(251 days)
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.
{0}------------------------------------------------
| SECTION 5 - 510(k) Summary | ELITech Clinical Systems Device | Predicate device | |||||
|---|---|---|---|---|---|---|---|
| ELITech Clinical Systems CHOLESTEROL HDL SL 2G AUG 3 1 2011 | CHOLESTEROL HDL SL 2G | (ABX PENTRA HDL Direct CP, K060854) | |||||
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. | Intended use | Intended for use with ELITech ClinicalSystems CHOLESTEROL HDL 2GCALIBRATOR and ELITech ClinicalSystems ELITROL I and ELITROL II onELITech Clinical Systems Selectraanalyzers for the quantitative in vitrodiagnostic determination of HighDensity Lipoprotein (HDL) Cholesterolin human serum and plasma. It is notintended for use in Point of Caresettings. | For quantitative in Vitro determination ofHigh-Density Lipoprotein Cholesterol(HDL-C) in human serum or plasma bycolorimetry. | |||
| The assigned 510(k) number is: K103747 | Indication(s) for Use | Intended to measure High DensityLipoprotein (HDL) Cholesterol inhuman serum and plasma. Lipoproteinmeasurements are used in thediagnosis and treatment of lipiddisorders (such as diabetes mellitus),atherosclerosis, and various liver andrenal diseases. | Intended to measure High DensityLipoprotein (HDL) Cholesterol in humanserum and plasma. Lipoproteinmeasurements are used in the diagnosisand treatment of lipid disorders (such asdiabetes mellitus), atherosclerosis, andvarious liver and renal diseases. | ||||
| 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 | Assay protocol | Enzymatic colorimetric test withaccelerator selective detergent | Enzymatic colorimetric test based onaccelerator Selective Detergent (withoutthe need for any off-line pretreatment orcentrifugation steps) | |||
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | Composition | Reagent R1:Good's buffer ,pH 6.0 ;Cholesterol oxidase < 1000 U/L ;Peroxidase < 1300 ppg U/L ;Ascorbate oxidase < 3000 U/L ;N,N-bis(4-sulphobutyl)-m-toluidine-disodium (DSBmT) < 1 mmol/L ;Accelerator < 1 mmol/LPreservative < 0.06 % | Reagent R1:Good's bufferCholesterol oxidase < 1000 U/L ;Peroxidase < 1300 ppg U/L ;N,N-bis(4-sulphobutyl)-m-toluidine-disodium(DSBmT) < 1 mmol/L ;Accelerator < 1 mmol/LPreservative < 0.06 % | |||
| Date of Preparation | November, 23rd, 2010 | Reagent R2:Good's buffer, pH 6.0 ;Cholesterol esterase < 1500 U/L ;4-Amino-Antipyrine < 1 mmol/L ;Detergent < 2%Preservative < 0.06 % | Reagent R2:Good's bufferCholesterol esterase < 1500 U/L ;4-Amino-Antipyrine < 1 mmol/L ;Detergent < 2%Restrainer < 0.15 %Preservative < 0.06 %Ascorbic acid oxidase < 3000 U/L | ||||
| Device names | Appearance of reagent | Liquid form, ready to use | Same | ||||
| REAGENT :Trade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code | ELITech Clinical Systems CHOLESTEROL HDL SL 2GHigh Density Lipoprotein (HDL) Cholesterol, "CHOLESTEROL HDL SL 2G"Class I,Lipoprotein test system (Sec.862.1475)LBS - LDL & VLDL Precipitation, Cholesterol Via Esterase-Oxidase, | Sample type | Serum | Serum | |||
| Predicate device | ABX PENTRA HDL Direct CP (K060854) | Plasma in lithium heparin | Plasma in lithium heparin | ||||
| Device description | 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. | Reagent storage | Store at 2-8 °C and protected from | Reagents in unopened cassette are | |||
| Intended Use | 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. | ||||||
| Indication(s) for Use | ELITech Clinical Systems CHOLESTEROL HDL SL 2G is intended to measure High Density Lipoprotein (HDL) Cholesterol in human serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. |
{1}------------------------------------------------
{2}------------------------------------------------
| ELITech Clinical Systems Device | Predicate device | |
|---|---|---|
| CHOLESTEROL HDL SL 2G | (ABX PENTRA HDL Direct CP, K060854) | |
| light. The reagents are stable until theexpiry date stated on the label. | stable up to expiry date on the label ifstored at 2-8 °C. | |
| Expected values | According to NCEP classificationaccording to the risk of developpingcoronary heart disease | According to NCEP classificationaccording to the risk of developpingcoronary heart disease |
