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510(k) Data Aggregation
(384 days)
The Albumin BCG2 assay is used for the quantitation of albumin in human serum or plasma on the ARCHITECT c System.
The Albumin BCG2 assay is to be used as an aid in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
The Albumin BCG2 assay is an automated clinical chemistry assay. The Albumin BCG2 procedure is based on the binding of bromocresol green in the assay reagent specifically with albumin in the patient sample to produce a colored complex. The absorbance of the complex at 604 nm is directly proportional to the albumin concentration in the sample.
Methodology: Colorimetric (Bromocresol Green)
The device in question is the Albumin BCG2 assay, used for the quantitation of albumin in human serum or plasma.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance (Albumin BCG2 assay) |
|---|---|---|
| Analytical Measuring Interval | Not explicitly stated, but established by LoQ and ULoQ | 0.3 – 9.4 g/dL |
| Reportable Interval | Not explicitly stated, but extends from LoD to ULoQ | 0.3 – 9.4 g/dL |
| Within-Laboratory Precision | Standard deviations and %CV values demonstrating acceptable precision | Panel 1 (0.4 g/dL): SD 0.00, %CV 0.0Control Level 2 (2.6 g/dL): SD 0.04, %CV 1.4Control Level 1 (4.1 g/dL): SD 0.06, %CV 1.5Panel 2 (5.7 g/dL): SD 0.06, %CV 1.0Panel 3 (9.4 g/dL): SD 0.07, %CV 0.8 |
| Accuracy | Bias within ± 2.4% relative to ERM-DA470k/IFCC | Bias was within ± 2.4% |
| Lower Limits of Measurement (LoB) | Not explicitly stated, but 95th percentile from zero-analyte samples | 0.0 g/dL |
| Lower Limits of Measurement (LoD) | Not explicitly stated, but 95% probability of detection | 0.3 g/dL |
| Lower Limits of Measurement (LoQ) | Maximum allowable precision of 20% CV met | 0.3 g/dL |
| Linearity | Linear across the analytical measuring interval | Linear across 0.3 to 9.4 g/dL |
| Interference | No significant interference (within ± 10%, based on 95% confidence intervals) | No significant interference observed for specified endogenous and exogenous substances |
| Method Comparison (Correlation with Predicate) | High correlation coefficient with the predicate device | Correlation Coefficient: 1.00 (Serum)Intercept: 0.03Slope: 1.03Concentration Range: 0.4 - 8.1 g/dL (Serum) |
| Tube Type Suitability | Acceptable for specified blood collection tube types | Serum tubes, Serum separator tubes, Dipotassium EDTA tubes, Lithium heparin tubes, Lithium heparin separator tubes, Sodium heparin tubes |
2. Sample Size Used for the Test Set and Data Provenance
- Within-Laboratory Precision: For each of the 2 controls and 3 human serum panels, 80 replicates were tested (2 duplicates per day for 20 days). The provenance of the human serum panels is not specified (e.g., country of origin, retrospective or prospective).
- Accuracy: The sample size for the accuracy study is not specified, but it involved determining bias relative to a standard reference material.
- Lower Limits of Measurement: For LoB, LoD, and LoQ, n ≥ 60 replicates of zero-analyte (LoB) or low-analyte (LoD, LoQ) samples were used.
- Linearity: The sample size for the linearity study is not explicitly stated.
- Potentially Interfering Substances: The sample size for this study is not explicitly stated.
- Method Comparison: 128 serum samples were used. The provenance of these samples is not specified.
- Tube Type: Samples were collected from a minimum of 40 donors. The provenance of these samples is not specified.
The studies described are non-clinical laboratory studies, suggesting they were conducted in a controlled lab setting rather than directly on patient data in a clinical environment. Whether the data is retrospective or prospective is not explicitly stated, but the nature of the studies (e.g., precision, linearity) typically involves prospective experimental designs.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the Albumin BCG2 assay studies described. This device is an in vitro diagnostic (IVD) quantitative assay, and its performance is evaluated against analytical benchmarks, reference materials, or a predicate device, not by expert interpretation of images or clinical outcomes that require a ground truth established by human experts.
4. Adjudication Method
Not applicable for this type of IVD device and studies. Performance is measured using quantitative analytical methods, not involving human adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a quantitative laboratory assay, not an imaging device or AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. Standalone Performance Study
Yes, the studies described are standalone performance studies of the Albumin BCG2 assay. The results reflect the algorithm/device's analytical performance (precision, accuracy, linearity, etc.) without human intervention in the result generation or interpretation to arrive at the reported quantitative values. The "human-in-the-loop" for this type of device typically refers to standard laboratory procedures for running samples and interpreting flagged results, which is inherent to its use but not a part of the core performance metrics discussed here.
7. Type of Ground Truth Used
- Accuracy: The ground truth for accuracy was established using a standard reference material: European Reference Materials Standard Reference Material - DA470k/ International Federation of Clinical Chemistry and Laboratory Medicine (ERM - DA470k/IFCC).
- Method Comparison: The predicate device, Albumin BCG (K981758; List No. 7D53), served as the reference for comparison, effectively acting as a "ground truth" or established method against which the new device's measurements were assessed for agreement.
- For other analytical performance characteristics (precision, linearity, limits of measurement, interference), the "ground truth" is understood as the expected or known concentrations in spiked samples, controls, or reference materials, or ideal analytical behavior.
8. Sample Size for the Training Set
Not applicable. This document describes a traditional in vitro diagnostic device, not one utilizing machine learning or artificial intelligence that would typically involve a "training set."
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for this device.
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(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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(23 days)
Rx Only
For in vitro diagnostic use only
The ALB test within the VITROS XT Chemistry Products ALB-TP Slides quantitatively measures albumin (ALB) concentration in serum and plasma using the VITROS XT 7600 Integrated System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
The new device, the VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte.
