# K013978: Synchron  Systems Pancreatic Amylase (Pam) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jan 15, 2002 after 43 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 K934293 (1994). 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)
- K934293: Beckman Pancreatic Amylase (Pamy) Reagent, Beckman-Diagnostic Systems Group (1994) Summary page 1.

## Indications for use
Pancreatic Amylase (PAM) Reagent is intended for the quantitative determination of pancreas-specific amylase activity in human serum, plasma, or urine on Beckman Coulter's SYNCHRON Systems by an immuno-inhibition method. Measurement of pancreatic amylase is useful in the diagnosis and treatment of pancreatitis.

Source page: https://510kreport.com/device/K013978
Methodology: https://510kreport.com/methodology