Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NIG — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
92 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack | Ortho Clinical Diagnostics | 2023-08-09 | 75 | 0 |
| K200997 | Lumipulse G CA19-9-N | Fujirebio Diagnostics,Inc. | 2020-05-14 | 28 | 0 |
| K191973 | Lumpipulse G CA19-9-N | Fujirebio Dianostics, Inc. | 2019-10-22 | 90 | 0 |
| K100375 | DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIM | Siemens Healthcare Diagnostics, Inc. | 2011-04-06 | 418 | 0 |
| K052889 | VITROS CA 19-9 | Fujirebio Diagnostics,Inc. | 2005-12-20 | 68 | 0 |
| K052000 | ARCHITECT CA 19-9XR ASSAY | Fujirebio Diagnostics,Inc. | 2005-10-25 | 92 | 1 |
| K033038 | GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOAS | Beckman Coulter, Inc. | 2003-12-29 | 91 | 1 |
| K031393 | BAYER ADVIA CENTAUR CA 19-9 ASSAY | Bayer Healthcare, LLC | 2003-06-24 | 53 | 6 |
| K023239 | AIA-PACK CA 19-9 | Tosoh Corp. | 2002-12-23 | 87 | 0 |
| K023240 | ST AIA-PACK CA 19-9 | Tosoh Corp. | 2002-12-23 | 87 | 0 |
| K020566 | FUJIREBIO DIAGNOSTICS CA 19-9 RIA | Fujirebio Diagnostics,Inc. | 2002-05-09 | 78 | 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