The ALB test is a multilayered, analytical element coated on a polyester support.
For the albumin measurement, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. When the fluid penetrates the reagent layer, the bromcresol green (BCG) dye diffuses to the spreading layer and binds to albumin in the sample. This binding results in a shift in wavelength of the reflectance maximum of the free dye. The color complex that forms is measured by reflectance spectrophotometry. The amount of albumin-bound dye is proportional to the concentration of albumin in the sample.
The provided document describes the analytical performance of the VITROS XT Chemistry Products ALB-TP Slides for measuring albumin (ALB) concentration, and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study data:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" for each performance metric in a dedicated table. Instead, performance is demonstrated through studies and compared against established clinical laboratory guidelines (CLSI protocols) or by showing strong correlation to the predicate device. For some metrics, an implied acceptance based on clinical relevance and comparison to the predicate can be inferred.
Here's a table summarizing the reported device performance, with inferred acceptance criteria based on the context of the studies:
| Performance Metric | Inferred Acceptance Criteria (Contextual) | Reported Device Performance |
|---|---|---|
| Method Comparison | Strong correlation (e.g., correlation coefficient close to 1, slope close to 1, intercept close to 0) with the predicate device, following CLSI EP09-A3. | Correlation for ALB (g/dL):- N: 127- Slope: 1.00- Intercept: -0.03- Correlation Coeff.: 0.999- Test Range: 1.0 - 5.9- Measuring Range: 1.0 - 6.0 |
| Matrix Comparison | Acceptable performance across different sample types (serum, plasma) compared to a reference serum type (red top plastic serum tube), with slopes near 1 and intercepts near 0, demonstrating equivalence. | Regression results vs. Serum Plastic:- Na Hep: Slope 0.96, Intercept 0.098- Li Hep: Slope 0.96, Intercept 0.088- PST: Slope 0.95, Intercept 0.107- SST: Slope 0.99, Intercept 0.033- Serum Glass: Slope 1.00, Intercept -0.007 |
| Precision | Meets performance guidelines for precision (e.g., CLSI EP05-A3), demonstrating low variability (low SD and %CV) across different concentrations and over time (repeatability, within-day, within-lab). Specific criteria for SD/CV are not explicitly given but are generally expected to be within clinically acceptable limits. | Representative Lot Precision (g/dL Albumin):- Mean Conc. 1.6: Repeatability %CV 1.2, Within Lab %CV 1.4- Mean Conc. 2.7: Repeatability %CV 0.9, Within Lab %CV 1.2- Mean Conc. 3.4: Repeatability %CV 0.8, Within Lab %CV 1.1- Mean Conc. 4.1: Repeatability %CV 1.0, Within Lab %CV 1.3- Mean Conc. 4.4: Repeatability %CV 0.7, Within Lab %CV 0.9- Mean Conc. 5.2: Repeatability %CV 0.9, Within Lab %CV 1.2 |
| Detection Limits (LoQ) | LoQ determined based on pre-defined Total Error (TE) goals, with a specific goal of ≤ 0.2 g/dL. | ALB (g/dL):- LOB: 0.24- LOD: 0.27- LOQ: 0.60- Claimed LOQ: 1.0 (This implies the device achieves a tighter LoQ than the claimed range allows) |
| Linearity | Supports the claimed measuring range (1.0 - 6.0 g/dL), demonstrated by a linear response across a wider range (e.g., 0.5 - 7.1 g/dL) with a high correlation (R close to 1) and appropriate slope/intercept. Follows CLSI EP06-A. | ALB:- Measuring Range: 1.0 - 6.0 g/dL- Linear Range: 0.5 - 7.1 g/dL- Least Squares Regression: y = 1.01x - 0.19 with R = 1.00 |
| Specificity (Interference) | Bias < 0.24 g/dL at ~3.6 g/dL albumin and bias < 0.30 g/dL at ~4.5 g/dL albumin for non-interfering substances. Known interferents are identified and qualified. Follows CLSI EP07-A3 and EP37. | *Known Interferences (Bias):**- Dextran 40: 6 g/dL (3.8 g/dL ALB) -> -0.38; 4 g/dL (4.8 g/dL ALB) -> -0.58- Hemoglobin: 300 mg/dL (3.8 g/dL ALB) -> 0.32; 200 mg/dL (4.6 g/dL ALB) -> 0.3747 test substances found not to interfere (bias < 0.24 g/dL or < 0.30 g/dL). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Sizes:
- Method Comparison: 127 patient samples.
- Matrix Comparison: Not explicitly stated as a number of unique patient samples, but various collection devices (serum: glass red top, plastic red top, SST; plasma: Na-heparin, Li-heparin, PST) were evaluated. The comparison used two replicates for the reference serum and two replicates for each feature tube.
- Precision: Patient pools and quality control materials. "80 observations (2 replicates per run, 2 runs per day over 20 days)" were used for the precision study, which implies that a smaller number of initial patient pools were tested multiple times.
- Linearity: A series of seventeen proportionally related admixtures of low and high test fluids were tested in quadruplicate.
- Specificity: Not explicitly stated as a number of unique patient samples; it likely used spiked samples or patient samples with known levels of interferents.
- Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It refers to "patient samples" and "patient pools" but provides no further details on their source.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement of albumin. "Ground truth" is established by the analytical method itself (measurement against a reference standard or validated method) rather than by expert consensus on qualitative interpretation of images or clinical findings. The predicate device (VITROS Chemistry Products ALB Slides) serves as the reference for method comparison.
4. Adjudication method for the test set
Not applicable. As this is an IVD device measuring a quantitative analyte, there is no subjective interpretation requiring an adjudication process for a "test set" in the way it would be applied to, for example, image-based diagnostic systems. The performance is assessed by comparing quantitative results against reference methods or established analytical performance criteria.
