# K051444: Sentinel Cholinesterase Liquid

- Pathway: 510(k) (Special)
- Applicant: Sentinel Ch. Srl
- Decided: Jun 20, 2005 after 18 days
- Product code: DIH (Colorimetry, Cholinesterase)
- Device class: 1
- Regulation: 21 CFR 862.3240
- 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 K981800 (1998). 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)
- K981800: Sentinel Cholinesterase Liquid Model Number 17.019A & 17.606, Equal Diagnostics, Inc. (1998) Summary page 1.

## Indications for use
The Sentinel Cholinesterase Liquid assay is used to measure cholinesterase in human specimens. There are two principal type of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is note present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inlhibition and disorders. For In Vitro diagnostics use only. CFR 862.3240

Source page: https://510kreport.com/device/K051444
Methodology: https://510kreport.com/methodology