# K020807: Afp Assay for the Advia Integrated Modular System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Diagnostics Corp.
- Decided: Oct 1, 2002 after 203 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) Immuno 1: named in the summary without a submission number

## Indications for use
The Buyer ADVIA®IMSTM AFP assay is an in vitro diagnostic device intended to quantitatively measure a-fetoprotein (AFP) in human serum on the Bayer ADVIA IMS system as an aid in the management of nonseminomatous testicular cancer. AFP values obtained using the Bayer ADVIA IMS assay method must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined. AFP testing is not recommended as a screening procedure to detect cancer in the general population.

Source page: https://510kreport.com/device/K020807
Methodology: https://510kreport.com/methodology