# K133519: Carolina Liquid Chemistries CLC 6410  Chemistry Analyzer; Carolina Liquid Chemistries Glucose Reagent, Car

- Pathway: 510(k) (Traditional)
- Applicant: Carolina Liquid Chemistries Corp.
- Decided: May 16, 2014 after 182 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- 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 Carolina Liquid Chemistries CLC 6410 chemistry analyzer is an automated clinical analyzer for in vitro diagnostic use only in clinical laboratories. It is intended to be used for a variety of assay methods. The analyzer provides in vitro quantitative determinations for glucose, sodium, potassium, and chloride in serum and plasma samples. The Carolina Liquid Chemistries Glucose Reagent is for use with the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for the measurement of glucose in serum and plasma. Gluicose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and of pancreatic islet cell carcinoma. The Carolina Liquid Chemistries ISE Kit is intended to be used with the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for measurement of sodium, potassium, and chloride in serum and plasma. The ISE Kit consists of ISE Buffer, internal reference solution, and reference solution. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used for the diagnosis and treatment of electrolyte and metabolic disorders. The Carolina Liquid Chemistries ISE Calibrator Kit consists of Calibrator 1,Calibrator 2, and Selectivity Check. It is used with the ISE Module on the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for the calibration of the Sodium, Potassium and Chloride assays. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K133519
Methodology: https://510kreport.com/methodology