# K020282: Jas Amylase Liquid Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Jas Diagnostics, Inc.
- Decided: Feb 28, 2002 after 31 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Intended for the In Vitro, quantitative determination of amylase in human serum on automated chemistry analyzers. Amylase measurements are used in the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Source page: https://510kreport.com/device/K020282
Methodology: https://510kreport.com/methodology