Search Results

The Sigma Diagnostics INFINITY™ BUN Reagent is intended for the in vitro quantitative, diagnostic determination of Urea (or Urea Nitrogen) in human serum or urine on both automated and manual svstems.

The Sigma Diagnostics INFINITY™ BUN Reagent is a device intended to measure urea nitrogen (an end product of nitrogen metabolism) in serum. Measurements obtained by the device are used in the diagnosis and treatment of certain renal and metabolic diseases.

The enzyme methodology employed in this reagent is based on the reaction first described by Talke and Schubert. To shorten and simplify the assay, the calculations are based on the discovery of Tiffany, et al.3 that urea concentration is proportional to absorbance change over a fixed time interval.

The series of reactions involved in the assay system is as follows:

1. Urea is hydrolyzed in the presence of water and urease to produce ammonia and carbon dioxide.
   Urea + H2O Urease

This 510(k) notification for the INFINITY™ BUN Reagent is a submission for an in vitro diagnostic device, not an AI/ML device, therefore, many of the requested categories related to AI/ML device studies are not applicable. The document states that the device is "substantially equivalent to, and is the same product as the TRACE Scientific BUN Reagent kit cleared by the FDA as K971477," indicating that performance is established through equivalence to a predicate device rather than a de novo study with acceptance criteria specific to this submission.

Here's a breakdown of the available information regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is an in vitro diagnostic (IVD) reagent intended to measure Urea Nitrogen, the typical acceptance criteria relate to analytical performance characteristics such as accuracy, precision, linearity, and interference. However, this 510(k) summary does not explicitly state specific acceptance criteria (e.g., a target accuracy percentage or precision coefficient of variation) or present a table of reported device performance data.

Instead, it relies on substantial equivalence to a previously cleared device. The implicit acceptance criterion is that the INFINITY™ BUN Reagent performs identically or equivalently to the TRACE Scientific BUN Reagent (K971477).

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

This information is not provided in the 510(k) summary. For IVD reagents, a "test set" typically refers to samples used in validation studies (e.g., patient samples, spiked samples, control materials). The document doesn't detail any specific studies conducted with this new reagent, as its equivalence is asserted.

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

This is not applicable/not provided. For an IVD reagent that measures a chemical analyte like Urea Nitrogen, "ground truth" is typically established through reference methods, certified reference materials, or highly accurate laboratory instruments, not through expert consensus in the way it would be for image analysis or clinical diagnosis by human experts.

4. Adjudication Method for the Test Set:

This is not applicable/not provided. Adjudication methods (e.g., 2+1, 3+1) are common in studies where multiple human readers interpret results, often in AI/ML performance studies to resolve discrepancies. This concept doesn't apply to the analytical performance of an IVD reagent.

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:

This is not applicable. This submission is for an in vitro diagnostic reagent, not an AI-assisted diagnostic device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been performed or would be relevant.

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

This is not applicable. The INFINITY™ BUN Reagent is a chemical reagent, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this device.

7. The Type of Ground Truth Used:

For the type of device described, the "ground truth" for evaluating its analytical performance would typically be:

• Reference Methods: Comparison against established, highly accurate laboratory methods for Urea Nitrogen measurement.
• Certified Reference Materials: Using materials with known, certified concentrations of Urea Nitrogen.
• Split Sample Comparisons: Testing patient samples with the new reagent and a predicate/reference method.

However, the 510(k) summary does not explicitly state the type of ground truth used for any specific validation studies, as it's primarily a substantial equivalence claim. The references provided (Tietz Textbook, Talke and Schubert, Tiffany et al.) relate to the scientific principles and historical context of BUN measurement methodology, not specific ground truth establishment for a validation study of this particular reagent.

8. The Sample Size for the Training Set:

This is not applicable. The INFINITY™ BUN Reagent is a chemical reagent, not an AI/ML model that requires a "training set."

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

This is not applicable, as there is no "training set" for a chemical reagent.

Summary of Substantial Equivalence Claim:

The core of this 510(k) is the statement: "The Sigma Diagnostics INFINITY™ BUN Reagent (Procedure No. 63) is substantially equivalent to, and is the same product as the TRACE Scientific BUN Reagent kit cleared by the FDA as K971477." This means that the FDA's acceptance of this device's safety and effectiveness relies on its demonstrated equivalence (likely through comparative analytical performance studies, though not detailed here) to the predicate device, which has already been deemed safe and effective. The original predicate device (K971477) would have undergone its own validation studies to establish its performance characteristics against acceptance criteria relevant to its intended use.

Ask a specific question about this device