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510(k) Data Aggregation
(536 days)
Medicon Hellas Albumin: Reagent for the quantitative measurement of albumin in serum. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Medicon Hellas Calcium: Reagent for the quantitative measurement of calcium in serum or urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Medicon Hellas Creatinine: Reagent for the quantitative measurement of creatinine in serum and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
Medicon Hellas Glucose: Reagent for the quantitative measurement of glucose in serum and urine. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Medicon Hellas Direct Bilirubin; Reagent for the quantitative measurement of direct bilirubin (conjugated) in serum. Measurements of the level of direct bilirubin is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall blader block.
Medicon Hellas Total Bilirubin: Reagent for the quantitative measurements of total bilirubin in serum. Measurements of the levels of total bilirubin is used in the diagnosis and treatment of liver. hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Medicon Hellas Urea Nitrogen: Reagent is for the quantitative measurement of urea nitrogen in serum and urine. Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
The Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Glucose, Medicon Hellas Direct Bilirubin, Medicon Hellas Total Bilirubin, and Medicon Hellas Urea Nitrogen are reagents for use with Diatron Pictus 500 Clinical Chemistry Analyzers. They are test systems for the quantitative measurement of albumin, calcium, creatinine, glucose, direct and total bilirubin, and urea nitrogen in human serum and urine where clinically applicable. The methods employed are photometric, utilizing reactions between the sample and reagents to produce a colored chromophore or a change in absorbance that is proportional to the concentration of the analyte. The analyzer photometer reads the absorbances at time intervals dictated by the method application stored in the analyzer memory, and the change in absorbance is calculated automatically.
The provided text describes the performance of several Medicon Hellas assays (Albumin, Calcium, Creatinine, Glucose, Direct Bilirubin, Total Bilirubin, and Urea Nitrogen) when run on the Diatron Pictus 500 Clinical Chemistry Analyzer, demonstrating their substantial equivalence to predicate devices (Beckman Coulter AU reagents on AU2700 analyzer, and Abbott Architect Direct Bilirubin on Architect c8000 analyzer).
Here's an analysis of the provided information, structured to address your specific points regarding acceptance criteria and study details:
1. A Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a single, overarching table with pass/fail remarks. Instead, it describes each performance characteristic and then presents the results. The "Summary" sections for each study type imply that the results met the pre-defined acceptance criteria for demonstrating substantial equivalence. For instance, for accuracy, it states "Accuracy studies completed on at least three lots of each candidate reagent confirm that Medicon albumin... are substantially equivalent to the related predicate devices." This implies that the statistical analyses (Deming regression, R2, slope, intercept) fell within acceptable ranges. Similarly, for precision, it states "All lots passed acceptance criteria for each applicable sample type at each level."
Since explicit acceptance criteria are not presented, they are inferred from the demonstrated performance and the statement that the devices "passed acceptance criteria" or "met statistical acceptance criteria." Below is a table summarizing the reported device performance for each analyte. The "Acceptance Criteria" column will reflect the general statements of success or the implied ranges from the results themselves, as explicit numerical targets for individual tests are not given.
