[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.5220]

[Page 219]
 
                        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 and classify one or more of the formed elements 
of the blood.
    (b) Classification. (1) Class II (performance standards) when the 
device is intended to flag or identify specimens containing abnormal 
blood cells.
    (2) Class III (premarket approval) when the device is intended for 
other uses, including to count or classify abnormal cells of the blood.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval for the device identified in paragraph (b)(2) of this section. 
See Sec. 864.3.

[45 FR 60596, Sept. 12, 1980, as amended at 55 FR 23511, June 8, 1990]