# K213626: Vitros Afp

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Clinical Diagnostics
- Decided: Jun 15, 2022 after 210 days
- Product code: LOJ (Kit, Test,Alpha-Fetoprotein For Testicular Cancer)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P820060 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983031: Vitros Immunodiagnostic Products Afp Assay, Ortho-Clinical Diagnostics, Inc. (1998) Summary page 4.

## Indications for use
For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITRO 5600 Integrated system to aid in the management of patients with non-seminomatous testicular cancer.

Source page: https://510kreport.com/device/K213626
Methodology: https://510kreport.com/methodology