ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II

Q: Who is the manufacturer of ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II?

Elitechgroup filed the 510(k) submission for ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II (K130765).

Q: What is the FDA product code for ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II?

JIX. It is classified under 21 CFR 862.1150 as a Class 2 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II?

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

Q: Who can help prepare an FDA 510(k) submission like ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II?

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.

K130765 · Elitechgroup · JIX · Apr 4, 2013 · Clinical Chemistry

Device Facts

Record ID	K130765
Device Name	ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II
Applicant	Elitechgroup
Product Code	JIX · Clinical Chemistry
Decision Date	Apr 4, 2013
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 862.1150
Device Class	Class 2

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 ELITech Clinical Systems Selectra Analyzers. ELITech Clinical Systems ELITROL I and 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.

Device Story

ELICAL 2 and ELITROL I/II are lyophilized human serum-based products used for calibration and quality control of quantitative assays on ELITech Clinical Systems Selectra Analyzers. ELICAL 2 provides calibration for quantitative methods; ELITROL I and II serve as multi-parametric controls to monitor accuracy and precision. Used in clinical laboratory settings by trained laboratory personnel. The calibrator and controls are reconstituted with distilled/deionized water. Healthcare providers use the resulting calibration and control data to ensure the accuracy of patient sample testing performed on the Selectra analyzers. These products help maintain the reliability of diagnostic results, supporting clinical decision-making by ensuring the analytical system is performing within established specifications.

Clinical Evidence

Bench testing only. Evidence includes value assignment verification for lipase, where target values were verified by calibrating the test system using previously qualified lots and measuring lipase levels. Acceptance criteria required values to be within ±9% of the target. Stability data for lyophilized and reconstituted states (including bilirubin exceptions) were compared to predicates.

Technological Characteristics

Lyophilized human serum-based calibrator and control sera. Prepared from human donor blood tested negative for HbsAg, HCV, and HIV. Reconstituted with distilled/deionized water. Designed for use on ELITech Clinical Systems Selectra Analyzers. Stability profiles provided for various temperature ranges (15-25°C, 2-8°C, -25 to -15°C).

Indications for Use

Indicated for in vitro diagnostic use as a multi-parametric calibrator (ELICAL 2) and quality control sera (ELITROL I and II) for quantitative ELITech Clinical Systems methods on Selectra analyzers. No specific patient population, age, or gender restrictions are defined.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Related Devices

