Who can help prepare an FDA 510(k) submission like ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL

Q: Who is the manufacturer of ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL?

Seppim S.A.S. filed the 510(k) submission for ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL (K102993).

Q: What is the FDA product code for ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL?

CDT. It is classified under 21 CFR 862.1705 as a Class 1 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL?

Horiba ABX PENTRA Cholesterol CP (k060854); Horiba ABX PENTRA Triglycerides CP (k060854); Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (k033501); Roche Diagnostics Precinorm U and Precipath U (k041227).

K102993 · Seppim S.A.S. · CDT · May 19, 2011 · Clinical Chemistry

Device Facts

Record ID	K102993
Device Name	ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL
Applicant	Seppim S.A.S.
Product Code	CDT · Clinical Chemistry
Decision Date	May 19, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1705
Device Class	Class 1

Intended 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. 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. 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.

Device Story

System uses enzymatic colorimetric assays to measure cholesterol and triglycerides in human serum/plasma; performed on Vital Scientific Selectra/Flexor analyzers. Cholesterol assay: cholesterol esterase/oxidase/peroxidase reaction produces quinoneimine complex; absorbance measured at 505 nm. Triglyceride assay: lipoprotein lipase/glycerol kinase/glycerol-3-phosphate oxidase/peroxidase reaction produces quinoneimine complex; absorbance measured at 505 nm. System includes calibrator (ELICAL 2) and controls (ELITROL I/II). Operated by laboratory personnel in clinical settings. Output is quantitative concentration (mg/dL) used by physicians to diagnose/treat lipid metabolism disorders and monitor patients with diabetes, nephrosis, or liver obstruction.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (n=80 per sample). Linearity per CLSI EP6-A (R^2 > 0.999). Interference testing per CLSI EP7-A. Method comparison against predicate (n=99) showed high correlation (r=0.999) for both assays. Traceability established via ID-MS reference method and CRMLN certification.

Technological Characteristics

Enzymatic colorimetric assays. Triglycerides reagent: Pipes buffer, Lipoprotein lipase, Glycerol kinase, Glycerol-3-phosphate oxidase, Peroxidase. Cholesterol reagent: Pipes buffer, Cholesterol esterase, Cholesterol oxidase, Peroxidase. Liquid, ready-to-use format. Calibrator/Controls: Lyophilized human serum-based. Analyzers: Vital Scientific Selectra/Flexor. Storage: 2-8°C. No software algorithm details provided.

Indications for Use

Indicated for quantitative measurement of triglycerides and cholesterol in human serum and plasma to aid in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, lipid metabolism disorders, and endocrine disorders. Calibrator and controls are indicated for use with ELITech Clinical Systems methods on Selectra/Flexor analyzers.

Regulatory Classification

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.

Predicate Devices

Horiba ABX PENTRA Cholesterol CP (k060854)
Horiba ABX PENTRA Triglycerides CP (k060854)
Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (k033501)
Roche Diagnostics Precinorm U and Precipath U (k041227)

