ERYTHROPOIETIN IMMUNOASSAY KIT

• K Number: K952559
• Device Name: ERYTHROPOIETIN IMMUNOASSAY KIT
• Manufacturer: NICHOLS INSTITUTE
• Date Cleared: 1996-05-29 ( 362 days)
• Product Code: GGT
• Regulation Number: 864.7250

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

§ 864.7250 Erythropoietin assay.

(a)
Identification. A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and anemia.(b)
Classification. Class II. The special control for this device is FDA's “Document for Special Controls for Erythropoietin Assay Premarket Notification (510(k)s).”

Summary

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