[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: 21CFR864.4400]

[Page 220]
 
                        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 E--Specimen Preparation Reagents
 
Sec. 864.4400  Enzyme preparations.

    (a) Identification. Enzyme preparations are products that are used 
in the histopathology laboratory for the following purposes:
    (1) To disaggregate tissues and cells already in established 
cultures for preparation into subsequent cultures (e.g., trypsin);
    (2) To disaggregate fluid specimens for cytological examination 
(e.g., papain for gastric lavage or trypsin for sputum liquefaction);
    (3) To aid in the selective staining of tissue specimens (e.g., 
diastase for glycogen determination).
    (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 60592, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 
66 FR 38789, July 25, 2001]