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510(k) Data Aggregation
(365 days)
Medicon Hellas, S.A
CHOLESTEROL: Reagent kit intended for the quantitative determination of Cholesterol in human serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, of lipid and lipoprotein metabolism disorders.
HDL-Cholesterol: Reagent kit intended for the quantitative determination of high-density lipoprotein in human serum. Measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.
LDL-Cholesterol: Reagent kit intended for the quantitative determination of low-density lipoprotein in human serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
TRIGLYCERIDES: Reagent kit intended for the quantitative determination of triglycerides (neutral fat) in human serum. Measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
CHOLESTEROL: The Cholesterol Oxidase peroxidase (CHOD-PAP) enzymatic method is used. The cholesterol esterase enzyme catalyzes the hydrolysis of cholesterol and free fatty and free fatty acids. Free cholesterol, including that originally present in the sample, is then oxidized by the enzyme cholesterol oxidase (CHOD) to cholest-4-en-3-one, by using molecular oxygen as the electron acceptor and concurrently producing hydrogen peroxide (H2O2). The H2O2 produced is then used in a subsequent chromogenic oxidative coupling reaction, catalyzed by the enzyme peroxidase, in the presence of a redox indicator system, which leads to the formation of a colored compound, absorbing light at 550 nm. The increase in absorbance is directly proportional to the cholesterol concentration in the sample.
HDL-Cholesterol: The Accelerator Selective Detergent method is applied. The determination of HDL-Cholesterol is based on the following reactions: LDL, VLDL, and chylomicrons are neutralized by the combined action of the enzymes Cholesterol Oxidase, Peroxidase, accelerators and N,N-bis-(4-sulfobutyl)-m-toluidine-disodium (DSBmT). HDL remaining in the sample is disrupted by the action of a selective detergent and cholesterol is converted to △4 Cholestenone by the enzymatic action of Cholesterol Esterase and Cholesterol Oxidase, with the subsequent production of H2O2, which reacts with DSBmT and 4-aminoantipyrine in the presence of Peroxidase to a colored complex that absorbs light at 590 nm. The absorbance measured is proportional to the concentration of HDL-Cholesterol in the sample.
LDL-Cholesterol: The Selective Detergent method is applied. The method is in a two-reagent format and depends on the properties of a unique detergent. The first detergent solubilizes only the non-LDL lipoprotein particles. The cholesterol released is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. The second detergent solubilizes the remaining LDL particles, and a chromogenic coupler allows for color formation. The enzyme reaction with LDL-Cholesterol in the presence of the coupler at 590 nm produces color that is proportional to the amount of LDL cholesterol present in the sample.
TRIGLYCERIDES: The enzymatic glycerol-3-phosphate-peroxidase (GPO-POD) method is used. The method enzymatically hydrolyzes by lipase to free fatty acids and glycerol is phosphorylated by adenosine triphosphate (ATP) with glycerokinase (GK) to produce glycerol-3-phosphate and adenosine diphosphate (ADP). Glycerol-3-phosphate-oxidase oxidizes glycerol-3-phosphate to dihydroxyacetone phosphate and H2O2. The catalytic action of peroxidase (POD) forms quinoneimine from H202, aminoantipyrine, and Dihydrate (N-Ethyl-N-(2hydroxy-3-sulfopropyl)-m-toluidine (TOOS). The absorption change at 550 nm is proportional to the triglycerides concentration in the sample.
Here's a breakdown of the acceptance criteria and the study information for the Medicon Hellas Cholesterol, HDL-Cholesterol, LDL-Cholesterol, and Triglycerides test systems, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by comparison to legally marketed predicate devices and alignment with clinical laboratory guidelines (CLSI). The document presents a clear comparison in the "Device Comparison Table" sections. For this summary, I'll focus on the key performance indicators for each analyte.
CHOLESTEROL
| Acceptance Criteria (Predicate: OLYMPUS CHOLESTEROL REAGENT (K925603)) | Reported Device Performance (Medicon Hellas CHOLESTEROL) |
|---|---|
| Method comparison (correlation to comparator): 1.000 | Method comparison (correlation to comparator): 0.9980 |
| Reportable range: 20 to 700 mg/dL | Reportable range: 20 to 700 mg/dL |
| Sensitivity LoD: 1 mg/dL (Predicate LoQ not defined) | Sensitivity LoD / LoQ: LoD 4.4 / LoQ 4.6 (mg/dL) |
| Precision (within run & total for all LVs): |
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(536 days)
Medicon Hellas, S.A
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 |
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(67 days)
MEDICON HELLAS S.A.
