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Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to tissue transglutaminase (tTg) in human serum.

Uses:

The results of the anti-fTg assay can be used as an aid in the diagnosis of Coeliac Disease. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.

In addition to the manual assay protocol, this device has been validated for use with the HYCOR HY.TEC automated EIA instrument.

For in vitro diagnostic use only.

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to tissue transglutaminase (tTg) in human serum.

Here's an analysis of the provided text regarding the AUTOSTAT™ II Anti-Tissue Transglutaminase IgG ELISA device, focusing on acceptance criteria and study data:

Acceptance Criteria and Device Performance

The provided document is a 510(k) clearance letter from the FDA, which primarily confirms substantial equivalence to a predicate device. It does not explicitly state specific acceptance criteria (e.g., sensitivity, specificity thresholds) or detailed reported device performance metrics (e.g., actual sensitivity and specificity percentages) from internal validation studies.

The "Indications For Use" section describes the intended use of the device, which implicitly defines the performance characteristics it must demonstrate to be deemed safe and effective.

Here's a breakdown of what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

Important Note: The FDA's 510(k) clearance process focuses on substantial equivalence. Detailed performance data, including specific sensitivity, specificity, accuracy, and precision with corresponding statistical analysis, would have been submitted by the manufacturer in their 510(k) application. This document is the outcome of that review, not the detailed performance report itself. Therefore, the specific numerical performance metrics are not available in this particular FDA letter.

2. Sample size used for the test set and the data provenance:

• Not specified in this document. The FDA letter does not include details on the sample size used for validation studies.
• Data Provenance: Not specified in this document. The country of origin for the data or whether it was retrospective or prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified in this document. The FDA letter does not detail the methodologies for establishing ground truth in the manufacturer's studies.

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

• Not specified in this document. The document does not provide details on how discrepancies in ground truth establishment were resolved.

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:

• Not applicable. This device is an Enzyme-Linked Immunosorbent Assay (ELISA), which is a laboratory test, not an imaging device or AI-assisted diagnostic tool that would involve human "readers" or "interpreters" in the context of an MRMC study.

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

• Partially applicable, but not explicitly detailed as "standalone AI performance." As an ELISA, the device's performance is inherently "standalone" in the sense that the test results are generated by the assay itself without real-time human interpretation in the way an imaging AI works. The document states it's validated for use with an automated EIA instrument, suggesting it operates without direct human intervention once initiated. However, the exact performance metrics of this "standalone" (algorithm-only) aspect are not provided in this letter.

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

• Not specified in this document. For a diagnostic test like this, ground truth for Coeliac Disease diagnosis would typically involve a combination of clinical assessment, endoscopy with duodenal biopsy showing characteristic pathology, and resolution of symptoms on a gluten-free diet. The specific methods used in the manufacturer's studies are not detailed here.

8. The sample size for the training set:

• Not applicable/Not specified. ELISA devices are not "trained" in the same way machine learning models are. They are biochemical assays developed and optimized based on chemical principles and validation studies, rather than using a "training set" to learn patterns.

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

• Not applicable. As explained above, the concept of a "training set" and associated ground truth establishment for AI/ML purposes does not directly apply to the development of an ELISA assay. The development involves optimization of reagents, reaction conditions, and calibration, which are different processes.

In summary: The provided FDA 510(k) clearance letter confirms the device's substantial equivalence and intended use. However, it does not contain the detailed technical specifications or study results (like sample sizes, expert qualifications, specific performance metrics, or ground truth methodologies) that would typically be found in the manufacturer's full 510(k) submission or a peer-reviewed publication.

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Enzyme linked immunosorbent assay method for the scmi-quantitative determination specific IgA autoantibodies to tissue transglutaminase (tTg) in human securi.

Uses:

The results of the anti-tTg assay can be used as an aid in the diagnosis of auto-immun diseases associated with elevated levels of anti-tTg antibodies including Coeliac Discuss a Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regine.

This device can be used with the HYCOR HY.TEC automated EIA instrument.

For in vitro diagnostic use only.

Prescription Use (Per 21 CFR 801.109)

Enzyme linked immunosorbent assay method for the scmi-quantitative determination specific IgA autoantibodies to tissue transglutaminase (tTg) in human securi.

I am sorry, but based on the limited information provided in the input text, I cannot describe the acceptance criteria and the study that proves the device meets them with the level of detail requested. The provided text is a premarket notification letter from the FDA regarding the "Autostat II Anti-tTg IgA ELISA" device, indicating its substantial equivalence to a predicate device.

The document lacks specific details on:

1. Acceptance criteria and reported device performance table: While it mentions the device is "substantially equivalent," it doesn't provide the quantitative or qualitative metrics for this equivalence or what performance targets were set.
2. Sample size and data provenance for the test set: There is no mention of a test set, its size, the country of origin of the data, or whether it was retrospective or prospective.
3. Number and qualifications of experts for ground truth: No information on expert involvement for ground truth establishment is present.
4. Adjudication method for the test set: Not mentioned.
5. MRMC comparative effectiveness study: No information on such a study or any effect size related to AI assistance. The device is an ELISA, not an AI-assisted diagnostic.
6. Standalone performance study: While the device itself performs a test, the document doesn't detail a standalone study with specific performance metrics (e.g., sensitivity, specificity, accuracy).
7. Type of ground truth used: It states the device aids in diagnosing diseases like Celiac Disease based on anti-tTg antibodies, but it does not describe how the ground truth for studying the device's performance was established (e.g., against biopsy, clinical consensus, pathology).
8. Sample size for the training set: Not mentioned. This would typically be relevant for AI/ML devices, which this ELISA is not.
9. How ground truth for the training set was established: Not mentioned.

The document primarily focuses on the regulatory determination of substantial equivalence. To answer your request comprehensively, information from the actual 510(k) submission, including performance studies and detailed methodologies, would be required.

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Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific 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 multifactorial diagnostic regime.

This device can be used with the HYCOR HY•TEC automated EIA instrument.

For in vitro diagnostic use only.

Prescription use

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

The provided text is a 510(k) premarket notification letter from the FDA regarding the Autostat™ II Anti-Cardiolipin IgA ELISA device.

Unfortunately, this document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This indicates that the FDA's decision is based on substantial equivalence to a predicate device, rather than a detailed presentation and review of a specific clinical performance study with acceptance criteria and ground truth validation for this particular device. The document primarily focuses on regulatory approval based on this equivalence and general controls, not on specific performance data from a new clinical study.

Therefore, I cannot provide the requested information based solely on the text provided. To answer your questions, I would need to review the actual 510(k) submission and its supporting documentation, which would contain the performance data and study details.

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Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA autoantibodies to ß2-Glycoprotein I (ß2-GPI) antibodies in human serum.

Uses:

The results of the anti- ß -2 GPI assay can be used as an aid in the diagnosis of auto-immune diseases associated with elevated levels of anti-ß-2 GPI antibodies including antiphospholipid syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.

This device can be used with the HYCOR HY.TEC automated EIA instrument.

For in vitro diagnostic use only.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Autostat II Anti-B-2 Glycoprotein I IGA Elisa." It confirms that the device is substantially equivalent to a legally marketed predicate device.

Unfortunately, the provided text does not contain the detailed study information needed to answer your questions regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study specifics. This document is a regulatory approval letter, not a scientific study report.

Therefore, I cannot provide the requested table and detailed answers based on the given input. The letter only states the device's name, regulation number, regulation name, regulatory class, and product code. It also includes the "Indications for Use" which describes what the device is intended for.

To answer your questions, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or the 510(k) submission itself, which would detail the performance studies conducted.

Ask a specific question about this device