(255 days)
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.
Not Found
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.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).