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The Cheshire Diagnostics Limited QAß2A IgM Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgM 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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I apologize, but this document does not contain the information requested about acceptance criteria and a study proving device performance. This is a 510(k) clearance letter from the FDA for the QAB2A IgM Elisa Kit HRP, which primarily discusses the regulatory approval process based on substantial equivalence to a predicate device.

The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes for test sets, data provenance.
3. Information on experts used to establish ground truth or adjudication methods.
4. Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or human-in-the-loop performance.
5. A standalone algorithm performance study.
6. The type of ground truth used (e.g., pathology, outcomes data).
7. Sample size for the training set or how its ground truth was established.

This document is a formal notification of FDA clearance, indicating that the device has been deemed substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It refers to an "Indications for Use Statement" (on page 2 of the provided text), but this statement defines the intended use of the device, not its performance specifications or the results of a performance study.

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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:

1. 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.
2. 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).
3. 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.
4. Adjudication method for the test set: No adjudication method is mentioned as a test set isn't detailed.
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: 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.
6. 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.
7. 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.
8. 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.
9. 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.

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The Cheshire Diagnostics Limited QACA IgG/IgM Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG and/or IgM antibodies to cardiolipin in human serum. The presence of cardiolipin antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis for individuals diagnosed with Systemic Lupus Erythematosus (SLE) or other lupus-like disorders.

Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG and/or IgM antibodies to cardiolipin in human serum.

The provided document is a 510(k) premarket notification letter from the FDA for a diagnostic kit, not a study report detailing acceptance criteria or device performance data. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not present in the provided text.

The document does contain:

• Device Name: QACA IgG/IgM Elisa Kit HRP
• Intended Use: An Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG and/or IgM antibodies to cardiolipin in human serum.
• Clinical Application: To be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis for individuals diagnosed with Systemic Lupus Erythematosus (SLE) or other lupus-like disorders.
• Regulatory Information: Class II device, Product Code MID, Regulation Number 21 CFR 866.5660.

To answer your specific questions, a detailed study report or clinical trial summary for the "QACA IgG/IgM Elisa Kit HRP" would be required. This document only confirms the FDA's clearance of the device for marketing based on substantial equivalence to a predicate device.

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The Cheshire Diagnostics Limited QAß2A IgG Elisa Kit is a semi quantitative enzyme linked immunoassay for the detection of the IgG isotype autoantibody 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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I am unable to find the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or MRMC studies within the provided text. The document is a 510(k) clearance letter from the FDA for a diagnostic kit, primarily discussing its substantial equivalence to a predicate device and its indications for use. It does not include the detailed study outcomes or criteria that you are asking about.

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The Cheshire Diagnostics Limited QAB2A IgM Elisa Kit is a semi quantitative enzyme linked immunoassay for the detection of the IgM isotype autoantibody to ß2-Glycoprotein-1 in human serum. The presence of ß2-GP1 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 document is a 510(k) premarket notification letter from the FDA for a diagnostic kit (QAB2A IgM Elisa Kit AP). It declares the device substantially equivalent to a predicate device but does not contain information about acceptance criteria or specific study details to prove the device meets such criteria. Therefore, I cannot generate the requested information based on the provided text.

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The Cheshire Diagnostics Limited QACA IgG/IgM Elisa Kit is an enzyme linked immunoassay for the in vitro semi-quantitative detection of IgG and IgM antibodies to cardiolipin in human serum.

Not Found

This document is a 510(k) clearance letter for the QACA IgG/IgM ELISA Kit, indicating substantial equivalence to a predicate device. It does not contain a detailed study report with acceptance criteria and performance data. Therefore, I cannot extract the requested information. The letter only confirms the device can be legally marketed based on its equivalence.

Ask a specific question about this device