Product Code: DHX
FDA class 2
21 CFR 866.6010
System, Test, Carcinoembryonic Antigen
Immunology
The Carcinoembryonic Antigen (CEA) Test System is a diagnostic immunoassay used to detect and measure carcinoembryonic antigen in blood, a tumor marker used in monitoring certain cancers, particularly colorectal cancer, and assessing treatment response. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 866.6010 within the Immunology specialty. This device qualifies for third-party 510(k) review.
510(k)s
28
FEI Numbers
30
Registration Numbers
30
Unique Applicants
25
Years Active
43
Basic Information
- Product Code
- DHX
- Device Class
- FDA class 2
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 28 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K223921 | Access CEA | Sep 22, 2023 | Substantially Equivalent | Beckman Coulter, Inc |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent Pack | Aug 23, 2023 | Substantially Equivalent | Ortho Clinical Diagnostics |
| K200215 | ADVIA Centaur CEA Assay | Apr 13, 2020 | Substantially Equivalent | Siemens Healthcare Disgnostics Inc. |
| K081615 | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN | Mar 18, 2009 | Substantially Equivalent | OLYMPUS AMERICA, INC. |
| K080194 | VIDAS CEA (S) ASSAY | Oct 09, 2008 | Substantially Equivalent | BIOMERIEUX, INC. |
| K071603 | DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) | Jun 25, 2008 | Substantially Equivalent | DADE BEHRING, INC. |
| K041322 | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS | Jun 17, 2004 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
| K031270 | ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS | May 06, 2003 | Substantially Equivalent | BECKMAN COULTER, INC. |
| K023893 | ST AIA-PACK CEA ENZYME IMMUNOASSAY | Dec 18, 2002 | Substantially Equivalent | TOSOH MEDICS, INC. |
| K013568 | CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Dec 21, 2001 | Substantially Equivalent | BAYER CORP. |
| K991707 | MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 | Jun 01, 1999 | Substantially Equivalent | BECKMAN |
| K990943 | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK | Jun 01, 1999 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
| K990774 | ABBOTT ARCHITECT CEA | May 11, 1999 | Substantially Equivalent | ABBOTT LABORATORIES |
| K981985 | ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 | Sep 24, 1998 | Substantially Equivalent | BECKMAN COULTER, INC. |
| K981478 | ACS:CENTAUR CEA | Aug 12, 1998 | Substantially Equivalent | CHIRON DIAGNOSTICS CORP. |
| K980887 | ELECSYS CEA ON THE ELECSYS 1010 | Jun 29, 1998 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K980855 | IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT | Apr 21, 1998 | Substantially Equivalent | DPC CIRRUS |
| K970877 | IMMULITE CEA | Sep 22, 1997 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K924857 | AIA-PACK CEA CALIBRATION VERIFICATION TEST SET | Mar 18, 1993 | Substantially Equivalent | TOSOH MEDICS, INC. |
| K864877 | TRI-LEVEL LIGAND CONTROL | May 21, 1987 | Substantially Equivalent | CIBA CORNING DIAGNOSTICS CORP. |
| K833318 | NORMAL GOAT SERUM | Jan 03, 1984 | Substantially Equivalent | BIOSAN LABORATORIES, INC. |
| K820298 | CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV | Apr 08, 1982 | Substantially Equivalent | VENTREX LABORATORIES, INC. |
| K812658 | CEA CONTROL PLASMA | Sep 29, 1981 | Substantially Equivalent | PACIFIC HEMOSTASIS |
| K810459 | THREE LEVEL CONTROL SERA | Aug 03, 1981 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K811394 | CEA DESALTING DOLUMN SEPHADEX R | Jun 12, 1981 | Substantially Equivalent | IMMUNO-DIAGNOSTIC LABORATORIES |
| K810810 | AMICON ULTRAFILTRATION MEMBRANES CMII | Apr 17, 1981 | Substantially Equivalent | AMICON, INC. |
| K801306 | CLINETICS PCA COLUMN | Sep 26, 1980 | Substantially Equivalent | CLINETICS CORP. |
| K792377 | CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL | Sep 26, 1980 | Substantially Equivalent | ENVIRONMENTAL CHEMICAL SPECIALTIES |
FEI Numbers
This FDA classification entry is associated with 30 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.