# K983031: Vitros Immunodiagnostic Products Afp Assay

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Dec 18, 1998 after 109 days
- Product code: LOJ (Kit, Test,Alpha-Fetoprotein For Testicular Cancer)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P820060 (1983). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P820060: Abbott Afp-Eia Diagnostic Kit for Cancer, Abbott Laboratories (1983) Summary page 1.

## Most influential descendants
- K213626: Vitros Afp (2022), 0 descendants of its own

## Recalls of this device
- May 9, 2016 · Class III · Z-2145-2016: Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction signal over time potentially resulting in

## Indications for use
VITROS AFP Reagent Pack - For the in vitro quantitative measurement of alpha-fetoprotein (AFP) in human serum to aid in the management of patients with non-seminomatous testicular cancer. VITROS AFP Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of AFP in human serum.

Source page: https://510kreport.com/device/K983031
Methodology: https://510kreport.com/methodology