LOJ · Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Immunology · 21 CFR 866.6010 · Class 2
Overview
| Product Code | LOJ |
|---|---|
| Device Name | Kit, Test,Alpha-Fetoprotein For Testicular Cancer |
| 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 (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220176 | Elecsys AFP | Roche Diagnostics | Sep 15, 2022 | SESE |
| K213626 | VITROS AFP | Ortho Clinical Diagnostics | Jun 15, 2022 | SESE |
| K090236 | DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 | Siemens Healthcare Diagnostics | Apr 27, 2009 | SESE |
| K081709 | OLYMPUS AFP - ALPHA-FETOPROTEIN | Olympus Life Science Research Europa GmbH (Europa) | Mar 16, 2009 | SESE |
| K080017 | VIDAS AFP ASSAY | bioMerieux, Inc. | Sep 26, 2008 | SESE |
| K071597 | DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 | Dade Behring, Inc. | Jun 4, 2008 | SESE |
| K023894 | ST AIA-PACK AFP ENZYME IMMUNOASSAY | Tosoh Medics, Inc. | Dec 17, 2002 | SESE |
| K020807 | AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | Oct 1, 2002 | SESE |
| K020806 | ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY | Bayer Corp. | Mar 27, 2002 | SESE |
| K990138 | DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 | Diagnostic Systems Laboratories, Inc. | Jun 21, 1999 | SESE |
| K983031 | VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY | Ortho-Clinical Diagnostics, Inc. | Dec 18, 1998 | SESE |
| K983263 | IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 | Diagnostic Products Corp. | Dec 7, 1998 | SESE |
| K981354 | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 | Beckman Instruments, Inc. | May 1, 1998 | SESE |
| K981282 | ELECSYS AFP | Roche Diagnostics GmbH | May 1, 1998 | SESE |
| K973351 | ELECSYS AFP | Boehringer Mannheim Corp. | Nov 21, 1997 | SESE |
| K972462 | AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | Sep 22, 1997 | SESE |
| K851891 | TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS | Richard Scott Elliott | Jul 19, 1985 | SESE |
Top Applicants
- Bayer Corp. — 2 clearances
- Bayer Diagnostics Corp. — 1 clearance
- Beckman Instruments, Inc. — 1 clearance
- Boehringer Mannheim Corp. — 1 clearance
- Dade Behring, Inc. — 1 clearance
