# K981216: AMY

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 8, 1998 after 66 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 K903309 (1990). 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)
- K903309: Roche Cobas Ready Amylase Reagent, Roche Diagnostic Systems, Inc. (1990) Summary page 2.

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

Source page: https://510kreport.com/device/K981216
Methodology: https://510kreport.com/methodology