ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2

Q: Who is the manufacturer of ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2?

Seppim S.A.S. filed the 510(k) submission for ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 (K100525).

Q: What is the FDA product code for ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2?

CGA. It is classified under 21 CFR 862.1345 as a Class 2 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2?

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

Q: What are the predicate devices for ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2?

HORIBA ABX PENTRA GLUCOSE PAP CP (k052007); Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (k033501); Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera (k041227).

Q: Who can help prepare an FDA 510(k) submission like ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2?

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.

K100525 · Seppim S.A.S. · CGA · Dec 15, 2010 · Clinical Chemistry

Device Facts

Record ID	K100525
Device Name	ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2
Applicant	Seppim S.A.S.
Product Code	CGA · Clinical Chemistry
Decision Date	Dec 15, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1345
Device Class	Class 2
Attributes	Pediatric

Intended Use

ELITech Clinical Systems GLUCOSE PAP SL is intended for use with ELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and ELITROL II for the quantitative in vitro diagnostic determination of glucose in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. ELITech Clinical Systems ELITROL I is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. ELITech Clinical Systems ELITROL II is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.

Device Story

Glucose PAP SL reagent; liquid ready-to-use; contains glucose oxidase, peroxidase, 4-aminoantipyrine, phenol. Input: human serum or plasma samples. Principle: enzymatic Trinder method; glucose oxidase oxidizes glucose to gluconic acid and H2O2; peroxidase catalyzes reaction of H2O2 with 4-AAP and phenol to form colored quinoneimine. Output: absorbance at 505 nm proportional to glucose concentration. Used on Vital Scientific Selectra/Flexor analyzers in clinical labs; operated by laboratory technicians. Output used by clinicians to diagnose/monitor carbohydrate metabolism disorders. Benefits: provides quantitative glucose levels for clinical decision-making.

Clinical Evidence

Bench testing only. Precision (CLSI EP5-A2) evaluated over 20 days (n=80 per level); total CV 2.1-2.9%. Linearity (CLSI EP6-A) confirmed 20.0-400.0 mg/dL (r2=0.999). Method comparison (CLSI EP9-A2) against predicate (k052007) using 100 samples yielded y=0.972x+2.4, r=0.999. Matrix comparison (serum vs. lithium-heparin plasma) yielded y=1.002x-0.8, r=0.998. Analytical specificity evaluated against common interferents.

Technological Characteristics

Enzymatic quantitative assay (glucose oxidase/peroxidase). Reagent: liquid, ready-to-use (Phosphate buffer, Phenol, 4-AAP, Glucose oxidase, Peroxidase, sodium azide). Calibrator/Controls: lyophilized human serum. Analyzers: Vital Scientific Selectra/Flexor. Measuring range: 20.0-400.0 mg/dL. Detection: spectrophotometric (505 nm). Standards: CLSI EP5-A2, EP6-A, EP7-A2, EP9-A2, EP17-A.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of glucose in human serum and plasma for diagnosis and treatment of carbohydrate metabolism disorders (diabetes mellitus, neonatal/idiopathic hypoglycemia, pancreatic islet cell carcinoma). Intended for prescription use in clinical laboratory settings; not for Point of Care.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

HORIBA ABX PENTRA GLUCOSE PAP CP (k052007)
Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (k033501)
Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera (k041227)

Related Devices

K153644 — ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II · Elitechgroup · Sep 7, 2016
K041052 — RAICHEM GLUCOSE UV (LIQUID) · Hemagen Diagnostics, Inc. · Jun 30, 2004
K970664 — GLUCOSE REAGENT · Derma Media Lab., Inc. · Aug 1, 1997

Submission Summary (Full Text)

