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AuraFlex TSH-3 is a "third generation" fluorescent enzyme immunoassay for the quantitative determination of thyroid stimulating hormone (TSH) in human serum or plasma using the AuraFlex system.

Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

AuraFlex TSH-3 is a "third generation" fluorescent enzyme immunoassay for the quantitative determination of thyroid stimulating hormone (TSH) in human serum or plasma using the AuraFlex system.

This document is an FDA 510(k) clearance letter for the AuraFlex® TSH-3 device, which is a fluorescent enzyme immunoassay for the quantitative determination of thyroid stimulating hormone (TSH). The letter indicates that the device has been found substantially equivalent to predicate devices. However, the provided text does not contain the acceptance criteria, details of a study that proves the device meets those criteria, or any of the specific information requested in points 1-9 of your prompt.

The document primarily focuses on:

• The FDA's decision of substantial equivalence (K980574).
• Regulatory classifications (Class II, Product Codes JLW, JIS).
• Applicable general and special controls provisions of the Federal Food, Drug, and Cosmetic Act.
• Instructions for the manufacturer regarding CLIA complexity, labeling, promotion, and other responsibilities.
• The intended use of the device ("third generation" fluorescent enzyme immunoassay for quantitative determination of TSH in human serum or plasma using the AuraFlex system to diagnose thyroid or pituitary disorders).

Therefore, based solely on the provided text, I cannot answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods. This information would typically be detailed in the 510(k) submission itself or a separate study report, which is not part of this letter.

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AuraFlex Ferritin is a fluorescent enzyme immunoassay for the quantitative determination of ferritin in human serum or plasma using the AuraFlex System.

Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemachromatosis (iron overload) and iron deficiency anemia.

Fluorescent immunoassay reagents.

Here's the analysis of the provided information regarding the AuraFlex® Ferritin device:

Due to the nature of the device (immunoassay for Ferritin), many of the acceptance criteria points (like expert readers, adjudication, MRMC studies) are not applicable as this is not an image-based or human-interpretive diagnostic device. The study described focuses on the analytical performance of the assay.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample size: 94 human serum samples.
   • Data provenance: Not explicitly stated, but the samples were human serum. The document doesn't specify the country of origin or if it was retrospective or prospective.

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

   • Not applicable. This is an immunoassay, and "ground truth" for its analytical performance is typically established by comparison to a reference method or a predicate device, not by expert interpretation.

3. Adjudication method for the test set:

   • Not applicable. The "ground truth" was established via a comparative study with another Ferritin assay.

4. 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 is an in vitro diagnostic (IVD) assay, not an AI-assisted diagnostic tool requiring human interpretation.

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

   • The study performed was a standalone analytical performance study of the AuraFlex® Ferritin assay. It compared the results of the new assay directly against an "Other Ferritin assay" without human-in-the-loop performance measurement.

6. The type of ground truth used:

   • The "ground truth" for demonstrating substantial equivalence was established by comparison to an "Other Ferritin assay," which implicitly served as the reference or predicate method. This is an analytical comparison rather than a clinical ground truth like pathology or outcome data.

7. The sample size for the training set:

   • Not applicable. This device is an immunoassay, not a machine learning or AI-driven algorithm that requires a training set in the conventional sense. The "training" here would be related to assay optimization and validation during development, not data-driven model training.

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

   • Not applicable (as per point 7).

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The AuraFlex® FT3 assay is a fluorescent immunoassay for the quantitative determination of free triiodothyronine assay in human serum or plasma using the AuraFlex® System.

Fluorescent immunoassay reagents.

The provided text describes a 510(k) premarket notification for the Alfa Biotech (UK) Ltd AuraFlex® FT3, an immunoassay for free triiodothyronine. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 110 human serum samples.
• Data Provenance: Not explicitly stated, but the submission is from Alfa Biotech (UK) Ltd, suggesting the study may have been conducted in the UK or with UK-sourced samples. The data type is retrospective as it refers to a "comparison study" that was "conducted."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given text. The "ground truth" appears to be established by comparison to another existing FT3 assay, rather than expert consensus on individual samples.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study conducted was a comparison of a new immunoassay against an existing one, not a study involving human readers or AI assistance.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this was a standalone study of the device (immunoassay) performance. There is no mention of human-in-the-loop performance or AI.

7. The Type of Ground Truth Used

The ground truth was established by comparison to the results of an "Other FT3 assay." This implies a reference method or legally marketed predicate device.

8. The Sample Size for the Training Set

This information is not provided in the given text. The text describes a "comparison study" of 110 samples, likely representing the test set for performance evaluation. There's no mention of a separate training set.

9. How the Ground Truth for the Training Set Was Established

Since no training set information is provided, how its ground truth was established is not applicable/not provided.

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