MOI · System, Test, Immunological, Antigen, Tumor
Immunology · 21 CFR 866.6010 · Class 2
Overview
| Product Code | MOI |
|---|---|
| Device Name | System, Test, Immunological, Antigen, Tumor |
| 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 28)
Showing 20 most recent of 28 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240403 | Access BR Monitor | Beckman Coulter, Inc. | May 9, 2024 | SESE |
| K233946 | IMMULITE® 2000 BR-MA | Siemens Healthcare Diagnostics Products, Ltd. | Mar 13, 2024 | SESE |
| K192524 | Lumipulse G CA15-3 | Fujirebio Diagnostics,Inc. | Sep 4, 2020 | SESE |
| K193489 | ADVIA Centaur BR | Siemens Healthcare Diagnostics, Inc. | Feb 13, 2020 | SESE |
| K192777 | ADVIA Centaur CA 15-3 assay | Siemens Healthcare Diagnostics, Inc. | Nov 22, 2019 | SESE |
| K181492 | Elecsys CA 15-3 II | Roche Diagnostics | Jun 22, 2018 | SESE |
| K171605 | Elecsys CA 15-3 II | Roche Diagnostics | Feb 20, 2018 | SESE |
| K100344 | DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 | Siemens Healthcare Diagnostics | Apr 18, 2011 | SESE |
| K072612 | ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 | Beckman Coulter, Inc. | Oct 26, 2007 | SESE |
| K042732 | ARCHITECT CA 15-3 ASSAY | Fujirebio Diagnostics,Inc. | Dec 22, 2004 | SESE |
| K033036 | BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 | Beckman Coulter, Inc. | Feb 3, 2004 | SESE |
| K022178 | CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | Nov 12, 2002 | SESE |
| K013984 | IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR | Diagnostic Products Corp. | Mar 28, 2002 | SESE |
| K012357 | CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM | Bayer Diagnostics Corp. | Feb 28, 2002 | SESE |
| K010796 | AIA-PACK BRCA, ST AIA PACK BRCA | Tosoh Medics, Inc. | Aug 16, 2001 | SESE |
| K010588 | ELECSYSCA 15-3 II ASSAY | Roche Diagnostics Corp. | Mar 28, 2001 | SESE |
| K001468 | ELECSYS CA 15-3 TEST SYSTEM | Roche Diagnostics Corp. | Oct 23, 2000 | SESE |
| K983690 | VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK | Ortho-Clinical Diagnostics, Inc. | Feb 2, 1999 | SESE |
| K982680 | CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY | Chiron Diagnostics Corp. | Oct 15, 1998 | SESE |
| K981698 | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) | Chiron Corp. | Jul 10, 1998 | SESE |
Top Applicants
- Beckman Coulter, Inc. — 3 clearances
- Chiron Diagnostics Corp. — 3 clearances
- Abbott Laboratories — 2 clearances
- Bayer Diagnostics Corp. — 2 clearances
- Chiron Corp. — 2 clearances
