[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1040]

[Page 200]
 
                        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. 862.1040  Aldolase test system.

    (a) Identification. An aldolase test system is a device intended to 
measure the activity of the enzyme aldolase in serum or plasma. Aldolase 
measurements are used in the diagnosis and treatment of the early stages 
of acute hepatitis and for certain muscle diseases such as progressive 
Duchenne-type muscular dystrophy.
    (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 Sec. 862.9.

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