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) → IBG — Trypsin

# IBG · Trypsin

_Pathology · 21 CFR 864.4400 · Class 1_

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

## Overview

- **Product Code:** IBG
- **Device Name:** Trypsin
- **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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K802493](https://fda.innolitics.com/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/IBG/K802493.md) | SPUTASOL | Oxoid U.S.A., Inc. | Nov 12, 1980 | SESE |
| [K771955](https://fda.innolitics.com/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/IBG/K771955.md) | TRYPSIN 1% | Flow Laboratories, Inc. | Nov 22, 1977 | SESE |

## Top Applicants

- Oxoid U.S.A., Inc. — 1 clearance
- Flow Laboratories, Inc. — 1 clearance

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

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