(223 days)
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/dLr²= 0.998Range: 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/dLr²= 0.999Range: 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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| SECTION 5 - 510(k) SummaryELITech Clinical Systems TRIGLYCERIDES SL reagent MAY 19 2011 | ||
|---|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination of sub-stantial equivalence. | |
| The assigned 510(k) number is: K102993 | ||
| SubmitterAddressPhone numberFax number | SEPPIM S.A.S.Zone Industrielle, 61500 SEES, FRANCE+ 33 (0)2 33 81 21 00+ 33 (0)2 33 28 77 51 | |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | |
| Date of Preparation | September 30th, 2010 | |
| Device name | ||
| REAGENT :Trade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code | ELITech Clinical Systems TRIGLYCERIDES SLTriglycerides, "TRIGLYCERIDES SL"Class ITriglyceride test system (Sec.862.1705)CDT - Lipase Hydrolysis/Glycerol kinase enzyme, Triglycerides | |
| Predicate device | ABX PENTRA TRIGLYCERIDES CP (K060854) | |
| Device description | The device for this submission is available as kit only. It consists of 1reagent, "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), Potas-sium ferrocyanide, Magnesium (Mg2+) and Sodium azide. | |
| Intended Use | ELITech Clinical Systems TRIGLYCERIDES SL is intended for the quantita-tive in vitro diagnostic determination of triglycerides in human serum andplasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not in-tended for use in Point of Care settings | |
| Indication for use | ELITech Clinical Systems TRIGLYCERIDES SL is intended to measuretriglycerides in human serum and plasma. Triglycerides measurements areused in the diagnosis and treatment of patients with diabetes mellitus, neph-rosis, liver obstruction, other diseases involving lipid metabolism, or variousendocrine disorders. |
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| ELITech Clinical Systems DeviceTRIGLYCERIDES SL | Predicate device(ABX PENTRA TRIGLYCERIDES CP) | |
|---|---|---|
| Intended use | For in vitro diagnostic use in the quan-titative determination of triglycerides inserum or plasma on ELITech VitalScientific Selectra/Flexor analyzers. Itis not intended for use in Point of Caresettings. | For in vitro diagnostic use in the quan-titative determination of triglycerides inserum or plasma. |
| Indication for Use | Intended to measure triglycerides inhuman serum and plasma. Triglyc-erides measurements are used in thediagnosis and treatment of patientswith diabetes mellitus, nephrosis, liverobstruction, other diseases involvinglipid metabolism, or various endocrinedisorders. | Intended to measure triglycerides inhuman serum and plasma. Triglyc-erides measurements are used in thediagnosis and treatment of patientswith diabetes mellitus, nephrosis, liverobstruction, other diseases involvinglipid metabolism, or various endocrinedisorders. |
| Assay protocol | Enzymatic colorimetric test | Enzymatic colorimetric test |
| Composition | Reagent:Pipes buffer 50 mmol/L ;Magnesium (Mg 2+) 14.8 mmol/L :p-chlorophenol 2.7 mmol/L ;ATP 3.15 mmol/L :Potassium ferrocyanide 10 µmol/L ;Amino-4-antipyrine 0.31 mmol/L :Lipoprotein lipase ≥ 2000 U/L ;Glycerol kinase ≥ 500 U/L ;Glycerol-3-phosphate oxidase ≥ 4000 U/L ;Peroxidase ≥ 500 U/L :Sodium azide < 0.1 % | Reagent:Pipes free acid 50 mmol/L;Sodium hydroxide 3.36 g/L;Triton X-100 1 ml/L;Magnesium salt 14.8 mmol/L;p-chlorophenol 2.7 mmol/L;ATP 3.15 mmol/L;Sodium azide 7.99 mmol/L;Potassium ferrocyanide 10 µmol/L;4-aminoantipyrine 0.31 mmol/L;Lipoprotein lipase ≥ 2000 U/L;Glycerokinase ≥ 500 U/L;Peroxidase ≥ 500 U/L;Glycerol phosphate Oxidase ≥ 4000 U/L; |
| Appearance of reagent | Liquid form, ready to use | Same |
| Sample type | SerumPlasma in lithium heparin | SerumPlasma in lithium heparin |
| Reagent storage | Store at 2-8 °C and protect from light.The reagent is stable until the expirydate stated on the label. | Reagents, in unopened cassette, arestable up to expiry date on the label ifstored at 2-8 °C. |
