Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart J — Products Used In Establishments That Manufacture Blood and Blood Products](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products) → [21 CFR 864.9400](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9400) → KSK — Solution, Stabilized Enzyme

# KSK · Solution, Stabilized Enzyme

_Hematology · 21 CFR 864.9400 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSK

## Overview

- **Product Code:** KSK
- **Device Name:** Solution, Stabilized Enzyme
- **Regulation:** [21 CFR 864.9400](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9400)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A stabilized enzyme solution is a reagent intended for medical purposes that is used to enhance the reactivity of red blood cells with certain antibodies, including antibodies that are not detectable by other techniques. These enzyme solutions include papain, bromelin, ficin, and trypsin.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Special Controls

*Classification.* Class II (special controls). The 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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K813342](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSK/K813342.md) | GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION | Gamma Biologicals, Inc. | Mar 4, 1982 | SESE |
| [K813404](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSK/K813404.md) | FREEZE DRIED FICIN | Biological Corp. of America | Feb 10, 1982 | SESE |
| [K810803](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSK/K810803.md) | FREEZE DRIED PAPAIN | Biological Corp. of America | Jul 21, 1981 | SESE |
| [K780962](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSK/K780962.md) | AUTOMATED ENZYME | Hyland Therapeutic Div., Travenol Laboratories | Jul 27, 1978 | SESE |
| [K760123](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSK/K760123.md) | AUTOZYME | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jul 20, 1976 | SESE |

## Top Applicants

- Biological Corp. of America — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Gamma Biologicals, Inc. — 1 clearance
- Hyland Therapeutic Div., Travenol Laboratories — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSK](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSK)

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