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 device for quantitative measurement of a biochemical analyte. It does not involve human readers interpreting images or data, nor does it involve AI assistance for such interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in essence, the performance studies described are for the standalone device (VITROS XT Chemistry Products ALB-TP Slides on the VITROS XT 7600 Integrated System) measuring albumin concentration. The device operates as a laboratory instrument without direct human-in-the-loop interpretation of the measurement itself. Human involvement is in operating the instrument and interpreting the quantitative result in a clinical context, but the device's analytical performance (accuracy, precision, linearity, etc.) is assessed independently.
7. The type of ground truth used
The "ground truth" for the performance studies is primarily established by:
- Comparison to a legally marketed predicate device: The VITROS Chemistry Products ALB Slides (K023875) on the VITROS 5600 Integrated System served as the reference for the method comparison study.
- Reference standards and established analytical methods: Precision, linearity, and detection limit studies rely on the inherent accuracy of the measurement procedure itself against known concentrations (e.g., patient pools, quality control materials, spiked samples, or reference materials).
- Clinical Laboratory Standards Institute (CLSI) protocols: The studies specifically cite adherence to CLSI EP09-A3 (Method Comparison), EP05-A3 (Precision), EP17-A2 (Detection Limits), EP06-A (Linearity), EP07-A3, and EP37 (Interference), which are widely accepted guidelines for validating IVD performance.
8. The sample size for the training set
Not applicable. This is not an AI/Machine Learning device that requires a "training set" in the conventional sense. It is a traditional in vitro diagnostic chemical assay. Its development involves chemical and engineering principles, not statistical learning from a data set.
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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(382 days)
BA400: The BA400 analyser is used to determine analyte concentrations by in vitro biochemical and turbidimetric measurements of human samples of serum, urine, plasma, cerebrospinal fluid or total blood. This device is intended to replace manual analytical procedures by performing automatically various steps such as pipetting, heating, and measuring color intensity.
ALBUMIN: Reagent for the measurement of albumin concentration in human serum or plasma. The obtained values are useful as an aid in the evaluation of protein synthesis of the liver in the chronic liver diseases and for the nutritional status. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
ALKALINE PHOSPHATASE (ALP) - AMP: Reagent for the measurement of alkaline phosphatase (ALP)-AMP concentration in human serum or plasma. The obtained values are useful as an aid in the diagnosis and treatment of hepatobiliary and bone diseases with impaired osteoblastic activity diseases. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
GLUCOSE-HEXOKINASE: Reagent for the measurement of glucose concentration in human serum, plasma, urine or cerebrospinal fluid. The obtained values are useful as an aid in the diagnosis and monitoring of the diabetes mellitus. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for several in vitro diagnostic reagents and an analyzer. It only provides information about the intended use of the devices and their regulatory classification. It does not contain any data, studies, acceptance criteria, or performance results for the devices mentioned (ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE reagents, or the BA400 analyzer).
Therefore, I cannot provide the requested information in the requested format because the input document does not contain it.
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(88 days)
ACE Albumin Reagent is intended for the quantitative determination of albumin concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
ACE Total Protein Reagent is intended for the quantitative determination of total protein concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of calcium concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. 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). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination of inorganic phosphorus concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
In the ACE Albumin Reagent assay, Bromcresol green binds specifically to albumin to form a green colored complex, which is measured bichromatically at 629 nm/692 nm. The intensity of color produced is directly proportional to the albumin concentration in the sample.
In the ACE Total Protein Reagent assay, cupric ions react with the peptide bonds of proteins under alkaline conditions to form a violet colored complex, which is measured bichromatically at 544 nm/692 nm. The intensity of color produced is directly proportional to the total protein concentration in the sample.
In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with Arsenazo III in an acidic solution to form a blue-purple colored complex, which is measured bichromatically at 647 nm/692 nm. The intensity of color produced is directly proportional to the calcium concentration in the sample.
In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic conditions, inorganic phosphorus in serum reacts with ammonium molybdate to form an unreduced phosphomolybdate complex, which absorbs strongly at 340 nm. The increase in absorbance, measured bichromatically at 340 nm/378 nm, is directly proportional to the amount of phosphorus in the sample.
Here's an analysis of the acceptance criteria and study information for the ACE Albumin Reagent, ACE Total Protein Reagent, ACE Calcium-Arsenazo Reagent, and ACE Inorganic Phosphorus U.V. Reagent, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The provided documentation does not explicitly state formal "acceptance criteria" with specific thresholds for each performance metric. However, it presents detailed performance data, particularly precision (within-run and total %CV) and method comparison (regression analysis, correlation coefficient), comparing the new reagents on various ACE clinical chemistry systems (ACE, ACE Alera, ACE Axcel) against existing predicate devices and among themselves. The implied acceptance is that the new reagents perform comparably to, or as effectively as, the predicate devices and demonstrate acceptable precision and linearity for clinical use.
Below is a summary of the reported device performance based on the "In-House Precision" and "In-House Matrix Comparison" tables. Since explicit acceptance criteria are not given, the performance data itself is presented as the evidence of meeting implied clinical utility and equivalence to predicate devices.
