[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1060]

[Page 186]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES--Table of Contents
 
               Subpart B--Clinical Chemistry Test Systems
 
Sec. 862.1060  Delta-aminolevulinic acid test system.

    (a) 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).
    (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 Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]