21 CFR 862.1475 — Microdensitometry Method, Lipoproteins
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1475
Identification
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
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 |
|---|---|---|---|---|
| JHL | Microdensitometry Method, Lipoproteins | 1 | 1 | |
| JHM | Colorimetric Method, Lipoproteins | 1 | 9 | |
| JHN | Turbidimetric Method, Lipoproteins | 1 | 7 | |
| JHO | Electrophoretic Separation, Lipoproteins | 1 | 26 | |
| JHP | Radial Immunodiffusion, Lipoproteins | 1 | 0 | |
| JHQ | Nephelometric Method, Lipoproteins | 1 | 1 | |
| JQI | Rotating Disc, Plasma Viscometry | 1 | 0 | |
| LBR | Ldl & Vldl Precipitation, Hdl | 1 | 66 | |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | 80 | |
| LBT | Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl | 1 | 8 | |
| MRR | System, Test, Low Density, Lipoprotein | 1 | 31 | |
| MSJ | Apolipoproteins | 1 | 50 | |
| MSM | System, Test, Lipoprotein(A) | 1 | 0 | |
| PYP | Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test | 1 | 1 | 3rd Party |
