# K040750: Bio-Chem Analyzer, Model 100

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Analysis Corporation, Inc.
- Decided: Oct 28, 2004 after 219 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The CAC Bio-Chem AnalyzerTM is a microprocessor-controlled electromechanical, portable instrument for the quantitative determination of specific analytes in whole blood and plasma. The instrument deploys single-use, single analyte disposable test cartridges for each of the following test analyte: potassium Potassium measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. The CAC Bio-Chem AnalyzerTM is a point-of-care device intended for hospital-use settings.

Source page: https://510kreport.com/device/K040750
Methodology: https://510kreport.com/methodology