# K070064: Amylase Eps Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: May 22, 2007 after 137 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K091846: Synchron Systems G7 Amylase (AMY7) Reagent with Model (S) A71607 (2009), 0 descendants of its own

## Indications for use
The Amylase EPS Reagent is used for the quantitative determination of oa-Amylase (1,4-a-D-glucan glucanohydrolase EC3.2.1.1) in human serum, plasma or urine on Beckman Coulter SYNCHRON CX ®/LX ® Systems. oc-Amylase is most frequently measured in the diagnosis of acute pancreatitis, when serum levels may be grossly elevated.

Source page: https://510kreport.com/device/K070064
Methodology: https://510kreport.com/methodology