21 CFR 862.1060 — Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1060

Identification

A delta-aminolevulinic acid test system is a device intended to measure the level of delta-aminolevulinic acid (a precursor of porphyrin) in urine. Delta-aminolevulinic acid measurements are used in the diagnosis and treatment of lead poisoning and certain porphyrias (diseases affecting the liver, gastrointestinal, and nervous systems that are accompanied by increased urinary excretion of various heme compounds including delta-aminolevulinic acid).

Classification Rationale

Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Product Codes