# K972462: Afp Assay for the Bayer Immuno 1 System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Sep 22, 1997 after 83 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 Assay: named in the summary without a submission number

## Indications for use
This in vitro diagnostic assay is intended to quantitatively measure a-fetoprotein (AFP) in human serum on the Bayer Immuno 1™ system as an aid in the management of nonseminomatous testicular cancer. AFP values obtained using the Bayer Immuno 1™ AFP assay method must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined.

Source page: https://510kreport.com/device/K972462
Methodology: https://510kreport.com/methodology