Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7525](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7525) → GFT — Protamine Sulphate

# GFT · Protamine Sulphate

_Hematology · 21 CFR 864.7525 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFT

## Overview

- **Product Code:** GFT
- **Device Name:** Protamine Sulphate
- **Regulation:** [21 CFR 864.7525](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7525)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)
- **3rd-party reviewable:** yes

## Identification

A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K944115](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFT/K944115.md) | HEPARIN ASSAY CARTRIDGES AND CONTROLS | Medtronic Hemotec, Inc. | Mar 24, 1995 | SESE |
| [K910105](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFT/K910105.md) | PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 | International Technidyne Corp. | Feb 26, 1991 | SESE |

## Top Applicants

- International Technidyne Corp. — 1 clearance
- Medtronic Hemotec, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFT](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GFT)

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