Medicon Ferritin - LATEX reagent is for the determination of Ferritin in human serum and plasma using automated clinical chemistry analyzers.
The measurement of ferritin may aid in the diagnosis of diseases affecting iron metabolism.
For in vitro diagnostic use.
The Ferritin – LATEX is an immunoturbidimetric assay. When serum or plasma specimen is mixed with the appropriate buffer (R1) and latex particles coated with anti-ferritin antibodies (R2), ferritin reacts with the antibodies leading to agglutination of latex particles. This agglutination is detected as turbidity change (600 nm) and it is proportional to ferritin concentration in the sample.
The Medicon Ferritin-LATEX device is an immunoturbidimetric assay for the quantitative determination of Ferritin in human serum and plasma using Olympus AU 400/600/640 automated clinical chemistry analyzers. The device's performance was compared to a predicate device, the Olympus Ferritin Reagent (K030124), to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Medicon Ferritin-LATEX device are implicitly established by demonstrating substantial equivalence to the predicate device, the Olympus Ferritin Reagent (K030124). The performance characteristics are compared as follows:
| Feature | Acceptance Criteria (Predicate Device K030124) | Reported Device Performance (Medicon Ferritin-LATEX) |
|---|---|---|
| Measuring Range | 8-450 µg/L | 4-450 ng/ml |
| Sample type | Serum | Serum and plasma |
| Precision | ||
| Within run CV | 2.25% @ 40.0 ng/ml | |
| 2.00% @ 101 ng/ml | ||
| 1.25% @ 383 ng/ml | 3.20% @ 38.0 ng/ml | |
| 1.31% @ 108.1 ng/ml | ||
| 0.99% @ 224.1 ng/ml | ||
| Precision | ||
| Total CV | 3.43% @ 40.0 ng/ml | |
| 2.81% @ 101 ng/ml | ||
| 2.12% @ 383 ng/ml | 3.94% @ 38.0 ng/ml | |
| 1.62% @ 108.1 ng/ml | ||
| 1.43% @ 224.1 ng/ml | ||
| Analytical Sensitivity (LDL) | 6.4 µg/L | 4 ng/ml |
| Linearity | 8.0 - 450 µg/L | 4 - 450 ng/ml |
| Method Comparison (Correlation to commercially available ferritin assay) | y = 0.964x - 2.549 | |
| R = 0.995 | y = 1.0016x + 4.3849 | |
| R = 0.9958 | ||
| Interferences | ||
| Haemolysis | ||
| Lipemic | ||
| Icterus | ||
| Rheumatoid Factor | Less than 10% up to 5 g/L hemoglobin | |
| Less than 10% up to 400mg/dL Intralipid® | ||
| Less than 5% up to 40mg/dL or 684 µmol/l bilirubin | ||
| Less than 5% up to 500 IU/ml RF | Less than 5% up to 500 mg/dl hemoglobin | |
| Less than 10% up to 400mg/L Intralipid® | ||
| Less than 5% up to 20mg/dl bilirubin | ||
| Less than 5% up to 900 IU/ml RF | ||
| Ascorbic acid: Less than 5% up to 3 mg/dl ascorbic acid | ||
| Prozone Effect | No hook effect observed up to 5000 ng/ml | No hook effect observed up to 10000 ng/ml |
| Reagent Stability (On board) | 30 days | 30 days |
| Calibration Interval | After each lot and 14 days | After each lot and 14 days |
| Traceability/Standardization | Standardized against the 3rd International Standard for ferritin, Recombinant NBSC code:94/572 | Standardized against the 3rd International Standard for ferritin, Recombinant NBSC code:94/572 |
Note on Units: The predicate device uses µg/L, and the new device uses ng/ml. While numerically equivalent (1 µg/L = 1 ng/ml), this is a difference in units presentation in the provided summary. For clarity in the table, the units as presented in the original text are retained.
Study Proving Device Meets Acceptance Criteria:
The study submitted for premarket notification K062746 comprised a series of analytical performance tests designed to demonstrate substantial equivalence to the predicate Olympus Ferritin Reagent (K030124). These tests included:
- Measuring Range/Linearity: Evaluation of the device's ability to accurately measure ferritin concentrations across its claimed range.
- Precision: Assessment of the reproducibility and repeatability of measurements (within-run and total CV).