K151552 — ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II · Elitechgroup · Jul 8, 2015
K112029 — ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 · Elitechgroup · Aug 30, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ | 510(k) Summary | | | | |--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|------------| | 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. | | APR 4 2013 | | | The assigned 510(k) number is: k130765 | | | | Submitter Address Phone number Fax number | ELITech Clinical Systems 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 | March 12th, 2013 | | | | | Purpose of this submission: To obtain clearance for the devices named in this submission for use with testing LIPASE. The devices, ELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and ELITROL II, have been cleared previously for use with testing other constituents. The LIPASE constituent has always been present as part of the formulation of the devices; the design and composition of the devices remains the same as it was when cleared previously for uses with testing other analytes. All the other previously cleared analytes remain the same for stability, value assignment procedure, and traceability. K numbers for the previously cleared constituents are k110830, k112029, k122858, k093883, k110780, k102993, k122083, k112029, k100525, k100263 and k102647. | | | | Device names: (Proprietary names) | ELITech Clinical Systems ELICAL 2 ELITech Clinical Systems ELITROL I and ELITROL II | | | | Predicate devices: | Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (k033501) Roche Diagnostics Precinorm U/Precipath U (k041227) | | | | Device names | | | | | 1. CALIBRATOR Trade/proprietary Name: Common or Usual Name: Device Class Classification name Product code | ELITech Clinical Systems ELICAL 2 Calibrator, multi-analyte mixture Class II Calibrator (21 CFR 862.1150) 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 according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A. | | | : 、: s ・・・・・ · {1}------------------------------------------------ #### 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 ELITech Clinical Systems Selectra Analyzers. ### Comparison to Predicate device . . | | ELITech Clinical Systems Device (ELICAL 2) | Predicate device (Roche Calibrator f.a.s. K033501) | |------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 ELITech Clinical Systems Selectra 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 lyophilizate, 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 lyophilizate, 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: Between 15-25 °C: 8 hours Between 2-8 °C: 2 days Between (-25)-(-15) °C: 4 weeks (when frozen once), Exceptions: - Stability of direct bilirubin (when stored protected from light): Between 15-25 °C: 3 hours Between 2-8 °C: 8 hours Between (-25)-(-15) °C: 2 weeks (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 Between (-25)-(-15) °C (when frozen once) Exception for bilirubin total & direct - Stability of direct bilirubin (when stored protected from light): Between 15-25 °C: 3 hours Between 2-8 °C: 8 hours Between (-25)-(-15) °C: 2 weeks (when frozen once) | | | ELITech Clinical Systems Device (ELICAL 2) | Predicate device (Roche Calibrator f.a.s. K033501) | | | - Stability of total bilirubin (when stored protected from light): Between 15-25 °C: 6 hours Between 2-8 °C: 1 day Between (-25)-(-15) °C: 2 weeks (when frozen once) | - Stability of total bilirubin (when stored protected from light): Between 15-25 °C: 6 hours Between 2-8 °C: 1 day Between (-25)-(-15) °C: 2 weeks (when frozen once) | | Traceability: | ELITech Clinical Systems ELICAL 2 is traceable to values established using a titrimetric manual method. | | | Value Assignment: | A target value for lipase is set for the production for the new lot of ELICAL 2. The ELITech Clinical Systems ELICAL 2 value for lipase is verified by calibrating the test system using a previously qualified lot of ELICAL 2 and two different approved lot of lipase reagents and then measuring the amount of lipase in the new lot of ELICAL 2. The calibration factor of the control lots systems must be within an acceptance range. The value obtained for lipase must be ±9% of the target value in order for the lot to be accepted. | | | Device name | | | | 2. 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 Class I, reserved Quality control material (assayed and unassayed). (21 CFR 862.1660) 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 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 and 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. | | {2}------------------------------------------------ ### Comparison to Predicate device | | ELITech Clinical Systems Device (ELITROL I / ELITROL II) | Predicate Device (Roche Precinorm U / Precipath U K041227) | |--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | ELITech Clinical Systems ELITROL I and ELITROL II are multi- parametric control sera for in vitro diagnostic use in accuracy control | For in vitro diagnostic use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheet. | | | ELITech Clinical Systems Device (ELITROL I / ELITROL II) | Predicate Device (Roche Precinorm U / Precipath U K041227) | | | of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Analyzers. | | | Format | Lyophilized human sera with constituents added as required to obtain desired components levels. | Lyophilized human sera with constituents added as required to obtain desired components levels. | | Levels | Two levels | Two levels | | Handling | Carefully open the vial, avoiding the loss of lyophilizate, 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 lyophilizate, 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: Between 15-25 °C: 12 hours Between 2-8 °C: 5 days Between (-25)-(-15) °C: 4 weeks (when frozen once) Exceptions: - Stability of direct bilirubin (when stored protected from light): Between 15-25 °C: 4 hours Between 2-8 °C: 8 hours Between (-25)-(-15) °C: 2 weeks (when frozen once) - Stability of total bilirubin (when stored protected from light): Between 15-25 °C: 8 hours Between 2-8 °C: 1 day Between (-25)-(-15) °C: 2 weeks (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: - Stability of direct bilirubin (when stored protected from light): Between 15-25 °C: 4 hours Between 2-8 °C: 8 hours Between (-25)-(-15) °C: 2 weeks (when frozen once) - Stability of total bilirubin (when stored protected from light): Between 15-25 °C: 8 hours Between 2-8 °C: 24 hours Between (-25)-(-15) °C: 2 weeks (when frozen once) | {3}------------------------------------------------ Traceability: ELITech Clinical Systems ELITROL I and ELITROL II are traceable to values established using a titrimetric manual method. Value Assignment: A target value for lipase is set for the production for the new lots of ELITROL I and ELITROL II. The ELITech Clinical Systems ELITROL I and ELITROL II values for lipase are verified by calibrating the test system using a previously qualified lot of ELICAL 2 with two different approved lots of lipase test reagents and then measuring the amount of lipase in the new lots of ELITROL i and ELITROL 11. The calibration factor of the control lots systems must be within an acceptance range. The values obtained for lipase must be ±9% of the target value in order for the lots to be accepted. {4}------------------------------------------------ #### 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 they met all acceptance criteria, demonstrating that . the devices are substantially equivalent to their respective predicate devices. {5}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized symbol. The symbol is a graphic representation of a person embracing a bird, which is meant to symbolize the agency's mission of protecting and promoting the health and well-being of Americans. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 ### April 4, 2013 ELITechgroup Epoch Biosciences C/O Debra K. Hutson 21720 23rd Drive. SE BOTHELL WA 98021 Re: K130765 Trade/Device Name: ELITech Clinical Systems ELICAL 2 ELITech Clinical Systems ELITROL 1 and ELITROL 2 Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIX, JJY Dated: March 19, 2013 Received: March 20, 2013 ### 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {6}------------------------------------------------ Page 2-Ms. Hutson If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Carol C. Benson -S for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Indications for Use Form 510(k) Number (if known): k130765 ELITech Clinical Systems ELICAL 2 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 ELITech Clinical Systems Selectra 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 Diagnostics and Radiological Health (OIR) ## Ruth A. Chester S. Division Sign-Off Office of In Vitro Diagnostics and Radiological Health k130765 510(k) Page 1 of 2 {8}------------------------------------------------ # Indications for Use Form 510(k) Number (if known): ___k130765_ Device Name: ELITech Clinical Systems ELITROL I ELITech Clinical Systems ELITROL II 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 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 Diagnostics and Radiological Health (OIR) ## Ruth A. Chesler -S Division Sign-Off Office of In Vitro Diagnostics and Radiological Health k130765 510(k) Page 2 of 2

ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II

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ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Related Devices

Submission Summary (Full Text)

Panel 1

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Product Code Matches

Special Control Matches

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