(a)Identification. Adelta -aminolevulinic acid test system is a device intended to measure the level ofdelta -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 includingdelta -aminolevulinic acid).
(b)Classification. 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.
[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]