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510(k) Data Aggregation
(252 days)
GENCHEM ISE ELECTROLYTE REFERENCE
GenChem ISE Electrolyte Reference, when used in conjunction with the GenChem ISE Electrolyte Buffer. GenChem CO2 Acid Reagent, GenChem CO2 Alkaline Buffer, GenChem Wash Concentrate, and appropriate Calibration Standards, is intended for the quantitative determination of sodium, potassium, chloride, and total CO2 in serum and plasma, and sodium, potassium and chloride in urine, and Reference will also determine calcium in serum, plasma and urine.
Sodium results are for the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by the destruction of the adrenal glands), dehvdration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium results are used to monitor electrolyte imbalance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels. Chloride results are used in the treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Carbon dioxide results are used in the diagnosis and treatment of numerous and potentially serious disorders associated with changes in the body's acid-base balance. Calcium results are used in the diagnosis and treatment of parathyroid diseases, chronic renal disease and tetany (intermittent muscular contractions or spasm).
Sodium, Potassium, Chloride, CO2 and Calcium are determined by the use of Ion Specific Electrodes, the conductivity of which is proportional to the concentration of electrolyte in the sample which is mixed with high ionic strength buffer using the ISE Solution as the reference.
The provided submission, K040971, describes the performance characteristics of the GenChem ISE Electrolyte Reference device. The studies conducted evaluate precision/reproducibility, linearity/assay reportable range, sensitivity, analytical specificity, and patient comparison.
Here's an analysis of the acceptance criteria and the studies that prove the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly state "acceptance criteria" as pass/fail thresholds for each performance characteristic. Instead, it presents the results of various validation studies, implying that these results are considered acceptable for demonstrating substantial equivalence to the predicate device (K925611). The predicate device comparison (Section 5.e) states, "Both Reagents are similar in design, function and chemical principle as well as ingredient composition and concentration," which suggests the performance targets are implicitly aligned with the predicate's known performance.
However, we can infer performance targets for linearity (high R² value, slope near 1, intercept near 0) and patient comparison (similar m, b, and r to predicate or acceptable clinical correlation). Let's present the reported performance.
| Performance Characteristic | Analyte | Specimen Type (where applicable) | Implicit Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|---|---|
| Precision/Reproducibility | Low %CV (acceptable variability) | |||
| Within-Day (N=60) | S-1 | 9.1% CV | ||
| S-2 | 1.9% CV | |||
| S-3 | 1.3% CV | |||
| U-1 | 3.8% CV | |||
| U-2 | 1.1% CV | |||
| Day-To-Day (N=60, 30 Days) | S-1 | 9.4% CV | ||
| S-2 | 1.9% CV | |||
| S-3 | 1.3% CV | |||
| U-1 | 3.9% CV | |||
| U-2 | 1.1% CV | |||
| Linearity/Reportable Range | R² close to 1, Slope close to 1, Intercept close to 0 | |||
| Calcium | R²=1.000, Slope=0.911, Intercept=0.34, Range: 0.8 – 14.3 mg/dL | |||
| Na | R²=1.000, Slope=0.968, Intercept=2.37, Range: 0 – 200 mmol/L | |||
| K | R²=1.000, Slope=1.017, Intercept=-0.09, Range: 0.9 – 15.2 mmol/L | |||
| CL | R²=1.000, Slope=0.999, Intercept=-0.71, Range: 0 – 197 mmol/L | |||
| CO2 | R²=1.000, Slope=1.000, Intercept=0.15, Range: 0 – 40 mmol/L | |||
| Sensitivity (Limit of Detection) | Detection limit below clinical relevance | |||
| Calcium | 1.5 mg/dL | |||
| Sodium | 10 mmol/L | |||
| Potassium | 1.0 mmol/L | |||
| Chloride | 15 mmol/L | |||
| Total CO2 | 5.0 mmol/L | |||
| Analytical Specificity | All | No adverse effect from interferences | Hemoglobin (up to 500 mg/dL), Bilirubin (up to 20 mg/dL), Lipemia (up to 1800 mg/dL) had no adverse effect. Only Sodium Heparin, Lithium Heparin, and Ammonium Heparin (up to 45 Units/mL) are acceptable anticoagulants. | |
| Patient Comparison | Strong correlation (m near 1, b near 0, r near 1) with predicate | |||
| Calcium | Serum | m=0.989, b=0.0, r=0.985 | ||
| Plasma | m=0.990, b=0.0, r=0.995 | |||
| Urine | m=1.007, b=-0.2, r=0.998 | |||
| Chloride | Serum | m=0.988, b=1.0, r=0.935 | ||
| Plasma | m=0.998, b=0.8, r=0.985 | |||
| Urine | m=1.049, b=-5.1, r=0.999 | |||
| CSF | m=1.024, b=-3.4, r=0.985 | |||
| Potassium | Serum | m=0.969, b=0.13, r=1.000 | ||
| Plasma | m=0.987, b=0.15, r=1.000 | |||
| Urine | m=0.993, b=0.01, r=1.000 | |||
| Sodium | Serum | m=0.930, b=9.1, r=0.938 | ||
| Urine | m=1.000, b=-0.3, r=1.000 | |||
| Total CO2 | Serum | m=0.949, b=1.2, r=0.953 | ||
| Plasma | m=0.965, b=0.9, r=0.960 |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Precision/Reproducibility:
- Within-Day: N=60 for each of 5 samples (S-1, S-2, S-3, U-1, U-2).
