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K Number
K992517
Device Name
BIOCHECK FERRITIN ELISA MODEL BC-1025
Manufacturer
BIOCHECK, INC.
Date Cleared
1999-09-24

(58 days)

Product Code
DBF
Regulation Number
866.5340
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The BioCheck Ferritin ELISA is intended for the quantitative determination of ferritin in human serum. This assay is to be used in the diagnosis of diseases affecting iron metabolism.

Device Description

BioCheck, Inc. Ferritin Enzyme Immunoassay Test Kit Model BC-1025

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, etc.), or expert involvement. The document is a 510(k) clearance letter from the FDA for a medical device called "BioCheck, Inc. Ferritin Enzyme Immunoassay Test Kit," approving its marketing. It primarily focuses on the regulatory aspects and indications for use, without detailing the performance study methodology or results.

§ 866.5340 Ferritin immunological test system.

(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).