# K970612: Sealite Sciences, Inc. Aqualite Ferritin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Sealite Sciences, Inc.
- Decided: Jun 24, 1997 after 126 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.
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) Chiron Diagnostics ACS:180 Ferritin Assay: named in the summary without a submission number

## Indications for use
The AquaLite® Ferritin Bioluminescent Immunoassay (BIA) Kit (or AquaLite® Ferritin Assay) is an in vitro diagnostic product intended for use in clinical laboratories for the quantitative measurement of ferritin in human serum and plasma. Ferritin measurements are used in the diagnosis of diseases affecting iron metabolism.

Source page: https://510kreport.com/device/K970612
Methodology: https://510kreport.com/methodology