Browse hierarchy: [Pathology (PA)](/submissions/PA) → [Subpart E — Specimen Preparation Reagents](/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents) → [21 CFR 864.4400](/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/864.4400) → IBF — Papain

# IBF · Papain

_Pathology · 21 CFR 864.4400 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/IBF

## Overview

- **Product Code:** IBF
- **Device Name:** Papain
- **Regulation:** [21 CFR 864.4400](/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/864.4400)
- **Device Class:** 1
- **Review Panel:** [Pathology](/submissions/PA)

## 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).

## Classification Rationale

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.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/IBF](https://fda.innolitics.com/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/IBF)

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