LTK · Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Immunology · 21 CFR 866.6010 · Class 2
Overview
| Product Code | LTK |
|---|---|
| Device Name | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) |
| 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 26)
Showing 20 most recent of 26 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240479 | Access OV Monitor | Beckman Coulter, Inc. | May 10, 2024 | SESE |
| K213510 | IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA | Siemens Healthcare Diagnostics Products, Ltd. | Sep 8, 2023 | SESE |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent Pack | Ortho Clinical Diagnostics | Dec 12, 2022 | SESE |
| K200199 | ADVIA Centaur CA 125II | Siemens Healthcare Diagnostics, Inc. | Apr 6, 2020 | SESE |
| K143534 | Elecsys CA-125 II assay | Roche Professional Diagnostics | Aug 6, 2015 | SESE |
| K142895 | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators | Fujirebio Diagnostics,Inc. | May 21, 2015 | SESE |
| K100321 | DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604 | Siemens Healthcare Diagnostics | Apr 12, 2011 | SESE |
| K080469 | VIDAS CA 15-3 ASSAY | bioMerieux, Inc. | Jun 22, 2009 | SESE |
| K080561 | VIDAS CA 125 II ASSAY | bioMerieux, Inc. | Apr 10, 2009 | SESE |
| K072794 | IMMULITE 2500 OM-MA, MODEL L5KOP | Siemens Medical Solutions Diagnostics | Nov 5, 2007 | SESE |
| K042731 | ARCHITECT CA 125 II ASSAY | Fujirebio Diagnostics,Inc. | Nov 19, 2004 | SESE |
| K031297 | ACCESS OV MONITOR ASSAY | Beckman Coulter, Inc. | May 2, 2003 | SESE |
| K023597 | ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY | Beckman Coulter, Inc. | Dec 11, 2002 | SESE |
| K023891 | ST AIA-PACK CA 125 ENZYME IMMUNOASSAY | Tosoh Medics, Inc. | Dec 6, 2002 | SESE |
| K022329 | CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Bayer Diagnostics Corp. | Nov 27, 2002 | SESE |
| K020828 | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM | Bayer Corp. | Jul 24, 2002 | SESE |
| K990431 | AIA-PACK CA 125 | Tosoh Medics, Inc. | Jun 3, 1999 | SESE |
| K983875 | VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK | Ortho-Clinical Diagnostics, Inc. | May 14, 1999 | SESE |
| K983715 | THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | May 14, 1999 | SESE |
| K983391 | IMMULITE 2000 OM-MA MODEL L2KOP2 | Diagnostic Products Corp. | Oct 15, 1998 | SESE |
Top Applicants
- Bayer Corp. — 3 clearances
- Beckman Coulter, Inc. — 3 clearances
- Boehringer Mannheim Corp. — 2 clearances
- Diagnostic Products Corp. — 2 clearances
- Fujirebio Diagnostics,Inc. — 2 clearances
