# K983263: Immulite Afp, Model Lkapi, LKAP5, Immulite 2000 Afp, Model L2KAP2

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Dec 7, 1998 after 81 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: 1 generation back to P820060 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
IMMULITE AFP is for in vitro diagnostic use with the IMMULITE Analyzer — for the quantitative measurement of alpha-fetoprotein (AFP) in serum, as an aid in the management of patients with nonseminomatous testicular cancer. IMMULITE 2000 AFP is for in vitro diagnostic use with the IMMULITE 2000 Analyzer — for the quantitative measurement of alpha-fetoprotein (AFP) in serum, as an aid in the management of patients with nonseminomatous testicular cancer.

Source page: https://510kreport.com/device/K983263
Methodology: https://510kreport.com/methodology