Elecsys AFP
FDA 510(k) K220176 · Roche Diagnostics
510(k) numberK220176
Submission
- Device name
- Elecsys AFP
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- January 21, 2022
- Decision date
- September 15, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LOJ – Kit, Test,Alpha-Fetoprotein For Testicular Cancer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
Other 510(k)s with product code LOJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213626 | Vitros AfpLOJ · Traditional | Ortho Clinical Diagnostics | 06/15/2022SE |
| K090236 | Dimension Vista Afp Flex Reagent Cartridge, Model 6454LOJ · Traditional | Siemens Healthcare Diagnostics | 04/27/2009SE |
| K081709 | Olympus Afp - Alpha-FetoproteinLOJ · Traditional | Olympus Life Science Research Europa GmbH (Europa) | 03/16/2009SE |
| K080017 | Vidas Afp AssayLOJ · Traditional | bioMerieux, Inc. | 09/26/2008SE |
| K071597 | Dimension Vista (R) Afp Flex(R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci…LOJ · Traditional | Dade Behring, Inc. | 06/04/2008SE |
| K023894 | ST Aia-Pack Afp Enzyme ImmunoassayLOJ · Special | Tosoh Medics, Inc. | 12/17/2002SE |
| K020807 | Afp Assay for the Advia Integrated Modular SystemLOJ · Traditional | Bayer Diagnostics Corp. | 10/01/2002SE |
| K020806 | ACS:180 & Advia Centaur Afp ImmunoassayLOJ · Special | Bayer Corp. | 03/27/2002SE |
| K990138 | DSL Active Afp Elisa, Model DSL-10-8400LOJ · Traditional | Diagnostic Systems Laboratories, Inc. | 06/21/1999SE |
| K983031 | Vitros Immunodiagnostic Products Afp AssayLOJ · Traditional | Ortho-Clinical Diagnostics, Inc. | 12/18/1998SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) PlasmaSET · Traditional | 08/19/2026SE |
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| K252431 | Elecsys CalcitoninJKR · Traditional | 04/24/2026SE |
| K252280 | Elecsys Anti-SARS-CoV-2 SQVP · Traditional | 04/13/2026SE |
| K260049 | Elecsys Anti-HBc IgMSEI · Traditional | 04/07/2026SE |
| K260048 | Elecsys Anti-HAV IgMLOL · Traditional | 04/07/2026SE |
| K260046 | Elecsys Anti-HBc IISEI · Traditional | 04/07/2026SE |
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | 04/02/2026SE |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | 02/12/2026SE |
Questions and answers
When was Elecsys AFP cleared by the FDA?
Elecsys AFP (K220176) received a 510(k) decision of Substantially Equivalent on September 15, 2022, 237 days after the submission was received.
What is the product code of K220176?
The FDA product code is LOJ – Kit, Test,Alpha-Fetoprotein For Testicular Cancer, a Class II (moderate risk) device regulated under 21 CFR 866.6010.