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510(k) Data Aggregation
(64 days)
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.
| Test Category | Analyte | Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|---|---|
| Precision | Sodium | Within-Run %CV & Run-to-Run %CV less than Westgard requirements. | Achieved; all Within-Run and Run-to-Run %CVs for Sodium at various concentrations (81-180 mEq/L) were lower than the specified Westgard requirements (e.g., Target Conc. 135 mEq/L: Westgard Within-Run %CV Req = 0.6%, Actual = 0.05%; Westgard Run-to-Run %CV Req = 0.7%, Actual = 0.04%). |
| Potassium | Within-Run %CV & Run-to-Run %CV less than Westgard requirements. | Achieved; all Within-Run and Run-to-Run %CVs for Potassium at various concentrations (1.5-10 mEq/L) were lower than the specified Westgard requirements (e.g., Target Conc. 5.8 mEq/L: Westgard Within-Run %CV Req = 4.6%, Actual = 0.12%; Westgard Run-to-Run %CV Req = 5.6%, Actual = 0.1%). | |
| Chloride | Within-Run %CV & Run-to-Run %CV less than Westgard requirements. | Achieved; all Within-Run and Run-to-Run %CVs for Chloride at various concentrations (60-130 mEq/L) were lower than the specified Westgard requirements (e.g., Target Conc. 101 mEq/L: Westgard Within-Run %CV Req = 1.2%, Actual = 0.48%; Westgard Run-to-Run %CV Req = 1.5%, Actual = 0.43%). | |
| Linearity/Reportable | Sodium | Slope, Intercept, R² within acceptable limits. Claimed Measuring Range (80-180 mmol/L). | Slope: 0.9987, Intercept: 1.1021, R²: 0.9995. Sample Range Tested: 80-180 mmol/L. Claimed Measuring Range: 80-180 mmol/L. These values indicate good linearity across the claimed range. |
| Range | Potassium | Slope, Intercept, R² within acceptable limits. Claimed Measuring Range (1.5-10 mmol/L). | Slope: 1.0048, Intercept: 0.0237, R²: 0.9999. Sample Range Tested: 1.5-10 mmol/L. Claimed Measuring Range: 1.5-10 mmol/L. These values indicate good linearity across the claimed range. |
| Chloride | Slope, Intercept, R² within acceptable limits. Claimed Measuring Range (60-140 mmol/L). | Slope: 0.9814, Intercept: 1.3911, R²: 0.9998. Sample Range Tested: 60-140 mmol/L. Claimed Measuring Range: 60-140 mmol/L. These values indicate good linearity across the claimed range. | |
| Analytical Specificity | All | Analyte Target Concentration ≤ ± 10% bias in the presence of interfering substances. | No bias greater than 10% was observed for Sodium and Chloride with Hemoglobin (500mg/dL), Bilirubin (342umol/L), and Triglycerides (37mmol/L). No bias greater than 10% was observed for Potassium with Bilirubin (342umol/L) and Triglycerides (37mmol/L). Hemolysis is a known factor for high potassium and hemolyzed samples should not be used. Other exogenous substances referenced Young, et al. |
| Comparison Studies | All | High correlation coefficient, slope near 1, intercept near 0, and acceptable bias against predicate. | Comparison between Synermed IR-1200 and Hitachi 717 shows strong correlation: Sodium (r=0.992246, slope=0.990656, intercept=0.943789), Potassium (r=0.993021, slope=0.985861, intercept=-0.10291), Chloride (r=0.993346, slope=0.998305, intercept=0.122558). These values demonstrate good agreement with the predicate. |
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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(252 days)
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.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Precision (Qualitative and Semi-Quantitative) - Demonstrate consistent results across multiple runs and within a run for various opiate concentrations. | Qualitative Precision (Table 4): All tested concentrations (0-1000 ng/mL) showed consistent "Negative" or "Positive" results for both within-run and run-to-run, matching the expected result. |
| Semi-Quantitative Precision (Table 3): Consistently matched "Expected Results Pos/Neg" for all tested concentrations (0-1000 ng/mL) for both within-run and run-to-run. Specific CV% and standard deviation data are mentioned as being determined but not explicitly reported in the summary tables. | |
| Linearity/Reportable Range - Demonstrate a consistent relationship between expected and observed opiate concentrations across the measuring range. | Analytical Recovery (Table 3): Recovery values ranged from 62.0% (at 25 ng/mL) to 90.0% (at 150 ng/mL) across various concentrations (25 ng/mL to 1250 ng/mL), indicating a generally good linear response, although the exact acceptance range for recovery is not specified. |
| Analytical Specificity - Demonstrate no significant interference from common endogenous compounds. | Compounds tested (Acetone, Ascorbic Acid, Creatinine, Ethanol, Glucose, Hemoglobin, Human Serum Albumin, Riboflavin, Sodium Chloride, Urea) at specified concentrations showed no interference (results remained Negative for -25% Cutoff samples and Positive for +25% Cutoff samples). |
| Method Comparison (IR-500 vs. LC/MS) - Demonstrate high agreement with a gold standard confirmatory method (LC/MS) at and around the cutoff. | Percent Agreement with LC/MS: 91% for Positive results and 100% for Negative results. |
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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