ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K

• K Number: K010844
• Device Name: ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
• Manufacturer: ASTORIA-PACIFIC,INC.
• Date Cleared: 2001-09-21 ( 184 days)
• Product Code: NAK
• Regulation Number: 862.1118

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

§ 862.1118 Biotinidase test system.

(a)
Identification. The biotinidase test system is an in vitro diagnostic device intended to measure the activity of the enzyme biotinidase in blood. Measurements of biotinidase are used in the treatment and diagnosis of biotinidase deficiency, an inborn error of metabolism in infants, characterized by the inability to utilize dietary protein bound vitamin or to recycle endogenous biotin. The deficiency may result in irreversible neurological impairment.(b)
Classification. Class II (special controls). The special control is sale, distribution, and use in accordance with the prescription device requirements in § 801.109 of this chapter.

Summary

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