27 | 84 | 0 |
| K081709 | OLYMPUS AFP - ALPHA-FETOPROTEIN | Olympus Life Science Research Europa GmbH (Europa) | 2009-03-16 | 272 | 0 |
| K080017 | VIDAS AFP ASSAY | bioMerieux, Inc. | 2008-09-26 | 267 | 0 |
| K071597 | DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K64 | Dade Behring, Inc. | 2008-06-04 | 358 | 0 |
| K023894 | ST AIA-PACK AFP ENZYME IMMUNOASSAY | Tosoh Medics, Inc. | 2002-12-17 | 25 | 0 |
| K020807 | AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-10-01 | 203 | 0 |
| K020806 | ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY | Bayer Corp. | 2002-03-27 | 15 | 0 |
| K990138 | DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 | Diagnostic Systems Laboratories, Inc. | 1999-06-21 | 153 | 0 |
| K983031 | VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY | Ortho-Clinical Diagnostics, Inc. | 1998-12-18 | 109 | 0 |
| K983263 | IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L | Diagnostic Products Corp. | 1998-12-07 | 81 | 0 |
| K981282 | ELECSYS AFP | Roche Diagnostics GmbH | 1998-05-01 | 23 | 0 |
| K981354 | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL | Beckman Instruments, Inc. | 1998-05-01 | 17 | 1 |
| K973351 | ELECSYS AFP | Boehringer Mannheim Corp. | 1997-11-21 | 77 | 0 |
| K972462 | AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | 1997-09-22 | 83 | 0 |
| K851891 | TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS | Richard Scott Elliott | 1985-07-19 | 80 | 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