OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE

• K Number: K011052
• Device Name: OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE
• Manufacturer: OSTEX INTL., INC.
• Date Cleared: 2001-07-30 ( 115 days)
• Product Code: JMM
• Regulation Number: 862.1400

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

§ 862.1400 Hydroxyproline test system.

(a)
Identification. A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.(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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