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The Synermed Glucose Reagent is for the in vitro quantitative measurement of glucose in serum on the Synermed IR-1200 Chemistry Analyzer. Glucose measurements are used in the diagnosis and treatment of carbolygrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and of pancreatic islet cell carcinoma.

The Synermed IR-1200 Chemistry Analyzer is intended for in vitro diagnostic use as a multiparameter chemistry instrument that quantitates the levels of constituents in serum. The analyzer is an automated, random eccess, computer controlled, clinical chemistry analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose in serum. The device is intended for use only in clinical laboratories.

Synermed IR-1200 Glucose Reagent

The Synermed Glucose is ready to use. The composition of the Synermed Glucose Oxidase Reagent is as follows: 280 umol/L N-sulfopropyl-N-ethyl-3, 5-dimethylaniline, 280 umol/L ampyrone, 1400 U/L peroxidase (horseradish) and 18,000 U/L glucose oxidase.

Synermed IR-1200 Chemistry Analyzer

The IR-1200 Chemistry Analyzer is a multiparameter chemistry instrument that quantitates the levels of analytes in serum using spectrophotometric measurement. The system uses Synermed liquid-stable reagent systems that have been previously cleared by FDA.

The IR-1200 Chemistry Analyzer is a discrete analyzer with STAT priority capabilities and an externalized computer. The instrument features a user-friendly software operating system, optical unit, precision pipetting and electronic system. Twelve wavelengths are included ranging from 340 nm to 800 nm. The instrument's capabilities include: sample pipetting, reagent pipetting, anti-interference, mixing, pre-heating, reaction monitoring, calculation, display and printing of results. After the measurement is complete, the system rinses and dries the cuvettes. The system automates the manual functions and, as a result, it enhances efficiency, diminishes errors, thus improving the accuracy and precision of test results.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Synermed Glucose Reagent and Synermed IR-1200 Chemistry Analyzer:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the performance of the Synermed Glucose Reagent on the Synermed IR-1200 Chemistry Analyzer. While it doesn't explicitly list "acceptance criteria" as a separate, pre-defined column, the "Results" sections and the discussions of "non-significant interference" imply the criteria used for evaluation. Therefore, I will reconstruct the table with implied acceptance criteria based on the reported results.

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

• Precision/Reproducibility:

  • Sample Size: 5 concentrations of pooled patient serum, with 80 measurements at each concentration (run in duplicate twice a day for twenty days). Total = 400 measurements (5 concentrations * 80 measurements/concentration). While 80 measurements per concentration are mentioned, it's 2 duplicates per day * 20 days.
  • Data Provenance: Not explicitly stated, but "pooled patient serum" suggests human biological samples. No mention of country of origin or whether it was retrospective/prospective.

• Linearity/Reportable Range:

  • Sample Size: 13 concentrations across the measuring range, with four replicates at each concentration. Total = 52 measurements (13 concentrations * 4 replicates). Sample preparation involved "intermixing a high serum pool with a low serum pool."
  • Data Provenance: Not explicitly stated. The use of "serum pool" implies human samples.

• Analytical Specificity (Interference):

  • Sample Size: Serum pools spiked with interferents at two analyte levels (80 mg/dL and 120 mg/dL glucose) and at two concentrations of interferent. Specific numbers of samples are not detailed beyond "serum pools."
  • Data Provenance: Not explicitly stated. Use of "serum pools" implies human samples.

• Detection Limit (LoB, LoD, LoQ):

  • Sample Size: Not explicitly stated, but the study "evaluated following CLSI EP17-A" suggests a scientifically rigorous approach with sufficient replicates, though the exact number isn't provided.
  • Data Provenance: Not explicitly stated.

• Comparison Studies (Method Comparison):

  • Sample Size: 115 samples for glucose. 15 of these were "modified to cover the entire claimed measuring range" by intermixing patient serum pools.
  • Data Provenance: Not explicitly stated, but "patient serum pools" and "patient serum samples" indicate human biological samples. No mention of country of origin or whether it was retrospective/prospective.

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

This document describes the performance of a quantitative laboratory diagnostic device (chemistry analyzer and reagent). For such devices, "ground truth" is typically established by:

• Reference Methods: Highly accurate and precise laboratory methods, often traceable to international standards (e.g., NIST).
• Predicate Devices: Comparison to an already FDA-cleared device provides a benchmark.

The studies presented here rely on these types of "ground truth":

• For linearity, the "expected values" are derived from known dilutions.
• For comparison studies, the "ground truth" is the measurement obtained from the predicate device (Hitachi 717 chemistry analyzer) using the same previously cleared reagent systems.

Therefore, no human experts were used to establish a subjective "ground truth" in the way they might be for interpreting medical images. The "ground truth" is analytical, derived from established laboratory methodologies and reference measurements. The Synermed IR Cal II calibrator is stated to be traceable to NIST standard number 917-C, which provides a form of metrological ground truth.

4. Adjudication Method for the Test Set:

Not applicable. As explained above, the "ground truth" is analytical/measurement-based, not based on human interpretation or consensus. There is no need for an adjudication method for these types of studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers interpreting cases/images, often with and without AI assistance, to assess the impact of AI on human performance. This document concerns a chemistry analyzer and reagents, which are distinct from image-based AI diagnostics.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, all presented studies are standalone (algorithm only). The Synermed IR-1200 Chemistry Analyzer is an automated instrument. The performance reported (precision, linearity, specificity, detection limits, method comparison) reflects the intrinsic analytical capabilities of the device itself, without human interpretation or intervention affecting the measurement results. The results are quantitative outputs directly from the instrument.

7. Type of Ground Truth Used:

The ground truth used is primarily measurement-based and comparative:

• Reference Values/Standards: For linearity, expected values from known dilutions. For calibration, traceability to NIST standards.
• Predicate Device Measurements: In the method comparison study, the measurements from the predicate Hitachi 717 chemistry analyzer serve as the comparative ground truth.
• Defined Analytical Procedures: Ground truth for precision, linearity, and detection limit studies are established through rigorous adherence to CLSI (Clinical and Laboratory Standards Institute) protocols, which are industry standards for analytical validation.

8. Sample Size for the Training Set:

This document describes the validation of a chemistry analyzer and reagent, which are based on established chemical reactions and spectrophotometric measurements. There is no mention of a "training set" in the context of machine learning or AI model development because the device does not employ a learning algorithm that requires training. Its operational parameters are based on fixed scientific principles and engineering designs.

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

Not applicable, as there is no training set for this type of device.

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