[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: 21CFR862.1235]

[Page 205-206]
 
                        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

[[Page 206]]

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]