# K013750: Advia 1650 Cholinesterase Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Diagnostics Corp.
- Decided: Jan 18, 2002 after 66 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 K912217 (1991). 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)
- K913198: Kodak Ektachem DT Slides (Che), Eastman Kodak Company (1991) Summary page 1.
- K912217: Kodak Ektachem Clinical Chemistry Slides, Eastman Kodak Company (1991) Summary page 1.

## Indications for use
The ADVIA 1650 Cholinesterase in vitro diagnostic procedure is intended to measure cholinesterase in human serum and plasma on the Bayer ADVIA 1650 system. Such measurement is used in the diagnosis and treatment of organophosphorus poisoning and of certain liver diseases such as cirrhosis and acute and chronic hepatitis.

Source page: https://510kreport.com/device/K013750
Methodology: https://510kreport.com/methodology