| High : < 40 mg/dL | High : < 40 mg/dL | |
| Low : ≥ 60 mg/dL | Low : ≥ 60 mg/dL | |
| Instrument | SELECTRA JUNIOR | ABX PENTRA 400 |
| Measuring range | 5 to 105 mg/dL | 5.4 to 151.9 mg/dL |
| Limit of detection (LoD) | 0.7 mg/dL | 1.16 mg/dL |
| Limit of quantification(LoQ) | 5.0 mg/dL | |
| Precision | Within run | Within run |
| Level 31 mg/dL CV=1.4%Level 56 mg/dL CV=0.7%Level 87 mg/dL CV=1.4%TotalLevel 31 mg/dL CV=3.0%Level 56 mg/dL CV=2.8%Level 87 mg/dL CV=3.3% | 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%TotalLevel 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% | |
| Method comparison | y=1.09x - 2.5 mg/dL$r^2$ = 0.972range: 5 to 105 mg/dL | y=0.91x + 1.98 mg/dL$r^2$ = 0.9768range: 5.4 to 151.9 mg/dL |
| Limitations | No significant interference for thefollowing components:Unconjugated bilirubin (up to 30mg/dL)Conjugated bilirubin (up to 29.5mg/dL)Hemoglobin (up to 500 mg/dL)Turbidity : Negative bias from 439mg/dL triglycerides equivalent. | Hemoglobin: No significant influence isobserved up to 479 mg/dL.Triglycerides: No significant influence isobserved up to 612.5 mg/dL.Total bilirubin: No significant influence isobserved up to 11.7 mg/dL.Direct bilirubin: No significant influenceis observed up to 28.1 mg/dL. |
| On board stability | refrigerated area : 28 days | refrigerated area: 31 days |
| Calibrator | Recommended calibration material (notincluded):ELITech Clinical Systems CholesterolHDL 2G Calibrator | Recommended calibration material (notincluded):ABX Pentra HDL Cal |
| ELITech Clinical Systems Device | Predicate device | |
| CHOLESTEROL HDL SL 2G | (ABX PENTRA HDL Direct CP, K060854) | |
| Controls | Recommended quality control material(not included): | Recommended quality control material(not included): |
| ELITech Clinical Systems Elitrol I(Normal control) | ABX Pentra N Control(Normal control) | |
| ELITech Clinical Systems Elitrol II(Pathologic control) | ABX Pentra P Control (Pathologic control) |
{3}------------------------------------------------
Conclusion
The performance data and other information demonstrate that the safety and effectiveness of this device versus the predicate device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.
{4}------------------------------------------------
SECTION 5 - 510(k) Summary - ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. | ELITech Clinical Systems Device(CHOLESTEROL HDL 2G CALIBRATOR) | Predicate device(Genzyme Ultra N-GeneousCHOLESTEROL HDL Calibrator ) | ||
|---|---|---|---|---|---|
| The assigned 510(k) number is: K103747 | Intended use | For in vitro diagnostic use in thecalibration of quantitative ELITech ClinicalSystems CHOLESTEROL HDL SL 2G onELITech Clinical Systems Selectraanalyzers. | For the calibration of Ultra N-GenousHDL Cholesterol | ||
| 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 | Format | Lyophilized calibrator based on humanserum on human serum containinglipoprotein from the various lipoproteinclasses including high densitylipoproteins. This calibrator containssodium azide as preservative. | Lyophilized calibrator based on humanserum on human serum containinglipoprotein from the various lipoproteinclasses including high densitylipoproteins. This calibrator containssodium azide as preservative. | |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | Level | Single level | Single level | |
| Date of Preparation | November, 23rd, 2010 | Handling | Carefully open the vial, avoiding the lossof lyophilizate, and pipette in exactly 1 mLof distilled/deionized water. Carefullyclose the vial and dissolve the content bysuccessive swirling. Wait for around 20minutes until the complete dissolution andhomogenize again. Do not shake stronglyto avoid formation of foam. | Carefully open the vial, avoiding the lossof lyophilizate, and reconstitute with 1mL of deionized water. Close the vialand let stand for 20 minutes. Dissolvethe contents of the vial by swirling gentlyto avoid the formation of foam. Do notshake. | |
| Device names | Stability | Lyophilized:To store at 2-8 °C and protected from lightuntil the expiry date | Lyophilized:To store at 2-8 °C and protected fromlight until the expiry date | ||
