[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: 21CFR864.5220]

[Page 227-228]
 
                        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. 864.5220  Automated differential cell counter.

    (a) Identification. An automated differential cell counter is a 
device used to identify one or more of the formed elements of the blood. 
The device may also have the capability to flag, count, or classify 
immature or abnormal hematopoietic cells of the blood, bone marrow, or 
other body fluids. These devices may combine an electronic particle 
counting method, optical method, or a flow cytometric method utilizing 
monoclonal CD (cluster designation) markers. The device includes 
accessory CD markers.
    (b) Classification. Class II (special controls). The special control 
for this device is the FDA document entitled

[[Page 228]]

``Class II Special Controls Guidance Document: Premarket Notifications 
for Automated Differential Cell Counters for Immature or Abnormal Blood 
Cells; Final Guidance for Industry and FDA.''

[67 FR 1607, Jan. 14, 2002]