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510(k) Data Aggregation
(366 days)
SEPPIM S.A.S.
ELITech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determination of creatinine in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Creatinine measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.
The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains: MOPS buffer (pH 7.50), EHSPT (N-Ethyl-N-2(-Hydroxy-3-Sulfopropyl)- m -Toluidine), Creatinase (microoganism), Sarcosine oxidase (microoganism), Ascorbate oxidase (vegetal). Reagent R2 contains: MOPS buffer (pH 7.50), Amino-4-antipyrine (4-AAP), Creatininase (bacterial), Peroxidase (horseradish), and Sodium azide.
The provided text describes the ELITech Clinical Systems CREATININE PAP SL device, its calibrator (ELICAL 2), and controls (ELITROL I and ELITROL II). It details their intended use, composition, and performance characteristics, comparing them to predicate devices. The document essentially serves as a summary for a 510(k) premarket notification to the FDA, demonstrating substantial equivalence.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it presents performance data for the ELITech Clinical Systems CREATININE PAP SL and compares it directly to a predicate device (Roche Diagnostics Creatinine plus ver.2). The implication is that performance comparable to or better than the predicate device satisfies the acceptance criteria for substantial equivalence.
Here's a table summarizing the performance metrics and their comparison to the predicate device:
| Performance Characteristic | ELITech Clinical Systems CREATININE PAP SL (Reported Performance) | Predicate Device (Roche Diagnostics Creatinine plus ver.2) | Implied Acceptance Criteria (Demonstrates Substantial Equivalence) |
|---|---|---|---|
| Measuring Range | 0.28 - 22.30 mg/dL | 0.06 - 30.5 mg/dL | Range should cover clinically relevant levels and be comparable to predicate. (ELITech's range is narrower on both ends than the predicate). |
| Limit of Detection (LoD) | 0.006 mg/dL | Serum/plasma: 0.06 mg/dL | LoD should be sufficiently low for clinical utility and comparable to predicate. (ELITech's LoD is lower/better than the predicate for serum/plasma). |
| Limit of Quantification (LoQ) | 0.28 mg/dL | Not explicitly stated for LoQ, but LoD provides a lower bound. | LoQ should be clinically acceptable. (Compared to predicate's LoD, ELITech's LoQ is higher, but this is a different metric). |
| Precision (Within Run) | Level 0.59 mg/dL: CV=1.3% | ||
| Level 1.62 mg/dL: CV=0.8% | |||
| Level 6.93 mg/dL: CV=1.4% | Level 0.97 mg/dL: CV=2.29% | ||
| Level 3.95 mg/dL: CV=1.16% | |||
| Level 0.77 mg/dL: CV=2.86% | |||
| Level 12.7 mg/dL: CV=1.26% | Coefficient of Variation (CV) should indicate acceptable reproducibility and be comparable to predicate. (ELITech's within-run CVs generally appear better at comparable levels). | ||
| Precision (Total) | Level 0.59 mg/dL: CV=3.2% | ||
| Level 1.62 mg/dL: CV=1.6% | |||
| Level 6.93 mg/dL: CV=2.8% | Level 0.97 mg/dL: CV=2.35% | ||
| Level 3.95 mg/dL: CV=0.91% | |||
| Level 0.75 mg/dL: CV=1.87% | |||
| Level 13.2 mg/dL: CV=0.60% | CV should indicate acceptable reproducibility over time and be comparable to predicate. (ELITech's total CVs are mixed; some better, some worse than predicate at comparable levels). | ||
| Method Comparison (Regression) | y = 1.045x - 0.01 mg/dL | ||
| r = 0.999 | |||
| Range: 0.30 to 20.30 mg/dL | y = 1.006x - 0.013 mg/dL | ||
| r = 0.9998 | |||
| Range: 0.52 to 18.9 mg/dL | Regression analysis (slope, intercept, correlation coefficient) should demonstrate strong agreement with the predicate method. (Both devices show excellent correlation (r close to 1) and similar regression equations). | ||
| Interferences (Limitations) | Hemoglobin: No interference up to 500 mg/dL. | ||
| Triglycerides: No interference up to 3198 mg/dL. | |||
| Unconjugated bilirubin: No interference up to 30.0 mg/dL. | |||
| Conjugated bilirubin: No interference up to 14.8 mg/dL. | |||
| Uric acid: No interference up to 24 mg/dL. | |||
| Glucose: No interference up to 550 mg/dL. | |||
| Ascorbic acid: No interference up to 20 mg/dL. | |||
| Methyl-dopa, L-dopa, Calcium dobesilate: Falsely low results at therapeutic conc. | |||
| Creatine: Positive bias from 5 mg/dL. | Hemoglobin: No interference up to 800 mg/dL. | ||
| Lipemia (Intralipid): No influence up to L index of 1000. | |||
| Icterus: No influence up to I Index of 20 (20 mg/dL bilirubin). | |||
| Ascorbic acid: |
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(251 days)
ELITECHGROUP SEPPIM S.A.S.
ELITech Clinical Systems CHOLESTEROL HDL SL 2G is intended for use with ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR and ELITech Clinical Systems ELITROL I and ELITROL II on ELITech Clinical Systems Selectra analyzers for the quantitative in vitro diagnostic determination of High Density Lipoprotein (HDL) Cholesterol in human serum and plasma. It is not intended for use in Point of Care settings. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR is a calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems CHOLESTEROL HDL SL 2G on the ELITech Clinical Systems Selectra analyzers.
ELITech Clinical Systems CHOLESTEROL LDL SL 2G is intended for use with ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR and ELITech Clinical Systems ELITROL I and ELITROL II for the quantitative in vitro diagnostic determination of Low Density Lipoprotein (LDL) Cholesterol in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR is a calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems CHOLESTEROL LDL SL 2G 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 2 reagents, "R1" and "R2". Reagent R1 contains: Good's buffer, Cholesterol oxidase (CO bacterial), Peroxidase (horseradish), Ascorbate oxidase (bacterial), N,N-bis(4-sulphobutyl)-m-toluidine-disodium (DSBmT), Accelerator. Reagent R2 contains: Good's buffer, Cholesterol esterase (CHE bacterial), 4-Amino-Antipyrine (4-AA), detergent.
ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR is a lyophilized calibrator based on human serum containing lipoprotein from the various lipoprotein classes including high density lipoproteins and sodium azide as preservative. CHOLESTEROL HDL 2G CALIBRATOR 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.
The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains: MES buffer, Detergent 1, Cholesterol esterase (CHE bacterial), Cholesterol oxidase (CO bacterial), Peroxidase (horseradish), 4-Amino-Antipyrine (4-AA), Ascorbate oxidase (vegetal). Reagent R2 contains: MES buffer, Detergent 2, N,N-bis(4-sulphobutyl)-m-toluidine-disodium (DSBmT).