| Expected values | Normal : < 150 mg/dLBordeline high : 150-199 mg/dLHigh : 200-499 mg/dLVery high : ≥ 500 mg/dL | Normal: < 150 mg/dlLow risk: 150 - 200 mg/dlHigh: 200 - 500 mg/dlExtremely high: > 500 mg/dl |
| Instrument | Vital Scientific SELECTRA JUNIOR | ABX PENTRA 400 |
| Measuring range | 30 to 1000 mg/dL | 3.1 to 1470 mg/dL |
| Precision | Within runLevel 48 mg/dL CV=1.5%Level 142 mg/dL CV=1.0%Level 273 mg/dL CV=0.7%Total | Within runLevel 126 mg/dL CV=2.52%Level 214 mg/dL CV=0.82%Level 60 mg/dL CV=2.83%Level 108 mg/dL CV=1.84%Level 232 mg/dL CV=1.00%Total |
| Level 48 mg/dL CV=3.9% | Level 128 mg/dL CV=1.91% | |
| ELITech Clinical Systems DeviceTRIGLYCERIDES SL | Predicate device(ABX PENTRA TRIGLYCERIDES CP) | |
| Level 142 mg/dL CV=2.7%Level 273 mg/dL CV=4.5% | Level 216 mg/dL CV=1.70%Level 132 mg/dL CV=1.57%Level 243 mg/dL CV=1.37% | |
| Method comparison | y=1.040x + 0.339 mg/dLr²= 0.998range: 22 to 936 mg/dL | y=0.99x + 0.20 mg/dLr²= 0.9994range: 3.1 to 1434.1 mg/dL |
| Limitations | Unconjugated bilirubin:No significant interference up to 15 mg/dL.Conjugated bilirubin:No significant interference up to 5.9 mg/dLHemoglobin:No significant interference up to 250 mg/dL.Uric acid:No significant interference up to 23.6 mg/dLAscorbic acid:No significant interference up to 2.0 mg/dL. Concentrations above the therapeutic levels will interfere and cause erroneous results.Methyl-dopa:No significant interference up to 1.0 mg/dL | Hemoglobin: No significant influence is observed up to 500 mg/dL.Total bilirubin: No significant influence is observed up to 22.5 mg/dL.Direct bilirubin: No significant influence is observed up to 22.5 mg/dL. |
| Calibration Frequency | 14 days | 14 days |
| On board stability | refrigerated area : 28 days | refrigerated area: 48 days |
| Calibrator | Recommended calibration material (not included):ELITech Clinical Systems ELICAL 2 | Recommended calibration material (not included):ABX Pentra Multical |
| Controls | Recommended quality control material (not included):ELITech Clinical Systems ELITROL I (Normal control)ELITech Clinical Systems ELITROL II (Pathologic control) | Recommended quality control material (not included):ABX Pentra N Control (Normal control)ABX Pentra P Control (Pathologic control) |
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Device name
REAGENT
| Trade/proprietary Name: | ELITech Clinical Systems CHOLESTEROL SL |
|---|---|
| Common or Usual Name: | Cholesterol (total), "CHOLESTEROL SL" |
| Device Class | Class I |
| Classification name | Cholesterol (total) test system (Sec.862.1175) |
| Product code | CHH - Enzymatic Esterase-Oxidase, Cholesterol |
Predicate device
ABX PENTRA CHOLESTEROL CP (K060854)
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| Device description | 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), Cholesterolesterase (CHE bacterial), Cholesterol oxidase (CHO microorganisms), Per-oxidase (POD horseradish), Sodium cholate, Phenol and Sodium azide. |
|---|---|
| Intended Use | ELITech Clinical Systems CHOLESTEROL SL is intended for the quantita-tive in vitro diagnostic determination of cholesterol in human serum andplasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. |
| Indication for use | ELITech Clinical Systems CHOLESTEROL SL is intended to measurecholesterol in human serum and plasma. Cholesterol measurements areused in the diagnosis and treatment of disorders involving excess choles-terol in the blood and lipid and lipoprotein metabolism disorders. |
| ELITech Clinical Systems DeviceCHOLESTEROL SL | Predicate device(ABX PENTRA CHOLESTEROL CP) | |
|---|---|---|
| Intended use | For in vitro diagnostic use in the quan-titative determination of cholesterol inserum or plasma on ELITech VitalScientific Selectra/Flexor analyzers. Itis not intended for use in Point of Caresettings. | For in vitro diagnostic use in the quan-titative determination of cholesterol inserum or plasma. |
