TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000

• K Number: K010266
• Device Name: TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000
• Manufacturer: BIOSITE INCORPORATED
• Date Cleared: 2001-03-16 ( 46 days)
• Product Code: NBC
• Regulation Number: 862.1117

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

§ 862.1117 B-type natriuretic peptide test system.

(a)
Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.(b)
Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”

Summary

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