ACE Albumin Reagent
| Metric | Acceptance Criteria (Implied) | Reported Performance (Range across ACE, Alera, Axcel systems) |
|---|---|---|
| Precision (%CV) | Clinically acceptable | Serum: Within-Run: 0.5-1.6%, Total: 0.6-1.8%Plasma: Within-Run: 0.8-1.7%, Total: 1.1-1.7% |
| Matrix Comparison (Serum vs. Plasma) | Slope close to 1, Intercept close to 0, High Correlation | Slope: 0.956 - 1.002Intercept: -0.01 - 0.20Correlation: 0.9850 - 0.9905 |
| Linearity | Broad clinical range, r^2 close to 1 | Linear to 7.6 g/dLy = 0.980x + 0.01, r^2 = 0.9982 |
| Detection Limits (ACE Alera) | Low enough for clinical utility | LoB: 0.08 g/dL, LoD: 0.09 g/dL, LoQ: 0.09 g/dL |
| Interferences (ACE Alera) | No significant interference at clinically relevant levels | Icterus: 60 mg/dL, Hemolysis: 250 mg/dL, Lipemia: 1000 mg/dL, Ascorbic Acid: 6 mg/dL |
ACE Total Protein Reagent
| Metric | Acceptance Criteria (Implied) | Reported Performance (Range across ACE, Alera, Axcel systems) |
|---|---|---|
| Precision (%CV) | Clinically acceptable | Serum: Within-Run: 0.7-1.3%, Total: 0.8-1.4%Plasma: Within-Run: 0.5-1.3%, Total: 0.7-1.4% |
| Matrix Comparison (Serum vs. Plasma) | Slope close to 1, Intercept close to 0, High Correlation | Slope: 0.994 - 1.001Intercept: 0.12 - 0.34Correlation: 0.9798 - 0.9885 |
| Linearity | Broad clinical range, r^2 close to 1 | Linear to 15.1 g/dLy=0.991x + 0.04, r^2 = 0.9979 |
| Detection Limits (ACE Alera) | Low enough for clinical utility | LoB: 0.08 g/dL, LoD: 0.13 g/dL, LoQ: 0.20 g/dL |
| Interferences (ACE Alera) | No significant interference at clinically relevant levels | Icterus: 56.8 mg/dL, Hemolysis: 250 mg/dL, Lipemia: 929 mg/dL, Ascorbic Acid: 6 mg/dL |
ACE Calcium-Arsenazo Reagent
| Metric | Acceptance Criteria (Implied) | Reported Performance (Range across ACE, Alera, Axcel systems) |
|---|---|---|
| Precision (%CV) | Clinically acceptable | Serum: Within-Run: 0.7-1.6%, Total: 0.9-2.7%Plasma: Within-Run: 0.5-1.9%, Total: 1.1-2.0% |
| Matrix Comparison (Serum vs. Plasma) | Slope close to 1, Intercept close to 0, High Correlation | Slope: 0.978 - 1.008Intercept: -0.06 - 0.33Correlation: 0.9793 - 0.9911 |
| Linearity | Broad clinical range, r^2 close to 1 | Linear to 16.5 mg/dLy=0.992x +0.27, r^2 = 0.9990 |
| Detection Limits (ACE Alera) | Low enough for clinical utility | LoB: 0.09 mg/dL, LoD: 0.11 mg/dL, LoQ: 0.23 mg/dL |
| Interferences (ACE Alera) | No significant interference at clinically relevant levels | Icterus: 58.8 mg/dL, Hemolysis: 1000 mg/dL, Lipemia: 1000 mg/dL, Ascorbic Acid: 6 mg/dL |
ACE Inorganic Phosphorus U.V. Reagent
| Metric | Acceptance Criteria (Implied) | Reported Performance (Range across ACE, Alera, Axcel systems) |
|---|---|---|
| Precision (%CV) | Clinically acceptable | Serum: Within-Run: 0.3-4.4%, Total: 0.5-5.0%Plasma: Within-Run: 0.9-5.1%, Total: 0.9-6.1% |
| Matrix Comparison (Serum vs. Plasma) | Slope close to 1, Intercept close to 0, High Correlation | Slope: 0.999 - 1.049Intercept: -0.28 - 0.04Correlation: 0.9927 - 0.9950 |
| Linearity | Broad clinical range, r^2 close to 1 | Linear to 21 mg/dLy=1.001x +0.03, r^2 = 0.9995 |
| Detection Limits (ACE Alera) | Low enough for clinical utility | LoB: 0.25 mg/dL, LoD: 0.35 mg/dL, LoQ: 0.35 mg/dL |
| Interferences (ACE Alera) | No significant interference at clinically relevant levels | Icterus: 11.5 mg/dL, Hemolysis: 250 mg/dL, Lipemia: 306 mg/dL, Ascorbic Acid: 6 mg/dL |
2. Sample Sizes Used for the Test Set and Data Provenance
The studies mentioned are "In-House Precision," "In-House Matrix Comparison: Serum vs. Plasma," "POL - Precision," and "POL – Method Comparison."
- In-House Precision (Serum vs. Plasma):
- Sample Size: Not explicitly stated for each "low, mid, high" concentration level, but implies multiple replicates for each level tested across the three systems (ACE, Alera, Axcel). For example, the ACE Alera precision table (pg. 16) shows 3 levels (low, mid, high) for serum, with reported mean, within-run SD, and total SD. Typically, precision studies involve running samples multiple times a day over several days.
- Data Provenance: "In-House" suggests it was conducted by Alfa Wassermann Diagnostic Technologies, LLC, likely at their own facilities. It is a prospective study as they are performing experiments to generate data.
- In-House Matrix Comparison: Serum vs. Plasma:
- Sample Size:
- Albumin: ACE: 55 pairs, ACE Alera: 56 pairs, ACE Axcel: 56 pairs
- Total Protein: ACE: 56 pairs, ACE Alera: 56 pairs, ACE Axcel: 81 pairs
- Calcium-Arsenazo: ACE: 56 pairs, ACE Alera: 56 pairs, ACE Axcel: 81 pairs
- Inorganic Phosphorus: ACE: 100 pairs, ACE Alera: 102 pairs, ACE Axcel: 56 pairs
- Data Provenance: "In-House" suggests it was conducted by Alfa Wassermann Diagnostic Technologies, LLC, likely at their own facilities. The comparison between serum and plasma samples implies these were collected from human subjects. This is a prospective study.