ELITech Clinical Systems CHOLESTEROL LDL 2GCALIBRATOR is a lyophilized calibrator based on human serum containing lipoprotein from the various lipoprotein classes including low density lipoproteins and sodium azide as preservative. CHOLESTEROL LDL 2G CALIBRATOR is prepared from plasma donor units tested individually by FDA - approved methods and found to be negative for HbsAg, anti-HCV antibody and anti-HIV1&2 antibodies.
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.
Here's a breakdown of the acceptance criteria and study information for the ELITech Clinical Systems CHOLESTEROL HDL SL 2G device, based on the provided text. Please note that the document is a 510(k) summary, which focuses on substantial equivalence to a predicate device rather than providing a detailed study protocol and raw data. Therefore, some information, especially regarding sample sizes for training sets or expert qualifications, may not be explicitly stated.
Device(s) being evaluated:
- ELITech Clinical Systems CHOLESTEROL HDL SL 2G (Reagent)
- ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR
- ELITech Clinical Systems ELITROL I and ELITROL II (Controls)
Predicate Devices:
- ABX PENTRA HDL Direct CP (K060854) for CHOLESTEROL HDL SL 2G
- Genzyme Ultra N-Geneous CHOLESTEROL HDL Calibrator for CHOLESTEROL HDL 2G CALIBRATOR
- Roche Diagnostics Precinorm U (K041227) and Roche Diagnostics Precipath U (K041227) for ELITROL I and ELITROL II
1. Table of Acceptance Criteria and Reported Device Performance
Device: ELITech Clinical Systems CHOLESTEROL HDL SL 2G (Reagent)
| Acceptance Criteria Category | Acceptance Criteria (from predicate/comparison) | Reported Device Performance (ELITech Clinical Systems CHOLESTEROL HDL SL 2G) |
|---|---|---|
| Measuring Range | 5.4 to 151.9 mg/dL (Predicate) | 5 to 105 mg/dL |
| Limit of Detection (LoD) | 1.16 mg/dL (Predicate) | 0.7 mg/dL |
| Limit of Quantification (LoQ) | Not explicitly stated for predicate in direct comparison, but likely inferred from measuring range. | 5.0 mg/dL |
| Precision (Within Run) | Level 35.82 mg/dL CV=1.29% | |
| Level 81.72 mg/dL CV=0.79% | ||
| Level 27.94 mg/dL CV=1.32% | ||
| Level 48.59 mg/dL CV=1.91% | ||
| Level 97.39 mg/dL CV=0.62% (Predicate) | Level 31 mg/dL CV=1.4% | |
| Level 56 mg/dL CV=0.7% | ||
| Level 87 mg/dL CV=1.4% | ||
| Precision (Total) | Level 35.85 mg/dL CV=2.88% | |
| Level 80.35 mg/dL CV=3.06% | ||
| Level 47.07 mg/dL CV=3.52% | ||
| Level 80.16 mg/dL CV=2.69% (Predicate) | Level 31 mg/dL CV=3.0% | |
| Level 56 mg/dL CV=2.8% | ||
| Level 87 mg/dL CV=3.3% | ||
| Method Comparison | y=0.91x + 1.98 mg/dL, r^2 = 0.9768 (Predicate) | y=1.09x - 2.5 mg/dL, r^2 = 0.972 |
| Interference | Hemoglobin: No significant influence up to 479 mg/dL. | |
| Triglycerides: No significant influence up to 612.5 mg/dL. | ||
| Total bilirubin: No significant influence up to 11.7 mg/dL. | ||
| Direct bilirubin: No significant influence up to 28.1 mg/dL. (Predicate) | Unconjugated bilirubin (up to 30 mg/dL), Conjugated bilirubin (up to 29.5 mg/dL), Hemoglobin (up to 500 mg/dL): No significant interference. | |
| Turbidity: Negative bias from 439 mg/dL triglycerides equivalent. | ||
| On-board Stability | 31 days (Predicate) | 28 days |
Device: ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR
| Acceptance Criteria Category | Acceptance Criteria (from predicate/comparison) | Reported Device Performance (ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR) |
|---|---|---|
| Stability (Lyophilized) | Up to expiry date at 2-8 °C, protected from light (Predicate) | Up to expiry date at 2-8 °C, protected from light |
| Stability (Reconstituted) | 14 days between 2 - 8 °C. | |
| 4 weeks between -70 °C (when frozen once) (Predicate) | 14 days between 2 - 8 °C. | |
| 4 weeks at less than - 80 °C (when frozen once) |
Device: ELITech Clinical Systems ELITROL I and ELITROL II (Controls)
| Acceptance Criteria Category | Acceptance Criteria (from predicate/comparison) | Reported Device Performance (ELITech Clinical Systems ELITROL I / ELITROL II) |
|---|---|---|
| Stability (Lyophilized) | Stable at 2-8°C up to expiration date (Predicate) | Stable at 2-8°C up to expiry date, protected from light |
| Stability (Reconstituted) | 12 hours at 15-25 °C. | |
| 5 days at 2-8 °C. | ||
| 4 weeks at (-25)-(-15) °C (when frozen once) (Predicate) | 12 hours between 15-25 °C. | |
| 5 days between 2-8 °C. | ||
| 4 weeks between -25 and -15 °C (when frozen once) |
2. Sample Size Used for the Test Set and Data Provenance
Given the nature of a 510(k) summary for an in vitro diagnostic (IVD) device, specific sample sizes for particular experiments (like method comparison, precision, or interference studies) are often summarized rather than detailed with exact numbers of individual patient samples.
- Test Set Sample Size: The document does not explicitly state the total number of samples used across all validation studies. However, for the method comparison for CHOLESTEROL HDL SL 2G, a range of "5 to 105 mg/dL" is mentioned for the ELITech device, implying that samples covering this range were used. Similar ranges are noted for the predicate.
- Data Provenance: Not explicitly stated. For IVDs, data typically comes from clinical laboratories. Without further information, it's difficult to determine the country of origin or if the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided for this type of device (in vitro diagnostic reagent, calibrator, and controls). The "ground truth" for these devices is established by reference methods or comparison to a legally marketed predicate device, not by expert human interpretation like in imaging or pathology. The performance is assessed by quantitative analytical metrics (e.g., precision, linearity, method correlation).
4. Adjudication Method for the Test Set
This is not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are typically used when there's subjective human interpretation involved (e.g., in diagnostic imaging or pathology assessments by multiple readers) to resolve disagreements and establish a consensual ground truth. This is not how the performance of an IVD reagent is evaluated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for devices that involve human readers (e.g., radiologists, pathologists) interpreting images or data, and are designed to assess the impact of AI assistance on human diagnostic performance. This submission is for an IVD diagnostic reagent, calibrator, and controls, which are intended for automated analytical measurement and do not involve human interpretation in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The documented studies are essentially "standalone" in the context of the device's function: they assess the analytical performance of the reagent system (algorithm being the chemical reactions and measurement process) without human interpretive input affecting the core measurement. The performance data presented (precision, linearity, method comparison, interference) are all measures of the device's inherent analytical capability.