Implied Acceptance Criteria and Reported Device Performance
| Analyte | Performance Characteristic | Implied/General Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Medicon Hellas Albumin | |||
| Accuracy (Method Comparison) | R2 Correlation | Values suggesting substantial equivalence (>0.98 is generally good) | R2 = 0.9862 |
| Slope | Values close to 1 | Slope = 1.0180 | |
| Intercept | Values close to 0 | Intercept = 0.05 | |
| Reportable Range (Serum) | Comparable to predicate device | 1.50 - 6.00 g/dL | 1.50 - 6.00 g/dL |
| LOD (Serum) | Acceptable for clinical use | 0.40 g/dL | 0.40 g/dL |
| LOQ (Serum) | Acceptable for clinical use | 0.50 g/dL | 0.50 g/dL |
| Precision (Serum) | CV% within acceptable clinical limits (e.g., typically <10% for these analytes) | Repeatability CV (Level 1,2,3): 2.21%, 1.45%, 1.37% | Between Run CV (Level 1,2,3): 5.25%, 3.80%, 2.36% |
| Interferences (Serum) | Recovered values within ±10% of neat samples | Insignificant interference up to noted concentrations (e.g., Hemoglobin 500 mg/dL, Triglycerides 3000 mg/dL) | (See document for detailed thresholds per interferent) |
| Medicon Hellas Calcium | |||
| Accuracy (Method Comparison) | R2 Correlation | Values suggesting substantial equivalence | Serum R2 = 0.9949, Urine R2 = 0.9965 |
| Slope | Values close to 1 | Serum Slope = 1.0099, Urine Slope = 0.9888 | |
| Intercept | Values close to 0 | Serum Intercept = -0.3, Urine Intercept = -0.8 | |
| Reportable Range | Comparable to predicate device | Serum: 4.0 - 18.0 mg/dL, Urine: 2.0 - 40.0 mg/dL | Serum: 4.0 - 18.0 mg/dL, Urine: 2.0 - 40.0 mg/dL |
| LOD | Acceptable for clinical use | Serum: 0.5 mg/dL, Urine: 1.3 mg/dL | Serum: 0.5 mg/dL, Urine: 1.3 mg/dL |
| LOQ | Acceptable for clinical use | Serum: 0.5 mg/dL, Urine: 1.5 mg/dL | Serum: 0.5 mg/dL, Urine: 1.5 mg/dL |
| Precision | CV% within acceptable clinical limits | Serum: Repeatability CV (L1,2,3): 1.16%, 1.06%, 0.82% | Between Run CV (L1,2,3): 3.37%, 1.51%, 1.95% |
| Interferences | Recovered values within ±10% of neat samples | Insignificant interference up to noted concentrations | (See document for detailed thresholds per interferent) |
| Medicon Hellas Creatinine | |||
| Accuracy (Method Comparison) | R2 Correlation | Values suggesting substantial equivalence | Serum R2 = 0.9989, Urine R2 = 0.9992 |
| Slope | Values close to 1 | Serum Slope = 1.0207, Urine Slope = 0.9904 | |
| Intercept | Values close to 0 | Serum Intercept = -0.10, Urine Intercept = -0.81 | |
| Reportable Range | Comparable to predicate device | Serum: 0.3 - 25.0 mg/dL, Urine: 1.2 - 300.0 mg/dL | Serum: 0.3 - 25.0 mg/dL, Urine: 1.2 - 300.0 mg/dL |
| LOD | Acceptable for clinical use | Serum: 0.2 mg/dL, Urine: 1.0 mg/dL | Serum: 0.2 mg/dL, Urine: 1.0 mg/dL |
| LOQ | Acceptable for clinical use | Serum: 0.2 mg/dL, Urine: 1.1 mg/dL | Serum: 0.2 mg/dL, Urine: 1.1 mg/dL |
| Precision | CV% within acceptable clinical limits | Serum: Repeatability CV (L1,2,3): 2.41%, 1.08%, 1.04% | Between Run CV (L1,2,3): 3.63%, 4.58%, 2.30% |
| Interferences | Recovered values within ±10% of neat samples | Insignificant interference up to noted concentrations | (See document for detailed thresholds per interferent) |
| Medicon Hellas Direct Bilirubin | |||
| Accuracy (Method Comparison) | R2 Correlation | Values suggesting substantial equivalence | R2 = 0.9978 |
| Slope | Values close to 1 | Slope = 0.9656 | |
| Intercept | Values close to 0 | Intercept = -0.01 | |
| Reportable Range (Serum) | Comparable to predicate device | 0.2 - 15.0 mg/dL | 0.2 - 15.0 mg/dL |
| LOD (Serum) | Acceptable for clinical use | 0.1 mg/dL | 0.1 mg/dL |
| LOQ (Serum) | Acceptable for clinical use | 0.2 mg/dL | 0.2 mg/dL |
| Precision (Serum) | CV% within acceptable clinical limits | Repeatability CV (L1,2,3): 3.11%, 2.46%, 2.48% | Between Run CV (L1,2,3): 2.31%, 3.14%, 2.29% |
