# K042767: Datapro Clinical Chelistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Electron Corporation
- Decided: Apr 27, 2005 after 204 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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 no predicate by number.

## Indications for use
The DataProTM/DataPro PlusTM Clinical Chemistry Analyzer is a fully automated clinical chemistry analyzer intended for routine diagnostic clinical laboratory use. The DataProTM has replaceable parts, automated maintenance monitoring and backup of both patient and system data. With a throughput of up to 230 tests per hour, the DataProTM is intended for small and medium-sized laboratories, or as a backup analyzer in large volume laboratories. The DataPro TM/DataPro PtusTM Clinical Chemistry Analyzer is intended to be used in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae related to the measurement of various clinical assays, such as Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Urea Nitrogen (BUN), Calcium, Cholesterol, Creatinine, Direct Bilirubin, Glucose, Phosphorus, Total Bilirubin, Total Protein, Triglyceride, and Uric Acid. The DataProTM , and all of the reagents included in this test system are for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K042767
Methodology: https://510kreport.com/methodology