7. The Type of Ground Truth Used
The "ground truth" for an IVD reagent and its associated calibrators/controls is established by:
- Comparison to a Legally Marketed Predicate Device: The primary method for proving substantial equivalence in a 510(k) submission. Performance characteristics of the new device are compared directly against those of the predicate device (ABX PENTRA HDL Direct CP, Genzyme Ultra N-Geneous CHOLESTEROL HDL Calibrator, Roche Diagnostics Precinorm U / Precipath U).
- Established Analytical Methods: For parameters like linearity, precision, and limit of detection, the "ground truth" is based on recognized statistical and analytical chemistry principles and established reference measurement procedures, where applicable, to demonstrate the device's inherent analytical accuracy and reliability.
- Reference Materials: For calibrators, the assigned values are based on established reference methods and reference materials.
8. The Sample Size for the Training Set
Not applicable/Not provided. This submission is for an IVD reagent and associated components, not an AI/ML model that typically requires a discrete training set. The "development" or "training" of such a chemical reagent involves formulation, optimization, and characterization through various analytical experiments rather than data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As mentioned above, there isn't a "training set" in the context of an AI/ML model for this type of IVD device. The development process relies on chemical principles, enzymatic reactions, and analytical validation against international standards or established methods.
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(223 days)
SEPPIM S.A.S.
ELITech Clinical Systems TRIGLYCERIDES SL is intended for the quantitative in vitro diagnostic determination of triglycerides in human serum and plasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Triglycerides 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.
ELITech Clinical Systems CHOLESTEROL SL is intended for the quantitative in vitro diagnostic determination of cholesterol in human serum and plasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
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 the ELITech Vital Scientific Selectra/Flexor Analyzers.
ELITech Clinical Systems ELITROL I & ELITROL II are multiparametric control sera for use in quality control of ELITech Clinical Systems methods on ELITech Vital Scientific Selectra/Flexor Analyzers.
The device for this submission is available as kit only. It consists of 1 reagent, "R". Reagent R contains: Pipes buffer, p-chlorophenol, ATP, Amino-4-antipyrine (4-AAP), Lipoprotein lipase (bacterial), Glycerol kinase (bacterial), Glycerol-3-phosphate oxidase (microorganisms), Peroxidase (horseradish), Potassium ferrocyanide, Magnesium (Mg2+) and Sodium azide.
The device for this submission is available as kit only. It consists of 1 reagent, "R". Reagent R contains: Pipes buffer, 4-Aminoantipyrine (4-AAP), Cholesterol esterase (CHE bacterial), Cholesterol oxidase (CHO microorganisms), Peroxidase (POD horseradish), Sodium cholate, Phenol and Sodium azide.
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.
Here's a summary of the acceptance criteria and the studies for the ELITech Clinical Systems TRIGLYCERIDES SL reagent, ELITech Clinical Systems CHOLESTEROL SL reagent, ELICAL 2 calibrator, and ELITROL I/ELITROL II controls, based on the provided documents.
ELITech Clinical Systems TRIGLYCERIDES SL Reagent
1. Table of Acceptance Criteria and Reported Device Performance
For TRIGLYCERIDES SL, the acceptance criteria are not explicitly stated as distinct numerical targets; instead, the performance is demonstrated through comparison with a predicate device. The implied acceptance is that the device performs comparably to the predicate or within clinically acceptable ranges for the specified parameters.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ELITech Clinical Systems TRIGLYCERIDES SL) |
|---|---|---|
| Measuring Range (Linearity) | Comparable to predicate (3.1 to 1470 mg/dL) | 30 to 1000 mg/dL |
| Precision (Within-run CV) | Comparable to predicate (e.g., CV=0.82% to 2.83%) | Level 48 mg/dL: CV=1.5% |
| Level 142 mg/dL: CV=1.0% | ||
| Level 273 mg/dL: CV=0.7% | ||
| Precision (Total CV) | Comparable to predicate (e.g., CV=1.37% to 2.96%) | Level 48 mg/dL: CV=3.9% |
| Level 142 mg/dL: CV=2.7% | ||
| Level 273 mg/dL: CV=4.5% | ||
| Method Comparison (Correlation with Predicate) | High correlation (r²=0.9994) with predicate | y=1.040x + 0.339 mg/dL |
| r²= 0.998 | ||
| Range: 22 to 936 mg/dL | ||
| Interference (Unconjugated Bilirubin) | No significant influence up to 22.5 mg/dL (Total) | No significant interference up to 15 mg/dL |
| Interference (Conjugated Bilirubin) | No significant influence up to 22.5 mg/dL (Direct) | No significant interference up to 5.9 mg/dL |
| Interference (Hemoglobin) | No significant influence up to 500 mg/dL | No significant interference up to 250 mg/dL |
| Interference (Uric Acid) | Not explicitly stated for predicate in this table | No significant interference up to 23.6 mg/dL |
| Interference (Ascorbic Acid) | Not explicitly stated for predicate in this table | No significant interference up to 2.0 mg/dL (Concentrations above therapeutic levels interfere) |
| Interference (Methyl-dopa) | Not explicitly stated for predicate in this table | No significant interference up to 1.0 mg/dL |
| Calibration Frequency | 14 days | 14 days |
| On-board Stability | 48 days (refrigerated) | 28 days (refrigerated) |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample size used for the test set for precision and method comparison studies.
- Data Provenance: Not specified in the provided text. It is a submission by SEPPIM S.A.S. from FRANCE, suggesting data could be of French origin or from other regions. Studies are generally retrospective as they are performance evaluations of an existing reagent formulation.
3. Number of Experts and Qualifications
This information is not applicable. The studies are laboratory-based analytical performance evaluations of a diagnostic reagent, not interpretations by medical experts.
4. Adjudication Method
This information is not applicable for this type of analytical performance study.
5. MRMC Comparative Effectiveness Study
- This information is not applicable. This is an analytical performance study of a diagnostic reagent, not a study evaluating human reader performance with or without AI assistance.
6. Standalone Performance Study
- Yes, the performance data presented (measuring range, precision, method comparison, limitations) are for the standalone performance of the ELITech Clinical Systems TRIGLYCERIDES SL reagent on the ELITech Vital Scientific Selectra/Flexor analyzers.
7. Type of Ground Truth Used
- For precision and linearity, the "ground truth" refers to laboratory controls and reference materials with known concentrations, or samples run repeatedly to establish variability.
