21 CFR 862.1630 — Electrophoretic, Protein Fractionation
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1630
Identification
A protein (fractionation) test system is a device intended to measure protein fractions in blood, urine, cerebrospinal fluid, and other body fluids. Protein fractionations are used as an aid in recognizing abnormal proteins in body fluids and genetic variants of proteins produced in diseases with tissue destruction.
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 |
|---|---|---|---|---|
| CEF | Electrophoretic, Protein Fractionation | 1 | 29 | |
| JQJ | Densitometeric, Protein Fractionation | 1 | 1 | |
| JQK | Immunodiffusion, Protein Fractionation | 1 | 1 |
