BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST

• K Number: K100817
• Device Name: BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
• Manufacturer: PRINCETON BIOMEDITECH CORP.
• Date Cleared: 2010-07-01 ( 104 days)
• Product Code: KHE
• Regulation Number: 864.6550

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

§ 864.6550 Occult blood test.

(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Summary

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