# K992157: Chiron Diagnostics Acs: 180 Ferritin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Chiron Diagnostics Corp.
- Decided: Aug 5, 1999 after 41 days
- Product code: DBF (Ferritin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Chiron Diagnostics ACS: 180 Ferritin Immunoassay: named in the summary without a submission number

## Most influential descendants
- K171642: Atellica IM Ferritin Assay (2017), 0 descendants of its own

## Indications for use
The intended use of Chiron Diagnostics ACS:180 Ferritin Assay is for the quantitative determination of Ferritin in serum or plasma using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems. it is to be used to aid in the diagnosis of iron deficiency anemia and iron overload.

Source page: https://510kreport.com/device/K992157
Methodology: https://510kreport.com/methodology