DSL AACTIVE DHEA EIA KIT

• K Number: K955114
• Device Name: DSL AACTIVE DHEA EIA KIT
• Manufacturer: DIAGNOSTIC SYSTEMS LABORATORIES, INC.
• Date Cleared: 1996-02-23 ( 106 days)
• Product Code: JKC
• Regulation Number: 862.1245

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

§ 862.1245 Dehydroepiandrosterone (free and sulfate) test system.

(a)
Identification. A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.(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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