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Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only.

Diazyme's 1.5-AG assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The assay uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd position hydroxyl group of 1,5-AG and to detect the generated hydrogen peroxide by colorimetry using peroxidase (POD). To eliminate reactive glucose in sample, it is pretreated by enzymatic reactions using hexokinase and pyruvate kinase (PK). Hexokinase uses adenosine triphosphate (ATP) to convert glucose into non-reactive glucose-6-phosphate (G-6-P), generating adenosine diphosphate (ADP). The reaction is driven to completion with PK, as ADP is phosphoralated to ATP during the conversion of phosphoenolpyruvate (PEP) into pyruvate.

The provided document is a 510(k) premarket notification for the Diazyme 1,5-AG Assay, a device for in vitro quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma to monitor glycemic control in people with diabetes.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaways:

• This submission focuses on substantial equivalence to a predicate device (GlycoMark™ 1,5-anhydroglucitol (1,5-AG) K031604) rather than a novel, de novo AI/ML device. Therefore, many standard AI/ML specific criteria like MRMC studies, human-in-the-loop performance, and expert consensus for ground truth are not applicable or detailed in this context.
• The studies presented are primarily analytical performance studies to demonstrate that the new device performs comparably to the predicate device and meets established laboratory testing standards.

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance by comparing the Diazyme 1,5-AG Assay's performance to the predicate device and established CLSI (Clinical and Laboratory Standards Institute) guidelines for analytical validation.

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

• Precision Study: Six serum samples (tested repeatedly over 240 measurements for each sample to calculate different CV% components).
• Linearity Study: Samples encompassing a wide range of 1,5-AG concentrations (Level 0 to Level 10), tested in triplicate for each level. The exact number of distinct patient samples is not specified, but it implies a spiked matrix or dilutions of real samples.
• Method Comparison (Accuracy) Study: 102 patient samples covering the Analytical Measurement Range (AMR).
• Reference Range Study: 140 apparently healthy males and 140 apparently healthy females (Total 280 samples).
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It refers to "clinical patient samples" for the method comparison study and "apparently healthy males and females" for the reference range study, implying real human samples. Given the nature of in vitro diagnostic device validation, these are typically prospective collection campaigns or use of well-characterized biobank samples.

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

• This device is an in vitro diagnostic assay for quantitative measurement of a biomarker, not an AI/ML device interpreting medical images or other complex data. Therefore, the concept of "experts establishing ground truth" in the same way as, for example, radiologists marking tumors, is not applicable.
• The "ground truth" for the test set is established by the measurement results obtained from the predicate device (GlycoMark™ 1,5-AG assay) for the method comparison study, and by the inherent concentration values of the samples used in precision, linearity, LoB/LoD/LoQ, and interference studies. These are not dependent on expert visual review or interpretation.
• The predicate device itself was validated and approved by the FDA based on its own clinical and analytical performance.

4. Adjudication Method for the Test Set:

• Not applicable in this context. Adjudication methods like 2+1 or 3+1 are used when human experts disagree on interpretations (e.g., in radiology image reading). For quantitative in vitro diagnostic assays, the "truth" is the measured value, and deviations are assessed statistically (e.g., bias, correlation, CV%).

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:

• No, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic device measuring a chemical biomarker, not an AI system assisting human readers of medical images or other data. The performance is assessed analytically against a predicate device and established laboratory standards.

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

• Yes, in essence, the Diazyme 1,5-AG Assay is a standalone device. It performs the quantitative measurement of 1,5-AG in a sample without direct human interpretation of its internal "algorithm" or sensing process for each test. The results are provided as a numeric value. Humans (lab technicians, clinicians) then interpret these numeric results in the clinical context, similar to any lab test. The performance studies (precision, linearity, method comparison, etc.) directly evaluate the performance of this "standalone" assay.

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

• Analytical Reference Values / Predicate Device Measurements:
  • For the method comparison study (accuracy), the "ground truth" was the measurements obtained from the legally marketed predicate device (GlycoMark™ 1,5-AG).
  • For linearity, LoB/LoD/LoQ, and precision studies, the "ground truth" refers to the expected or true concentrations of the analytes in the reference materials or spiked samples. These values are typically established through highly accurate reference methods or certified reference materials traceable to international standards (though not explicitly detailed, this is standard practice for IVD validation).

8. The Sample Size for the Training Set:

• Not applicable in the typical AI/ML sense. This is a chemical assay, not a machine learning algorithm that learns from training data. The "training" for such a device involves optimizing reagents and reaction conditions during development, but there isn't a "training set" of patient data in the same way an AI model is trained.

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

• Not applicable. As explained above, this device does not have a "training set" in the context of AI/ML. The "ground truth" for the analytical studies are the established reference values or predicate device measurements.

Ask a specific question about this device

The GlycoMark™ test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in serum or plasma. The test is for professional use, and is indicated for the intermediate term monitoring of glycemic control in people with diabetes.

The GlycoMark™ reagents provide for a fully automated enzymatic test for 15AG. The assay requires the two-reagent boxed set (Reagent 1 and Reagent 2) and the 15AG standard (purchased separately). A two-level control set ("Low" and "High") is also available separately.

The provided text describes the 510(k) summary for the GlycoMark™ device. It includes nonclinical and clinical data, but it does not specify acceptance criteria for the device's performance in a traditional sense (e.g., a specific sensitivity or specificity threshold that must be met). Instead, it presents performance characteristics and clinical study results primarily for comparison with a predicate device and to demonstrate safety and effectiveness for its intended use.

However, I can extract the reported device performance and infer "acceptance" by its successful 510(k) clearance by the FDA, implying these performance characteristics were deemed adequate.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since explicit "acceptance criteria" are not stated as quantitative targets that the device must meet (e.g., "sensitivity must be >X%"), I will present the reported performance characteristics. The FDA's clearance (K031604) implies these performance results were acceptable for market entry.

Ask a specific question about this device