| Indication for Use | Cholesterol measurements are usedin the diagnosis and treatment of dis-orders involving excess cholesterol inthe blood and lipid and lipoproteinmetabolism disorders. | Cholesterol measurements are usedin the diagnosis and treatment of dis-orders involving excess cholesterol inthe blood and lipid and lipoproteinmetabolism disorders. |
| Assay protocol | Enzymatic colorimetric method usingcholesterol esterase/ cholesteroloxidase coupled withperoxidase(Trinder method). | Enzymatic colorimetric method usingcholesterol esterase/ cholesterol oxi-dase coupled with peroxidase (Trindermethod). |
| Composition | Reagent:Pipes buffer 50 mmol/L;Phenol 24 mmol/L;Sodium cholate 5 mmol/L;4-Aminoantipyrine 0.5 mmol/L;Cholesterol esterase ≥ 180 U/L;Cholesterol oxidase ≥ 200 U/L;Peroxidase ≥ 1 000 U/L;Sodium azide < 1 g/L | Reagent:Good's buffer 50 mmol/L;Phenol 5 mmol/L;4-Aminoantipyrine 0.3 mmol/L;Cholesterol esterase ≥ 200 U/L;Cholesterol oxidase ≥ 50 U/L;Peroxidase ≥ 3 000 U/L;Sodium azide 0.95 g/L |
| Appearance of re-agent | Liquid form, ready to use | Same |
| Sample type | SerumPlasma in lithium heparin | SerumPlasma in lithium heparin |
| Reagent storage | Store at 2-8°C and protect from light.The reagent is stable until the expirydate stated on the label. | Reagents, in unopened cassette, arestable up to expiry date on the label ifstored at 2-8°C and contamination isavoided. |
| Expected values | Desirable: < 200 mg/dLBordeline high: 200-239 mg/dLHigh: ≥ 240 mg/dL | Desirable: ≤ 200 mg/dlBorderline high risk: 200-239 mg/dLHigh risk: > 240 mg/dL |
| ELITech Clinical Systems DeviceCHOLESTEROL SL | Predicate device(ABX PENTRA CHOLESTEROL CP) | |
| Instrument | Vital Scientific SELECTRA JUNIOR | ABX PENTRA 400 |
| Measuring range | 20 to 600 mg/dL | 2.55 to 580 mg/dL |
| Precision | Within runLevel 116 mg/dL CV=2.4%Level 190 mg/dL CV=1.9%Level 298 mg/dL CV=1.7%TotalLevel 116 mg/dL CV=2.6%Level 190 mg/dL CV=2.7%Level 298 mg/dL CV=2.7% | Within runLevel 113 mg/dL CV=0.82%Level 186 mg/dL CV=0.74%Level 117 mg/dL CV=1.21%Level 191 mg/dL CV=0.53%Level 389 mg/dL CV=0.62%TotalLevel 109 mg/dL CV=2.96%Level 183 mg/dL CV=2.34%Level 170 mg/dL CV=2.80%Level 250 mg/dL CV=3.01% |
| Method comparison | y=1.006 x - 1.734 mg/dL$r^2$ = 0.999range: 20 to 579 mg/dL | y=0.95x + 1.90 mg/dL$r^2$ = 0.9943range: 2.55 to 583.26 mg/dL |
| Cholesterol ReferenceLaboratory Network(CRMLN) certification | Certified | Certified |
| Limitations | Unconjugated bilirubin: No significant interference up to 6.0 mg/dL.Conjugated bilirubin: No significant interference up to 5.9 mg/dL.Hemoglobin: No significant interference up to 250 mg/dL.Turbidity: No significant interference up to 614 mg/dL triglyceride equivalent.Ascorbic acid: No significant interference up to 2.0 mg/dL. Concentrations above the therapeutic levels will interfere and cause erroneous results.Methyl-dopa: No significant interference up to 0.8 mg/dL. Concentrations above the therapeutic levels will interfere and cause erroneous results.Uric acid: No significant interference up to 23.4 mg/dL. | Hemoglobin: No significant influence is observed up to 336 mg/dL.Total bilirubin: No significant influence is observed up to 20.5 mg/dL.Direct bilirubin: No significant influence is observed up to 6.8 mg/dL.Triglycerides: No significant influence is observed up to 612.5 mg/dL |
| Calibration Frequency | 28 days | 8 days |
| On board stability | refrigerated area : 28 days | refrigerated area: 48 days |
| Calibrator | Recommended calibration material(not included):ELITech Clinical Systems ELICAL 2 | Recommended calibration material(not included):ABX Pentra Multical |
| Controls | Recommended quality control material(not included):ELITech Clinical Systems ELITROL I(Normal control)ELITech Clinical Systems ELITROL II(Pathologic control) | Recommended quality control material(not included):ABX Pentra N Control(Normal control)ABX Pentra P Control (Pathologiccontrol) |
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Device name
| CALIBRATOR : | |
|---|---|