| Trade/proprietary NameCommon or Usual NameDevice ClassClassification nameProduct code | ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATORCalibrator "CHOLESTEROL HDL 2G CALIBRATOR"Class IICalibrator (Sec.862.1150)JIS- Calibrator, Primary | After reconstitution, the stabilities are :- 14 days between 2 - 8 °C.- 4 weeks at less than - 80 °C (whenfrozen once) | After reconstitution, the stabilities are :- 14 days between 2 - 8 °C.- 4 weeks between -70 °C (when frozenonce) | ||
| Predicate device | Ultra N-Geneous HDL Calibrator from Genzyme (K021316) | ||||
| Device description | ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR is alyophilized calibrator based on human serum containing lipoprotein from thevarious lipoprotein classes including high density lipoproteins and sodiumazide as preservative.CHOLESTEROL HDL 2G CALIBRATOR is prepared exclusively from theblood of donors tested individually and found to be negative for HbsAg and toantibodies to HCV and HIV according to FDA-approved methods. | ||||
| Intended Use | ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR is acalibrator for in vitro diagnostic use in the calibration of quantitative ELITechClinical Systems CHOLESTEROL HDL SL 2G on ELITech Clinical SystemsSelectra analyzers. |
{5}------------------------------------------------
Conclusion The performance data and other information demonstrate that the safety and effectiveness of this device versus the predicate device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.
{6}------------------------------------------------
SECTION 5 - 510(k) Summary ELITech Clinical Systems CHOLESTEROL LDL SL 2G
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. | ELITech Clinical Systems DeviceCHOLESTEROL LDL SL 2G | Predicate device(ABX PENTRA LDL DIRECT CP) | |
|---|---|---|---|---|
| The assigned 510(k) number is: K103747 | Intended use | Intended for use with ELITechClinical Systems CHOLESTEROLLDL 2G CALIBRATOR andELITech Clinical Systems ELITROLI and ELITROL II for thequantitative in vitro diagnosticdetermination of Low DensityLipoprotein (LDL) Cholesterol inhuman serum and plasma onELITech Clinical Systems Selectraanalyzers. It is not intended for usein Point of Care settings. | For quantitative in vitrodetermination of Low DensityLipoprotein Cholesterol (LDL-C) inserum or plasma by colorimetry. | |
| 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 | Indication(s) for Use | Intended to measure Low DensityLipoprotein (LDL) Cholesterol inhuman serum and plasma.Lipoprotein measurements areused in the diagnosis and treatmentof lipid disorders (such as diabetesmellitus), atherosclerosis, andvarious liver and renal diseases. | Intended to measure Low DensityLipoprotein (LDL) Cholesterol inhuman serum and plasma. Lipopro-tein measurements are used in thediagnosis and treatment of lipiddisorders (such as diabetes melli-tus), atherosclerosis, and variousliver and renal diseases. |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | Assay protocol | Enzymatic colorimetric test withselective detergent | Enzymatic colorimetric test withselective detergent |
| Date of Preparation | November, 23rd, 2010 | Composition | Reagent R1:MES buffer ,pH 6.3 ;Detergent 1 < 1.0 %,Cholesterol esterase < 1500 U/L,Cholesterol oxidase < 1500 U/L;Peroxidase < 1300 ppg U/L;4-Amino-Antipyrine < 0.1 %,Ascorbate oxidase < 3000 U/LPreservativeReagent R2:MES buffer, pH 6.3 ;Detergent 2 < 1.0 %.N,N-bis(4-sulphobutyl)-m-toluidine-disodium < 1 mmol/LPreservative | Reagent R1:MES buffer ,pH 6.3 ;Detergent 1 < 1.0 %,Cholesterol esterase < 1500 U/L,Cholesterol oxidase < 1500 U/L;Peroxidase < 1300 ppg U/L;4-Amino-Antipyrine < 0.1 %.Ascorbate oxidase < 3000 U/LPreservativeReagent R2:MES buffer, pH 6.3 ;Detergent 2 < 1.0 %.N,N-bis(4-sulphobutyl)-m-toluidine-disodium < 1 mmol/LPreservative |
| Device names | Appearance of reagent | Liquid form, ready to use | Same | |
| REAGENT :Trade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code | ELITech Clinical Systems CHOLESTEROL LDL SL 2GLow Density Lipoprotein (LDL) Cholesterol, "CHOLESTEROL HDL SL 2G"Class ILipoprotein test system (Sec.862.1475)LBS - LDL & VLDL Precipitation, Cholesterol Via Esterase | Sample type | SerumPlasma in lithium heparin | SerumPlasma in lithium heparin |
