[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: 21CFR864.5800]

[Page 229]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES--Table of Contents
 
       Subpart F--Automated and Semi-Automated Hematology Devices
 
Sec. 864.5800  Automated sedimentation rate device.

    (a) Identification. An automated sedimentation rate device is an 
instrument that measures automatically the erythrocyte sedimentation 
rate in whole blood. Because an increased sedimentation rate indicates 
tissue damage or inflammation, the erythrocyte sedimentation rate device 
is useful in monitoring treatment of a disease.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60602, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 
66 FR 38790, July 25, 2001]