| Trade/proprietary Name: | ELITech Clinical Systems ELICAL 2 |
| Common or Usual Name: | Calibrator, multi-analyte mixture, "ELICAL 2" |
| Device Class | Class II |
| Classification name | Calibrator (21 CFR 862.1150) |
| Product code | JIX- Calibrator, multi-analyte mixture |
| Predicate device | Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (K033501) |
| Device description | ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based onhuman serum containing constituents to ensure optimal calibration.ELICAL 2 is prepared exclusively from the blood of donors tested individuallyand found to be negative for HbsAg and to antibodies to HCV and HIV ac-cording to FDA-approved methods or methods in compliance with the Euro-pean Directive 98/79/EC, Annex II, List A. |
| Intended Use | ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitrodiagnostic use in the calibration of quantitative ELITech Clinical Systems me-thods on the ELITech Vital Scientific Selectra/Flexor Analyzers. |
| ELITech Clinical Systems Device(ELICAL 2) | Predicate device(Roche Calibrator f.a.s.) | |
|---|---|---|
| Intended use | 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. | For in vitro diagnostic use in the calibration of quantitative Roche methods on Roche clinical chemistry analysers as specified in the value sheets. |
| Format | Lyophilized calibrator based on human serum with constituents added as required to obtain desired components levels | Lyophilized calibrator based on human serum with constituents added as required to obtain desired components levels |
| Level | Single level | Single level |
| Handling | Carefully open the vial, avoiding the loss of lyophilate, and pipette in exactly 3 mL of distilled/deionized water. Carefully close the vial and dissolve the contents completely by occasional gentle swirling within 30 minutes avoiding the formation of foam. | Carefully open one bottle, avoiding the loss of lyophilate, and pipette in exactly 3 mL of distilled/deionized water. Carefully close the bottle and dissolve the contents completely by occasional gentle swirling within 30 minutes. Avoid the formation of foam. |
| Traceability | Traceability information is given in the value sheet included in the box. | Traceability of the target value is given in the respective instruction for use of the system reagents. |
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| ELITech Clinical Systems Device(ELICAL 2) | Predicate device(Roche Calibrator f.a.s.) | |
|---|---|---|
| Stability | Lyophilized:To store at 2-8°C and protectedfrom light until the expiry date | Lyophilized:Stable at 2-8°C up to expirationdate. |
| After reconstitution, the stabilitiesare :- 8 hours between 15-25 °C.- 2 days between 2-8 °C.- 4 weeks between -25 and -15 °C(when frozen once) | After reconstitution, the stabilities*are :- 8 hours at 15-25 °C.- 2 days at 2-8 °C.- 4 weeks at (-25)-(-15) °C (whenfrozen once) | |
| *Exception for bilirubin total & directas noted in package insert |
Device names
| CONTROLS: | |
|---|---|
| Trade/proprietary Name: | ELITech Clinical Systems ELITROL I and ELITROL II |
| Common or Usual Name: | Multi-analyte controls – all kinds, "ELITROL I"- "ELITROL II" |
| Device Class | Class I |
| Classification name | Quality control material (assayed and unassayed). (21 CFR862.1660) |
| Product code | JJY Multi-analyte controls - all kinds |
| Predicate device | Roche Diagnostics Precinorm U (K041227) |
| Roche Diagnostics Precipath U (K041227) | |
| Device description | ELITech Clinical Systems ELITROL I and ELITROL II are two level qualitycontrol products consisting of lyophilized human serum containing constitu-ents at desired levels. |
| Elitrol I and Elitrol II are prepared exclusively from the blood of donors testedindividually and found to be negative for HbsAg and to antibodies to HCV andHIV according to FDA-approved methods or methods in compliance with theEuropean Directive 98/79/EC, Annex II, List A. | |
