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Ask a specific question about this device

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA rheumatoid factor (RF) antibodies in human serum.

Uses:

The results of the RF IgA assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations.

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 for the "Autostat II Rheumatoid Factor IgA ELISA" device, indicating it has been deemed substantially equivalent to a legally marketed predicate device. This document primarily focuses on regulatory approval and does not contain detailed information about specific acceptance criteria or the study data that proved the device met those criteria.

Therefore, most of the requested information cannot be extracted from the given text. The relevant sections from the prompt that can be addressed from the text are the device name and its intended use.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

• Cannot be answered from the provided text. The letter states the device is "substantially equivalent" to a predicate device, but it does not specify the performance acceptance criteria or report the actual performance metrics of the Autostat II Rheumatoid Factor IgA ELISA.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be answered from the provided text. The document does not describe the test set size or its provenance.

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)

• Cannot be answered from the provided text. This information would typically be in a study report, not a regulatory clearance letter.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be answered from the provided text. This detail is not present.

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

• Cannot be answered from the provided text. This device is an ELISA (Enzyme-linked immunosorbent assay), a laboratory diagnostic test, not an image-based device that would typically involve human readers or AI assistance in the way described for MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Partially addressed indirectly. As an ELISA test, its performance is typically "standalone" in that it produces a result without direct human interpretation in the same way an imaging AI might. However, the document doesn't explicitly state whether a standalone performance study was conducted or its results.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Cannot be answered from the provided text. While the device aids in the diagnosis of rheumatoid arthritis, the method used to establish the ground truth in any underlying studies is not disclosed.

8. The sample size for the training set

• Cannot be answered from the provided text. This information is not included.

9. How the ground truth for the training set was established

• Cannot be answered from the provided text. This information is not included.

Based on the provided text, here's what can be stated:

• Device Name: Autostat II Rheumatoid Factor IgA ELISA (also referred to as Autostat Rheumatoid Factor IgA ELISA)
• Indications for Use: Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA rheumatoid factor (RF) antibodies in human serum.
• Uses: The results of the RF IgA assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations. 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.
• Regulatory Status: Cleared by FDA on March 3, 2000, under K993557, as substantially equivalent to a legally marketed predicate device.

To obtain the detailed study information regarding acceptance criteria, sample sizes, ground truth establishment, and performance metrics, one would typically need to refer to the full 510(k) submission summary or a separate study report, which is not included here.

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ENZAME LINKED IMMUNDSOKERAT ASSIM METHOD FOR THE SOMI - QUATITATUE DEFERENTIAN ATTON OF SFECIFIC IGM RHEUMATOLD FACTOR (RF) ANTIES DIES IN HUMAN SEBENA. USES: THE RESULTS OF THE REIGM ASSAY CAN BE USED AS AN AID IN THE DIRENCES & RHERMATORD ARTHRITIS CRA) WHEN SUPPORTED BY OTHER CABORATORY AND CUMCAL INVESTIGATIONS . LEVELS OF THESE AUTOANTIES ARE ONE ONE MINICATION IN A MUTIFACTORIAL DIAGNOSTIC GIME. THE ASSAY MAT BE USED ON THE HAUSE HYOTEC AUTOMATED EIA INSTRUMENT. FOR IN UTRO DIAGNOSIAC USE CAULY

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them, as requested. The document is an FDA 510(k) clearance letter for the "Autostat™ II Rheumatoid Factor IgM ELISA" device, indicating that it has been deemed substantially equivalent to a legally marketed predicate device.

The letter does not include:

• A table of acceptance criteria or reported device performance.
• Details about the sample size, data provenance, number of experts, adjudication methods for ground truth, or qualifications of experts.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Details about standalone algorithm performance studies.
• The type of ground truth used for any studies.
• Information about the training set size or how its ground truth was established.

The document only states the device's trade name, regulatory class, product code, and its intended use: "ENZYME LINKED IMMUNOSORBENT ASSAY METHOD FOR THE SEMI-QUANTITATIVE DETERMINATION OF SPECIFIC IGM RHEUMATOID FACTOR (RF) ANTIBODIES IN HUMAN SERA. USES: THE RESULTS OF THE RF IGM ASSAY CAN BE USED AS AN AID IN THE DIAGNOSIS OF RHEUMATOID ARTHRITIS (RA) WHEN SUPPORTED BY OTHER LABORATORY AND CLINICAL INVESTIGATIONS. LEVELS OF THESE AUTOANTIBODIES ARE ONE INDICATION IN A MULTIFACTORIAL DIAGNOSTIC SCHEME. THE ASSAY MAY BE USED ON THE HAAKE HYPOTEC AUTOMATED EIA INSTRUMENT. FOR IN VITRO DIAGNOSTIC USE ONLY."