- Sample Size:
- POL (Physician Office Laboratory) - Precision:
- Sample Size: For each reagent and each system (ACE and ACE Alera), there are 3 "samples" (representing different concentration levels) tested at 3 different POL sites. Each sample/site combination has "Within-Run" and "Total" precision reported, implying multiple replicates for each measurement.
- Data Provenance: Conducted at "POL 1," "POL 2," and "POL 3" sites, indicating external collection and testing beyond the manufacturer's immediate facilities. This is a prospective study.
- POL (Physician Office Laboratory) - Method Comparison:
- Sample Size:
- Albumin: 50 samples for each POL site (x3 POLs)
- Total Protein: 51 samples for each POL site (x3 POLs)
- Calcium-Arsenazo: 50 samples for each POL site (x3 POLs)
- Inorganic Phosphorus: 50 samples for POL 1 & 3, 48 samples for POL 2
- Data Provenance: Comparisons between "ACE In-House (x)" and "ACE POL (y)" or "ACE In-House (x)" and "ACE Alera POL (y)". This indicates the data for these studies was collected at both in-house facilities and external Physician Office Laboratories. This is a prospective study design, comparing results from different testing environments.
- Sample Size:
- Detection Limits & Linearity (ACE Alera):
- Sample Size: Not specified for these specific studies, but typically involves a series of diluted and concentrated samples to define the measuring range.
- Data Provenance: In-House, prospective.
- Interference (ACE Alera):
- Sample Size: Not specified, but involves spiking samples with various interferents at different concentrations.
- Data Provenance: In-House, prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For these types of in vitro diagnostic (IVD) assays, the "ground truth" is typically established by reference methods or validated comparative methods, often using certified calibrators and controls. The documentation does not mention the use of human experts to establish ground truth for the test set in the traditional sense of medical image interpretation (e.g., radiologists interpreting images). Instead, the studies rely on quantitative measurements and statistical comparisons with established methods (the predicate devices or in-house reference measurements) to demonstrate performance. Therefore, no information is provided on the number or qualifications of experts for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, the "ground truth" for these quantitative chemical assays is not established through expert consensus or adjudication in the way it would be for qualitative or interpretive diagnostic devices like medical imaging. Performance is evaluated by statistical comparison of numerical results.
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 device consists of chemical reagents for laboratory measurement, not an AI-assisted diagnostic tool interpreted by human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
The performance presented for these reagents is inherently "standalone" in the sense that it reflects the direct analytical performance of the assays on the specified automated clinical chemistry systems. The results are quantitative measurements produced by the device without human interpretation of raw data beyond reading the numerical output. The "without human-in-the-loop" aspect applies here as the device itself performs the measurement and outputs a numerical value of concentration. The method comparison studies demonstrate the standalone performance of the candidate devices compared to predicate devices.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for these assays is established through reference methods and comparison to legally marketed predicate devices.
- For precision, the "ground truth" for each replicate is assumed to be the true concentration within the sample, and the study assesses the reproducibility of the device in measuring that concentration.
- For method comparison studies (e.g., In-House vs. POL, or ACE vs. ACE Alera), one method's results (often the predicate or an established in-house method) serve as the comparative 'truth' to evaluate the new method's agreement. The reference method would itself be calibrated against known standards.
- For linearity, samples of known, graded concentrations are used.
- For detection limits, the ground truth involves samples with very low, known concentrations.
These are established analytical chemistry principles rather than "expert consensus" or "pathology" in the diagnostic interpretation sense.
8. The Sample Size for the Training Set
The concept of a "training set" is primarily relevant for machine learning or AI algorithms which are iteratively developed and optimized using data. These reagents are chemical assays with a defined photometric measurement principle. While there is a development phase that involves optimizing reagent formulations and instrument parameters, there isn't a "training set" in the computational sense. The data presented here are from formal "verification and validation studies" to demonstrate performance characteristics (precision, linearity, accuracy/comparison, interference, detection limits).
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" is not directly applicable to these chemical reagents. The "ground truth" for establishing and validating the performance of such assays is based on:
- Reference materials/calibrators: Solutions with precisely known concentrations of the analyte (albumin, total protein, calcium, phosphorus) traceable to international standards.
- Validated comparison methods: Measurements made by existing, legally marketed predicate devices or other well-established and accurate laboratory methods.
- Controlled spiking experiments: Adding known amounts of substance to samples to assess recovery, linearity, and interference.
These methods establish the quantitative "truth" against which the performance of the new reagents is measured.
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(240 days)
The ACE Albumin Reagent is intended for the quantitative determination of albumin concentration in serum using the ACE Axcel Clinical Chemistry System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Total Protein Reagent is intended for the quantitative determination of total protein concentration in serum using the ACE Axcel Clinical Chemistry System. Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of calcium concentration in serum using the ACE Axcel Clinical Chemistry System. 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). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination of inorganic phosphorus concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
In the ACE Albumin Reagent assay, Bromcresol green binds specifically to albumin to form a green colored complex, which is measured bichromatically at 629 nm/692 nm. The intensity of color produced is directly proportional to the albumin concentration in the sample.
In the ACE Total Protein Reagent assay, cupric ions react with the peptide bonds of proteins under alkaline conditions to form a violet colored complex which is measured bichromatically at 544 nm/692 nm. The intensity of color produced is directly proportional to the total protein concentration in the sample.
In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with Arsenazo III in an acidic solution to form a blue-purple colored complex, which is measured bichromatically at 647 nm/692 nm. The intensity of color produced is directly proportional to the calcium concentration in the sample.
In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic conditions, inorganic phosphorus in serum reacts with ammonium molybdate to form an unreduced phosphomolybdate complex, which absorbs strongly at 340 nm. The increase in absorbance, measured bichromatically at 340 nm/378 nm, is directly proportional to the amount of phosphorus in the sample.
The ACE Albumin Reagent consists of a single reagent bottle. The reagent contains Bromcresol green and acetate buffer.