| Predicate device | ABX PENTRA LDL Direct CP (K060854) | Reagent storage | Store at 2-8 °C and protected fromlight. The reagent is stable until theexpiry date stated on the label. | Reagents, in unopened cassette,are stable up to expiry date on thelabel if stored at 2-8 °C. |
| Device description | The device for this submission is available as kit only. It consists of 2reagents, "R1" and "R2".Reagent R1 contains: MES buffer, Detergent 1, Cholesterol esterase (CHEbacterial), 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). | Expected values | According to NCEP, classificationaccording to the risk of developingcoronary heart disease:Optimal : < 100 mg/dLNear or above optimal: 100-129 mg/dLBorderline High : 130-159 mg/dLHigh: 160-189 mg/dLVery high : ≥ 190 mg/dL | Following NCEP cutpoints forpatient classification are used forthe prevention and management ofcoronary artery disease:Desirable : < 130 mg/dLBorderline High risk: 130 -159 mg/dLHigh risk : 160 mg/dL |
| Intended Use | ELITech Clinical Systems CHOLESTEROL LDL SL 2G is intended for usewith ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR andELITech Clinical Systems ELITROL I and ELITROL II for the quantitative invitro diagnostic determination of Low Density Lipoprotein (LDL) Cholesterolin human serum and plasma on ELITech Clinical Systems Selectraanalyzers. It is not intended for use in Point of Care settings. | |||
| Indication(s) for Use | ELITech Clinical Systems CHOLESTEROL LDL SL 2G is intended tomeasure Low Density Lipoprotein (LDL) Cholesterol in human serum andplasma. Lipoprotein measurements are used in the diagnosis and treatmentof lipid disorders (such as diabetes mellitus), atherosclerosis, and variousliver and renal diseases. |
{7}------------------------------------------------
{8}------------------------------------------------
| ELITech Clinical Systems DeviceCHOLESTEROL LDL SL 2G | Predicate device(ABX PENTRA LDL DIRECT CP) | |
|---|---|---|
| Instrument | Vital Scientific SELECTRA JUNIOR | ABX PENTRA 400 |
| Measuring range | 15 to 380 mg/dL | 1.35 to 369.39 mg/dL |
| Limit of Detection (LoD) | 0.3 mg/dL | 1.55 mg/dL |
| Limit of Quantification (LoQ) | 10.0 mg/dL | |
| Precision | Within run | Within run |
| Level 108 mg/dL CV=1.4% | Level 61.26 mg/dL CV=1.01% | |
| Level 122 mg/dL CV=1.3% | Level 75.08 mg/dL CV=2.82% | |
| Level 162 mg/dL CV=2.0% | Level 111.26 mg/dL CV=0.91% | |
| Level 141.45 mg/dL CV=1.00% | ||
| Total | Level 191.16 mg/dL CV=0.63% | |
| Level 108 mg/dL CV=2.6% | ||
| Level 122 mg/dL CV=2.7% | Total | |
| Level 162 mg/dL CV=4.0% | Level 60.64 mg/dL CV=5.59% | |
| Level 74.27 mg/dL CV=6.39% | ||
| Level 156.58 mg/dL CV=3.94% | ||
| Level 191.62 mg/dL CV=4.04% | ||
| Method comparison | y= 0.999 x - 0.5 mg/dL | y=0.96x - 0.21 mg/dL |
| $r^2$ = 0.993 | $r^2$ = 0.9963 | |
| range: 16-378 mg/dL | range: 1.35 to 369.39 mg/dL | |
| Limitations | Hemoglobin: No significantinterference up to 500 mg/dL.Turbidity: No significantinterference up to 614 mg/dLtriglycerides equivalent.Unconjugated bilirubin: No | Hemoglobin: No significantinfluence is observed up to 460mg/dL.Triglycerides: No significantinfluence is observed up to 613 |
| significant interference up to 30mg/dL.Conjugated bilirubin: No | mg/dL.Total bilirubin: No significantinfluence is observed up to 8.19mg/dL. | |
| significant interference up to 29.5mg/dL. | Direct bilirubin: No significantinfluence is observed up to 5.63mg/dL. | |
| Calibration Frequency | 28 days | 14 days |
| On board stability | refrigerated area : 28 days | refrigerated area: 97 days |
| Calibrator | Recommended calibration material(not included):ELITech Clinical SystemsCholesterol LDL 2G Calibrator | Recommended calibration material(not included):ABX Pentra LDL Cal |
| Controls | Recommended quality controlmaterial (not included):ELITech Clinical Systems Elitrol I(Normal control)ELITech Clinical Systems Elitrol II(Pathologic control) | Recommended quality controlmaterial (not included):ABX Pentra N Control(Normal control)ABX Pentra P Control (Pathologiccontrol) |
Conclusion
The performance data and other information demonstrate that the safety and effectiveness of this device versus the predicate device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.
