# K020806: Acs:180 & Advia Centaur Afp Immunoassay

- Pathway: 510(k) (Special)
- Applicant: Bayer Corp.
- Decided: Mar 27, 2002 after 15 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: 2 generations back to P920030 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P930036: Advia Centaur Afp Reagents and Calibrators, Siemens Healthcare Diagnostics, Inc. (1995) Summary page 1.
- K981592: Acs:Centaur Afp, Chiron Diagnostics Corp. (1998) Summary page 1.

## Indications for use
For the quantitative determination of alpha-fetoprotein (AFP) in the following: human serum, as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the Bayer Diagnostics ACS:180 Automated Chemiluminescence System or the ADVIA Centaur System.

Source page: https://510kreport.com/device/K020806
Methodology: https://510kreport.com/methodology