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) → JBR — Test, Heparin Neutralization

# JBR · Test, Heparin Neutralization

_Hematology · 21 CFR 864.7525 · Class 2_

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

## Overview

- **Product Code:** JBR
- **Device Name:** Test, Heparin Neutralization
- **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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K925452](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBR/K925452.md) | DADE HEPZYME | Baxter Diagnostics, Inc. | Jan 11, 1993 | SESE |
| [K874373](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBR/K874373.md) | PT PRO-CLOT | Probe-Tek, Inc. | Jan 5, 1988 | SESE |
| [K770722](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBR/K770722.md) | THROMBO SCREEN QUANTITATIVE HEPARIN ASSA | Bay Area Hema. Onco. Clinic. & Res. L | Jul 11, 1977 | SESE |

## Top Applicants

- Baxter Diagnostics, Inc. — 1 clearance
- Bay Area Hema. Onco. Clinic. & Res. L — 1 clearance
- Probe-Tek, Inc. — 1 clearance

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

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