CEDIA SIROLIMUS ASSAY

• K Number: DEN040008
• Device Name: CEDIA SIROLIMUS ASSAY
• Manufacturer: MICROGENICS CORP.
• Date Cleared: 2004-07-28 ( 41 days)
• Product Code: NRP
• Regulation Number: 862.3840

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

§ 862.3840 Sirolimus test system.

(a)
Identification. A sirolimus test system is a device intended to quantitatively determine sirolimus concentrations in whole blood. Measurements are used as an aid in management of transplant patients receiving therapy with sirolimus.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Sirolimus Test Systems.” See § 862.1(d) for the availability of this guidance document.

Summary

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