System, Test, Immunological, Antigen, Tumor
FDA product code MOI · Class II (moderate risk) · 21 CFR 866.6010 · Immunology
28510(k) clearances
0PMA approvals
14recalls
Manufacturers
- Roche Diagnostics Corp. 4
- Chiron Diagnostics Corp. 3
- Beckman Coulter Inc. 3
- Siemens Healthcare Diagnostics, Inc. 3
- Abbott Laboratories 2
- Chiron Corp. 2
- Bayer Diagnostics Corp. 2
- Fujirebio Diagnostics,Inc. 2
- Centocor, Inc. 1
- Biomira USA, Inc. 1
- Bayer Corp. 1
- Ortho-Clinical Diagnostics 1
- Tosoh Medics, Inc. 1
- Diagnostic Products Corp. 1
- Siemens Healthcare Diagnostics Products GmbH 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240403 | Access BR MonitorMOI · Traditional | Beckman Coulter, Inc. | 05/09/2024SE |
| K233946 | Immulite® 2000 Br-MaMOI · Traditional | Siemens Healthcare Diagnostics Products, Ltd. | 03/13/2024SE |
| K192524 | Lumipulse G CA15-3MOI · Traditional | Fujirebio Diagnostics,Inc. | 09/04/2020SE |
| K193489 | ADVIA Centaur BRMOI · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/13/2020SE |
| K192777 | ADVIA Centaur CA 15-3 assayMOI · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/22/2019SE |
| K181492 | Elecsys CA 15-3 IIMOI · Traditional | Roche Diagnostics | 06/22/2018SE |
| K171605 | Elecsys CA 15-3 IIMOI · Traditional | Roche Diagnostics | 02/20/2018SE |
| K100344 | Dimension Vista Loci Ca 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator…MOI · Traditional | Siemens Healthcare Diagnostics | 04/18/2011SE |
| K072612 | Access Immunoassay Systems BR Monitor, and Calibrators, Model(S) 387620,AND 387647MOI · Special | Beckman Coulter, Inc. | 10/26/2007SE |
| K042732 | Architect Ca 15-3 AssayMOI · Traditional | Fujirebio Diagnostics,Inc. | 12/22/2004SE |
| K033036 | BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620…MOI · Traditional | Beckman Coulter, Inc. | 02/03/2004SE |
| K022178 | Ca 15-3 Assay for the Advia Integrated Modular SystemMOI · Traditional | Bayer Diagnostics Corp. | 11/12/2002SE |
| K013984 | Immulite Br-Ma, Model #Lkbr; Immulite 2000 Br-Ma, Model #L2KBRMOI · Traditional | Diagnostic Products Corp. | 03/28/2002SE |
| K012357 | Ca 15-3 Assay for the Advia Centaur SystemMOI · Traditional | Bayer Diagnostics Corp. | 02/28/2002SE |
| K010796 | Aia-Pack Brca, ST Aia Pack BrcaMOI · Traditional | Tosoh Medics, Inc. | 08/16/2001SE |
| K010588 | Elecsysca 15-3 II AssayMOI · Special | Roche Diagnostics Corp. | 03/28/2001SE |
| K001468 | Elecsys Ca 15-3 Test SystemMOI · Traditional | Roche Diagnostics Corp. | 10/23/2000SE |
| K983690 | Vitros Immunodiagnostic Products Ca 15-3 Calibrators,Vitros Immunodiagnostic Products Ca…MOI · Traditional | Ortho-Clinical Diagnostics, Inc. | 02/02/1999SE |
| K982680 | Chiron Diagnostics Corporation Acs: Centaur BR ImmunoassayMOI · Traditional | Chiron Diagnostics Corp. | 10/15/1998SE |
| K981698 | ACS:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen…MOI · Traditional | Chiron Corp. | 07/10/1998SE |
| K980190 | Acs 180 BR (Automated Chemiluminescence System)MOI · Traditional | Chiron Corp. | 03/06/1998SE |
| K964703 | The Ca 15-3 Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System)MOI · Traditional | Bayer Corp. | 12/01/1997SE |
| K964407 | Imx Ca 15-3MOI · Traditional | Abbott Laboratories | 11/10/1997SE |
| K965141 | Truquant BR RiaMOI · Traditional | Biomira USA, Inc. | 10/31/1997SE |
| K963926 | Axsym Ca 15-3MOI · Traditional | Abbott Laboratories | 09/15/1997SE |
| K970695 | ACS:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen…MOI · Traditional | Chiron Diagnostics Corp. | 08/08/1997SE |
| K971418 | Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur AnalyzerMOI · Traditional | Chiron Diagnostics Corp. | 07/17/1997SE |
| K963803 | Centocor Ca 15-3 Ria Model No. 800-033MOI · Traditional | Centocor, Inc. | 05/23/1997SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1648-2022 Class II | Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the…Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of… | Siemens Healthcare Diagnostics, Inc. | 07/18/2022Open, Classified |
| Z-2426-2021 Class II | Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the…Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU… | Siemens Healthcare Diagnostics, Inc | 07/06/2021Open, Classified |
| Z-2425-2021 Class II | Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the…Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU… | Siemens Healthcare Diagnostics, Inc | 07/06/2021Open, Classified |
| Z-2424-2021 Class II | Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative…Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU… | Siemens Healthcare Diagnostics, Inc | 07/06/2021Open, Classified |
| Z-2070-2018 Class II | ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor MarkerAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-1691-2018 Class II | IMMULITE 2000/IMMULITE 2000 XPi BR-MA (CA15-3)Concentrations for the level of biotin that does not interfere is not currently listed in the instruction… | Siemens Healthcare Diagnostics, Inc. | 01/02/2018Terminated |
| Z-1677-2018 Class II | IMMULITE /IMMULITE 1000 BR-MA (CA15-3)Concentrations for the level of biotin that does not interfere is not currently listed in the instruction… | Siemens Healthcare Diagnostics, Inc. | 01/02/2018Terminated |
| Z-2074-2017 Class II | Access BR Monitor, Part No. 387620Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been… | Beckman Coulter Inc. | 04/13/2017Terminated |
| Z-1749-2017 Class II | Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF)…Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA… | Siemens Healthcare Diagnostics, Inc | 03/08/2017Terminated |
| Z-1748-2017 Class II | Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR…Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA… | Siemens Healthcare Diagnostics, Inc | 03/08/2017Terminated |
| Z-1747-2017 Class II | Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR Assay…Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA… | Siemens Healthcare Diagnostics, Inc | 03/08/2017Terminated |
| Z-0507-2013 Class II | Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref…Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature… | Siemens Healthcare Diagnostics, Inc | 11/14/2012Terminated |
| Z-0162-2013 Class II | Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests)…BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected… | Siemens Healthcare Diagnostics, Inc | 09/11/2012Terminated |
| Z-1027-2007 | AxSYM CA 15-3 Reagent Pack; list 03B42; 100 test pack; an in vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | Abbott Laboratories | 04/23/2007Terminated |