DHX · System, Test, Carcinoembryonic Antigen
Immunology · 21 CFR 866.6010 · Class 2
Overview
| Product Code | DHX |
|---|---|
| Device Name | System, Test, Carcinoembryonic Antigen |
| Regulation | 21 CFR 866.6010 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.
Classification Rationale
Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
Special Controls
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
Recent Cleared Devices (20 of 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K223921 | Access CEA | Beckman Coulter, Inc. | Sep 22, 2023 | SESE |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent Pack | Ortho Clinical Diagnostics | Aug 23, 2023 | SESE |
| K200215 | ADVIA Centaur CEA Assay | Siemens Healthcare Disgnostics, Inc. | Apr 13, 2020 | SESE |
| K081615 | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN | Olympus America, Inc. | Mar 18, 2009 | SESE |
| K080194 | VIDAS CEA (S) ASSAY | bioMerieux, Inc. | Oct 9, 2008 | SESE |
| K071603 | DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) | Dade Behring, Inc. | Jun 25, 2008 | SESE |
| K041322 | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | Jun 17, 2004 | SESE |
| K031270 | ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | May 6, 2003 | SESE |
| K023893 | ST AIA-PACK CEA ENZYME IMMUNOASSAY | Tosoh Medics, Inc. | Dec 18, 2002 | SESE |
| K013568 | CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Corp. | Dec 21, 2001 | SESE |
| K991707 | MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 | Beckman | Jun 1, 1999 | SESE |
| K990943 | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK | Ortho-Clinical Diagnostics, Inc. | Jun 1, 1999 | SESE |
| K990774 | ABBOTT ARCHITECT CEA | Abbott Laboratories | May 11, 1999 | SESE |
| K981985 | ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 | Beckman Coulter, Inc. | Sep 24, 1998 | SESE |
| K981478 | ACS:CENTAUR CEA | Chiron Diagnostics Corp. | Aug 12, 1998 | SESE |
| K980887 | ELECSYS CEA ON THE ELECSYS 1010 | Boehringer Mannheim Corp. | Jun 29, 1998 | SESE |
| K980855 | IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT | Dpc Cirrus | Apr 21, 1998 | SESE |
| K970877 | IMMULITE CEA | Diagnostic Products Corp. | Sep 22, 1997 | SESE |
| K924857 | AIA-PACK CEA CALIBRATION VERIFICATION TEST SET | Tosoh Medics, Inc. | Mar 18, 1993 | SESE |
| K864877 | TRI-LEVEL LIGAND CONTROL | Ciba Corning Diagnostics Corp. | May 21, 1987 | SESE |
Top Applicants
- Beckman Coulter, Inc. — 3 clearances
- Ortho-Clinical Diagnostics, Inc. — 2 clearances
- Tosoh Medics, Inc. — 2 clearances
- Abbott Laboratories — 1 clearance
- Amicon, Inc. — 1 clearance
