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K Number
K981786
Device Name
IGA MININEPH ANTISERUM
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
1999-11-24

(553 days)

Product Code
CFQ
Regulation Number
866.5510
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This assay is designed for the in vitro measurement of human IgA in serum using the MININEPH analyzer.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device named "Minineph IgA antiserum." This document indicates that the device is a reclassified in vitro diagnostic device and does not contain information about the acceptance criteria, study details, or performance metrics in the context of an AI/ML powered device. The letter is a clearance notification and not a study report. Therefore, I cannot extract the requested information from this document.

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).