{9}------------------------------------------------
SECTION_5 - 510(k) Summary -ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of
substantial equivalence.
| The assigned 510(k) number is: K103747 | |
|---|---|
| Submitter | SEPPIM S.A.S. |
| Address | Zone Industrielle, 61500 SEES, FRANCE |
| Phone number | + 33 (0)2 33 81 21 00 |
| Fax number | + 33 (0)2 33 28 77 51 |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) |
| Date of Preparation | November, 23rd, 2010 |
| Trade/proprietary Name: | ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR |
|---|---|
| Common or Usual Name: | Calibrator "CHOLESTEROL LDL 2G CALIBRATOR" |
| Device Class | Class II |
| Classification name | Calibrator (Sec.862.1150) |
| Product code | JIS- Calibrator, Primary |
| Predicate device | N-geneous LDL Calibrator from Genzyme (K971573) |
|---|---|
| Device description | ELITech Clinical Systems CHOLESTEROL LDL 2GCALIBRATOR is alyophilized calibrator based on human serum containing lipoprotein from thevarious lipoprotein classes including low density lipoproteins and sodiumazide as preservative.CHOLESTEROL LDL 2G CALIBRATOR is prepared from plasma donor unitstested individually by FDA - approved methods and found to be negative forHbsAg, anti-HCV antibody and anti-HIV1&2 antibodies. |
| Intended Use | ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR intendedfor use with ELITech Clinical Systems CHOLESTEROL LDL 2GCALIBRATOR and ELITech Clinical Systems ELITROL I and ELITROL II forthe quantitative in vitro diagnostic determination of Low Density Lipoprotein(LDL) Cholesterol in human serum and plasma on ELITech Clinical SystemsSelectra analyzers. It is not intended for use in Point of Care settings. |
{10}------------------------------------------------
| ELITech Clinical Systems Device(CHOLESTEROL LDL 2GCALIBRATOR) | Predicate device(Genzyme N-geneous LDLCholesterol Calibrator) | |
|---|---|---|
| Intended use | For in vitro diagnostic use in thecalibration of quantitative ELITechClinical Systems CHOLESTEROLLDL SL 2G on ELITech ClinicalSystems Selectra analyzers. | For the calibration of Ultra N-Genous LDL Cholesterol assay inserum or plasma. |
| Format | Lyophilized calibrator basedonhuman serum on human serumcontaining lipoprotein from thevarious lipoprotein classesincluding low density lipoproteins.This calibrator contains sodiumazide as preservative. | Lyophilized calibrator basedonhuman serum on human serumcontaining lipoprotein from thevarious lipoprotein classesincluding low density lipoproteins.This calibrator contains sodiumazide as preservative |
| Level | Single level | Single level |
| Handling | Carefully open the vial, avoiding theloss of lyophilizate, and pipette inexactly 1 mL of distilled/deionizedwater. Carefully close the vial anddissolve the content by successiveswirling. Wait for around 5 minutesuntil the complete dissolution andhomogenize again. Do not shakestrongly to avoid formation of foam. | Reconstitute by adding 1 mL ofdistilled or deionized water. Closethe vial and let stand for 5 minutes.Dissolve the contents of the vial byswirling gently to avoid theformation of foam. Do not shake. |
| Stability | Lyophilized:To store at 2-8 °C and protectedfrom light until the expiry dateAfter reconstitution, the stabilitiesare:- 14 days between 2 - 8 °C.- 4 weeks at less than -80 °C(frozen only once) | Lyophilized:To store at 2-8 °C and protectedfrom light until the expiry dateAfter reconstitution, the stabilitiesare:- 2 weeks at 2 - 8 °C.- the reconstituted calibrator may bealiquoted and stored at -80 °C. |
Conclusion
The performance data and other information demonstrate that the safety and effectiveness of this device versus the predicate device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.
