URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING

• K Number: K001810
• Device Name: URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING
• Manufacturer: FLEXSITE DIAGNOSTICS, INC.
• Date Cleared: 2000-08-14 ( 60 days)
• Product Code: JIR
• Regulation Number: 862.1645

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

§ 862.1645 Urinary protein or albumin (nonquantitative) test system.

(a)
Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Summary

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