# K981592: Acs:Centaur Afp

- Pathway: 510(k) (Traditional)
- Applicant: Chiron Diagnostics Corp.
- Decided: Jul 7, 1998 after 64 days
- Product code: LOQ (Device, General Purpose, Hematology)
- 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: 1 generation back to P920030 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P920030: Ciba Corning Acs Psa Immunoassay, Bayer Healthcare, LLC (1998) Summary page 1.

## Most influential descendants
- K020806: Acs:180 & Advia Centaur Afp Immunoassay (2002), 0 descendants of its own

## Indications for use
The ACS:Centaur AFP Immunoassay is 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 Chiron Diagnostics ACS:Centaur Automated Chemiluminescence System.

Source page: https://510kreport.com/device/K981592
Methodology: https://510kreport.com/methodology