- For method comparison, the "ground truth" is established by comparing the device's results to those obtained using the legally marketed predicate device (ABX PENTRA TRIGLYCERIDES CP). The predicate device's results serve as the reference for comparison.
8. Sample Size for Training Set
- This information is not applicable. This is a chemical reagent, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set was Established
- This information is not applicable.
ELITech Clinical Systems CHOLESTEROL SL Reagent
1. Table of Acceptance Criteria and Reported Device Performance
For CHOLESTEROL SL, similar to TRIGLYCERIDES SL, acceptance is implied by comparison to the predicate device and being within clinically acceptable ranges.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ELITech Clinical Systems CHOLESTEROL SL) |
|---|---|---|
| Measuring Range (Linearity) | Comparable to predicate (2.55 to 580 mg/dL) | 20 to 600 mg/dL |
| Precision (Within-run CV) | Comparable to predicate (e.g., CV=0.53% to 1.21%) | Level 116 mg/dL: CV=2.4% |
| Level 190 mg/dL: CV=1.9% | ||
| Level 298 mg/dL: CV=1.7% | ||
| Precision (Total CV) | Comparable to predicate (e.g., CV=2.34% to 3.01%) | Level 116 mg/dL: CV=2.6% |
| Level 190 mg/dL: CV=2.7% | ||
| Level 298 mg/dL: CV=2.7% | ||
| Method Comparison (Correlation with Predicate) | High correlation (r²=0.9943) with predicate | y=1.006 x - 1.734 mg/dL |
| r²= 0.999 | ||
| Range: 20 to 579 mg/dL | ||
| Interference (Unconjugated Bilirubin) | Not explicitly stated for predicate in this table | No significant interference up to 6.0 mg/dL |
| Interference (Conjugated Bilirubin) | No significant influence up to 6.8 mg/dL (Direct) | No significant interference up to 5.9 mg/dL |
| Interference (Hemoglobin) | No significant influence up to 336 mg/dL | No significant interference up to 250 mg/dL |
| Interference (Turbidity) | No significant influence up to 612.5 mg/dL triglycerides | No significant interference up to 614 mg/dL triglyceride equivalent |
| Interference (Ascorbic Acid) | Not explicitly stated for predicate in this table | No significant interference up to 2.0 mg/dL (Concentrations above therapeutic levels interfere) |
| Interference (Methyl-dopa) | Not explicitly stated for predicate in this table | No significant interference up to 0.8 mg/dL (Concentrations above therapeutic levels interfere) |
| Interference (Uric Acid) | Not explicitly stated for predicate in this table | No significant interference up to 23.4 mg/dL |
| Calibration Frequency | 8 days | 28 days |
| On-board Stability | 48 days (refrigerated) | 28 days (refrigerated) |
| CRMLN Certification | Certified | Certified |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample size used for the test set for precision and method comparison studies.
- Data Provenance: Not specified in the provided text. It is a submission by SEPPIM S.A.S. from FRANCE, suggesting data could be of French origin or from other regions. Studies are generally retrospective as they are performance evaluations of an existing reagent formulation.
3. Number of Experts and Qualifications
This information is not applicable. The studies are laboratory-based analytical performance evaluations of a diagnostic reagent, not interpretations by medical experts.
4. Adjudication Method
This information is not applicable for this type of analytical performance study.
5. MRMC Comparative Effectiveness Study
- This information is not applicable. This is an analytical performance study of a diagnostic reagent, not a study evaluating human reader performance with or without AI assistance.
6. Standalone Performance Study
- Yes, the performance data presented (measuring range, precision, method comparison, limitations) are for the standalone performance of the ELITech Clinical Systems CHOLESTEROL SL reagent on the ELITech Vital Scientific Selectra/Flexor analyzers.
7. Type of Ground Truth Used
- For precision and linearity, the "ground truth" refers to laboratory controls and reference materials with known concentrations, or samples run repeatedly to establish variability.
- For method comparison, the "ground truth" is established by comparing the device's results to those obtained using the legally marketed predicate device (ABX PENTRA CHOLESTEROL CP). The predicate device's results serve as the reference for comparison.
8. Sample Size for Training Set
- This information is not applicable. This is a chemical reagent, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set was Established
- This information is not applicable.
ELITech Clinical Systems ELICAL 2 Calibrator
1. Table of Acceptance Criteria and Reported Device Performance
For ELICAL 2, the primary acceptance criteria revolve around format, stability, and handling being comparable to the predicate, and traceability being established.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ELITech Clinical Systems ELICAL 2) |
|---|---|---|
| Format | Lyophilized human serum based | Lyophilized human serum based |
| Level | Single level | Single level |
| Handling (Reconstitution) | Exactly 3 mL water, gentle swirling, dissolve within 30 min | Exactly 3 mL water, gentle swirling, dissolve within 30 min |
| Lyophilized Stability | Stable at 2-8°C until expiration date | Stable at 2-8°C until expiry date |
| Reconstituted Stability (15-25°C) | 8 hours | 8 hours |
| Reconstituted Stability (2-8°C) | 2 days | 2 days |
| Reconstituted Stability (-25 to -15°C, frozen once) | 4 weeks | 4 weeks |
| Traceability | Traceability given in value sheets/instructions | Traceability given in value sheet |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not specified for stability studies.
- Data Provenance: Not specified. From SEPPIM S.A.S. (FRANCE). Studies are for characterization of the calibrator's properties.
3. Number of Experts and Qualifications
Not applicable.
4. Adjudication Method
Not applicable.
5. MRMC Comparative Effectiveness Study
- Not applicable.
6. Standalone Performance Study
- Yes, the stability and handling characteristics are for the standalone performance of the ELICAL 2 calibrator.
7. Type of Ground Truth Used
- For stability, the "ground truth" involves testing the calibrator's analyte concentrations over time under specified storage conditions and comparing them against initial established values or specified ranges. For traceability, it refers to documentation linking the analyte values to international reference methods or materials.
8. Sample Size for Training Set
- Not applicable.
9. How Ground Truth for Training Set was Established
- Not applicable.
ELITech Clinical Systems ELITROL I and ELITROL II Controls
1. Table of Acceptance Criteria and Reported Device Performance
For ELITROL I and ELITROL II, the acceptance criteria focus on comparable format, levels, handling, and stability to the predicate.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ELITech Clinical Systems ELITROL I / ELITROL II) |
|---|---|---|
| Format | Lyophilized human sera based | Lyophilized human sera based |
| Levels | Two levels | Two levels |
| Handling (Reconstitution) | Exactly 5 mL water, gentle swirling, dissolve within 30 min | Exactly 5 mL water, gentle swirling, dissolve within 30 min |
| Lyophilized Stability | Stable at 2-8°C until expiration date | Stable at 2-8°C until expiry date |
| Reconstituted Stability (15-25°C) | 12 hours | 12 hours |
| Reconstituted Stability (2-8°C) | 5 days | 5 days |
| Reconstituted Stability (-25 to -15°C, frozen once) | 4 weeks | 4 weeks |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not specified for stability studies.
