# K971825: Pancreatic Amylase, Ethylidene Blocked-PNPG7 Enzyme Colorimetric Test

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Jul 24, 1997 after 69 days
- Product code: JFJ (Catalytic Methods, Amylase)
- Device class: 2
- Regulation: 21 CFR 862.1070
- Recalls of this device: 1 (0 Class I)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jul 10, 2020 · Class II · Z-2924-2020: Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020.

## Indications for use
Randox Laboratories Limited Pancreatic o - Amylase (Ethylidene Blocked - pNPG, Enzyme Colorimetric Test) is an in vitro diagnostic reagent for the quantitative determination of pancreatic a - amylase in serum and urine samples. This test kit measures pancreatic isoamylase and therefore has greater clinical specificity for the diagnosis of pancreatic disorders when compared to total amylase assessment. This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K971825
Methodology: https://510kreport.com/methodology