21 CFR 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 § 864.9.