[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.2]

[Page 177]
 
                        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 A--General Provisions
 
Sec. 862.2  Regulation of calibrators.

    Many devices classified in this part are intended to be used with a 
calibrator. A calibrator has a reference value assigned to it which 
serves as the basis by which test results of patients are derived or 
calculated. The calibrator for a device may be (a) manufactured and 
distributed separately from the device with which it is intended to be 
used, (b) manufactured and distributed as one of several device 
components, such as in a kit of reagents, or (c) built-in as an integral 
part of the device. Because of the central role that a calibrator plays 
in the measurement process and the critical effect calibrators have on 
accuracy of test results, elsewhere in this part, all three of these 
types of calibrators (Secs. 862.1150 and 862.3200 of this part) are 
classified into class II, notwithstanding the classification of the 
device with which it is intended to be used. Thus, a device and its 
calibrator may have different classifications, even if the calibrator is 
built into the device.