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The Synermed ISE Reagents are used for in-vitro diagnostic use to quantitate levels of Sodium, Potassium and Chloride in serum. This device is for use in clinical laboratories only. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The Synermed ISE reagents contain the following ingredients: Sodium Chloride, Potassium Chloride, Sodium Bicarbonate, Potassium Phosphate. The ISE buffer contains trlethanolamine preservatives 0.1M, phosphoric acid 0.3% and nonreactive preservatives. The ISE Mid-Standard contains sodium chloride 2.96mM, potassium chloride 0.12M, buffer and non-reactive preservatives. The ISE Reference contains 1M potassium chloride.

Here's a breakdown of the acceptance criteria and study information for the Synermed ISE Reagents, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

Device: Synermed ISE Reagents for Sodium, Potassium, and Chloride.

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

• Precision/Reproducibility: The tables show "80 results" for each analyte (Sodium, Potassium, Chloride) across various target concentrations. This implies a sample size of 80 measurements for each analyte to calculate precision metrics.
• Linearity/Reportable Range: The document lists "Sample Range Tested" for each analyte, indicating the range of control samples or diluted patient samples used to assess linearity. The exact number of discrete samples within these ranges is not specified beyond the range itself.
• Analytical Specificity: The document mentions testing "the following concentrations of endogenous substances" but does not specify the number of samples or replicates used for these interference studies.
• Comparison Studies: The document does not explicitly state the sample size (number of patient samples) used for the comparison study between the IR-1200 and Hitachi 717.
• Data Provenance: Not explicitly stated. The studies were conducted in accordance with CLSI/NCCLS guidelines, which are international standards, but the country of origin of the data or whether it was retrospective or prospective is not provided. Given these are in vitro diagnostic reagents, the data would likely be from laboratory testing rather than patient cohorts in the way typical of imaging studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable to this type of device. The Synermed ISE Reagents are in vitro diagnostic devices for quantitative measurement of electrolytes. The "ground truth" for these tests is established by reference methods or highly accurate laboratory instruments, not by expert human interpretation (e.g., radiologists interpreting images). The accuracy of the measurements is compared against known standards or predicate devices.

4. Adjudication Method

This section is not applicable as the device involves quantitative laboratory measurements rather than subjective interpretation requiring adjudication among experts. The performance is assessed through statistical analysis of numerical results against predefined criteria and reference methods.

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

This is not applicable. An MRMC study assesses the impact of AI on human readers' performance (e.g., diagnostic accuracy in interpreting medical images). This document is for in vitro diagnostic reagents, which do not involve human interpretation in the same manner.

6. Standalone Performance Study

Yes, the studies presented are primarily standalone (algorithm only without human-in-the-loop performance), as they evaluate the intrinsic performance characteristics of the reagents and their compatibility with the Synermed IR-1200 instrument.

• Precision/Reproducibility: This measures the inherent consistency of the device's measurements.
• Linearity/Reportable Range: This assesses the device's ability to accurately measure across its claimed concentration range.
• Analytical Specificity: This evaluates the device's resilience to common interfering substances.
• Comparison Studies: This evaluates the device's concordance with a predicate device.

These studies assess the direct analytical performance of the reagents.

7. Type of Ground Truth Used

The ground truth for evaluating the Synermed ISE Reagents is established through:

• Reference materials/standards: Used to set target concentrations for precision and linearity studies.
• Predicate device measurements: For the comparison studies, the results from the legally marketed predicate device (Synermed ISE Reagents using the Hitachi 717) serve as a comparative "ground truth" or reference for demonstrating substantial equivalence.
• Defined concentrations of interfering substances: For analytical specificity, known concentrations of substances like bilirubin, hemoglobin, and triglycerides are used.

8. Sample Size for the Training Set

This information is not provided. The document details performance testing for validation (test set), but does not discuss any "training set." This device is a chemical reagent product, not a machine learning or AI algorithm in the typical sense that would require a distinct training data set to "learn." Its performance is based on chemical and electrochemical principles.

9. How Ground Truth for the Training Set Was Established

This section is not applicable as no training set is discussed or implied for this type of in vitro diagnostic reagent.

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The Synermed Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of opiates in human urine at a cutoff value of 300 ng/mL when calibrated against morphine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. This assay is for prescription use only. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmatory method such as GCMS or permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/ MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The Synermed Opiate Enzyme Immunoassay is ready to use. The composition of the Synermed Opiate Enzyme Immunoassay Reagent is as follows:

Antibody/Substrate Reagent (R1): Contains mouse monoclonal anti-morphine antibody, opiate-6-phosphate (G6P), nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09 %) as a preservative.