| Interferences (Serum) | Recovered values within ±10% of neat samples | Insignificant interference up to noted concentrations | (See document for detailed thresholds per interferent) |
| Medicon Hellas Glucose | |||
| Accuracy (Method Comparison) | R2 Correlation | Values suggesting substantial equivalence | Serum R2 = 0.9992, Urine R2 = 0.9989 |
| Slope | Values close to 1 | Serum Slope = 0.9715, Urine Slope = 1.0222 | |
| Intercept | Values close to 0 | Serum Intercept = 2.7, Urine Intercept = -0.9 | |
| Reportable Range | Comparable to predicate device | Serum: 10 - 700 mg/dL, Urine: 10 - 660 mg/dL | Serum: 10 - 700 mg/dL, Urine: 10 - 660 mg/dL |
| LOD | Acceptable for clinical use | Serum: 1.7 mg/dL, Urine: 2.4 mg/dL | Serum: 1.7 mg/dL, Urine: 2.4 mg/dL |
| LOQ | Acceptable for clinical use | Serum: 4.0 mg/dL, Urine: 6.0 mg/dL | Serum: 4.0 mg/dL, Urine: 6.0 mg/dL |
| Precision | CV% within acceptable clinical limits | Serum: Repeatability CV (L1,2,3): 1.72%, 0.99%, 0.96% | Between Run CV (L1,2,3): 1.35%, 1.48%, 2.08% |
| Interferences | Recovered values within ±10% of neat samples | Insignificant interference up to noted concentrations | (See document for detailed thresholds per interferent) |
| Medicon Hellas Total Bilirubin | |||
| Accuracy (Method Comparison) | R2 Correlation | Values suggesting substantial equivalence | R2 = 0.9996 |
| Slope | Values close to 1 | Slope = 1.0125 | |
| Intercept | Values close to 0 | Intercept = -0.06 | |
| Reportable Range (Serum) | Comparable to predicate device | 0.10 - 30.00 mg/dL | 0.10 - 30.00 mg/dL |
| LOD (Serum) | Acceptable for clinical use | 0.01 mg/dL | 0.01 mg/dL |
| LOQ (Serum) | Acceptable for clinical use | 0.09 mg/dL | 0.09 mg/dL |
| Precision (Serum) | CV% within acceptable clinical limits | Repeatability CV (L1,2,3): 0.92%, 0.38%, 0.57% | Between Run CV (L1,2,3): 1.69%, 1.38%, 1.79% |
| Interferences (Serum) | Recovered values within ±10% of neat samples | Insignificant interference up to noted concentrations | (See document for detailed thresholds per interferent) |
| Medicon Hellas Urea Nitrogen | |||
| Accuracy (Method Comparison) | R2 Correlation | Values suggesting substantial equivalence | Serum R2 = 0.9983, Urine R2 = 0.9972 |
| Slope | Values close to 1 | Serum Slope = 1.0001, Urine Slope = 0.9844 | |
| Intercept | Values close to 0 | Serum Intercept = -0.2, Urine Intercept = 21.9 | |
| Reportable Range | Comparable to predicate device | Serum: 3 - 100 mg/dL, Urine: 24 - 1300 mg/dL | Serum: 3 - 100 mg/dL, Urine: 24 - 1300 mg/dL |
| LOD | Acceptable for clinical use | Serum: 2 mg/dL, Urine: 21 mg/dL | Serum: 2 mg/dL, Urine: 21 mg/dL |
| LOQ | Acceptable for clinical use | Serum: 3 mg/dL, Urine: 24 mg/dL | Serum: 3 mg/dL, Urine: 24 mg/dL |
| Precision | CV% within acceptable clinical limits | Serum: Repeatability CV (L1,2,3): 1.94%, 2.14%, 1.07% | Between Run CV (L1,2,3): 2.24%, 2.56%, 3.16% |
| Interferences | Recovered values within ±10% of neat samples | Insignificant interference up to noted concentrations | (See document for detailed thresholds per interferent) |
2. Sample sizes used for the test set and the data provenance:
-
Sample Size for Test Set:
- Accuracy (Method Comparison): "A minimum of 70 clinical specimens, spanning the dynamic ranges, were assayed." Specific numbers are provided per analyte:
- Medicon Hellas Albumin: 112 samples (Serum)
- Medicon Hellas Calcium: 94 samples (Serum), 81 samples (Urine)
- Medicon Hellas Creatinine: 126 samples (Serum), 98 samples (Urine)
- Medicon Hellas Direct Bilirubin: 77 samples (Serum)
- Medicon Hellas Glucose: 99 samples (Serum), 100 samples (Urine)
- Medicon Hellas Total Bilirubin: 95 samples (Serum)
- Medicon Hellas Urea Nitrogen: 116 samples (Serum), 81 samples (Urine)
- Reportable Range (Linearity): "At least nine levels of each sample types were tested." (N=4 per level on Pictus P500)
- Sensitivity (LOD/LOQ):
- LoB/LoD: "5 Blank samples and 5 Low Levels samples respectively which were measured 4 times each day for a total of 60 measurements in 3 days."
