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The EUROIMMUN Anti-HSV-1 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against Herpes simplex virus type 1 (HSV-1) specific glycoprotein C1 in human serum. It is intended for the presumptive diagnosis of type specific HSV-1 infection with EUROIMMUN Anti-HSV-2 EUSA (IgG) in persons suspected of herpes viral infection.

The EUROIMMUN Anti-HSV-2 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against herpes simplex virus type 2 (HSV-2) specific glycoprotein G2 in human serum. It is intended for the presumptive diagnosis of type specific HSV-2 infection with EUROIMMUN Anti-HSV-1 EUSA (lgG) in persons suspected of herpes viral infection.

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This document is a 510(k) premarket notification decision letter from the FDA for the EUROIMMUN Anti-HSV-1 ELISA (IgG) Kit and EUROIMMUN Anti-HSV-2 ELISA (IgG) Kit. It primarily focuses on the FDA's determination of substantial equivalence to previously marketed devices. While it states the intended use of the devices, it does not contain detailed information about the acceptance criteria and study proving the device meets those criteria.

Therefore, I cannot provide the requested information based on the input text. The document is a regulatory approval letter, not a study report.

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The EUROIMMUN ANA IFA:HEp-20-10 is an indirect fluorescent antibody test for the qualitative or semiquantitative detection of antibodies against cell nuclei (ANA) in human serum and EDTA-plasma. This test system is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings.

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The provided text does not contain information about acceptance criteria, device performance, or any studies with AI or human readers. The document is a 510(k) clearance letter from the FDA for a device called "EUROIMMUN ANA IFA: Hep-20-10," which is an indirect fluorescent antibody test for detecting antibodies against cell nuclei.

Therefore, I cannot provide the requested information.

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The EUROIMMUN Endomysium IFA kit is designed for the semi-quantitative and qualitative determination of antibodies against Endomysium (EMA) in human serum. It is used as an aid in the diagnosis of gluten-sensitive enteropathies associated with celiac disease in conjunction with other laboratory and clinical findings.

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I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA clearance letter for a medical device (EUROIMMUN Endomysium IFA kit) and primarily discusses its regulatory classification and substantial equivalence to a predicate device. It does not include details about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert qualifications for performance evaluation.

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This test kit is designed for the determination of anti-proteinase 3 antibodies (PR3) in human serum and plasma. This test is used as an aid in the differential diagnosis of Wegener's granulomatosis and other autoimmune vasculitides, in conjunction with other laboratory and clinical findings.

This test kit is designed for the determination of anti-myeloperoxidase antibodies (MPO) in human serum and plasma. This test is used as an aid in the differential diagnosis of microscopic polyangitis, Churg-Strauss syndrome and other autoimmune vasculitides, in conjunction with other laboratory and clinical findings.

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I apologize, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and study details. The document is a 510(k) clearance letter from the FDA for two ELISA test kits (EUROIMMUN anti-Proteinase 3 (PR3) ELISA IgG and EUROIMMUN anti-Myeloperoxidase (MPO) ELISA IgG).

It confirms the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use. However, it does not include:

• A table of acceptance criteria and reported device performance. This kind of data is typically found in the 510(k) submission itself, not the clearance letter.
• Sample size and data provenance for the test set.
• Details on experts used for ground truth or adjudication methods.
• Information about multi-reader multi-case studies or standalone algorithm performance. This is an IVD device, not an AI-powered diagnostic device, so these specific details are not applicable.
• Type of ground truth used. While the indications mention "in conjunction with other laboratory and clinical findings," the specific method for establishing ground truth for the study is not described.
• Sample size for the training set or how its ground truth was established. This refers to machine learning models, which are not relevant for this type of ELISA test kit.

To obtain the information you're looking for, you would generally need to review the full 510(k) submission document, which often includes detailed study designs, performance data, and other technical information. The clearance letter acts as the FDA's confirmation of marketability based on that submission.

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This test kit is designed for qualitatively or semi-quantitatively determination of anti-Neutrophil cytoplasmic antibodies (ANCA) in serum. These antibodies are associated with Wegener's granulomatosis, microscopic arteriitis, Churg-Strauss syndrome and classic polyarteriitis nodosa. For in vitro diagnostics use.

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This is a premarket notification (510(k)) letter from the FDA, not a study report. Therefore, it does not contain the detailed acceptance criteria or the specifics of a study proving the device meets those criteria.

The document states that the FDA has reviewed the 510(k) submission for the EUROIMMUN ANCA IFA Granulocyte BIOCHIP MOSAIC™ Test System and determined it to be substantially equivalent to legally marketed predicate devices. This means that the device is considered as safe and effective as a device already on the market, but it doesn't provide the detailed study results that would typically include acceptance criteria and performance data.

To answer your request thoroughly, a full 510(k) submission document (which is usually much more extensive than this letter) or specific study reports would be needed.

However, based on the provided text, I can infer some general information:

1. A table of acceptance criteria and the reported device performance:

• Not Available. The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) or detailed device performance metrics. The FDA's determination of "substantial equivalence" implies that the submitted data met the necessary standards for comparison to a predicate device, but the specific performance numbers are not present here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Available. This information is typically found in the clinical study section of the 510(k) submission, not in the FDA's decision letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Available. This level of detail about ground truth establishment is not provided in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Available. The document does not describe the adjudication method used for any test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This device is an in-vitro diagnostic (IVD) test system for detecting autoantibodies, not an AI-assisted diagnostic tool interpreted by human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Implied, but details not available. As an IVD test system, its performance is inherently "standalone" in the sense that the test results are produced by the system itself, not through human interpretation of an algorithm's output. However, the specific performance metrics (sensitivity, specificity, accuracy) of this standalone operation are not detailed in this letter.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Implied to be clinical diagnosis or reference methods. For an ANCA test, ground truth typically involves a clinical diagnosis of the associated autoimmune diseases (Wegener's granulomatosis, microscopic arteriitis, Churg-Strauss syndrome, polyarteriitis nodosa) established by clinical experts, often supported by other laboratory tests or histopathology. However, the document itself does not explicitly state how the ground truth was established for the studies.

8. The sample size for the training set:

• Not Available. The document does not mention anything about a training set, which is more common for machine learning-based devices. This is an immunoassay test system, which generally relies on established biochemical reactions, not a deep learning model requiring a large training set in the same way.

9. How the ground truth for the training set was established:

• Not Applicable/Not Available. As above, a "training set" in the context of machine learning is not directly relevant to this type of immunoassay device. If optimization or validation runs were performed, the ground truth would likely follow similar principles to those for establishing the test set performance.

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