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The Immuno Concepts IgG Anti-nDNA Fluorescent Test System is for in vitro diagnostic use for the qualitative detection and semi-quantitation of anti-nDNA antibodies of the IgG class in human serum by manual fluorescent microscopy or with the Image Navigator® Fluorescence Semiautomated Microscope. The Immuno Concepts IgG Anti-IDNA Fluorescent Test System is to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with other clinical and laboratory findings. A trained operator must confirm results generated with the Image Navigator® semi-automated device and software.

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The provided text is a 510(k) premarket notification clearance letter from the FDA for the "Immuno Concepts IgG Anti-nDNA Fluorescent Test System" and the "Image Navigator® Fluorescence Semiautomated Microscope." It details the device's indications for use and general regulatory information but does not contain the specific acceptance criteria, study details, or performance data that would allow for a complete answer to your request.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size
• Whether a standalone (algorithm only) performance study was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

The document primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. To find the detailed study information, one would typically need to review the full 510(k) summary or the pivotal study report submitted by the manufacturer to the FDA, which is not included in this clearance letter.

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This is an indirect fluorescent antibody test for screening and semiquantitative detection of IgG anti-nDNA antibody in human serum. This test system is to be used as an aid in the diagnosis of systemic lupus erythematosus.

This is an indirect fluorescent antibody test for screening and semiquantitative detection of IgG anti-nDNA antibody in human serum.

Immuno Concepts IgG Anti-nDNA Fluorescent Test System - Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

The study compares the Immuno Concepts IgG Anti-nDNA Fluorescent Test System to a legally marketed predicate device, "Crithidia lucilliae DS DNA Kit (Diagnostic Use)" (K930987). The acceptance criteria are implicitly derived from the reported statistics based on this comparison.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 223 samples
  • 121 samples submitted to clinical laboratories for anti-nDNA testing.
  • 100 blood donors.
  • 2 WHO standards known to contain anti-nDNA antibodies.
• Data Provenance: Not explicitly stated, but based on the context of samples submitted to clinical laboratories and blood donors, it is likely retrospective clinical samples. The country of origin is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. The ground truth for comparative effectiveness was established by the predicate device's results, not by independent experts.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The study is a direct comparison to a predicate device, where the predicate device's results serve as the reference. There is no mention of an adjudication process by human readers for the primary comparison.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described. This study directly compared the performance of the new device to a predicate device, rather than assessing human reader performance with and without AI assistance.

6. Standalone Performance Study

• Standalone Performance: Yes, a standalone performance study was done in the sense that the device's diagnostic performance metrics (sensitivity, specificity, etc.) were calculated based on its output compared to a reference standard (the predicate device). The algorithm's output was directly compared to the predicate's output for all 223 samples.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used for the primary comparative effectiveness study was the results obtained from the legally marketed predicate device ("Crithidia lucilliae DS DNA Kit (Diagnostic Use)"). Additionally, two WHO standards known to contain anti-nDNA antibodies were used as positive controls, and samples submitted to clinical laboratories and blood donors provided a range of reactivity.

8. Sample Size for the Training Set

• Sample Size for Training: Not applicable. This device is an indirect fluorescent antibody test kit, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The device's performance is inherently based on its physical and chemical components and their interaction, which are generally developed through R&D and quality control, rather than machine learning training.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as explained in point 8. The "training" for this type of test involves developing and optimizing the reagents and assay procedure, ensuring consistency and reliability through standard laboratory practices and quality control, not by processing a "training set" with established ground truth labels for an algorithm.

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