(14 days)
The REAADS Anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation THE KEADS AM-D2GFI antibodies in human serum or plasma as an aid for assessing the risk of the risk of the make in 01 TEM and DEOTT annovetes in hemantosus (SLE) and lupus-like disorders (antiphospholipid syndrome).
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This is an in vitro diagnostic (IVD) device, and the provided text is a 510(k) clearance letter from the FDA. It does not contain the detailed technical study information typically found in a Section 510(k) Premarket Notification submission or a clinical study report. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document alone.
Here's what can be inferred or stated based on the provided text, and where gaps exist:
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A table of acceptance criteria and the reported device performance
- Not available in this document. The clearance letter confirms the device is substantially equivalent to a predicate device. The actual performance data (e.g., sensitivity, specificity, accuracy) and the acceptance criteria used to demonstrate this equivalence are typically found in the 510(k) submission itself, not the clearance letter.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not available in this document. The number of samples for the test set, their origin, and whether the study was retrospective or prospective would be detailed in the study report within the 510(k) submission.
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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 applicable / Not available. For an IVD like an antibody test, "ground truth" is typically established by well-characterized patient samples (e.g., from diagnosed patients and healthy controls) or by comparison to a gold standard laboratory method, rather than by expert consensus. This document does not describe the method for establishing ground truth for the test set.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not available. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where human readers provide interpretations that need to be resolved. For an IVD, the assay result is generally definitive, and ground truth is established externally.
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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 is an in vitro diagnostic test kit (REAADS IgM anti-B2GPI Test Kit) used to detect antibodies in human serum or plasma. It is not an AI-powered diagnostic imaging device that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, by nature of the device. This is an in vitro diagnostic test kit. It is designed to produce results directly from a biological sample. Its performance is evaluated intrinsically through laboratory studies (e.g., analytical and clinical performance studies) rather than as an algorithm requiring human interaction for interpretation in a clinical context. The "standalone" performance is its core function.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated in this document. For this type of IVD, ground truth would typically be established by:
- Clinical diagnosis of Systemic Lupus Erythematosus (SLE) or antiphospholipid syndrome (based on clinical criteria, other laboratory tests, and patient history).
- Comparison to a validated reference method for IgM anti-B2GPI antibodies, if one exists and is considered a gold standard.
- Patient outcomes or follow-up data, although this is less common for establishing initial diagnostic performance.
- Not explicitly stated in this document. For this type of IVD, ground truth would typically be established by:
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The sample size for the training set
- Not applicable / Not available. This device is a manual or semi-automated assay kit for laboratory use, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The "training" for such a device involves optimizing reagent concentrations, incubation times, and other assay parameters during its development, but this isn't typically referred to as a "training set" in the context of AI/ML.
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How the ground truth for the training set was established
- Not applicable / Not available. As noted above, this concept of a "training set" with established ground truth is not relevant to this type of IVD device.
Summary of available information:
- Device Name: REAADS IgM anti-B2GPI Test Kit
- Indications for Use: In vitro diagnostic assay for the detection and semi-quantitation of IgM anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombotic events in Systemic Lupus Erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). Intended for use by clinical (hospital and reference) laboratories.
- Regulatory Status: 510(k) cleared, substantially equivalent to predicate devices.
- Performance Study Information: Not available in this document.
§ 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).