# K974053: Amylase-SL Assay Catalogue Number 341-10

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Dec 8, 1997 after 42 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
For the quantitative determination of «-amylase in serum. For IN VITRO diagnostic use. α-Amylase (1,4-α-D-Glucan glucanohydrolase, EC3.2.1.1) is an enzyme of the digestive tract. It hydrolyzes dietary starch and glycogen to form maltose by splitting their chains at alternate hemiacetal linkages. The enzyme is normally secreted into the digestive tract from the parotid glands and the pancreas. In diseases affecting these glands, and particularly when the pancreatic duct is obstructed, the amount of enzyme in serum is increased. Burtis, Carl A. and Ashwood, Edward, R. (Ed.), Tietz, Textbook of Clinical Chemistry, W.B. Saunders Co. Pennsylvania, 854-856 (1994).

Source page: https://510kreport.com/device/K974053
Methodology: https://510kreport.com/methodology