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K Number
K972209
Device Name
SPECTROLYSE HEPARIN (ANTI-IIA)
Manufacturer
MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
Date Cleared
1997-08-12

(62 days)

Product Code
KFF
Regulation Number
864.7525
Type
Traditional
Panel
HE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Spectrolyse® Heparin (anti-IIa) is intended for the quantitative determination of therapeutic heparin (standard and low molecular weight) in human plasma by anti-fl activity.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "Spectrolyse® Heparin (anti-IIa)". It is a regulatory approval document and does not contain the acceptance criteria or study details requested in the prompt. The letter only states that the device is substantially equivalent to legally marketed predicate devices and outlines the general regulatory requirements.

Therefore, I cannot provide the requested information based on the provided text.

§ 864.7525 Heparin assay.

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