# K990138: DSL Active Afp Elisa, Model DSL-10-8400

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: Jun 21, 1999 after 153 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Abbott IMx AFP Immunoassay: named in the summary without a submission number

## Indications for use
The DSL 10-8400 AFP ELISA assay is intended for the quantitative determination of AFP in human serum. It is intended for in vitro diagnostic use to aid in the management of patients with nonseminomatous testicular cancer.

Source page: https://510kreport.com/device/K990138
Methodology: https://510kreport.com/methodology