The ACE Total Protein Reagent consists of a single reagent bottle. The reagent contains copper sulfate, sodium potassium tartrate, potassium iodide and sodium hydroxide.
The ACE Calcium-Arsenazo Reagent consists of a single reagent bottle. The Reagent contains Arsenazo III.
The ACE Inorganic Phosphorus U.V. Reagent consists of a single reagent bottle. The reagent contains ammonium molybdate and sulfuric acid.
Acceptance Criteria and Device Performance Study for ACE Reagents
The provided 510(k) summary (K113374) describes the performance of four reagents: ACE Albumin Reagent, ACE Total Protein Reagent, ACE Calcium-Arsenazo Reagent, and ACE Inorganic Phosphorus U.V. Reagent, when used with the Alfa Wassermann ACE Axcel Clinical Chemistry System. The study establishes the substantial equivalence of these devices to their predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical terms (e.g., "CV must be < X%"). Instead, the performance is reported and compared to the established performance of the predicate device (implied through correlation studies). The key performance metrics are precision (within-run CV and total CV), accuracy (correlation coefficient, standard error estimate, confidence intervals for slope and intercept from regression analysis against a predicate device), and detection limit.
Note: For each analyte, the "acceptance criteria" can be inferred from the reported performance, which demonstrates that the new device performs comparably to the predicate device and within acceptable analytical limits for clinical use. The confidence intervals for the slope and intercept being close to 1 and 0 respectively for accuracy, and low CVs for precision, suggest good performance. A direct numerical acceptance criterion for each metric is not specifically stated in this summary but is inherent in the demonstration of substantial equivalence.
| Performance Metric | ACE Albumin Reagent | ACE Total Protein Reagent | ACE Calcium-Arsenazo Reagent | ACE Inorganic Phosphorus U.V. Reagent |
|---|---|---|---|---|
| Precision | ||||
| Within-run CV (Lab) | 0.9 to 1.7% (at 4 levels) | 0.8 to 2.4% (at 4 levels) | 1.3 to 2.3% (at 4 levels) | 1.4 to 1.9% (at 4 levels) |
| Total CV (Lab) | 1.2 to 2.0% (at 4 levels) | 1.0 to 2.9% (at 4 levels) | 1.4 to 2.3% (at 4 levels) | 1.5 to 2.5% (at 4 levels) |
| Within-run CV (POL) | 0.0 to 1.6% (at 3 sites, 3 levels) | 0.7 to 1.3% (at 3 sites, 3 levels) | 0.8 to 1.4% (at 3 sites, 3 levels) | 0.6 to 3.2% (at 3 sites, 3 levels) |
| Total CV (POL) | 0.0 to 2.3% (at 3 sites, 3 levels) | 0.8 to 1.6% (at 3 sites, 3 levels) | 1.1 to 2.9% (at 3 sites, 3 levels) | 1.0 to 3.9% (at 3 sites, 3 levels) |
| Accuracy | ||||
| Correlation Study | ||||
| Sample Size | 118 samples | 121 samples | 111 samples | 110 samples |
| Range | 0.4 to 6.4 g/dL | 0.4 to 13.5 g/dL | 0.7 to 14.5 mg/dL | 0.6 to 19.6 mg/dL |
| Correlation Coeff. | 0.9959 | 0.9977 | 0.9935 | 0.9983 |
| Std Error Est. | 0.08 | 0.12 | 0.22 | 0.16 |
| CI Slope | 0.980 to 1.013 | 0.978 to 1.002 | 0.998 to 1.042 | 0.994 to 1.017 |
| CI Intercept | -0.04 to 0.10 | -0.12 to 0.06 | -0.50 to -0.08 | -0.06 to 0.05 |
| Patient Corr. (POL) | ||||
| Correlation Coeff. | 0.9894 to 0.9966 (3 sites) | 0.9932 to 0.9987 (3 sites) | 0.9895 to 0.9977 (3 sites) | 0.9977 to 0.9996 (3 sites) |
| Std Error Est. | 0.08 to 0.13 (3 sites) | 0.09 to 0.24 (3 sites) | 0.16 to 0.23 (3 sites) | 0.11 to 0.19 (3 sites) |
| CI Slope | 0.946 to 1.037 (3 sites) | 0.973 to 1.047 (3 sites) | 0.969 to 1.075 (3 sites) | 1.014 to 1.067 (3 sites) |
| CI Intercept | -0.14 to 0.39 (3 sites) | -0.41 to 0.19 (3 sites) | -0.43 to 0.42 (3 sites) | -0.33 to 0.09 (3 sites) |
| Detection Limit | 0.09 g/dL | 0.15 g/dL | 0.11 mg/dL | 0.07 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
The studies are retrospective in nature, as they involve testing samples on both the new device (ACE Axcel System with new reagents) and a predicate device (Alfa Wassermann ACE Clinical Chemistry System).
The data provenance is not explicitly stated regarding country of origin, but the testing was conducted at "three separate Physician Office Laboratory (POL) sites" in addition to the primary laboratory testing. This suggests the data is from a clinical laboratory environment.
Test Set Sample Sizes:
- ACE Albumin Reagent: 118 samples (correlation study)
- ACE Total Protein Reagent: 121 samples (correlation study)
- ACE Calcium-Arsenazo Reagent: 111 samples (correlation study)
- ACE Inorganic Phosphorus U.V. Reagent: 110 samples (correlation study)
These sample sizes were used for the accuracy/correlation studies comparing the new device to the predicate. The precision studies involved testing at 4 levels for 22 days in the main lab and at 3 levels over 5 days at the three POL sites, without specifying the exact number of individual samples for precision.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of submission (IVD reagent for clinical chemistry) does not typically involve human experts establishing ground truth for individual measurements in the same way an imaging AI might. The "ground truth" for the test set is established by the predicate device, the Alfa Wassermann ACE Clinical Chemistry System. The performance of this predicate device is assumed to be accurate and clinically acceptable, serving as the comparative standard. Therefore, no external experts are explicitly mentioned for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. This is a quantitative chemical assay, not an assessment requiring human interpretation or adjudication. The comparison is between quantitative measurements from two different analytical systems.
