Product code MOI
- Device name
- System, Test, Immunological, Antigen, Tumor
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.6010
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240403 | Access BR Monitor | Beckman Coulter, Inc. | 2024-05-09 |
| K233946 | IMMULITE® 2000 BR-MA | Siemens Healthcare Diagnostics Products, Ltd. | 2024-03-13 |
| K192524 | Lumipulse G CA15-3 | Fujirebio Diagnostics,Inc. | 2020-09-04 |
| K193489 | ADVIA Centaur BR | Siemens Healthcare Diagnostics, Inc. | 2020-02-13 |
| K192777 | ADVIA Centaur CA 15-3 assay | Siemens Healthcare Diagnostics, Inc. | 2019-11-22 |
| K181492 | Elecsys CA 15-3 II | Roche Diagnostics | 2018-06-22 |
| K171605 | Elecsys CA 15-3 II | Roche Diagnostics | 2018-02-20 |
| K100344 | DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 | Siemens Healthcare Diagnostics | 2011-04-18 |
| K072612 | ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 | Beckman Coulter, Inc. | 2007-10-26 |
| K042732 | ARCHITECT CA 15-3 ASSAY | Fujirebio Diagnostics,Inc. | 2004-12-22 |
| K033036 | BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 | Beckman Coulter, Inc. | 2004-02-03 |
| K022178 | CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-11-12 |
| K013984 | IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR | Diagnostic Products Corp. | 2002-03-28 |
| K012357 | CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM | Bayer Diagnostics Corp. | 2002-02-28 |
| K010796 | AIA-PACK BRCA, ST AIA PACK BRCA | Tosoh Medics, Inc. | 2001-08-16 |
| K010588 | ELECSYSCA 15-3 II ASSAY | Roche Diagnostics Corp. | 2001-03-28 |
| K001468 | ELECSYS CA 15-3 TEST SYSTEM | Roche Diagnostics Corp. | 2000-10-23 |
| K983690 | VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK | Ortho-Clinical Diagnostics, Inc. | 1999-02-02 |
| K982680 | CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY | Chiron Diagnostics Corp. | 1998-10-15 |
| K981698 | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) | Chiron Corp. | 1998-07-10 |
| K980190 | ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM) | Chiron Corp. | 1998-03-06 |
| K964703 | THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | 1997-12-01 |
| K964407 | IMX CA 15-3 | Abbott Laboratories | 1997-11-10 |
| K965141 | TRUQUANT BR RIA | Biomira USA, Inc. | 1997-10-31 |
| K963926 | AXSYM CA 15-3 | Abbott Laboratories | 1997-09-15 |
| K970695 | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) | Chiron Diagnostics Corp. | 1997-08-08 |
| K971418 | CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER | Chiron Diagnostics Corp. | 1997-07-17 |
| K963803 | CENTOCOR CA 15-3 RIA MODEL NO. 800-033 | Centocor, Inc. | 1997-05-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04560189210172 | ST AIA-PACK 27.29 | TOSOH CORPORATION | 2026-02-02 |
| 14560189212081 | ST AIA-PACK 27.29 | TOSOH CORPORATION | 2026-02-02 |
| 07613336218334 | Elecsys CA 15-3 II | Roche Diagnostics GmbH | 2024-07-30 |
| 00630414293479 | Atellica IM BR | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00630414293486 | Atellica IM BR Calibrator | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00630414293509 | Atellica IM CA 15-3 | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00630414294063 | Atellica IM CA 15-3 | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00630414294056 | Atellica IM BR Calibrator | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00630414294049 | Atellica IM BR | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00816870022185 | CA 15-3 AccuLite CLIA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022178 | CA 15-3 AccuLite CLIA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870020501 | CA 15-3 AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870020495 | Monobind AccuBind CA 15-3 ELISA Kit - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 04015630939961 | Elecsys CA 15-3 II | Roche Diagnostics GmbH | 2018-03-15 |
| 04251269200144 | Pin Type Socket Wrench | Noras MRI products GmbH | 2017-09-13 |
| 04251269200632 | Bore Gauge Alpha Maquet Plus EU | Noras MRI products GmbH | 2017-09-06 |
| 04251269200595 | Head Holder Flexibility | Noras MRI products GmbH | 2017-09-06 |
| 04251269200601 | Back Cushion Flexibility Maquet | Noras MRI products GmbH | 2017-09-06 |
| 04251269200625 | Bore Gauge Alpha Maquet Plus US | Noras MRI products GmbH | 2017-09-06 |
| 14560189210179 | ST AIA-PACK 27.29 | TOSOH CORPORATION | 2016-09-24 |
| 04015630934379 | Elecsys CA 153 II Assay | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630918225 | Elecsys CA 153 II CalSet | Roche Diagnostics GmbH | 2016-09-20 |
| 15099590231859 | Access BR Monitor | Beckman Coulter, Inc. | 2016-09-09 |
| 10758750001323 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |
| 10758750000531 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |
| 00380740003357 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740003340 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740003333 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740003326 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740003319 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |