# K013101: Wiener Lab. Amilasa 405 Cinetica AA, Wiener Lab.Amilasa 405 Cinetica Unitest,Wiener Lab.Amilasa Cinetica AA

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories Saic
- Decided: Nov 16, 2001 after 60 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GENZYME DIRECT AMYLASE test system: named in the summary without a submission number
- (no number) Trace Amylase DST: named in the summary without a submission number

## Indications for use
The “Wiener lab. Amilasa 405 cinética” test system is a quantitative in vitro diagnostic device intended to measure the activity of the enzyme amylase in serum, plasma and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas)

Source page: https://510kreport.com/device/K013101
Methodology: https://510kreport.com/methodology