LogoFDA 510(k) Search
K Number
K041891
Device Name
MININEPH HUMAN RHEUMATOID FACTOR KIT
Manufacturer
THE BINDING SITE
Date Cleared
2004-11-05

(116 days)

Product Code
DHR
Regulation Number
866.5775
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This kit is designed for the In Vitro measurement of human mulcations for 050. This in to assigned in NINEPH. Measurement of Rheumatoid Factor may aid in the diagnosis of rheumatoid arthritis.

Device Description

Minineph Human Rheumatoid Factor Kit

AI/ML Overview

This is a 510(k) clearance letter for the Minineph Human Rheumatoid Factor Kit, an in vitro diagnostic device used to aid in the diagnosis of rheumatoid arthritis. The document does not contain the detailed study information regarding acceptance criteria and device performance that you are requesting.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is typically found in the 510(k) submission summary or associated clinical study reports, which are not included in this document.

§ 866.5775 Rheumatoid factor immunological test system.

(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).