{0}------------------------------------------------ K/oos25 #### DEC 1 5 2010 SECTION 5 - 510(k) Summary ELITech Clinical Systems GLUCOSE PAP SL reagent According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. The assioned 510(k) number is: K100525 Submitter SEPPIM S.A.S. Zone Industrielle, 61500 SEES, FRANCE Address 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) Monday, February 15th 2010 Date of Preparation Device names REAGENT : Trade/proprietary Name: ELITech Clinical Systems GLUCOSE PAP SL Common or Usual Name: Glucose, "GLUCOSE PAP SL" Device Class Class II Classification name Glucose test system (Sec.862.1345) Product code CGA - Glucose Oxidase, Glucose ABX PENTRA GLUCOSE PAP CP (K052007) Predicate device The device for this submission is available as kit only. It consists of 1 Device description reagent, "R." Reagent R consists of Phosphate buffer (pH 7.4), Phenol, 4-Aminoantipyrine (4-AAP), Glucose oxidase (Aspergillus sp.), Peroxidase (horseradish) and sodium azide. ELITech Clinical Systems GLUCOSE PAP SL is intended for use with Intended Use ELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELI-TROL I and ELITROL II on Vital Scientific Selectra/Flexor analyzers for the quantitative in vitro diagnostic determination of glucose in human serum and plasma. It is not intended for use in Point of Care settings. ELITech Clinical Systems GLUCOSE PAP SL is intended to measure Indication(s) for Use - glucose in human serum and plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma {1}------------------------------------------------ ### Comparison to Predicate device | | ELITech Clinical Systems Device GLUCOSE PAP SL | Predicate device (ABX PENTRA GLUCOSE PAP CP) | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | Intended for use with ELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELI- TROL I and ELITROL II on Vital Scientific Selectra/Flexor analyz- ers for the quantitative in vitro diagnostic determination of glu- cose in human serum and plas- ma. It is not intended for use in Point of Care settings. | For in vitro diagnostic use in the quantitative determination of glucose in serum and plasma. | | Indication(s) for Use | Intended to measure glucose in human serum and plasma. Glu- cose measurements are used in the diagnosis and treatment of carbohydrate metabolism disor- ders including diabetes mellitus, neonatal hypoglycemia, and idio- pathic hypoglycemia, and of pan- creatic islet cell carcinoma. | Intended to measure glucose in hu- man serum and plasma. Glucose measurements are used in the diag- nosis and treatment of carbohydrate metabolism disorders including dia- betes mellitus, neonatal hypoglyce- mia, and idiopathic hypoglycemia, and of pancreatic islet cell carci- noma. | | Assay protocol | Enzymatic method using glucose oxidase coupled with peroxidase (Trinder method). | Enzymatic method using glucose oxidase coupled with peroxidase (Trinder method). | | Composition | Reagent R: Phosphate buffer; pH 7.4 13.8 mmol/L ; Phenol 10 mmol/L ; 4-Aminoantipyrine 0.3 mmol/L : Glucose oxidase ≥ 10 000 U/L : Peroxidase ≥ 700 U/L ; Sodium azide < 0.1%; | Reagent : Phosphate buffer; pH 7.4 13.8 mmol/L ; Phenol 10 mmol/L ; 4-Aminoantipyrine 0.3 mmol/L ; Glucose oxidase ≥ 10 000 U/L ; Peroxidase ≥ 700 U/L ; Sodium azide < 0.1%; | | Appearance of reagent | Liquid form, ready to use | Same | | Sample type | Serum Plasma | Serum Plasma | | Reagent storage | Store at 2-8 °C and protected 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 | Serum, plasma 74 - 106 mg/dL | Serum, plasma 74 - 106 mg/dL | | Instrument | SELECTRA JUNIOR | ABX PENTRA 400 | | Measuring range | 20.0 to 400.0 mg/dL Rerun: 800.0 mg/dL | 1.8 to 432 mg/dL Automatic post-dilution: 1296 mg/dL | | Detection | 0.5 mg/dL | 1.8 mg/dL | | Precision | Within run Level 36.5 mg/dL CV=1.6% Level 107.4 mg/dL CV=1.4% Level 301.5 mg/dL CV=1.0% | Within run Level 89.36 mg/dL CV=0.41% Level 230.53 mg/dL CV=0.40% Level 42.76 mg/dL CV=0.62% Level 111.47 mg/dL CV=0.30% Level 296.22 mg/dL CV=0.49% | | | ELITech Clinical Systems Device GLUCOSE PAP SL | Predicate device (ABX PENTRA GLUCOSE PAP CP) | | | Total | Total | | | Level 36.5 mg/dL CV=2.9% | Level 90.20 mg/dL CV=1.23% | | | Level 107.4 mg/dL CV=2.5% | Level 235.44 mg/dL CV=1.12% | | | Level 301.5 mg/dL CV=2.1% | Level 107.18 mg/dL CV=1.44% | | | | Level 298.97 mg/dL CV=1.05% | | Method comparison | y=0.953 x + 3.05 mg/dL $r^2$ = 0.997 range: 17.9 to 417.2 mg/dL | y= 0.98 x + 0.72 mg/dL $r^2$ = 0.9974 | | Limitations | Hemoglobin: Positive bias from 250 mg/dL on low human serum. No significant interference up to 500 mg/dL on medium human serum. Triglycerides: Positive bias from 814 mg/dL. Unconjugated bilirubin: Positive bias from 15 mg/dL on low human serum. Negative bias from 18 mg/dL on medium human serum. Conjugated bilirubin: Negative bias from 8 mg/dL on low human serum and from 18 mg/dL on medium human serum. Ascorbic acid: Negative bias from 2 mg/dL on low human serum and from 12 mg/dL on medium human serum. Uric acid: Negative bias from 19 mg/dL on low human serum. No significant interference up to 24 mg/dL on medium human serum. Methyldopa: Negative bias from 0.9 mg/dL on low human serum. No significant interference up to 1 mg/dL on medium human serum. | Hemoglobin: No significant influence is observed up to 460 mg/dL. Triglycerides: No significant influence is observed up to 613 mg/dL. Total bilirubin: No significant influence is observed up to 8.19 mg/dL. Direct bilirubin: No significant influence is observed up to 5.63 mg/dL. | | Calibration Frequency | 28 days | 11 days | | On board stability | refrigerated area : 28 days | refrigerated area: 83 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}------------------------------------------------ #### 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 predicate device. {3}------------------------------------------------ ## SECTION 5 - 510(k) Summary - ELITech Clinical Systems ELICAL 2 | Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a de- termination of substantial equivalence. | | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | The assigned 510(k) number is: K100525 | | | 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 | Monday, February 15th 2010 | | | Device names | | | | REAGENT : | ELITech Clinical Systems ELICAL 2 | | | 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 Sys- tems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. | | {4}------------------------------------------------ ### Comparison to Predicate device | | 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 Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. | For in vitro diagnostic use in the calibration of quantitative Roche methods on Roche clinical chemis- try 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. | | Stability | Lyophilized: To store at 2-8°C and protected from light until the expiry 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) | Lyophilized: Stable at 2-8°C up to expiration date. 