# K210633: Amylase2

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Ireland Diagnostics Division
- Decided: May 26, 2022 after 449 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: 2 generations back to K882225 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981653: AMY, Abbott Laboratories (1998) Summary page 5.

## Indications for use
The Amylase2 assay is used for the quantitation of amylase in human serum, plasma, or urine on the ARCHITECT c System. The Amylase2 assay is to be used primarily as an aid in the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Source page: https://510kreport.com/device/K210633
Methodology: https://510kreport.com/methodology