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 a clinical chemistry reagent, not an AI imaging or diagnostic algorithm that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies evaluate the standalone performance of the ACE Axcel Clinical Chemistry System using the new reagents. The measurements are automated, and the results are directly compared to those obtained from the predicate device. There is no "human-in-the-loop" aspect to the analytical process itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for these studies is the quantitative measurements obtained from the legally marketed predicate device, the Alfa Wassermann ACE Clinical Chemistry System. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices, where the performance of the new device is validated against an already approved method.
8. The sample size for the training set
Not applicable. These are chemical reagents and an associated analyzer system, not a machine learning or AI model that requires a "training set" in the conventional sense. The performance characteristics were determined through analytical studies.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this device technology.
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(168 days)
The Poly-Chem 90 Albumin test system is an in vitro diagnostic procedure intended to measure the albumin concentration in human serum on the Poly-Chem 90 analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
The Poly-Chem 90 BUN test system is an in vitro diagnostic procedure intended to measure urea nitrogen (an end-product of nitrogen metabolism) in human serum on the Poly-Chem 90 analyzer. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
The Poly-Chem 90 Calcium test system is an in vitro diagnostic procedure intended to measure the total calcium level in human serum on the Poly-Chem 90 analyzer. 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).
The Poly-Chem 90 Carbon Dioxide test system is an in vitro diagnostic procedure intended to measure bicarbonate/carbon dioxide in human serum on the Poly-Chem 90 analyzer. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
The Poly-Chem 90 Creatinine test system is an in vitro diagnostic procedure intended to measure creatinine levels in human serum on the Poly-Chem 90 analyzer. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
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This document is a 510(k) clearance letter for an in vitro diagnostic device, the Poly-Chem 90 Albumin, BUN, Calcium, Carbon Dioxide, and Creatinine tests. It is not a study report or clinical trial document. Therefore, it does not contain the specific information requested about acceptance criteria, device performance, study design, or ground truth establishment.
A 510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, not typically on a new clinical study with acceptance criteria and performance metrics described in detail within the clearance letter itself. The types of studies referenced in your request (e.g., sample size for test set, expert involvement, MRMC studies, standalone performance) are more common for novel or higher-risk devices that require a PMA (Premarket Approval) or for performance studies conducted by the manufacturer that are submitted as part of the 510(k) but not fully detailed in the FDA's clearance summary.
Therefore, I cannot provide the requested information from the provided text. The document primarily confirms that the FDA has reviewed the manufacturer's submission and found the device substantially equivalent to existing devices, allowing it to be marketed.
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(88 days)
ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. 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).
ELITech Clinical Systems ALBUMIN is intended for the quantitative in vitro diagnostic determination of albumin in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
The device for this submission is available as kit only. It consists of 1 reagent "R". Reagent R contains: MES buffer (pH 6.50), Arsenazo III [2,7-(bis(2-arsonophenylazo))-1,8-dihydronaphtalene-3,6-disulphonic acid].
The device for this submission is available as kit only. It consists of 1 reagent "R". Reagent R contains: Succinate buffer (pH 4.20), Bromocresol green, Brij 35.
ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
The provided text describes several in-vitro diagnostic devices (reagents, calibrators, and controls) and their performance characteristics. However, it does not contain information about studies involving AI, human readers, or image analysis. The data provided is for traditional laboratory assays, comparing a new device to a predicate device.
Therefore, many of the requested elements for describing an AI device's acceptance criteria and study are not applicable or cannot be extracted from this document, such as:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - Not specified for clinical samples in the context of an AI study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts - Not applicable for chemical assays.
- Adjudication method - Not applicable for chemical assays.
- 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 - No AI component described.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - No AI component described.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc) - Not explicitly stated in terms of expert consensus or pathology for clinical samples, but implied to be analytical results from established methods.
- The sample size for the training set - No AI component described, so no training set discussed.
- How the ground truth for the training set was established - No AI component described.
Below is an attempt to address the request based only on the information available in the provided text, primarily focusing on the "ELITech Clinical Systems CALCIUM ARSENAZO" reagent as it is the first device detailed.
