(57 days)
The Cheshire Diagnostics Limited QAß2A IgG Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG antibodies to ß2-Glycoprotein-I in human serum. The presence of ß2-GPI antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis in patients with Systemic Lupus Erythematosus or other lupus like disorders.
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The provided text is a 510(k) premarket notification letter from the FDA for a medical device called the "QAB2A IgG Elisa Kit HRP." This document primarily focuses on the regulatory clearance of the device based on substantial equivalence to a predicate device, rather than a detailed study evaluating its performance against specific acceptance criteria.
Therefore, the specific information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be fully extracted from the provided text. The document does not describe a performance study as you've outlined.
However, I can infer some aspects and highlight what is missing:
Information that can be partially inferred or is explicitly mentioned:
- Device Name: QAB2A IgG Elisa Kit HRP
- Intended Use: "Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG antibodies to ß2-Glycoprotein-I in human serum. The presence of ß2-GPI antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis in patients with Systemic Lupus Erythematosus or other lupus like disorders."
Information that is NOT present in the provided text:
- A table of acceptance criteria and the reported device performance: This document does not contain a table or description of specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or the actual performance results of the QAB2A IgG Elisa Kit HRP.
- Sample size used for the test set and the data provenance: There is no mention of a test set sample size or its origin (country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The text does not describe any human experts being used to establish ground truth for a test set.
- Adjudication method for the test set: No adjudication method is mentioned as a test set isn't detailed.
- 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: This device is an immunoassay kit, not an AI-powered diagnostic imaging tool. Therefore, an MRMC study with human readers and AI assistance is not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As this is an immunoassay kit, the concept of "algorithm only" performance (as in AI) doesn't directly apply. Its performance is measured by its analytical and clinical validity directly.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The document does not specify how ground truth would be established for any performance claims, though for an ELISA kit, it would typically involve clinical diagnosis, other standard tests, or possibly pathology/outcome data for cases of thrombosis.
- The sample size for the training set: Not applicable and not mentioned, as this is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable and not mentioned.
Summary:
The provided FDA 510(k) clearance letter confirms that the QAB2A IgG Elisa Kit HRP is "substantially equivalent" to predicate devices, allowing it to be marketed. However, it does not include the detailed performance study data, acceptance criteria, or methodological specifics that you've requested. Such information would typically be detailed in the 510(k) submission itself, not necessarily in the FDA clearance letter.
§ 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).