- Data Provenance: Not specified. From SEPPIM S.A.S. (FRANCE). Studies are for characterization of the control materials' properties.
3. Number of Experts and Qualifications
Not applicable.
4. Adjudication Method
Not applicable.
5. MRMC Comparative Effectiveness Study
- Not applicable.
6. Standalone Performance Study
- Yes, the stability and handling characteristics are for the standalone performance of the ELITROL I and ELITROL II controls.
7. Type of Ground Truth Used
- For stability, the "ground truth" involves testing the control's analyte concentrations over time under specified storage conditions and comparing them against initial established values or specified ranges. The control materials are "assayed," meaning their analyte concentrations are determined using reference methods or established analytical procedures.
8. Sample Size for Training Set
- Not applicable.
9. How Ground Truth for Training Set was Established
- Not applicable.
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(448 days)
SEPPIM S.A.S.
ELITech Clinical Systems HbA1c is intended for use in the quantitative in vitro diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood on Vital Scientific SelectralFlexor analyzers.It is not intended for use in Point of Care settings.
HbA1c measurements are used for the monitoring of long term blood glucose control in diabetic patients.
ELITech Clinical Systems HbA1c CALIBRATOR SET is a calibrator with 4 different levels of values for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems HbA1c on Vital Scientific Selectra/Flexor analyzers as specified in the instructions for use.
ELITech Clinical Systems HbA1c Control L+H is a quality control with.2 levels of values (Low and High values) for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems HbA1c on Vital Scientific SelectralFlexor analyzers as specified in the instructions for use.
The device for this submission is available as a kit only. It consists of 3 reagents. Reagent R1 contains suspended latex particles in a buffer with stabilizers and sodium azide. Reagent R2a and Reagent R2b are mixed to prepare a working reagent, Reagent 2. This mixture contains Mouse anti-human HbA1c monoclonal antibody and Goat anti-mouse IgG polyclonal antibody in a buffer containing stabilizers and sodium azide. Reagent R3, a hemolysis reagent, is an aqueous solution containing sodium azide.
The device for this submission is available as kit only. It consists of 4 different levels of calibrator at 0.5 mL volume. Each level consists of lyophilized hemolysates prepared from human erythrocytes. HbA1c CALIBRATOR SET is prepared exclusively from the blood of donors teste individually and found to be negative for HbsAg and to antibodies to HCV and HI according to FDA-approved methods.
ELITech Clinical Systems HbA1c Control L + H is a two level quality control products consisting of lyophilized hemolysates prepared from human erythrocytes containing constituents at desired levels. HbA1c CONTROL L+ H 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.
The provided document is a 510(k) summary for the ELITech Clinical Systems HbA1c reagent, calibrator set, and control set. It details the substantial equivalence of these devices to a predicate device, focusing on their intended use, assay principle, composition, and performance characteristics. However, it does not include detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt (e.g., sample sizes for training/test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance).
The document is a regulatory submission for in vitro diagnostic (IVD) assays, not an AI/ML-based medical device. Therefore, many of the requested categories (e.g., test set sample size, data provenance, expert-established ground truth, adjudication method, MRMC studies, standalone performance, training set sample size, how training ground truth was established) are not applicable or typically reported in this type of submission. Performance for IVD devices is usually evaluated through analytical studies (precision, accuracy/method comparison, linearity, interference) rather than clinical studies with expert-adjudicated ground truth as seen in AI/ML device submissions.
Here's an attempt to answer based on the provided text, highlighting where information is not available or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative table for accuracy. Instead, it compares the proposed device's performance to the predicate device's performance and clinical utility. The "Conclusion" sections uniformly state that the device "met all acceptance criteria" without detailing what those criteria were. However, we can infer some performance metrics:
| Performance Metric | Acceptance Criteria (Not explicitly stated, but implied by comparison/predicate) | Reported Device Performance (ELITech Clinical Systems HbA1c) |
|---|---|---|
| Measuring Range | Comparable to predicate (2 to 16 %) | 2.5 to 16 % |
| Limit of Blank (LoB) | Established and comparable to predicate | 0.6 % |
| Limit of Detection (LoD) | Established and comparable to predicate | 0.7 % |
| Within-Run Precision (CV) | Expected to be low and comparable to predicate for various HbA1c levels | Level 4.4 %: CV= 1.1 % |
| Level 6.7 %: CV= 0.9 % | ||
| Level 9.5 %: CV= 1.0 % | ||
| Total Precision (CV) | Expected to be low and comparable to predicate for various HbA1c levels | Level 4.4 %: CV= 2.3 % |
| Level 6.7 %: CV= 1.9 % | ||
| Level 9.5 %: CV= 2.9 % | ||
| Method Comparison (Correlation to Predicate) | Strong correlation (high 'r' value) and good agreement (slope close to 1, intercept close to 0) to predicate. | y = 0.926x + 0.1 % |
| r = 0.984 | ||
| Interference | No significant interference from common interfering substances (bilirubin, triglycerides, Hb variants, etc.) | No significant interference reported for: Unconjugated bilirubin (up to 30 mg/dL), Conjugated bilirubin (up to 29.5 mg/dL), Triglycerides (up to 2000 mg/dL), Acetylsalicylic acid (up to 200 mg/dL), Rheumatoid factor (up to 1000 IU/mL), Ascorbic acid (up to 20 mg/dL), HbC, HbS, HbD, HbE, HbA2. High HbF leads to underestimation. No significant interference from carbamylated or acetylated hemoglobin, or labile HbA1c. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not explicitly state the sample size used for the method comparison (accuracy) study. It provides the regression equation and correlation coefficient (r = 0.984) derived from this study, but not the 'n' value.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). This type of detail is not typically included in a 510(k) summary for an IVD reagent. The study would have been an analytical validation study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For an IVD assay like HbA1c, "ground truth" for individual samples is typically established by comparative methods (e.g., a reference method like HPLC or a legally marketed predicate device) rather than expert adjudication. The study is a method comparison study against the predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As this is an IVD assay comparison, not an AI/ML image-based diagnosis, expert adjudication methods are not used.
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/ML device, and no MRMC study or evaluation of human reader improvement is relevant or discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a quantitative diagnostic reagent kit for an automated analyzer. Its performance is inherently "standalone" in the sense that the instrument processes the sample and the reagent measures the HbA1c level without direct human interpretive intervention beyond running the assay and interpreting the numerical result. There is no "algorithm" in the AI/ML sense to be evaluated in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the method comparison study, the "ground truth" (or reference) for evaluation appears to be the predicate device (Pointe Scientific Hemoglobin A1c Reagent Set). The study compares the ELITech device's results (Y) against the predicate device's results (X) using regression analysis ($y=0.926x + 0.1 %$).