Acceptance Criteria and Device Performance Study for ELITech Clinical Systems CALCIUM ARSENAZO
The provided document describes the performance characteristics of the ELITech Clinical Systems CALCIUM ARSENAZO reagent, a quantitative in vitro diagnostic device for total calcium in human serum and plasma. The study presented is a comparison to a legally marketed predicate device, Stanbio Calcium LiquiColor® (Arsenazo III) (K921625), to demonstrate substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device, where the new device's performance metrics are expected to be comparable or better. The table below summarizes the reported performance of the ELITech Clinical Systems CALCIUM ARSENAZO. Specific numerical acceptance criteria (e.g., "must be ≥X") are not explicitly stated as separate targets, but rather demonstrated through direct comparison to the predicate's known performance or through established analytical performance ranges.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ELITech Clinical Systems CALCIUM ARSENAZO) |
|---|---|---|
| Intended Use | Quantitative in vitro diagnostic determination of total calcium in human serum and plasma. | Same as predicate. |
| Measuring Range | Comparable to 0 to 15 mg/dL | 5.0 - 15.0 mg/dL |
| Limit of Detection (LoD) | Not explicitly stated for predicate in summary, but assumed to be very low. | 0.36 mg/dL |
| Limit of Quantification (LoQ) | Not explicitly stated for predicate. | 5.00 mg/dL |
| Precision (Within Run) | Comparable to CV=1.3% (Level 11.0 mg/dL) and CV=0.9% (Level 14.3 mg/dL) | Level 8.75 mg/dL CV= 1.3%Level 9.68 mg/dL CV= 0.9%Level 11.97 mg/dL CV=0.7% |
| Precision (Total/Run-to-run) | Comparable to CV=1.1% (Level 11.2 mg/dL) and CV=1.3% (Level 14.3 mg/dL) | Level 8.75 mg/dL CV= 1.9%Level 9.68 mg/dL CV= 1.9%Level 11.97 mg/dL CV= 1.9% |
| Method Comparison | Linear regression parameters and correlation coefficient (r) comparable to y=0.99x+0.10 mg/dL, r=0.989. | y= 1.008x - 0 mg/dLr= 0.996 (range: 4.90 to 14.37 mg/dL) |
| Interference | Minimal interference from common substances (Hemoglobin, Bilirubin, Lipemia). | Hemoglobin: No significant interference up to 500 mg/dL.Triglycerides: No significant interference up to 1119 mg/dL. A positive bias observed above 1119 mg/dL.Unconjugated bilirubin: No significant interference up to 30.0 mg/dL.Conjugated bilirubin: No significant interference up to 29.5 mg/dL.Magnesium: No significant interference up to 10.91 mg/dL.Ascorbic acid: No significant interference up to 20 mg/dL.Acetaminophen: No significant interference up to 30 mg/dL.Acetylsalicylic acid: No significant interference up to 200 mg/dL. |
| Calibration Frequency | Comparable to 30 days | 28 days |
| On-board Stability | Comparable to 30 days | 28 days |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size for the clinical test set used in method comparison or interference studies. It is described as testing human serum and plasma.
The data provenance (country of origin, retrospective/prospective) is not specified in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a chemical assay, not an assessment requiring expert interpretation of images or clinical findings. The "ground truth" for the test set would be established by the predicate device's accepted analytical results, or other reference methods for analytical performance studies.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human adjudication of clinical findings.
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 document describes an in vitro diagnostic reagent; there is no AI component or human reader study involved.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes an in vitro diagnostic reagent; there is no algorithm or AI component. The "standalone" performance here refers to the analytical performance of the reagent on the specified analyzer.
7. The Type of Ground Truth Used
For method comparison, the ground truth is established by comparing the results of the ELITech Clinical Systems CALCIUM ARSENAZO with analyses performed using the predicate device (Stanbio Calcium LiquiColor®) on the same samples. For precision, linearity, and interference studies, ground truth would be based on known concentrations or preparations in control materials and spiked samples. This is a form of analytical ground truth.
8. The Sample Size for the Training Set
Not applicable. There is no AI component, and thus no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set for an AI model. For the analytical studies, ground truth is established through standard laboratory practices for calibrators, controls, and comparative methods.
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(350 days)
The EasyRA albumin reagent is intended for the quantitative determination of Albumin (ALB) in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. For in vitro diagnostic use only.
The EasyRA total calcium reagent is intended for the quantitative measurement of Total Calcium (Ca) in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety if bone diseases, chronic renal disease and tetany. For in vitro diagnostic use only.
The EasyRA magnesium reagent is intended for the quantitative measurement of Magnesium (Mg) in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Magnesium measurements are used in the diagnosis and treatment of: Hypermagnesemia occuring during renal failure, acute diabetic acidosis, dehydration or in Addison's disease. Hypomagnesemia observed in cases of chronic alcoholism, malabsorption, acute pancreatitis and kidney disorders.
This reagent is intended for the quantitative measurement of Inorganic Phosphorous (PHOS) in human serum and plasma. Phosphorus measurements are used in the diagnosis and treatment of parathyroid gland, kidney diseases, and vitamin D imbalance.
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This document is a 510(k) clearance letter for in vitro diagnostic reagents, not a study describing the performance of an AI-powered medical device. As such, most of the requested information (acceptance criteria, study design, sample sizes, expert involvement, ground truth establishment, MRMC studies, standalone performance) is not applicable or cannot be extracted from this document.
The document discusses the regulatory clearance of "EasyRA Albumin Reagent, EasyRA Calcium Reagent, Easy RA Magnesium Reagent, Easy RA Inorganic Phosphorus Reagent" for use with the MEDICA "EasyRA Chemistry Analyzer" for quantitative determination of various substances in human serum and plasma.
Therefore, I cannot provide a table of acceptance criteria, device performance, study details, or information related to AI performance from this document.
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(326 days)
The EasyRA Albumin (ALB) reagent is intended for the quantitative determination of Albumin in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
The EasyRA Alkaline Phosphatase (ALP) reagent is intended for the quantitative determination of Alkaline Phosphatase in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurement of Alkaline Phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases.
The EasyRA Aspartate Aminotranferase (AST) reagent is intended for the quantitative determination of the enzyme Aspartate Aminotranferase in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurement of Aspartate Aminotranferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
The EasyRA Carbon Dioxide (CO2) reagent is intended for the quantitative measurement of Carbon Dioxide (CO2) in human serum, Bicarbonate/carbon dioxide measurements arc used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
The Carbon Dioxide calibrator establishes points of reference that are used in the determination of values in the measurement of Bicarbonate/Carbon dioxide on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's CO2 reagent.
The EasyRA CREA reagent is a device intended to measure creatinine levels in serum. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes.
The EasyRA CK reagent is a device intended to measure creatinine kinase activity in serum. Measurements of CK are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
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I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for various EasyRA reagents (Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Carbon Dioxide, Creatinine, Creatine Kinase) and a Carbon Dioxide Calibrator.
The document primarily states that the FDA has determined these devices are substantially equivalent to legally marketed predicate devices, allowing them to be marketed. It lists the indications for use for each reagent but does not detail any performance studies, acceptance criteria, or specific data from such studies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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