# K091846: Synchron Systems G7 Amylase (AMY7) Reagent with Model (S) A71607

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Oct 16, 2009 after 116 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 K070064 (2007). 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)
- K070064: Amylase Eps Reagent, Thermo Fisher Scientific (2007) Summary page 1.

## Indications for use
AMY7 reagent, in conjunction with SYNCHRON® System(s) and UniCel® DxC System(s), is intended for the quantitative determination of total Amylase activity in human serum, plasma or urine. Amylase measurements are used primarily in the diagnosis and treatment of pancreatitis.

Source page: https://510kreport.com/device/K091846
Methodology: https://510kreport.com/methodology