# K023992: Wiener Lab Colinesterasa AA

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories Saic
- Decided: Feb 12, 2003 after 72 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.
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) SIGMA DIAGNOSTICS Cholinesterase (BTC) (Cat. 421-10): named in the summary without a submission number

## Indications for use
The "Wiener lab. Colinesterasa AA" test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human serum or plasma, on both manual and automated systems. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo Cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

Source page: https://510kreport.com/device/K023992
Methodology: https://510kreport.com/methodology