21 CFR 862.1210 — Conversion To Creatinine, Creatine
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1210
Identification
A creatine test system is a device intended to measure creatine (a substance synthesized in the liver and pancreas and found in biological fluids) in plasma, serum, and urine. Measurements of creatine are used in the diagnosis and treatment of muscle diseases and endocrine disorders including hyperthyroidism.
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 |
|---|---|---|---|---|
| JLA | Conversion To Creatinine, Creatine | 1 | 2 | |
| JLB | Atp And Creatine Kinase (Enzymatic), Creatine | 1 | 3 |