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Enzyme linked immunosorbent assay method for the detection of IgG, IgM and IgA autoantibodies to cardiolipin in human serum.

Uses:

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

I apologize, but the provided text from the FDA 510(k) K993085 document for the Autostat™II ACA Screen ELISA does not contain the detailed information required to answer your specific questions regarding acceptance criteria, study design, and performance metrics.

The document is a clearance letter, indicating that the device has been found substantially equivalent to a predicate device. It defines the "Indications for Use" but does not delve into the validation studies or specific performance characteristics that led to this clearance.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance: This information is not present in the clearance letter. Such details would typically be found in the manufacturer's 510(k) submission, which is not provided here.
2. Sample size used for the test set and data provenance: Not available.
3. Number of experts used to establish ground truth and their qualifications: Not available. The device is for in vitro diagnostic use, and ground truth would likely be established through a combination of clinical diagnosis and confirmation with other established laboratory methods, but specific details of this process are not in the document.
4. Adjudication method for the test set: Not available.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information: This is an in vitro diagnostic device (ELISA assay), not an imaging device or AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not applicable in this context.
6. Standalone performance (algorithm only without human-in-the-loop performance): This is an in vitro diagnostic device and its performance is inherently "standalone" in the sense that it provides a quantitative or qualitative result without human interpretation beyond reading the result. However, the specific metrics of its standalone performance (e.g., sensitivity, specificity) are not detailed here.
7. Type of ground truth used: General indication that it's an "aid in the diagnosis of autoimmune diseases associated with elevated levels of anti-cardiolipin antibodies including anti-phospholipid syndrome," implying clinical diagnoses and potentially other lab tests, but no specific ground truth methodology is described.
8. Sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

This document serves as an official confirmation of regulatory clearance based on a submission that would have contained all of the study details you are asking about, but those details are not part of the clearance letter itself.

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Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG rheumatoid factor (RF) antibodies in human serum.

Uses:

The results of the RF IgG assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations.

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 clearance letter from the FDA for the Autostat™I Rheumatoid Factor IgG ELISA device (K993304). It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or details about the study that proves the device meets those criteria, based on the information provided. The document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines the regulatory framework for its marketing.

To answer your request, I would need access to the original 510(k) submission document (K993304) itself, or a summary of its performance data.

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

Uses:

The results of the anti-gliadin IgG assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-gliadin antibodies including Coeliac Disease.

Levels of these antibodies 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

This FDA communication is a clearance letter for a medical device (Autostat™ II Anti-Gliadin IgG ELISA). It indicates that the device has been reviewed and found to be "substantially equivalent" to legally marketed predicate devices. However, the document does not contain the acceptance criteria for the device's performance, nor does it detail the study that proves the device meets those criteria.

Therefore, I cannot extract the requested information from this document. The letter focuses on regulatory approval based on equivalence rather than presenting performance data or study specifics.

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

Uses:

The results of the anti-gliadin IgA assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-gliadin antibodies including Coeliac Disease.

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

I am sorry, but the provided text does not contain enough information to fulfill your request. The document is a 510(k) clearance letter from the FDA for an in vitro diagnostic device, "Autostat™ II Anti-Gliadin IgA ELISA."

While it mentions the intended use of the device as an aid in the diagnosis of diseases associated with elevated levels of anti-gliadin antibodies (including Coeliac Disease), it does not provide any details about:

• Acceptance criteria: What specific performance metrics (e.g., sensitivity, specificity, accuracy, precision, correlation) were established and what values were set as acceptable.
• Reported device performance: The actual results from any studies demonstrating these performance metrics.
• Study design details: Such as sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, or whether standalone or MRMC studies were conducted.

The document primarily focuses on the FDA's determination of substantial equivalence and regulatory classification, not on the detailed technical or clinical study results that would typically include acceptance criteria and performance data.

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