[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: 21CFR862.1118]

[Page 187-188]
 
                        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. 862.1118  Biotinidase test system.

    (a) Identification. The biotinidase test system is an in vitro 
diagnostic device intended to measure the activity of the enzyme 
biotinidase in blood. Measurements of biotinidase are used in the 
treatment and diagnosis of biotinidase deficiency, an inborn error of 
metabolism in infants, characterized by the inability to utilize dietary 
protein

[[Page 188]]

bound vitamin or to recycle endogenous biotin. The deficiency may result 
in irreversible neurological impairment.
    (b) Classification. Class II (special controls). The special control 
is sale, distribution, and use in accordance with the prescription 
device requirements in Sec. 801.109 of this chapter.

[65 FR 16521, Mar. 29, 2000]