8. The sample size for the training set
- Not Applicable. This is an IVD diagnostic reagent, not an AI/ML algorithm that undergoes "training." The device's performance is characterized through analytical validation studies.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or establishment of ground truth for training in the context of this type of device.
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(463 days)
SEPPIM S.A.S.
ELITech Clinical Systems PHOSPHORUS reagent is for the quantitative in vitro diagnostic determination of inorganic phosphorus in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
ELITech Clinical Systems URIC ACID MONO SL reagent is for the quantitative in vitro diagnostic determination of uric acid in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
ELITech Clinical Systems UREA UV SL reagent is for the quantitative in vitro diagnostic determination of urea nitrogen in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
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 the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL I is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. ELITech Clinical Systems ELITROL II is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.
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.
The device for this submission is available as kit only. It consists of 2 reagents: Reagent 1 contains Tris buffer (pH 7.60), Adenosine diphosphate potassium salt (ADP), alpha-Ketoglutarate, Urease (jack bean), Glutamate dehydrogenase (GIDH) (bovine liver) and sodium azide. Reagent 2 contains NADH and sodium azide
The device for this submission is available as kit only. It consists of 1 reagent R. Reagent R consists of sulfuric acid and ammonium molybdate.
The device for this submission is available as kit only. It consists of 1 reagent R. Reagent R consists of Phosphate buffer (pH 7.0), N-Ethyl-N-(2-Hydroxy-3-Sulfopropyl) m-Toluidine (EHSPT), Ferrocyanide, Amino-4-antipyrine (4-AAP), Uricase (microorganisms), Peroxidase (horseradich) and sodium azide.
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 (IVD) devices: ELITech Clinical Systems ELICAL 2 (calibrator), ELITech Clinical Systems UREA UV SL (reagent), ELITech Clinical Systems PHOSPHORUS (reagent), ELITech Clinical Systems URIC ACID MONO SL (reagent), and ELITech Clinical Systems ELITROL I and ELITROL II (controls).
The studies performed for these devices are primarily method comparison and precision studies, focusing on demonstrating substantial equivalence to predicate devices rather than proving a specific clinical utility through a multi-reader multi-case study or a standalone algorithm performance study.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate devices. The performance metrics presented are directly compared.
For ELITech Clinical Systems UREA UV SL (K100263):
| Performance Metric | Acceptance Criteria (Predicate: ABX PENTRA UREA CP) | Reported Device Performance (ELITech Clinical Systems UREA UV SL) |
|---|---|---|
| Measuring Range | 1.03 to 140.3 mg/dL (Automatic post-dilution: 701.5 mg/dL) | 4.7 to 140.0 mg/dL (Extended measuring range: 140.0 to 670.0 mg/dL) |
| Limit of Detection (LoD) | Not explicitly stated | 0.3 mg/dL |
| Limit of Quantification (LoQ) | 0.9 mg/dL | 2.3 mg/dL |
| Precision | ||
| Within Run (Level 7.3 mg/dL) | 2.27% (for 18.7 mg/dL) | CV=2.1% |
| Within Run (Level 29.2 mg/dL) | 1.66% (for 72.8 mg/dL) | CV=0.8% |
| Within Run (Level 72.4 mg/dL) | 2.76% (for 6.0 mg/dL) etc. | CV=0.7% |
| Total (Level 7.3 mg/dL) | 2.14% (for 18.5 mg/dL) | CV=2.8% |
| Total (Level 29.2 mg/dL) | 1.93% (for 71.7 mg/dL) | CV=1.3% |
| Total (Level 72.4 mg/dL) | 2.14% (for 19.2 mg/dL) etc. | CV=1.6% |
| Method Comparison | y=0.99 x - 0.06 mg/dL, r²=0.996, range: 1.03 to 138.89 mg/dL | y=0.991 x + 0.6 mg/dL, r=0.999, range: 4.4 to 139.8 mg/dL |
| Interference (Hemoglobin) | No significant influence up to 460 mg/dL | No significant interference up to 500 mg/dL |
| Interference (Triglycerides) | No significant influence up to 612.5 mg/dL | No significant interference up to 614 mg/dL triglyceride equivalent |
| Interference (Total Bilirubin) | No significant influence up to 22.23 mg/dL | No significant interference up to 30 mg/dL (unconjugated) / 29.5 mg/dL (conjugated) |
| Calibration Frequency | 8 days | 7 days |
| On-board Stability | 70 days | 14 days |
For ELITech Clinical Systems PHOSPHORUS (K100263):
| Performance Metric | Acceptance Criteria (Predicate: ABX PENTRA PHOSPHORUS CP) | Reported Device Performance (ELITech Clinical Systems PHOSPHORUS) |
|---|---|---|
| Measuring Range | 0.30 to 24.18 mg/dL (Automatic post-dilution: 96.72 mg/dL) | 2.0 to 20.0 mg/dL |
| Limit of Detection (LoD) | 0.28 mg/dL | 0.02 mg/dL |
| Limit of Quantification (LoQ) | Not explicitly stated | 1.00 mg/dL |
| Precision | ||
| Within Run (Level 2.37 mg/dL) | 1.25% (for 4.08 mg/dL) | CV=1.1% |
| Within Run (Level 4.80 mg/dL) | 0.77% (for 6.34 mg/dL) | CV=1.5% |
| Within Run (Level 9.55 mg/dL) | 2.48% (for 2.39 mg/dL) etc. | CV=1.7% |
| Total (Level 2.37 mg/dL) | 2.50% (for 4.01 mg/dL) | CV=1.9% |
| Total (Level 4.80 mg/dL) | 1.82% (for 6.35 mg/dL) | CV=1.7% |
| Total (Level 9.55 mg/dL) | 3.56% (for 2.50 mg/dL) etc. | CV=2.2% |
| Method Comparison | y=1.04x + 0.15 mg/dL, r²=0.998, range: 0.30 to 24.08 mg/dL | y=0.999 - 0.09 mg/dL, r=0.999, range: 2.02 to 20.08 mg/dL |
| Interference (Hemoglobin) | No significant influence up to 125 mg/dL | No significant interference up to 50 mg/dL |
| Interference (Triglycerides) | No significant influence up to 262.5 mg/dL | No significant interference up to 732 mg/dL |
| Interference (Total Bilirubin) | No significant influence up to 6 mg/dL | No significant interference up to 15 mg/dL (unconjugated) / 1.5 mg/dL (conjugated) |
| Calibration Frequency | 34 days | 28 days |
| On-board Stability | 70 days | 28 days |
For ELITech Clinical Systems URIC ACID MONO SL (K100263):
| Performance Metric | Acceptance Criteria (Predicate: ABX PENTRA URIC ACID CP) | Reported Device Performance (ELITech Clinical Systems URIC ACID MONO SL) |
|---|---|---|
| Measuring Range | 0.18 to 25.00 mg/dL (Automatic post-dilution: 75.00 mg/dL) | 1.5 to 25.0 mg/dL (Extended measuring range: 25 to 78 mg/dL) |
| Limit of Detection (LoD) | 0.19 mg/dL | 0.02 mg/dL |
| Limit of Quantification (LoQ) | Not explicitly stated | 0.50 mg/dL |
| Precision | ||
| Within Run (Level 2.49 mg/dL) | 0.45% (for 4.62 mg/dL) | CV=0.8% |
| Within Run (Level 5.19 mg/dL) | 0.34% (for 11.63 mg/dL) | CV=1.3% |
| Within Run (Level 7.63 mg/dL) | 1.24% (for 2.53 mg/dL) etc. | CV=1.1% |
| Total (Level 2.49 mg/dL) | 2.81% (for 4.64 mg/dL) | CV=2.6% |
| Total (Level 5.19 mg/dL) | 1.39% (for 11.73 mg/dL) | CV=2.0% |
| Total (Level 7.63 mg/dL) | 2.64% (for 4.67 mg/dL) etc. | CV=2.1% |
