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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.

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AESKUSLIDES ANA-HEp-2 is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum. AESKUSLIDES ANA-HEp-2 Test System is intended for use as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.

Not Found

I am sorry, but the provided text does not contain detailed information about acceptance criteria, study design, or device performance metrics for the AESKUSLIDES ANA-HEp-2. The document is primarily an FDA clearance letter and an "Indications for Use Form," which state the device's purpose and regulatory classification but do not elaborate on the specific studies conducted to demonstrate its performance relative to acceptance criteria.

Therefore, I cannot provide the requested information, including:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or their data provenance.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) studies or effect sizes.
• Details on standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This type of information is usually found in the 510(k) summary or the full 510(k) submission, which is not provided in the given text.

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