# K040534: Vitalab Amylase Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Data, Inc.
- Decided: Mar 11, 2004 after 9 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) Roche α-Amylase EPS ver.2 Reagent, product no. 03183742: named in the summary without a submission number

## Indications for use
The Vitalab ct-Amylase Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of cx-amylase in serum and plasma. Amylase results may be used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Source page: https://510kreport.com/device/K040534
Methodology: https://510kreport.com/methodology