FACTOR V LEIDEN KIT

• K Number: DEN030005
• Device Name: FACTOR V LEIDEN KIT
• Manufacturer: ROCHE DIAGNOSTICS CORP.
• Date Cleared: 2003-12-17 ( 9 days)
• Product Code: NPQ
• Regulation Number: 864.7280
• Type: Post-NSE
• Panel: Pathology
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 864.7280 Factor V Leiden DNA mutation detection systems.

(a)
Identification. Factor V Leiden deoxyribonucleic acid (DNA) mutation detection systems are devices that consist of different reagents and instruments which include polymerase chain reaction (PCR) primers, hybridization matrices, thermal cyclers, imagers, and software packages. The detection of the Factor V Leiden mutation aids in the diagnosis of patients with suspected thrombophilia.(b)
Classification. Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems.” (See § 864.1(d) for the availability of this guidance document.)