21 CFR 862.1400 — Column Chromatography & Color Development, Hydroxyproline
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1400
Identification
A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and 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 § 862.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JMM | Column Chromatography & Color Development, Hydroxyproline | 1 | 21 | |
| JMN | Extraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline | 1 | 0 |
