# K981653: AMY

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 28, 1998 after 109 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 K882225 (1989). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882225: -Amylase Eps, Boehringer Mannheim Corp. (1989) Summary page 5.

## Most influential descendants
- K210633: Amylase2 (2022), 0 descendants of its own

## Indications for use
The Amylase assay is used for the quantitation of amylase in serum, plasma, or urine on the AEROSET System. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Source page: https://510kreport.com/device/K981653
Methodology: https://510kreport.com/methodology