Related Devices

K034000 — VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR · Clinical Data, Inc. · Mar 10, 2004
K060854 — ABX PENTRA 400: LIPOPROTEINS · Horiba Abx · Aug 24, 2006
K122757 — ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT · Alfa Wassermann Diagnostic Technologies, Inc. · Oct 5, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ . | SECTION 5 - 510(k) Summary ELITech Clinical Systems TRIGLYCERIDES SL reagent MAY 19 2011 | | | |----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of sub- stantial equivalence. | | | | The assigned 510(k) number is: _K102993_ | | | Submitter Address Phone number Fax 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 Class Classification name Product code | ELITech Clinical Systems TRIGLYCERIDES SL Triglycerides, "TRIGLYCERIDES SL" Class I Triglyceride 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 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), 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 and plasma 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 measure triglycerides in human serum and plasma. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, neph- rosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. | | {1}------------------------------------------------ | | ELITech Clinical Systems Device TRIGLYCERIDES SL | Predicate device (ABX PENTRA TRIGLYCERIDES CP) | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | For in vitro diagnostic use in the quan- titative determination of triglycerides in serum or plasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. | For in vitro diagnostic use in the quan- titative determination of triglycerides in serum or plasma. | | Indication for Use | Intended to measure triglycerides in human serum and plasma. Triglyc- erides 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. | Intended to measure triglycerides in human serum and plasma. Triglyc- erides 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. | | 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 | Serum Plasma in lithium heparin | Serum Plasma in lithium heparin | | Reagent storage | Store at 2-8 °C and protect from light. The reagent is stable until the expiry date stated on the label. | Reagents, in unopened cassette, are stable up to expiry date on the label if stored at 2-8 °C. | | Expected values | Normal : < 150 mg/dL Bordeline high : 150-199 mg/dL High : 200-499 mg/dL Very high : ≥ 500 mg/dL | Normal: < 150 mg/dl Low risk: 150 - 200 mg/dl High: 200 - 500 mg/dl Extremely 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 run Level 48 mg/dL CV=1.5% Level 142 mg/dL CV=1.0% Level 273 mg/dL CV=0.7% Total | Within run Level 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 Device TRIGLYCERIDES 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/dL r²= 0.998 range: 22 to 936 mg/dL | y=0.99x + 0.20 mg/dL r²= 0.9994 range: 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/dL Hemoglobin: No significant interference up to 250 mg/dL. Uric acid: No significant interference up to 23.6 mg/dL 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 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) | {2}------------------------------------------------ ### 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) {3}------------------------------------------------ | 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), Cholesterol esterase (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 and plasma 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 measure cholesterol in human serum and plasma. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess choles- terol in the blood and lipid and lipoprotein metabolism disorders. | | | ELITech Clinical Systems Device CHOLESTEROL SL | Predicate device (ABX PENTRA CHOLESTEROL CP) | |----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | For in vitro diagnostic use in the quan- titative determination of cholesterol in serum or plasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. | For in vitro diagnostic use in the quan- titative determination of cholesterol in serum or plasma. | | Indication for Use | Cholesterol measurements are used in the diagnosis and treatment of dis- orders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. | Cholesterol measurements are used in the diagnosis and treatment of dis- orders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. | | Assay protocol | Enzymatic colorimetric method using cholesterol esterase/ cholesterol oxidase coupled with peroxidase (Trinder method). | Enzymatic colorimetric method using cholesterol esterase/ cholesterol oxi- dase coupled with peroxidase (Trinder method). | | 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 | Serum Plasma in lithium heparin | Serum Plasma in lithium heparin | | Reagent storage | Store at 2-8°C and protect from light. The reagent is stable until the expiry date stated on the label. | Reagents, in unopened cassette, are stable up to expiry date on the label if stored at 2-8°C and contamination is avoided. | | Expected values | Desirable: < 200 mg/dL Bordeline high: 200-239 mg/dL High: ≥ 240 mg/dL | Desirable: ≤ 200 mg/dl Borderline high risk: 200-239 mg/dL High risk: > 240 mg/dL | | | ELITech Clinical Systems Device CHOLESTEROL 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 run Level 116 mg/dL CV=2.4% Level 190 mg/dL CV=1.9% Level 298 mg/dL CV=1.7% Total Level 116 mg/dL CV=2.6% Level 190 mg/dL CV=2.7% Level 298 mg/dL CV=2.7% | Within run Level 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% Total Level 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 $r^2$ = 0.999 range: 20 to 579 mg/dL | y=0.95x + 1.90 mg/dL $r^2$ = 0.9943 range: 2.55 to 583.26 mg/dL | | Cholesterol Reference Laboratory 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 (Pathologic control) | {4}------------------------------------------------ {5}------------------------------------------------ . ### 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 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 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 vitro diagnostic 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. | {6}------------------------------------------------ | | ELITech Clinical Systems Device (ELICAL 2) | Predicate device (Roche Calibrator f.a.s.) | |-----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Stability | Lyophilized: To store at 2-8°C and protected from light until the expiry date | Lyophilized: Stable at 2-8°C up to expiration date. | | | After reconstitution, the stabilities are : - 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 (when frozen once) | | | | *Exception for bilirubin total & direct as 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 CFR 862.1660) | | 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 quality control 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 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 multiparametric control sera for use in quality control of ELITech Clinical Systems methods on ELITech Vital Scientific Selectra/Flexor Analyzers. | | | ELITech Clinical Systems Device ELITROL I / ELITROL II | Predicate Device Roche Precinorm U / Precipath U | |--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | ELITech Clinical Systems ELITROL I & ELITROL II are multiparametric control sera for use in quality con- trol of ELITech Clinical Systems methods on ELITech Vital Scientific | For in vitro diagnostic use in quality control by monitoring accuracy and precision for the quantitative meth- ods as specified in the value sheet | {7}------------------------------------------------ | | 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 the loss of lyophilate, and pipette in exactly 5 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 the bottle, avoiding the loss of lyophilate, and pipette in exactly 5 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. | | Stability | Lyophilized: To store at 2-8°C and protected from light until the expiry date After reconstitution, the stabilities are: - 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 expiration date. After reconstitution, the stabilities* are: - 12 hours at 15-25 °C. - 5 days at 2-8 °C. - 4 weeks at (-25)-(-15) °C (when frozen 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 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. {8}------------------------------------------------ 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). {9}------------------------------------------------ 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 {10}------------------------------------------------ 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 {11}------------------------------------------------ 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 {12}------------------------------------------------ 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 {13}------------------------------------------------ 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

ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL

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ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

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Predicate Devices

Related Devices

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