# K030045: Olympus Cholinesterase Reagent (Catalog Number OSR6114)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Feb 21, 2003 after 46 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K103373: Synchron Systems Cholinesterase (Chex) Model A53722 (2011), 0 descendants of its own

## Indications for use
Reagent for the determination of cholinesterase concentrations in human serum and plasma using the Olympus family of clinical chemistry analyzers. Measurement of serum cholinesterase has been used to assess liver hnction and to investigate the variants of cholinesterase enzyme. It is also usehl in predicting susceptibility to prolonged apnea after the administration of succinylcholine and in monitoring excessive exposure to organophosphorus insecticides.

Source page: https://510kreport.com/device/K030045
Methodology: https://510kreport.com/methodology