[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: 21CFR862.1235]

[Page 191]
 
                        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. 862.1235   Cyclosporine test system.

    (a) Identification. A cyclosporine test system is a device intended 
to quantitatively determine cyclosporine concentrations as an aid in the 
management of transplant patients receiving therapy with this drug. This 
generic type of device includes immunoassays and chromatographic assays 
for cyclosporine.
    (b) Classification. Class II (special controls). The special control 
is ``Class II Special Controls Guidance Document: Cyclosporine and 
Tacrolimus Assays; Guidance for Industry and FDA.'' See Sec. 862.1(d) 
for the availability of this guidance document.

[67 FR 58329, Sept. 16, 2002]