# K153644: ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II

- Pathway: 510(k) (Traditional)
- Applicant: Elitechgroup
- Decided: Sep 7, 2016 after 261 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
Longest line of descent: 3 generations back to K811832 (1981). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes, Roche Diagnostic Systems, Inc. (1995) Summary page 4.
- K041227: Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera, Roche Diagnostics Corp. (2004) Summary page 8.
- K033501: Modification to Calibrator for Automatic Systems (Cfas), Roche Diagnostics Corp. (2003) Summary page 9.

## Indications for use
ELITech Clinical Systems GLUCOSE HK SL is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic diseases. ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers. ELITech Clinical Systems ELITROL I & ELITROL II are multiparametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers.

Source page: https://510kreport.com/device/K153644
Methodology: https://510kreport.com/methodology