# K974125: IL Test Amylase

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Dec 17, 1997 after 44 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 K932467 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932467: Ilab 900/1800 Clinical Chemistry System, Instrumentation Laboratory CO (1993) Summary page 1.
- K943595: Serum/Urine Appli Ilab (TM) Clinical Chemistry System, Instrumentation Laboratory CO (1994) Summary page 1.

## Indications for use
IL Test™ Amylase is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of amylase in human serum, plasma or urine by CNP-Maltotrioside methodology. Amylase is used in the diagnosis and treatment of pancreatitis.

Source page: https://510kreport.com/device/K974125
Methodology: https://510kreport.com/methodology