- LoQ: "10 samples that span the low end of linearity were measured 5 times each day for a total of 150 measurements in 3 days."
- Interferences: "Serum and urine sample pools at low and high levels were prepared." The exact number of individual samples forming these pools is not specified beyond being "pools."
- Precision: "Precision study results from running applicable serum and urine samples (Level 1, Level 2 and Level 3) were tested in duplicate, twice a day, for 20 days, for a total of 80 results per level."
- Accuracy (Method Comparison): "A minimum of 70 clinical specimens, spanning the dynamic ranges, were assayed." Specific numbers are provided per analyte:
-
Data Provenance (e.g., country of origin of the data, retrospective or prospective):
- The document implies that the studies were conducted by Medicon Hellas, S.A. in Greece, given their address on the first page.
- The data appears to be prospective as it describes experiments conducted ("studies were performed," "testing confirmed," "protocol followed"). It references the collection and analysis of clinical specimens specifically for these validation studies. It does not mention retrospective analysis of existing patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable in the context of this 510(k) submission. This type of submission is for in vitro diagnostic (IVD) reagents, which measure specific analytes in bodily fluids. The "ground truth" for these measurements is typically established by comparative analysis against predicate devices and well-characterized reference methods (e.g., those detailed in CLSI guidelines for accuracy, linearity, precision). These are not image-based AI models requiring human expert interpretation for ground truth.
The "experts" involved would be the laboratory personnel performing the assays according to established clinical laboratory standards and the statistical analysis, rather than medical experts providing subjective interpretations. The document does not specify the number or qualifications of the laboratory personnel who conducted the tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This concept (e.g., 2+1, 3+1 reader adjudication) is primarily used in studies where human readers provide subjective interpretations (e.g., radiology studies). For IVD devices, the "ground truth" is based on the analytical performance against established reference methods or predicate devices, which involves quantitative measurements and statistical analysis, not human adjudication of subjective interpretations.
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 not an AI-assisted diagnostic imaging device. It is a chemical reagent intended for quantitative measurement of analytes in bodily fluids. Therefore, MRMC studies and the effect size on human readers are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device (reagent) essentially operates in a "standalone" fashion in terms of its chemical reaction and measurement, independent of human interpretive intervention for the measurement itself. The performance data (accuracy, precision, linearity, etc.) presented is the standalone performance of the reagent on the specified analyzer. Human involvement is in operating the instrument, quality control, and interpreting the numerical results in a clinical context, but not in the measurement process being tested for substantial equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is established by:
- Comparative Method: The primary method for proving substantial equivalence is by demonstrating strong correlation and agreement with legally marketed predicate devices (Beckman Coulter AU reagents and Abbott Architect Direct Bilirubin reagent) using real patient clinical specimens. This acts as the standard for comparison.
- CLSI Guidelines: Various performance characteristics (linearity, sensitivity, precision, interferences) were evaluated according to Clinical and Laboratory Standards Institute (CLSI) guidelines (e.g., CLSI EP09c for accuracy, CLSI EP06-A for linearity, CLSI EP17-A2 for sensitivity, CLSI EP07-A and EP37 for interferences, CLSI EP05-A3 for precision). These guidelines represent accepted industry standards for validating in vitro diagnostic devices, thereby defining the "ground truth" for these analytical measurements.
- Reference Values: For linearity studies, "samples were assigned their reference values arithmetically from serial dilutions of the high-level sample," indicating a quantitatively derived reference for linearity.
Therefore, the ground truth is based on a combination of comparison to predicate devices and adherence to established analytical reference methods and industry standards (CLSI guidelines).
8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. It is a chemical reagent. The "training" here would be the chemical formulation and manufacturing process, which is established through R&D and QA/QC, not data input to an algorithm.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" for a chemical reagent. The "ground truth" for the development of the reagent itself would be the established chemical principles and desired analytical performance characteristics (e.g., reactivity, specificity, stability, sensitivity) based on scientific literature and previous experience with similar assays.
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