Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
The CA125 Epithelial Ovarian Tumor-Associated Antigen Test is an in vitro diagnostic device used to measure CA125 levels in patient serum, used as an aid in monitoring epithelial ovarian cancer, detecting recurrence, and assessing response to treatment. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification. The product code is LTK, regulated under 21 CFR 866.6010, within the Immunology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- LTK
- Device Class
- FDA class 2
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 26 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240479 | Access OV Monitor | May 10, 2024 | Substantially Equivalent | Beckman Coulter, Inc. |
| K213510 | IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA | Sep 08, 2023 | Substantially Equivalent | Siemens Healthcare Diagnostics Products, Ltd. |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent Pack | Dec 12, 2022 | Substantially Equivalent | Ortho Clinical Diagnostics |
| K200199 | ADVIA Centaur CA 125II | Apr 06, 2020 | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. |
| K143534 | Elecsys CA-125 II assay | Aug 06, 2015 | Substantially Equivalent | Roche Professional Diagnostics |
| K142895 | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators | May 21, 2015 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K100321 | DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604 | Apr 12, 2011 | Substantially Equivalent | Siemens Healthcare Diagnostics |
| K080469 | VIDAS CA 15-3 ASSAY | Jun 22, 2009 | Substantially Equivalent | bioMerieux, Inc. |
| K080561 | VIDAS CA 125 II ASSAY | Apr 10, 2009 | Substantially Equivalent | bioMerieux, Inc. |
| K072794 | IMMULITE 2500 OM-MA, MODEL L5KOP | Nov 05, 2007 | Substantially Equivalent | Siemens Medical Solutions Diagnostics |
| K042731 | ARCHITECT CA 125 II ASSAY | Nov 19, 2004 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K031297 | ACCESS OV MONITOR ASSAY | May 02, 2003 | Substantially Equivalent | Beckman Coulter, Inc. |
| K023597 | ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY | Dec 11, 2002 | Substantially Equivalent | Beckman Coulter, Inc. |
| K023891 | ST AIA-PACK CA 125 ENZYME IMMUNOASSAY | Dec 06, 2002 | Substantially Equivalent | Tosoh Medics, Inc. |
| K022329 | CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Nov 27, 2002 | Substantially Equivalent | Bayer Diagnostics Corp. |
| K020828 | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM | Jul 24, 2002 | Substantially Equivalent | Bayer Corp. |
| K990431 | AIA-PACK CA 125 | Jun 03, 1999 | Substantially Equivalent | Tosoh Medics, Inc. |
| K983875 | VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK | May 14, 1999 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
| K983715 | THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | May 14, 1999 | Substantially Equivalent | Bayer Corp. |
| K983391 | IMMULITE 2000 OM-MA MODEL L2KOP2 | Oct 15, 1998 | Substantially Equivalent | Diagnostic Products Corp. |
| K981297 | IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 | Sep 18, 1998 | Substantially Equivalent | Diagnostic Products Corp. |
| K980240 | ELECSYS CA 125II ON THE ELECSYS 1010 | Mar 25, 1998 | Substantially Equivalent | Boehringer Mannheim Corp. |
| K972162 | ELECSYS CA 125 II | Mar 18, 1998 | Substantially Equivalent | Boehringer Mannheim Corp. |
| K964185 | IMX CA 125 | Nov 04, 1997 | Substantially Equivalent | Abbott Diagnostics |
| K964020 | AXSYM CA 125 | Nov 04, 1997 | Substantially Equivalent | Abbott Laboratories |
| K964098 | CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | Oct 31, 1997 | Substantially Equivalent | Bayer Corp. |
FEI Numbers
This FDA classification entry is associated with 30 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.