21 CFR 862.1365 — Chromatographic, Glutathione
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1365
Identification
A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in erythrocytes (red blood cells). Glutathione measurements are used in the diagnosis and treatment of certain drug-induced hemolytic (erythrocyte destroying) anemias due to an inherited enzyme deficiency.
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 the limitations in § 862.9
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JLN | Chromatographic, Glutathione | 1 | 0 | |
| JLO | Enzymatic (Glutathione Reductase), Glutathione | 1 | 0 |
