(274 days)
Instrument & Software:
The HELIOS® AUTOMATED IFA SYSTEM is an automated system for immunofluorescence processing with an integrated fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions. All suggested results obtained with the HELIOS® AUTOMATED IFA SYSTEM must be confirmed by trained personnel.
Assay:
AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies (ANA) in human serum by manual microscopy or with HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS® AUTOMATED IFA SYSTEM instrument must be confirmed by trained personnel.
The HELIOS® AUTOMATED IFA SYSTEM is an automated system for immunofluorescence processing with an integrated fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions.
This document is a 510(k) premarket notification for the HELIOS® AUTOMATED IFA SYSTEM and AESKUSLIDES® ANA-HEp-2-Gamma. It describes the device's indications for use and confirms that the FDA has found it substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.
The document primarily focuses on regulatory approval and the device's intended use. Information about the performance study, including acceptance criteria and results, would typically be found in a separate section of the 510(k) submission, such as a "Summary of Safety and Effectiveness" or a "Performance Data" section, which is not included in the provided snippets.
§ 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).