| Method Comparison | y=0.95 x + 0.09 mg/dL, r²=0.996, range: 0.18 to 23.59 mg/dL | y=1.015 x + 0.03 mg/dL, r=0.999, range: 1.49 to 24.40 mg/dL |
| Interference (Hemoglobin) | No significant influence up to 500 mg/dL | No significant interference up to 50 mg/dL |
| Interference (Triglycerides) | No significant influence up to 612.5 mg/dL | No significant interference up to 1070 mg/dL |
| Interference (Total Bilirubin) | No significant influence up to 36 mg/dL | No significant interference up to 30 mg/dL (unconjugated) / 14.8 mg/dL (conjugated) |
| Calibration Frequency | 15 days | 28 days |
| On-board Stability | 41 days | 28 days |
2. Sample size used for the test set and the data provenance
- UREA UV SL: The method comparison study gives a range of 4.4 to 139.8 mg/dL for the device. The R-value of 0.999 implies a good correlation across the study range. While a specific number of samples isn't explicitly stated, the R-value is usually calculated from a sufficiently large set of patient samples spanning the analytical range. The data provenance is not stated (e.g., country of origin, retrospective/prospective), but it is implied to be clinical samples used for method comparison.
- PHOSPHORUS: The method comparison study gives a range of 2.02 to 20.08 mg/dL for the device. The R-value of 0.999 implies a good correlation. Similar to UREA UV SL, the number of samples is not explicitly stated, and data provenance is not provided but implied to be clinical samples.
- URIC ACID MONO SL: The method comparison study gives a range of 1.49 to 24.40 mg/dL for the device. The R-value of 0.999 implies a good correlation. The number of samples is not explicitly stated, and data provenance is not provided but implied to be clinical samples.
For ELICAL 2, ELITROL I, ELITROL II: These are calibrators and controls; their performance is validated through stability studies and their intended use in calibrating and controlling assays. No "test set" in the sense of patient samples for diagnostic performance is applicable here. The device description for ELICAL 2, ELITROL I, and ELITROL II mentions they 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." This suggests human-derived materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are in vitro diagnostic devices for quantitative measurements, not imaging or subjective diagnostic interpretations requiring expert consensus for ground truth. "Ground truth" in this context refers to the measured values obtained by the predicate device or a reference method for the method comparison studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication.
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, not an AI-assisted diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is an IVD reagent and calibrator kit, not an algorithm. The performance data presented (e.g., precision, method comparison, LoD, LoQ) represents the "standalone" analytical performance of the device on the specified analyzer (Selectra Junior/Flexor Junior).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the method comparison studies is the quantitative result obtained from the predicate device (ABX PENTRA UREA CP, ABX PENTRA PHOSPHORUS CP, ABX PENTRA URIC ACID CP) or a reference method assumed to be the "truth" for those studies. For precision studies, there isn't an external "ground truth" but rather a measure of the device's own reproducibility.
8. The sample size for the training set
Not applicable. These are traditional IVD reagents and calibrators, not machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, no training set for a machine learning algorithm is involved.
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(294 days)
SEPPIM S.A.S.
ELITech Clinical Systems GLUCOSE PAP SL is intended for use with ELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and ELITROL II for the quantitative in vitro diagnostic determination of glucose in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. 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.
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 the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL I is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL II is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.
ELITech Clinical Systems GLUCOSE PAP SL is available as kit only. It consists of 1 reagent, "R." Reagent R consists of Phosphate buffer (pH 7.4), Phenol, 4-Aminoantipyrine (4-AAP), Glucose oxidase (Aspergillus sp.), Peroxidase (horseradish) and sodium azide.
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 three medical devices seeking 510(k) clearance: ELITech Clinical Systems GLUCOSE PAP SL reagent, ELITech Clinical Systems ELICAL 2 calibrator, and ELITech Clinical Systems ELITROL I and ELITROL II controls. The submissions focus on demonstrating substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study data presented for each device, structured according to your requested information:
1. ELITech Clinical Systems GLUCOSE PAP SL reagent
This device is a glucose reagent used for quantitative determination of glucose in human serum and plasma. The submission compares its performance to the ABX PENTRA GLUCOSE PAP CP predicate device.
- 1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | ELITech Clinical Systems GLUCOSE PAP SL (Reported Performance) | Predicate Device (ABX PENTRA GLUCOSE PAP CP) |
|---|---|---|---|
| Intended Use | Quantitative in vitro diagnostic determination of glucose in human serum and plasma. Not for Point of Care. | For quantitative in vitro diagnostic determination of glucose in human serum and plasma. Not for Point of Care. | For quantitative determination of glucose in serum and plasma. |
| Indication(s) for Use | Diagnosis and treatment of carbohydrate metabolism disorders. | Measures glucose for diagnosis and treatment of carbohydrate metabolism disorders (diabetes, hypoglycemia, pancreatic islet cell carcinoma). | Measures glucose for diagnosis and treatment of carbohydrate metabolism disorders (diabetes, hypoglycemia, pancreatic islet cell carcinoma). |
| Assay Protocol | Enzymatic method using glucose oxidase coupled with peroxidase (Trinder method). | Enzymatic method using glucose oxidase coupled with peroxidase (Trinder method). | Enzymatic method using glucose oxidase coupled with peroxidase (Trinder method). |
| Composition | Phosphate buffer (pH 7.4), Phenol, 4-Aminoantipyrine (4-AAP), Glucose oxidase, Peroxidase, Sodium azide. | Identical composition: Phosphate buffer (pH 7.4) 13.8 mmol/L, Phenol 10 mmol/L, 4-Aminoantipyrine 0.3 mmol/L, Glucose oxidase ≥ 10 000 U/L, Peroxidase ≥ 700 U/L, Sodium azide |
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(276 days)
SEPPIM S.A.S.
