# K080017: Vidas Afp Assay

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Sep 26, 2008 after 267 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) Tosoh Medical, Inc. ST AIA Pack AFP Enzyme Immunoassay: named in the summary without a submission number

## Indications for use
VIDAS® AFP is an automated quantitative test for use on the VIDAS instruments for the quantitative measurement of alpha-fetoprotein (AFP) in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS AFP assay is indicated for the quantitative measurement of Alpha-Fetoprotein (AFP) in serum to aid in the management of patients with nonseminomatous testicular carcinoma.

Source page: https://510kreport.com/device/K080017
Methodology: https://510kreport.com/methodology