Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7060](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7060) → JPE — Antithrombin Iii, Two Stage Clotting Time Assay

# JPE · Antithrombin Iii, Two Stage Clotting Time Assay

_Hematology · 21 CFR 864.7060 · Class 2_

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

## Overview

- **Product Code:** JPE
- **Device Name:** Antithrombin Iii, Two Stage Clotting Time Assay
- **Regulation:** [21 CFR 864.7060](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7060)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)
- **3rd-party reviewable:** yes

## Identification

An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K933125](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JPE/K933125.md) | BERICHROM ANTITHROMBIN III (A) | Behring Diagnostics, Inc. | Apr 19, 1994 | SESE |

## Top Applicants

- Behring Diagnostics, Inc. — 1 clearance

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

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