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 | ### Elical 2 assigned values are the following ones: | Components | Under review | Included in this submission | Cleared | |---------------|--------------|--------------------------------|---------| | AST-GOT | | | K093883 | | Glucose | | X | | | Phosphorus | K100263 | | | | Total Protein | | X | | | Urea | K100263 | | | | BUN | K100263 | | | {5}------------------------------------------------ | A-L-A-A-A-A-A-A-A- Uric acıd | K100263 | | | |---------------------------------|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | Cholesteroi | 1 K102993 | A PROPER OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTI Comments of Concession of Children of | Sheep States of Corporary of Career of Carrier of Children Company of Children Company of | | Triglycerides A 80 000 000 | K102993 | | | #### 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 ELITROL I and ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a de- termination of substantial equivalence. | |----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The assigned 510(k) number is: K100525 | | 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 | Monday, February 15th 2010 | | Device names | | | CONTROLS: Trade/proprietary Name: Common or Usual Name: Device Class Classification name Product code | ELITech Clinical Systems ELITROL I and ELITROL II Multi-analyte controls - all kinds, "ELITROL I"- "ELITROL II" Class I Quality control material (assayed and unassayed). (21 CFR 862.1660) 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 is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Sys- tems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. ELITech Clinical Systems ELITROL II is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Sys- tems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. | {7}------------------------------------------------ ### Comparison to Predicate device | | ELITech Clinical Systems Device ELITROL I / ELITROL II | Predicate Device Roche Precinorm U / Precipath U | |--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | ELITech Clinical Systems ELITROL I is a multi-parametric control serum for in vitro diagnostic use in accu- racy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Ana- lyzer and the Vital Scientific Flexor Junior Analyzer. ELITech Clinical Systems ELITROL II is a multi-parametric control se- rum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Jun- ior Analyzer and the Vital Scientific Flexor Junior Analyzer. | For in vitro diagnostic use in quality control by monitoring accuracy and precision for the quantitative meth- ods as specified in the value sheet | | 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. | Lyophilized: Stable at 2-8°C up to expiration date. After reconstitution, the stabilities* are : - 12 hours at 15-25 °C. | #### Elitrol I & Elitrol II assigned values are the following ones: | Components | Under review | Included in this submission | Cleared | |------------|--------------|--------------------------------|---------| | AST-GOT | | | K093883 | | Glucose | | X | | | Phosphorus | K100263 | | | {8}------------------------------------------------ | Total Protein | | X | | |---------------|---------|---|--| | Urea | K100263 | | | | BUN | K100263 | | | | Uric acid | K100263 | | | | Cholesterol | K102993 | | | | Triglycerides | K102993 | | | #### 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. {9}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread, symbolizing the department's mission related to health and well-being. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Seppim S.A.S. c/o Debra K. Hutson ELITechGroup Epoch Biosciences 21720 2310 Dr. SE, Suite 150 Bothell, Washington 98021 DEC 1 5 20:0 Re: k100525 Trade Name: ELITech Clinical Systems Glucose PAP SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL 1 and ELITROL 2 Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: CGA, JIX, JJX Dated: December 13, 2010 Received: December 15, 2010 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). {10}------------------------------------------------ #### 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 Viro 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, CJC. Courthey 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 {11}------------------------------------------------ ## Indications for Use Form 510(k) Number (if known): _K100525 Device Name: Indications for Use: ELITech Clinical Systems GLUCOSE PAP SL is intended for use with ELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and ELITROL II for the quantitative in vitro diagnostic determination of glucose in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. X ____________________________________________________________________________________________________________________________________________________________________________ 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) Division Sign Off Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k/00.25 Page 1 of 3 {12}------------------------------------------------ ## Indications for Use Form 510(k) Number (if known): _K100525 ___________________________________________________________________________________________________________________________________________ DEC 1 5 2010 Device Name: _________ELITech Clinical Systems ELICAL 2_______________________________________________________________________________________________________________________ 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 Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. 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) Ans 25 Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k/00(-2) Page Dof 3 {13}------------------------------------------------ # Indications for Use Form DEC 1 5 2010 510(k) Number (if known): K100525 Device Name: ELITech Clinical Systems ELITROL 1 and ELITROL 2 Indications for Use: ELITech Clinical Systems ELITROL I is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. ELITech Clinical Systems ELITROL II is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers. 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) K100524 Page of 3

ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Welcome

Check your email

Welcome!