---
kind: "section"
citation: "21 C.F.R. § 864.4400"
title: "21"
number: "864.4400"
heading: "Enzyme preparations."
url: "https://uscodex.org/cfr/21/864.4400"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 864.9](/cfr/21/864.9.md).

## Notes

### Amendments

[45 FR 60592, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38789, July 25, 2001]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Amendments

[45 FR 60592, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38789, July 25, 2001]