# K990025: Careside Amylase

- Pathway: 510(k) (Traditional)
- Applicant: Careside, Inc.
- Decided: Feb 8, 1999 after 35 days
- Product code: JFJ (Catalytic Methods, Amylase)
- Device class: 2
- Regulation: 21 CFR 862.1070
- 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 K912844 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912844: Kodak Ektachem Dtii System, Eastman Kodak Company (1991) Summary page 1.

## Indications for use
For in vitro diagnostic use with the CARESIDE Analyzer™ to measure amylase from whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with disease of the pancreas, salivary gland, and kidney.

Source page: https://510kreport.com/device/K990025
Methodology: https://510kreport.com/methodology