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Diazyme Glycated Serum Protein Enzymatic Assay Kit in conjunction with Diazyme Glycated Serum Protein single calibrator, are intended for the quantitative determination of glycated serum proteins (fructosamine) in serum. The measurement of glycated serum proteins (fructosamine) is useful for monitoring diabetic patients.

Diazyme Glycated Serum Protein Enzymatic Assay Kit contains a single calibrator. The calibrator is used in the calculation of glycated serum protein concentrations in unknown serum samples.

Diazyme Glycated Serum Protein Enzymatic Assay has controls for normal glycated serum protein level and abnormal glycated serum protein level. The controls are used as reference samples for checking the functionality of the Diazyme Glycated Serum Protein Enzymatic Assay.

Diazyme's glycated serum protein (Dia-GSPTM) assay is a specific enzymatic method for direct determination of fructosamine in serum. The assay utilizes Diazyme's proprietary frucosyl amine-oxygen oxidoreductase (fructosaminase™) to specifically react with the glycated amino acid substrates generated by on-line digestion of serum sample proteins with Proteinases. Liberation of hydrogen peroxide from the fructosaminase™ reaction allows a colorimeter determination of the amount of glycated protein through a coupled reaction with peroxidase.

Diazyme's Glycated Serum Protein enzymatic assay is a two reagent (R1 and R2) based end point assay system. The results are obtained in 10 min by measuring absorbance at 550 mm. No off line pretreatment is needed.

Here's a breakdown of the acceptance criteria and study information for the Diazyme Glycated Serum Protein Enzymatic Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for each performance characteristic. However, based on the performance characteristics reported and the conclusion of the 510(k) submission, we can infer the implied acceptance criteria were sufficient for demonstrating substantial equivalence. The predicate device is the Randox Fructosamine assay.

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

• Sample Size: The document mentions "clinical patient serum samples" for the correlation study but does not specify an exact number for the test set used to establish the correlation coefficient of 0.98.
• Data Provenance: The document does not explicitly state the country of origin. The fact that the submitter is "Diazyme Laboratories Division, General Atomics" in "San Diego, CA 92121" suggests the testing was likely conducted in the US. The study is retrospective, as it involves testing "clinical patient serum samples" rather than following patients prospectively.

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

This information is not provided in the document. The study uses a comparative method against a predicate device (Randox Fructosamine assay), where the predicate assay provides the comparative "truth" for the correlation study, not expert consensus on individual patient samples.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of this type of analytical assay validation. The assessment is based on the quantitative results from the Diazyme assay compared to the quantitative results from the predicate Randox assay, not on qualitative interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. This device is an enzymatic assay for measuring levels of a biomarker (glycated serum protein), not an imaging or diagnostic AI device that involves human readers or interpretation of images. Therefore, an MRMC study and AI assistance are not relevant here.

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

This information is not applicable. The device is a laboratory assay kit, not an algorithm. Its performance is inherent to the chemical reactions and spectrophotometric measurements it performs. The "standalone" performance is simply the analytical performance of the assay itself, as demonstrated by the precision, linearity, and interference studies.

7. The Type of Ground Truth Used

The "ground truth" for the comparative effectiveness study (correlation) was established by the results obtained from the legally marketed predicate device, Randox Fructosamine assay (K023763). This is a form of comparative analytical performance. For precision and interference studies, the ground truth is based on known concentrations of analytes and interferents in control samples.

8. The Sample Size for the Training Set

This information is not provided. As an enzymatic assay, there isn't a "training set" in the sense of machine learning. The "training" for such an assay comes from its chemical formulation, optimization of reaction conditions, and calibration procedures.

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

This information is not applicable/provided in the machine learning context. For an enzymatic assay, the "ground truth" for developing and optimizing the assay (analogous to training) would involve:

• Careful preparation of standards with known concentrations of glycated serum protein.
• Validation of the enzymatic reactions and detection methods using pure compounds and well-characterized biological samples.
• Optimization of reagent concentrations, reaction times, and temperature.
  This developmental process is inherent to creating any in vitro diagnostic assay.

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