21 CFR 862.2500 — Analyzer, Enzyme, For Clinical Use
Clinical Chemistry (CH) · Part 862 Subpart C—Clinical Laboratory Instruments · § 862.2500
Identification
An enzyme analyzer for clinical use is a device intended to measure enzymes in plasma or serum by nonkinetic or kinetic measurement of enzyme-catalyzed reactions. This device is used in conjunction with certain materials to measure a variety of enzymes as an aid in the diagnosis and treatment of certain enzyme-related 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 |
|---|---|---|---|---|
| JJI | Analyzer, Enzyme, For Clinical Use | 1 | 8 |
