Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DHX — Predicate Candidate Screening
28 FDA 510(k) clearances under this product code; the 50 most recent screened below.
99 daysmedian FDA review time
282 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223921 | Access CEA | Beckman Coulter, Inc. | 2023-09-22 | 267 | 0 |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent Pack | Ortho Clinical Diagnostics | 2023-08-23 | 90 | 0 |
| K200215 | ADVIA Centaur CEA Assay | Siemens Healthcare Disgnostics, Inc. | 2020-04-13 | 76 | 0 |
| K081615 | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN | Olympus America, Inc. | 2009-03-18 | 282 | 0 |
| K080194 | VIDAS CEA (S) ASSAY | bioMerieux, Inc. | 2008-10-09 | 258 | 0 |
| K071603 | DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRI | Dade Behring, Inc. | 2008-06-25 | 379 | 0 |
| K041322 | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR | Ortho-Clinical Diagnostics, Inc. | 2004-06-17 | 30 | 0 |
| K031270 | ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEM | Beckman Coulter, Inc. | 2003-05-06 | 15 | 1 |
| K023893 | ST AIA-PACK CEA ENZYME IMMUNOASSAY | Tosoh Medics, Inc. | 2002-12-18 | 26 | 0 |
| K013568 | CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Corp. | 2001-12-21 | 56 | 0 |
| K991707 | MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IM | Beckman | 1999-06-01 | 13 | 0 |
| K990943 | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMM | Ortho-Clinical Diagnostics, Inc. | 1999-06-01 | 71 | 0 |
| K990774 | ABBOTT ARCHITECT CEA | Abbott Laboratories | 1999-05-11 | 63 | 0 |
| K981985 | ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL | Beckman Coulter, Inc. | 1998-09-24 | 111 | 1 |
| K981478 | ACS:CENTAUR CEA | Chiron Diagnostics Corp. | 1998-08-12 | 110 | 0 |
| K980887 | ELECSYS CEA ON THE ELECSYS 1010 | Boehringer Mannheim Corp. | 1998-06-29 | 112 | 0 |
| K980855 | IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT | Dpc Cirrus | 1998-04-21 | 47 | 1 |
| K970877 | IMMULITE CEA | Diagnostic Products Corp. | 1997-09-22 | 196 | 3 |
| K924857 | AIA-PACK CEA CALIBRATION VERIFICATION TEST SET | Tosoh Medics, Inc. | 1993-03-18 | 171 | 0 |
| K864877 | TRI-LEVEL LIGAND CONTROL | Ciba Corning Diagnostics Corp. | 1987-05-21 | 160 | 0 |
| K833318 | NORMAL GOAT SERUM | Biosan Laboratories, Inc. | 1984-01-03 | 99 | 0 |
| K820298 | CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV | Ventrex Laboratories, Inc. | 1982-04-08 | 63 | 0 |
| K812658 | CEA CONTROL PLASMA | Pacific Hemostasis | 1981-09-29 | 11 | 0 |
| K810459 | THREE LEVEL CONTROL SERA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-08-03 | 164 | 0 |
| K811394 | CEA DESALTING DOLUMN SEPHADEX R | Immuno-Diagnostic Laboratories | 1981-06-12 | 25 | 0 |
| K810810 | AMICON ULTRAFILTRATION MEMBRANES CMII | Amicon, Inc. | 1981-04-17 | 24 | 0 |
| K801306 | CLINETICS PCA COLUMN | Clinetics Corp. | 1980-09-26 | 115 | 0 |
| K792377 | CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL | Environmental Chemical Specialties | 1980-09-26 | 305 | 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