SPECTROLYSE ANTITHROMBIN III (ANTI-XA)

• K Number: K960871
• Device Name: SPECTROLYSE ANTITHROMBIN III (ANTI-XA)
• Manufacturer: MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
• Date Cleared: 1996-08-14 ( 163 days)
• Product Code: JBQ
• Regulation Number: 864.7060

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 864.7060 Antithrombin III assay.

(a)
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).(b)
Classification. Class II (performance standards).

Summary

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