Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Kit, Test, Alpha-Fetoprotein for Testicular Cancer is a diagnostic immunoassay kit used to measure alpha-fetoprotein (AFP) levels in serum as a tumor marker for testicular germ cell tumors (particularly non-seminomatous tumors), used in initial diagnosis, staging, monitoring of treatment response, and surveillance for recurrence. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LOJ, regulated under 21 CFR 866.6010, within the Immunology medical specialty. This device is eligible for third-party 510(k) review.
Research product code LOJ in seconds
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Basic Information
- Product Code
- LOJ
- 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 17 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K220176 | Elecsys AFP | Sep 15, 2022 | Substantially Equivalent | Roche Diagnostics |
| K213626 | VITROS AFP | Jun 15, 2022 | Substantially Equivalent | Ortho Clinical Diagnostics |
| K090236 | DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 | Apr 27, 2009 | Substantially Equivalent | Siemens Healthcare Diagnostics |
| K081709 | OLYMPUS AFP - ALPHA-FETOPROTEIN | Mar 16, 2009 | Substantially Equivalent | Olympus Life Science Research Europa GmbH (Europa) |
| K080017 | VIDAS AFP ASSAY | Sep 26, 2008 | Substantially Equivalent | bioMerieux, Inc. |
| K071597 | DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 | Jun 04, 2008 | Substantially Equivalent | Dade Behring, Inc. |
| K023894 | ST AIA-PACK AFP ENZYME IMMUNOASSAY | Dec 17, 2002 | Substantially Equivalent | Tosoh Medics, Inc. |
| K020807 | AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Oct 01, 2002 | Substantially Equivalent | Bayer Diagnostics Corp. |
| K020806 | ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY | Mar 27, 2002 | Substantially Equivalent | Bayer Corp. |
| K990138 | DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 | Jun 21, 1999 | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. |
| K983031 | VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY | Dec 18, 1998 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
| K983263 | IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 | Dec 07, 1998 | Substantially Equivalent | Diagnostic Products Corp. |
| K981354 | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 | May 01, 1998 | Substantially Equivalent | Beckman Instruments, Inc. |
| K981282 | ELECSYS AFP | May 01, 1998 | Substantially Equivalent | Roche Diagnostics GmbH |
| K973351 | ELECSYS AFP | Nov 21, 1997 | Substantially Equivalent | Boehringer Mannheim Corp. |
| K972462 | AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Sep 22, 1997 | Substantially Equivalent | Bayer Corp. |
| K851891 | TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS | Jul 19, 1985 | Substantially Equivalent | Richard Scott Elliott |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.