(654 days)
Assay:
ZEUS IFA™ ANA HEp-2 Test System is an indirect immunofluorescence assay for the qualitative detection and semiquantitative determination of IgG anti-nuclear antibodies in human serum by manual fluorescence microscopy or with ZEUS dlFine®. The presence of anti-nuclear antibodies can be used in conjunction with other serological tests and clinical findings to aid in the diagnosis of systemic lupus erythematosus and other systemic rheumatic diseases. All suggested results obtained with ZEUS dIFine® must be confirmed by a trained operator.
Instrument:
ZEUS dIFine® is an automated instrument consisting of a fluorescent microscope and software that acquires, interprets, stores and displays digital images of stained indirect immunofluorescence slides. ZEUS dlFine can only be used with FDA cleared or approved ZEUS in vitro diagnostic assays that are indicated for use on this instrument. All suggested results obtained with ZEUS dIFine must be confirmed by a trained operator
ZEUS dIFine® is an automated instrument consisting of a fluorescent microscope and software that acquires, interprets, stores and displays digital images of stained indirect immunofluorescence slides.
The provided text is an FDA 510(k) clearance letter for the Zeus IFA ANA HEp-2 Test System and Zeus dIFine. While it states the device is "substantially equivalent" and outlines its indications for use, it does not contain the detailed study information required to answer your specific questions about acceptance criteria and performance data.
The FDA 510(k) summary, often referred to as the 510(k) "Premarket Notification Summary" or "Special 510(k) Notification Summary," would contain the information you are seeking regarding acceptance criteria and performance data. This document is typically publicly available on the FDA's website alongside the 510(k) clearance letter.
Therefore, I cannot provide the requested information based solely on the text you provided. To answer your questions, I would need access to the 510(k) summary document for K201956.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).