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Intended for the in vitro determination of mitochondrial (M2) antibody in human serum. Anti-M2 assays are used as an aid in the diagnosis of Primary Biliary Cirrhosis - CFR 866.5090

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The provided text is a 510(k) approval letter from the FDA for a device called "TRACE Enzymatic Mitochondria (M2) Antibody Reagent." This document does not contain the detailed information required to answer your questions about acceptance criteria and the study proving device performance.

Specifically, the letter is a regulatory filing indicating substantial equivalence to a previously marketed device, allowing it to be sold. It does not include:

• Details of a performance study.
• Acceptance criteria for such a study.
• Sample sizes for test or training sets.
• Information on expert ground truth, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested table or answer the specific questions based on the input text.

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The Urea Nitrogen assay is used for the quantitation of urea nitrogen in human serum, plasma, or urine. Measurements obtained by this device are used in diagnosis and treatment of certain renal and metabolic diseases.

Urea Nitrogen is an in vitro diagnostic assay for the quantitative determination of urea nitrogen in human serum, plasma, or urine. The Urea Nitrogen assay is a clinical chemistry assay in which the the urea in the sample is hydrolyzed by urease to ammonia (NH3) and carbon dioxide (CO2). A second reaction, catalyzed by glutamate dehydrogenase (GLD), converts ammonia and a-ketoglutarate to glutamate and water with the concurrent oxidation of reduced nicotinamide adenine dinucleotide (NADH) to nicotinamide adenine dinucleotide (NAD). Two moles of NADH are oxidized for each mole of urea present. The initial rate of decrease in absorbance at 340 nm is proportional to the urea concentration in the sample.

The Abbott Laboratories Urea Nitrogen assay is an in vitro diagnostic device for the quantitative determination of urea nitrogen in human serum, plasma, or urine, used in the diagnosis and treatment of renal and metabolic diseases. It underwent a 510(k) submission to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly defined by demonstrating "acceptable correlation" in comparative performance studies and acceptable precision. The reported performance is as follows:

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

The document does not specify the exact sample size for the test set used in the comparative performance studies. It only states that "Comparative performance studies were conducted" and presents summary statistics (correlation coefficient, slope, Y-intercept).

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given it's a 510(k) submission for a clinical chemistry assay, the data would typically be derived from laboratory tests, and the intent is for prospective clinical use.

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

Not applicable. This is an in vitro diagnostic assay where the "ground truth" is established by the comparative performance against legally marketed predicate devices using objective measurements, not by expert interpretation of images or other subjective assessments.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessment to resolve discrepancies in expert opinions. This device's performance is assessed through quantitative comparisons with predicate devices.

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 is a standalone in vitro diagnostic assay, not an AI-assisted diagnostic tool designed to aid human readers. Therefore, an MRMC study and
the concept of human reader improvement with AI assistance do not apply.

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

Yes, a standalone performance study was done. The entire submission describes the performance of the Abbott Urea Nitrogen assay itself (the "algorithm only" in the context of an IVD) without human-in-the-loop performance modifications or assistance. Its performance characteristics (correlation, precision, linearity, sensitivity) were measured intrinsically and compared to predicate devices.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the comparative performance studies, the "ground truth" was established by the results obtained from the legally marketed predicate devices:

• Roche Cobas Mira Plus Automated Chemistry System Urea Nitrogen assay (K954000) for the serum application.
• Boehringer Mannheim Urea Nitrogen assay on the Hitachi 717 Analyzer (K771923) for the urine application.

These predicate devices are assumed to provide accurate measurements of urea nitrogen, serving as the reference for determining the substantial equivalence of the new device.

8. The Sample Size for the Training Set

Not applicable. This is a traditional in vitro diagnostic assay, not a machine learning or AI-based device that requires a distinct "training set" in the conventional sense. The development of such an assay involves reagent formulation, instrument calibration, and optimization based on chemical principles and experimental data, rather than training on a dataset.

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

Not applicable, as there is no specific "training set" in the context of this traditional IVD development. The "ground truth" in the development of such assays is based on established analytical chemistry principles, reference methods, and quality control materials.

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