(76 days)
The SpotChem EZ Total Cholesterol, HDL and Triglyceride test and panel system are an in vitro diagnostic procedures intended to measure Total Cholesterol/HDL Triglyceride quantitatively in human serum and plasma on the SpotChem EZ analyzer.
Total Cholesterol measurements are used the diagnosis and treatment of lipid and lipoprotein metabolism disorders.
HDL-Cholesterol measurements are used the diagnosis and treatment of lipid and lipoprotein metabolism disorders.
Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
Not Found
This a 510(k) summary for "The SpotChem EZ Total Cholesterol, HDL and Triglyceride Individual Tests and Panel Tests". The document focuses on the regulatory clearance for this in vitro diagnostic device and does not contain detailed information about acceptance criteria, specific study designs, or performance metrics in the format requested.
Therefore, I cannot provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document is a regulatory letter of substantial equivalence and does not include the detailed technical study information.
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.