.
{11}------------------------------------------------
| SECTION 5 - 510(k) Summary – | |
|---|---|
| ELITech Clinical Systems ELITROL I and ELITROL II | |
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
| The assigned 510(k) number is: K103747 | |
| Submitter | SEPPIM S.A.S. |
| Address | Zone Industrielle, 61500 SEES, FRANCE |
| Phone number | + 33 (0)2 33 81 21 00 |
| Fax number | + 33 (0)2 33 28 77 51 |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) |
| Date of Preparation | November, 23rd, 2010 |
| 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 CFR 862.1660) |
| Product code | JJX- 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 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. |
| Intended Use | 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. |
{12}------------------------------------------------
| ELITech Clinical Systems Device | Predicate Device | |
|---|---|---|
| ELITROL I / ELITROL II | Roche Precinorm U / Precipath U | |
| Intended use | ELITech Clinical Systems ELITROLI & ELITROL II are multi-parametriccontrol sera for in vitro diagnosticuse in quality control of quantitativeELITech Clinical Systems methodson ELITech Clinical SystemsSelectra analyzers. | For in vitro diagnostic use in qualitycontrol by monitoring accuracy andprecision for the quantitativemethods as specified in the valuesheet |
| Format | Lyophilized human sera withconstituents added as required toobtain desired components levels | Lyophilized human sera withconstituents added as required toobtain 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 date.After 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 & direct as noted in package insert |
Conclusion
The performance data and other information demonstrate that the safety and effectiveness of these devices versus the predicate devices are not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.
{13}------------------------------------------------
Image /page/13/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and an emblem. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. The emblem is a stylized depiction of an eagle or bird with its wings spread, facing right.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
ELITech SEPPIM S.A.S. c/o Debra K Hutson 21720 236d Dr SE. Suite 150 Bothell. WA 98021
MJG 3 1 2011
Rc: K103747
Trade/Device Name:
ELITech Clinical Systems CHOLESTEROL HDL SL 2G, ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR, ELITech Clinical Systems CHOLESTEROL LDL SL 2G, .ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR, and ELITech Clinical Systems ELITROL I and ELITROL II Regulation Number: 21 CFR 862.1475 Regulation Name: LDL & VLDL Precipitation, Cholesterol Via Esterase-Oxidase, HDL Regulatory Class: Class 1, meets limitations per 21 CFR 862.9(c)(4) Product Codes: LBS, JIT, JJY, MRR Dated: August 25, 2011 Received: August 30. 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 class II (Special Controls), 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). This letter
{14}------------------------------------------------
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Virro 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
{15}------------------------------------------------
Indications for Use Form
510(k) Number (if known): K103747
ELITech Clinical Systems CHOLESTEROL HDL SL 2G Device Name: ELITech Clinical Systems CHOLESTEROL HDL 2G CALIBRATOR
Indications for Use:
Reagent:
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.
Calibrator
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.
Prescription Use × (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)
Rute Chalon
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103747
{16}------------------------------------------------
Indications for Use Form
510(k) Number (if known): _K103747
ELITech Clinical Systems CHOLESTEROL LDL SL 2G Device Name: ELITech Clinical Systems CHOLESTEROL LDL 2G CALIBRATOR
Indications for Use:
Reagent:
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.
Calibrator:
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.
Prescription Use × (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)
Rute Anslen
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103747
{17}------------------------------------------------
Indications for Use Form
510(k) Number (if known): K103747
Device Name:
Indications for Use:
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.
Prescription Use × (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)
Rute charlier
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 103747 .
Page 2 of 3
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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.