21 CFR 862.1175 — Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1175
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.
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 |
|---|---|---|---|---|
| CGO | Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol | 1 | 11 | |
| CHD | Acid, Ferric Ion-Sulfuric, Cholesterol | 1 | 3 | |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 230 | |
| NAQ | Lipoprotein, High Density, Hdl, Over The Counter | 1 | 2 | 3rd Party |
| NFX | Test, Cholesterol, Total, Over The Counter | 1 | 1 | 3rd Party |
