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510(k) Data Aggregation
(223 days)
ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL
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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