- Day-to-Day: N=60 over 30 days for each of 5 samples.
- Linearity/Assay Reportable Range: Commercially available linearity standards were analyzed in triplicate. The exact number of points in the range for each analyte is not specified beyond "standards."
- Sensitivity: Repetitive assay of a serum control, then diluted, run in "replicates of 10."
- Analytical Specificity: Tested with varying levels of Hemoglobin, Bilirubin, and Lipemia in stock samples, and different types of Heparin. The exact N for each interference study is not explicitly stated.
- Patient Comparison:
- Calcium (Serum/Plasma): 80 samples for each.
- Calcium (Urine): 74 samples.
- Chloride (Serum/Plasma): 80 samples for each.
- Chloride (Urine): 78 samples.
- Chloride (CSF): 44 samples.
- Potassium (Serum/Plasma/Urine): 80 samples for each.
- Sodium (Serum): 80 samples.
- Sodium (Urine): 78 samples.
- Total CO2 (Serum/Plasma): 80 samples for each.
- Data Provenance: The document states that specimens were "collected from adult patients." There is no information regarding the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for an IVD for general clinical use, these studies are typically prospective tests on patient samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is an In Vitro Diagnostic (IVD) for quantitative measurement of analytes. Ground truth for such devices is typically established through reference methods or established predicate devices, not by human expert interpretation.
- For the Precision/Reproducibility, Linearity, Sensitivity, and Analytical Specificity studies, the "ground truth" or reference values are inherent to the controls and standards used, or are derived by diluting known concentrations.
- For the Patient Comparison study, the "ground truth" is established by the results obtained from the predicate device, the Beckman CX3® Synchron Analyzer using Beckman flow cell reagents, wash solutions, and calibrators. No human experts are involved in establishing ground truth for these quantitative measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is an IVD device for quantitative measurements. Clinical laboratory results are typically determined by automated analyzers or technician analysis against established assay protocols, not by expert adjudication as seen in image analysis or pathology studies.
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
Not applicable. This is an In Vitro Diagnostic (IVD) device for quantitative chemical analysis, not an AI-assisted diagnostic imaging or interpretation system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, directly. The entire performance evaluation focuses on the standalone performance of the GenChem ISE Electrolyte Reference device (reagents) when run on the Beckman CX3® Synchron Analyzer. The reported results for precision, linearity, sensitivity, analytical specificity, and patient comparison reflect the inherent performance of the device itself. There is no human-in-the-loop component being evaluated in the context of improving performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for performance evaluation is primarily:
- Reference standards and controls: For precision, linearity, sensitivity.
- Predicate device results: For patient comparison, the results from the Beckman CX3 employing the Beckman reagents serve as the comparative "ground truth" to demonstrate substantial equivalence.
8. The sample size for the training set
Not applicable. This is a traditional IVD device (reagent for an analyzer), not a machine learning or AI-driven algorithm that requires a "training set" in the computational sense. The device's performance is based on its chemical and electrical properties and calibration against known standards.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm. Calibration and validation are instead performed using:
- Commercially available linearity standards with known concentrations (for linearity).
- Serum controls with known concentrations (for sensitivity).
- Reference materials for establishing the validity of the testing performed (implicitly for methods like NCCLS EP5-A, EP6-A, EP7-A).
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