The Vital Scientific Selectra Junior Analyzer (also trademarked as the Vital Scientific Flexor Junior Analyzer) is a discrete photometric chemistry analyzer for in vitro diagnostic use.
ELITech Clinical Systems AST/GOT 4+1 SL reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate amino transferase in human serum and plasma on the Vital Scientific Selectra/Flexor Analyzers. Aspartate Amino Transferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
ELITech Clinical Systems ELICAL 2 is a single parameter calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL I is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL II is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.
The reagent device for this submission is available as kit only. It consists of 2 reagents:
Reagent 1 contains Tris buffer, L-Aspartate; Lactate dehydrogenase (LDH) (microorganisms), Malate dehydrogenase (MDH) (bacterial) and sodium azide.
Reagent 2 contains alpha-Ketoglutarate, NADH and sodium azide
The Vital Scientific Selectra Junior is a benchtop discrete chemistry photometric analyzer for in vitro diagnostic use.
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.
Here's an analysis of the provided text to extract the acceptance criteria and study information for the ELITech Clinical Systems AST/GOT 4+1 SL device:
Device: ELITech Clinical Systems AST/GOT 4+1 SL reagent on Vital Scientific Selectra Junior Analyzer.
1. Table of Acceptance Criteria and Reported Device Performance
This submission focuses on demonstrating substantial equivalence to a predicate device (ABX PENTRA AST CP and Vitalab Flexor). The acceptance criteria are implicitly defined by demonstrating comparable performance to the predicate device within acceptable ranges for clinical diagnostic assays. The table below summarizes the performance metrics reported for the subject device.
| Performance Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ELITech Clinical Systems AST/GOT 4+1 SL) | Comments |
|---|---|---|---|
| Precision | Comparable to predicate | Within-run: |
- Level 21.2 U/L: CV=2.3%
- Level 46.4 U/L: CV=0.8%
- Level 203.4 U/L: CV=0.5% | These CVs (Coefficient of Variation) demonstrate good within-run reproducibility. |
| | | Total: - Level 21.2 U/L: CV=3.8%
- Level 46.4 U/L: CV=1.2%
- Level 203.4 U/L: CV=2.7% | These CVs demonstrate good total precision. |
| Method Comparison | Strong correlation with predicate (e.g., R² > 0.98, slope ~1, intercept ~0) | $y = 1.016x - 1.86$ U/L
$R^2 = 0.9998$
Range: 9.5 to 234.4 U/L | Excellent correlation ($R^2=0.9998$) to the predicate method, indicating substantial agreement over the tested range. The slope is very close to 1 and the intercept close to 0. |
| Measuring Range | Comparable to predicate for clinical utility (Predicate: 3.70 U/L to 600 U/L) | 10 to 250 U/L (with automatic post-dilution up to 1800 U/L) | While the initial measuring range is narrower than the predicate, the automatic post-dilution extends it significantly, indicating broader clinical utility or comparable range with dilution. |
| Calibration Frequency | Clinically acceptable stability (Predicate: 8 days) | 28 days | Improved calibration frequency compared to the predicate, indicating better stability. |
| On-board Stability | Clinically acceptable stability (Predicate: 55 days) | 28 days (refrigerated area) | Slightly shorter, but still well within typical clinical laboratory operational periods for on-board reagents. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the specific sample sizes used for the precision and method comparison studies. However, for diagnostic device submissions, "levels" (e.g., Level 21.2 U/L, Level 46.4 U/L, Level 203.4 U/L for precision studies) typically refer to replicates of control materials or pooled patient samples at different concentrations. A method comparison study using a range of 9.5 to 234.4 U/L implies a set of patient samples covering a broad clinical range.
- Sample Size for Test Set: Not explicitly stated for each study, but implied to be sufficient for statistical analysis of precision (CVs) and method comparison ($R^2$ and linear regression parameters).
- Data Provenance: The submitter is SEPPIM S.A.S. located in France. The studies were likely conducted in a setting compliant with regulatory standards (e.g., GLP/GCP-like principles) for diagnostic device validation. The document does not explicitly state if the samples were retrospective or prospective, nor does it specify the country of origin for the patient samples, but given the manufacturer's location, the data most likely originates from France or other European countries.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The device is a quantitative clinical chemistry assay for AST. For such assays, "ground truth" is typically established by comparing the results of the new device to a legally marketed predicate device or a reference method, rather than through expert consensus on individual results.
- The ground truth for the method comparison study was established by the predicate device (ABX PENTRA AST CP) or a method traceable to IFCC formulation.
- Number of Experts: Not applicable in the context of establishing ground truth for a quantitative biochemical assay. Experts are involved in setting the performance specifications and interpreting the results, but not in generating the "ground truth" values for the samples themselves in this type of study.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in imaging studies or other diagnostic scenarios where human interpretation is subjective and consensus among experts is needed to establish a definitive "ground truth" diagnosis.
- Adjudication Method: Not applicable. For quantitative biochemical assays, the comparison is made directly between the numerical results of the candidate device and the predicate/reference method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with/without AI
- MRMC Study: No, this is not an MRMC comparative effectiveness study. This device is a fully automated in vitro diagnostic (IVD) reagent and analyzer system, not an AI-assisted diagnostic tool requiring human-in-the-loop performance evaluation involving multiple readers.
- Effect Size of Human Improvement with/without AI: Not applicable, as there is no human-in-the-loop interaction or AI component discussed for this specific diagnostic device in the provided text.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, the performance data presented (precision, method comparison, measuring range, calibration frequency, on-board stability) represents the standalone performance of the ELITech Clinical Systems AST/GOT 4+1 SL reagent when used on the Vital Scientific Selectra Junior Analyzer. It describes the direct analytical capabilities of the system.
7. The Type of Ground Truth Used
- Type of Ground Truth: The primary type of ground truth used for performance evaluation (specifically, method comparison) is comparison to a legally marketed predicate device/method (ABX PENTRA AST CP, optimized UV test according to IFCC modified method without pyridoxal phosphate). For precision, it's based on repeated measurements of control materials or pooled samples.
8. The Sample Size for the Training Set
This submission describes a diagnostic reagent and analyzer system, not a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense. The development of such chemical reagents and assay protocols does not involve machine learning training data.
- Sample Size for Training Set: Not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for this type of IVD device, this question is not applicable. The development of the reagent assay formulation (Modified IFCC method without pyridoxal-phosphate) is based on established biochemical principles and extensive R&D, rather than machine learning on a dataset with pre-established ground truth.
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