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Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgM autoantibodies to cardiolipin in human serum.

Uses:

The results of the anti-cardiolipin assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-cardiolipin antibodies including antiphospholipid syndrome.

Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.

The assay may be used on the Hycor Hy•Tec Automated EIA instrument.

For in vitro diagnostic use only.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the "Autostat II Anti-Cardiolipin IgM ELISA" device. It does not contain any information regarding acceptance criteria, study details, performance data, or ground truth establishment. The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can proceed to market, subject to general controls and potential additional controls for Class II devices.

Therefore, an answer based solely on the provided text will indicate a lack of this information.

Here's an example of how to frame the answer given the absence of information in the document:

Based on the provided FDA 510(k) clearance letter (K992449) for the Autostat II Anti-Cardiolipin IgM ELISA, the following information regarding acceptance criteria and the study that proves the device meets them is not available:

1. A table of acceptance criteria and the reported device performance: This document is an FDA clearance letter confirming substantial equivalence, not a summary of the performance study itself. Therefore, specific acceptance criteria or detailed performance metrics (like sensitivity, specificity, accuracy, etc.) are not presented.
2. Sample size used for the test set and the data provenance: The letter does not describe any specific test set size or whether the data was retrospective or prospective, nor does it mention the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of expert involvement in establishing ground truth for any test set.
4. Adjudication method for the test set: The document does not describe any adjudication methods.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This device is an ELISA assay for antibodies, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC study or AI-related metrics are not applicable and are not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As an ELISA kit, the concept of "standalone algorithm performance" (without human-in-the-loop) as typically applied to AI/software devices is not relevant. The device is a laboratory assay.
7. The type of ground truth used: The letter does not specify how the "ground truth" (e.g., actual presence of antiphospholipid syndrome or elevated anti-cardiolipin antibodies) was established in any studies supporting this clearance. It states the assay can be used as an aid in diagnosis and that autoantibody levels are one indicator in a multi-factorial diagnostic regime, implying the need for clinical correlation rather than the assay being the sole determinant of ground truth.
8. The sample size for the training set: There is no mention of a training set or its size in the context of this device.
9. How the ground truth for the training set was established: No information regarding a training set or its ground truth establishment is provided.

The FDA 510(k) process primarily evaluates a device's substantial equivalence to a predicate device, and while performance data is part of the submission, this clearance letter itself does not detail that data.

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