# K171642: Atellica IM Ferritin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Aug 31, 2017 after 90 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
Longest line of descent: 4 generations back to K902336 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992157: Chiron Diagnostics Acs: 180 Ferritin Assay, Chiron Diagnostics Corp. (1999) Summary page 4.
- K041133: Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer, Bayer Healthcare, LLC (2004) Summary page 5.

## Indications for use
The Atellica™ IM Ferritin (Fer) assay is for in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma (EDTA and OLWKLXP heparin) using the Atellica™ IM Analyzer. This assay can be used as an aid in the diagnosis of iron deficiency anemia and iron overload.

Source page: https://510kreport.com/device/K171642
Methodology: https://510kreport.com/methodology