21 CFR 862.1240 — Nitroprusside Reaction (Qualitative, Urine), Cystine
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1240
Identification
A cystine test system is a device intended to measure the amino acid cystine in urine. Cystine measurements are used in the diagnosis of cystinuria (occurrence of cystine in urine). Patients with cystinuria frequently develop kidney calculi (stones).
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 |
|---|---|---|---|---|
| JLC | Nitroprusside Reaction (Qualitative, Urine), Cystine | 1 | 2 | |
| JLD | Chromatographic, Cystine | 1 | 0 |