| Intended Use | ELITech Clinical Systems ELITROL I & ELITROL II are multiparametriccontrol sera for use in quality control of ELITech Clinical Systems methodson ELITech Vital Scientific Selectra/Flexor Analyzers. |
| ELITech Clinical Systems DeviceELITROL I / ELITROL II | Predicate DeviceRoche Precinorm U / Precipath U | |
|---|---|---|
| Intended use | ELITech Clinical Systems ELITROLI & ELITROL II are multiparametriccontrol sera for use in quality con-trol of ELITech Clinical Systemsmethods on ELITech Vital Scientific | For in vitro diagnostic use in qualitycontrol by monitoring accuracy andprecision for the quantitative meth-ods as specified in the value sheet |
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| Selectra/Flexor Analyzers. | ||
|---|---|---|
| Format | Lyophilized human sera with con-stituents added as required to ob-tain desired components levels | Lyophilized human sera with con-stituents added as required to ob-tain desired components levels |
| Levels | Two levels | Two levels |
| Handling | Carefully open the vial, avoiding theloss of lyophilate, and pipette inexactly 5 mL of distilled/deionizedwater. Carefully close the vial anddissolve the contents completely byoccasional gentle swirling within 30minutes avoiding the formation offoam. | Carefully open the bottle, avoidingthe loss of lyophilate, and pipette inexactly 5 mL of distilled/deionizedwater. Carefully close the bottle anddissolve the contents completely byoccasional gentle swirling within 30minutes. Avoid the formation offoam. |
| Stability | Lyophilized:To store at 2-8°C and protectedfrom light until the expiry dateAfter reconstitution, the stabilitiesare:- 12 hours between 15-25 °C.- 5 days between 2-8 °C.- 4 weeks between -25 and -15 °C(when frozen once) | Lyophilized:Stable at 2-8°C up to expirationdate.After reconstitution, the stabilities*are:- 12 hours at 15-25 °C.- 5 days at 2-8 °C.- 4 weeks at (-25)-(-15) °C (whenfrozen once)*Exception for bilirubin total & directas noted in package insert |
Conclusion
The performance data and other information demonstrate that the safety and effectiveness of these devices versus their respective predicate devices are not compromised, and that they met all acceptance criteria, demonstrating that the devices are substantially equivalent to their respective predicate devices.
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Image /page/8/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle or bird-like symbol on the right side. To the left of the bird, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MAY 19 2011
SEPPIM S.A.S. Elitech Group Epoch Biosciences c/o Ms. Debra Hutson Director. Ouality Assurance/Regulatory Affairs 21720 23rd Drive, S.E., Suite 150 Bothell, Washington 98021
Re: K102993
Trade Name: ELITech Clinical Systems Cholesterol SL, ELITech Clinical Systems Triglycerides SL, ELITech Clinical Systems Elical 2, ELITech Clinical Systems Elitrol I and II
Regulation Number: 21 CFR $862.1175
Regulation Name: Cholesterol Test System.
Regulatory Class: Class I, meets the limitations to exemptions 21 CFR 862.9 (c)(4)
Product Codes: CHH, CDT, JIX, JJY
Dated: April 29, 2011
Received: May 03, 2011
Dear Ms. Hutson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _K102993 _________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
ATT
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102993
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510(k) Number (if known): K102993
Device Name:
Indications for Use:
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102993
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510(k) Number (if known): K102993
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use: .
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Kr02993
Page 3 of 4
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510(k) Number (if known): __ K 102993
Device Name:
Indications for Use:
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102993
Page 4 of 4
§ 862.1705 Triglyceride test system.
(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.