Vitros Afp
FDA 510(k) K213626 · Ortho Clinical Diagnostics
510(k) numberK213626
Submission
- Device name
- Vitros Afp
- Applicant
- Ortho Clinical Diagnostics
Pencoed, GB - Received
- November 17, 2021
- Decision date
- June 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 |
|---|---|---|---|
| K220176 | Elecsys AFPLOJ · Traditional | Roche Diagnostics | 09/15/2022SE |
| 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 |
More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI · Traditional | 10/29/2025SE |
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent PackLIP · Traditional | 08/28/2024SE |
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA · Traditional | 05/08/2024SE |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW · Traditional | 09/05/2023SE |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent PackDHX · Traditional | 08/23/2023SE |
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent PackNIG · Traditional | 08/09/2023SE |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK · Traditional | 12/12/2022SE |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent PackJHX · Traditional | 01/28/2022SE |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent PackNBC · Traditional | 10/04/2021SE |
| K210858 | VITROS Chemistry Products PHBR SlidesDLZ · Traditional | 08/13/2021SE |
Questions and answers
When was Vitros Afp cleared by the FDA?
Vitros Afp (K213626) received a 510(k) decision of Substantially Equivalent on June 15, 2022, 210 days after the submission was received.
What is the product code of K213626?
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.