ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE

• K Number: DEN030002
• Device Name: ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
• Manufacturer: SPECTRAL DIAGNOSTICS, INC.
• Date Cleared: 2003-06-16 ( 63 days)
• Product Code: NGS
• Regulation Number: 866.3210

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

§ 866.3210 Endotoxin assay.

(a)
Identification. An endotoxin assay is a device that uses serological techniques in whole blood. The device is intended for use in conjunction with other laboratory findings and clinical assessment of the patient to aid in the risk assessment of critically ill patients for progression to severe sepsis.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance entitled “Class II Special Controls Guidance Document: Endotoxin Assay.” See § 866.1(e) for the availability of this guidance document.

Summary

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