21 CFR 862.1705 — Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1705
Identification
A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 151 | |
| CEA | Tlc Chromatographic Separation Triglycerides | 1 | 0 | |
| JGW | Fluorometric Method, Triglycerides | 1 | 3 | |
| JGX | Turbidimetric Method, Triglycerides | 1 | 1 | |
| JGY | Colorimetric Method, Triglycerides | 1 | 22 | |
| NGO | Test, Triglycerides, Over The Counter | 1 | 0 | 3rd Party |