- Analytical Sensitivity (Lower Detection Limit - LDL): Determination of the lowest concentration of ferritin that can be reliably detected.
- Method Comparison: Correlation of results from the Medicon Ferritin-LATEX with a "commercially available ferritin assay" using patient samples. Additionally, comparisons were made between serum and plasma samples using the Medicon Ferritin-LATEX.
- Interference Testing: Evaluation of the effect of potential interferents (hemolysis, lipemia, icterus, rheumatoid factor, ascorbic acid) on assay accuracy.
- Prozone Effect: Assessment of high-dose hook effect.
- Reagent Stability and Calibration Interval: Verification of the claimed stability and calibration requirements.
- Traceability/Standardization: Confirmation of standardization against recognized international standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Method Comparison (Ferritin-LATEX vs. commercially available ferritin assay): The summary states "patient serum samples," but the exact number of samples is not specified.
- Method Comparison (Ferritin-LATEX: serum vs. EDTA plasma): The summary states "patient serum and EDTA plasma," but the exact number of samples is not specified.
- Method Comparison (Ferritin-LATEX: serum vs. Li-Heparine plasma): The summary states "patient serum and Li-Heparine plasma," but the exact number of samples is not specified.
- Precision: Data is reported for 3 levels (38.0 ng/ml, 108.1 ng/ml, 224.1 ng/ml), implying multiple replicates were tested at each level to calculate CVs, but the total number of samples or runs is not explicitly stated.
- Interference: Concentrations for various interferents are provided, suggesting samples spiked with these substances were tested, but the number of samples is not specified.
- Prozone Effect: Samples up to 10000 ng/ml were tested, but the number of samples is not specified.
- Data Provenance: The document does not explicitly state the country of origin of the data. Given the "Medicon Hellas S.A." submitter information (Greece), it is plausible the studies were conducted in Greece or Europe, but this is not confirmed. The data appears to be from retrospective clinical samples (patient serum/plasma samples) and controlled laboratory studies (spiking experiments for interference, known concentrations for precision and linearity).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For an in vitro diagnostic device like a Ferritin assay, ground truth is typically established through reference methods or established laboratory practices rather than expert consensus on interpretation.
- No "experts" in the sense of clinicians or radiologists interpreting images were involved in establishing ground truth for individual test samples.
- The ground truth for the method comparison study was established by another "commercially available ferritin assay." This assay itself would have been validated against a reference method or known standards.
- The predicate device and the new device are both stated to be "Standardized against the 3rd International Standard for ferritin, Recombinant NBSC code: 94/572." This international standard serves as the ultimate ground truth for ferritin concentration measurements.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth for this in vitro diagnostic device is based on quantitative measurements against an international standard and comparison to a legally marketed predicate device, not on expert consensus or adjudication of subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is an in vitro diagnostic device (a reagent for an automated clinical chemistry analyzer) and not an imaging or interpretive device that would typically involve human readers. Therefore, an MRMC study is not relevant or performed for this type of device.
6. Standalone Performance
Yes, the studies described (Precision, Analytical Sensitivity, Linearity, Interference, Prozone Effect) are all assessments of the standalone performance of the Medicon Ferritin-LATEX algorithm/reagent system on an automated analyzer. The method comparison studies also demonstrate the standalone performance against an existing method. The entire submission focuses on the performance of the device without human interpretation of the assay results, relying instead on the quantitative output of the automated analyzer.
7. Type of Ground Truth Used
The ground truth used is primarily:
- Reference Standards: The device is standardized against the "3rd International Standard for ferritin, Recombinant NBSC code:94/572." This is the fundamental ground truth for ferritin concentration.
- Comparative Reference Method: For method comparison, another "commercially available ferritin assay" served as the reference method, which itself would have been validated against standards.
- Known Concentrations: For studies like precision and linearity, samples with known or spiked concentrations were used against which the device's measurements were assessed.
8. Sample Size for the Training Set
The provided 510(k) summary does not contain information on a "training set" in the context of machine learning. This device is a biochemical reagent system, not an AI or machine-learning algorithm that typically requires a large training dataset. The development and optimization of such a reagent assay would involve internal development testing, but this is distinct from a "training set" as understood in AI/ML contexts.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" or AI/ML components in this 510(k) submission for a biochemical reagent. The ground truth for the device's development and validation would have been established using the accepted methods for in vitro diagnostics, as outlined in point 7.
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