Enzyme-drug Conjugate Reagent (R2): Contains morphine-labeled opiate-6-phosphate dehydrogenase (G6PDH) in buffer with sodium azide (0.09 %) as a preservative.

Acceptance Criteria and Study for Synermed Opiate Enzyme Immunoassay

This response describes the acceptance criteria and the study conducted for the Synermed Opiate Enzyme Immunoassay, based on the provided FDA 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The core of the performance evaluation for this device is the demonstration of substantial equivalence to a predicate device (Lin-Zhi Opiate Immunoassay) and the validation of its performance characteristics on a new analyzer (Synermed IR-500) compared to an existing one (Hitachi 717). The primary analytical performance aspects evaluated are precision, linearity, analytical specificity, and method comparison.

Note: The document does not explicitly state numerical acceptance criteria in the typical "pass if X" format. Instead, it presents results and implies that these results meet the required performance for substantial equivalence. For the comparative data, the percentage agreement with LC/MS serves as a key performance indicator.

2. Sample Size and Data Provenance for the Test Set

• Precision/Reproducibility:
  • Sample Size: Eleven concentrations of pooled human urine were used for opiate. Each aliquot was run in duplicate twice a day for twenty days, totaling 80 measurements at each concentration.
  • Data Provenance: The data provenance is not explicitly stated beyond "pooled human urine." It is implicitly retrospective or manufactured for testing purposes, as it's a controlled laboratory study to assess device performance rather than patient data. The country of origin is not specified but is presumably the US given the FDA submission.
• Linearity/Reportable Range:
  • Sample Size: Ten concentrations were obtained by intermixing a high urine pool with a low urine pool. Each concentration was tested with four replicates.
  • Data Provenance: Similar to precision, it's "pooled human urine," suggesting retrospective or manufactured data for a controlled study.
• Analytical Specificity:
  • Sample Size: A unspecified number of urine samples spiked with morphine to +/- 25% of cutoff were used, containing specific endogenous compounds.
  • Data Provenance: This involves controlled laboratory spiking experiments, indicating manufactured test samples.
• Comparison Studies (Method Comparison):
  • Sample Size: 100 samples for opiate were tested.
  • Data Provenance: "Pooled human urine" is mentioned. Given it's a comparison against LC-MSMS, these are likely retrospective samples from a laboratory setting. The country of origin is not specified but is presumably the US.

3. Number of Experts and their Qualifications for Ground Truth

The concept of "experts" as human readers/interpreters does not directly apply to this type of in-vitro diagnostic device. The ground truth is established through:

• Ultra High-Performance Liquid Chromatography Tandem Mass Spectrometry (UHPLC-MSMS or LC-MSMS): This is considered the analytical "gold standard" for confirming drug concentrations in urine.
• The document does not mention any human experts establishing ground truth for the test set.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in imaging or pathology studies where human interpretation is involved. For this immunoassay device, the ground truth is established by a more specific alternative analytical chemistry method (LC-MSMS). There is no mention of human adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The Synermed Opiate Enzyme Immunoassay is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance Study

Yes, the studies described are essentially standalone performance studies for the Synermed Opiate Enzyme Immunoassay. The device (reagents on the Synermed IR-500 analyzer) directly performs the analysis and provides a result. Its performance is evaluated independently against a gold standard (LC-MSMS) and compared to a predicate device, without direct human-in-the-loop interaction for the primary diagnostic output.

7. Type of Ground Truth Used

The ground truth used for the test set was:

• Analytical Chemistry (LC-MSMS): Specifically, Ultra High-Performance Liquid Chromatography Tandem Mass Spectrometry (UHPLC-MSMS or LC-MSMS) was used to confirm target concentrations for precision, linearity, and as the comparative gold standard in the method comparison studies.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is an immunoassay, which functions based on a biochemical reaction, not a machine learning algorithm that requires a training set. The various studies described (precision, linearity, specificity, comparison) serve as validation studies for the device's analytical performance.

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

Since there is no "training set" in the AI/ML sense, this question is not applicable. The device's operational parameters and calibration are established through standard laboratory practices and quality control using known standards and calibrators, which would have their concentrations confirmed by analytical reference methods.

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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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