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The K-ASSAY Alpha-1 AG Assay is intended to be used for the quantitative determination of Alpha-1 AG in human serum by immunoturbidimetric assay. Measurement of Alpha-1 AG may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes. FOR IN VITRO DIAGNOSTIC USE.

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The provided text is a 510(k) clearance letter from the FDA for a device named "K-ASSAY Alpha-1 AG." This document outlines the regulatory approval for an in vitro diagnostic device and does not contain information about acceptance criteria or specific study results that would typically be associated with an AI/ML-driven device.

Therefore, I cannot fulfill your request as the necessary information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information) is not present in the provided text.

The document states:

• Device Name: K-ASSAY Alpha-1 AG.
• Intended Use: "The K-ASSAY Alpha-1 AG Assay is intended to be used for the quantitative determination of Alpha-1 AG in human serum by immunoturbidimetric assay. Measurement of Alpha-1 AG may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes. FOR IN VITRO DIAGNOSTIC USE."
• Regulatory Clearance: Substantial equivalence to a predicate device.

To address your request, I would need a document that describes the clinical performance study of a device, usually found in a clinical study report or a 510(k) summary for devices that rely on quantitative or qualitative performance metrics against defined acceptance criteria.

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The N-Assay TIA Alpha-l-Acid Glycoprotein Test Kit is intended for the quantification of human alpha-l-acid glycoprotein in human serum by immunoturbidimetric assay. Measurement of alpha 1acid glycoprotein may aid in the diagnosis of collagen ( connective tissue ) disorders, tuberculosis, infections, extensive malignancy and diabetes.

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This document is a 510(k) clearance letter from the FDA for a medical device (N-Assay TIA Alpha-1-Acid Glycoprotein Test Kit) and does not provide detailed information on acceptance criteria or the specific study details that would typically be found in a study report or clinical trial summary.

Therefore, most of the requested information cannot be extracted from the provided text.

However, based on the limited information, here's what can be stated:

1. A table of acceptance criteria and the reported device performance: Not available in the provided text. The document is a regulatory clearance, not a performance report.

2. Sample size used for the test set and the data provenance: Not available in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in the provided text.

4. Adjudication method: Not available in the provided text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not available in the provided text. This type of study is more common for imaging diagnostics, whereas this device is a laboratory test kit.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an "immunoturbidimetric assay" test kit, implying an automated or semi-automated process for quantification. Its performance would be evaluated in a standalone manner, but the details of such a study are not provided.

7. The type of ground truth used: For an immunoturbidimetric assay, the "ground truth" for a performance study would typically be established against a reference method or another validated laboratory assay, measuring the actual concentration of alpha-1-acid glycoprotein. The document does not specify the method used to establish ground truth in any study.

8. The sample size for the training set: Not applicable/not available. This device is a diagnostic test kit, not an AI/machine learning algorithm that typically requires a 'training set.'

9. How the ground truth for the training set was established: Not applicable/not available.

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The IMMAGE Immunochemistry System Alpha - Acid Glycoprotein (AAG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human alpha-acid glycoprotein by rate nephelometry.

The IMMAGE Immunochemistry System AAG Reagent in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of alpha-acid glycoprotein concentrations respectively in human serum samples on Beckman's IMMAGE Immunochemistry System.

Here's a breakdown of the acceptance criteria and study information for the IMMAGE™ Immunochemistry System Alpha-Acid Glycoprotein (AAG) Reagent, based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" with specific thresholds for method comparison metrics (Slope, Intercept, r-value). However, the "Summary of Performance Data" presents the results of these studies, implying these values are deemed acceptable for demonstrating substantial equivalence. The predicate device's performance would serve as the implicit benchmark.

Since explicit acceptance criteria are not provided for the method comparison, I will present the reported performance as fulfilling the implied acceptance for substantial equivalence based on the comparison to the predicate.

Note: The section for "Estimated Within-Run Imprecision" contains garbled text. Therefore, specific acceptance criteria and performance data for this metric cannot be extracted from the provided document.

Study Details

This submission describes the development of a reagent for use on an existing system (IMMAGE™ Immunochemistry System), not a standalone diagnostic device in the sense of an AI algorithm or imaging system. Therefore, some of the requested categories (like number of experts for ground truth, adjudication method, MRMC studies) are not applicable to this type of device and study.

1. Sample Sizes and Data Provenance:

• Test Set Sample Size (Method Comparison): 141 samples
• Data Provenance: Human serum samples. Country of origin not specified. The study appears to be prospective in nature, comparing the new reagent's performance against the existing predicate on new samples.

2. Number of Experts and Qualifications for Ground Truth:

• Not Applicable. This is a quantitative chemical assay. The "ground truth" for the method comparison is the measurement obtained from the established predicate device (Beckman AAG Reagent on Array® 360). There are no "experts" in the sense of clinical decision-makers involved in establishing ground truth for individual samples in this context.

3. Adjudication Method for Test Set:

• Not Applicable. As a quantitative assay comparison, there is no need for adjudication by experts. The comparison is between two quantitative measurements.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• No. This type of study is not applicable to a chemical assay reagent. MRMC studies are typically used for diagnostic imaging or other subjective interpretation tasks where human readers are involved.

5. Standalone Performance Study:

• Yes, in essence. The "Method Comparison Study Results" section directly shows the performance of the IMMAGE AAG Reagent (the "algorithm/device" in this context) in generating quantitative results compared to an established method. This demonstrates the reagent's performance on its own, albeit in comparison to a predicate, not necessarily against a "true" gold standard across all possible ranges.

6. Type of Ground Truth Used:

• Comparison to a Predicate Method. The "ground truth" for the method comparison study was the quantitative results obtained from the Beckman AAG Reagent on Array® 360, which is the well-established predicate device. This is a form of comparative truth rather than an absolute biological truth like pathology or outcomes data.

7. Sample Size for Training Set:

• Not specified. The document does not mention a "training set" in the context of an algorithm. This is a chemical reagent, likely optimized through laboratory development and testing rather than machine learning training.

8. How Ground Truth for Training Set was Established:

• Not Applicable. As there's no specified "training set" in the machine learning sense, this question is not relevant. The reagent development would have involved various analytical chemistry and formulation studies, but not "ground truth" establishment for training an algorithm.

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