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The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and standardization of instruments and methods for the determination of Ethyl alcohol in whole blood or serum. The Standard Solutions may also be used for validation of the standardization of instruments and/or control materials.

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The provided text is a 510(k) clearance letter from the FDA for an "Ethyl Alcohol Calibrator" product. It states that the device is substantially equivalent to a predicate device and can be marketed.

However, the document does not contain specific information about:

• Acceptance criteria for device performance.
• The study that proves the device meets acceptance criteria (e.g., performance metrics, statistical analyses).
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or effect sizes.
• Standalone algorithm performance.
• Types of ground truth used or how it was established.

The document is a regulatory approval letter, not a performance study report. Therefore, I cannot extract the requested information from the given text.

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The Ammonia assay is used for the quantitation of ammonia in human plasma.

The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and standardization of instruments and methods for the determination of ethyl alcohol in whole blood or serum. The Standard Solutions may also be used for validation of the laboratory's routine standards and/or control materials.

Ammonia is an in vitro diagnostic assay for the quantitative determination of ammonia in human plasma. The Ammonia assay is a clinical chemistry assay which utilizes the amination of x-ketoglutarate by ammonia (NH3) along with the concomitant oxidation of NHzDPH. These reactions, catalyzed by glutamate dehydrogenase (GLDH), produce glutamate and NH2DP*. The oxidation of NHxDPH produces a decrease in absorbance at 340 nm which is directly proportional to the concentration of ammonia in the sample.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the Ammonia assay (K981926):

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size used for the method comparison or precision studies. It mentions "Comparative performance studies were conducted" and "Precision studies were conducted using three levels of control material," but no specific number of patient samples or replicates are given.

The data provenance is not explicitly stated (e.g., country of origin). Since it's a 510(k) submission to the FDA, it is highly likely the studies were conducted in the US, but this is not confirmed in the text. The studies appear to be prospective as performance characteristics were "conducted" using the new device and compared to a predicate.

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

This information is not applicable to this type of in vitro diagnostic device (IVD) study. The ground truth for quantitative assays like ammonia is established by the reference method (the predicate device in this case) or by well-characterized control materials, not by expert consensus on interpretations.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical imaging or diagnostic studies where human interpretation of results is involved, and there's a need to resolve discrepancies. For this quantitative IVD, the comparison is direct numerical measurement against a predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This is not applicable. MRMC studies are used for assessing the performance of human readers, often aided by AI, in interpreting diagnostic images or data. The Ammonia assay is a fully automated quantitative measurement, not requiring human interpretation of visual or complex data in the same way.

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

Yes, the studies described are standalone performance studies for the Ammonia assay. The device directly measures ammonia concentrations without human intervention in the interpretive process. The "performance characteristics" outlined (method comparison, precision, linearity, sensitivity) all evaluate the algorithmic and analytical performance of the device itself.

7. The Type of Ground Truth Used

The primary ground truth used is the performance of the predicate device, the A-GENT® Ammonia assay on the ABBOTT SPECTRUM® Series II™ System. For precision, well-characterized control materials at three different levels were used as ground truth.

8. The Sample Size for the Training Set

The document does not provide information on a separate training set. For in vitro diagnostic assays of this nature, especially those based on established chemical reactions, there isn't typically a "training set" in the machine learning sense. The assay is developed and validated based on the underlying chemical principles and established analytical performance characteristics.

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

As no "training set" is described for this IVD, this information is not applicable. The development of such an assay relies on well-understood chemical principles and rigorous analytical validation rather than data-driven machine learning training.

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The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and standardization caruments and methods for the determination of ethyl alcohol in whole blood or serum. The Standard tions may also be used for validation of the laboratory's routine standards and/or control materials.

Not Found

This document is a 510(k) clearance letter from the FDA for "Ethyl Alcohol Clinical Standard Solutions." It does not contain information about acceptance criteria or a study proving device performance in the way described in the request. The letter confirms substantial equivalence to a legally marketed predicate device, but it doesn't detail performance metrics or studies.

Therefore, I cannot extract the requested information from the provided text. The document is regulatory approval, not a performance study report.

Ask a specific question about this device