§ 862.1595 — Porphyrins Test System

(a) Identification. A porphyrins test system is a device intended to measure porphyrins (compounds formed during the biosynthesis of heme, a constituent of hemoglobin, and related compounds) in urine and feces. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning, porphyrias (primarily inherited diseases associated with disturbed porphyrin metabolism), and other diseases characterized by alterations in the heme pathway.

(b) Classification. 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.