ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05

Q: Who is the manufacturer of ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05?

Elitechgroup filed the 510(k) submission for ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 (K112029).

Q: What is the FDA product code for ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05?

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 MODEL CALI-05?

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 MODEL CALI-05?

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.

K112029 · Elitechgroup · JIX · Aug 30, 2011 · Clinical Chemistry

Device Facts

Record ID	K112029
Device Name	ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05
Applicant	Elitechgroup
Product Code	JIX · Clinical Chemistry
Decision Date	Aug 30, 2011
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 & 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

ELITech Clinical Systems ELICAL 2 (calibrator) and ELITROL I/II (quality control sera) are lyophilized human serum-based products used to calibrate and monitor quantitative clinical chemistry assays on ELITech Selectra analyzers. These products are sourced from a commercial vendor and re-labeled. The calibrator ensures accurate system calibration, while the controls verify assay performance. Healthcare providers, such as laboratory technicians, reconstitute the lyophilized material with distilled or deionized water and run the samples on the Selectra analyzer. The analyzer compares the measured values against assigned target ranges provided in lot-specific value sheets. If results fall outside specified ranges, the provider performs recalibration or maintenance. These products benefit patients by ensuring the accuracy and reliability of clinical chemistry test results used for diagnosis and monitoring.

Clinical Evidence

Bench testing only. No clinical data provided. Verification of calibrator and control values was performed by running samples in quadruplicate on two Selectra analyzers using two reagent lots. Results were compared against assigned bottle values, with acceptance criteria set at +/- 9% of the previously assigned values.

Technological Characteristics

Lyophilized human serum-based calibrator and control materials. Reconstitution required with distilled or deionized water. Stability: 2-8°C unopened; specific post-reconstitution stability windows provided for 15-25°C, 2-8°C, and -25 to -15°C. Traceability to IFCC formulations and ERM-AD454. Designed for use on ELITech Clinical Systems Selectra analyzers.

Indications for Use

Indicated for in vitro diagnostic use as a multi-parametric calibrator (ELICAL 2) and multi-parametric control sera (ELITROL I & II) for quantitative clinical chemistry assays on ELITech Clinical Systems Selectra analyzers.

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.

Predicate Devices

Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (K033501)
Roche Diagnostics Precinorm U (K041227)
Roche Diagnostics Precipath U (K041227)

Related Devices

K130765 — ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II · Elitechgroup · Apr 4, 2013
K151552 — ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II · Elitechgroup · Jul 8, 2015
K102016 — PRECICONTROL CLINCHEM MULTI 1 AND 2 · Roche Diagnostics · Sep 1, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ ## SECTION 8 - 510(k) Summary AUG 3 0 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: K112029 | | 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 | July 14, 2011 | | Device names | | | 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 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 Selec- tra Analyzers. | 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 | | | ELITech Clinical Systems Device (ELICAL 2) | Predicate device (Roche Calibrator f.a.s. K033501) | | 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 | Lyophilized: Stable at 2-8°C up to expiration date. | | | After reconstitution, the stabilities are : | After reconstitution, the stabilities* are : | | | Between 15-25 °C: 8 hours | - 8 hours at 15-25 °C. | | | Between 2-8 °C: 2 days Between (-25)-(-15) °C: 4 weeks (when frozen once) | - 2 days at 2-8 °C. - 4 weeks at Between (-25)-(-15) °C (when frozen once) | | | Exceptions : - Stability of direct bilirubin (when stored protected from light): | Exception for bilirubin total & direct - Stability of direct bilirubin (when stored protected from light): | | | Between 15-25 °C: 3 hours | Between 15-25 °C: 3 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 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: 6 hours | Between 15-25 °C: 6 hours | | | Between 2-8 °C: 1 day Between (-25)-(-15) °C: 2 weeks (when frozen once) | Between 2-8 °C: 1 day Between (-25)-(-15) °C: 2 weeks (when frozen once) | · {1}------------------------------------------------ {2}------------------------------------------------ | Device name | | |---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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) 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 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. | ### 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 of quantitative ELITech Clinical Systems methods on ELITech Clin- ical Systems Selectra Analyzers. | 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 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. | {3}------------------------------------------------ | | ELITech Clinical Systems Device (ELITROL I / ELITROL II) | Predicate Device (Roche Precinorm U / Precipath U K041227) | |-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 : Between 15-25 °C : 12 hours Between 2-8 °C : 5 days Between (-25)-(-15) °C : 4 weeks (when frozen once) | 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) | | | 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) | *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: 1 day 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) | #### 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 device is substantially equivalent to its respective predicate device. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 ELITechGroup SEPPIM S.A.S. Epoch Biosciences c/o Ms. Debra K. Hutson 21720 23 rd Dr SE Suite 150 Bothell, Washington 98021 AUG 300 2011 Re: k112029 Trade Name: ELITech Clinical Systems ELICAL 2 ELITech Clinical Systems ELITROL I /II Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIX, JJY Dated: July 14, 2011 Received: July 15, 2011 Dear Ms. Hutson: We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) prematic is substantially equivalent (for the indications referenced above and have determined the device is desires marketed in intersta for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrossile) to regally manage province and one of the Enderal Food. Drug commerce prior to May 20, 1970, the chacinent with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with as personal application (PMA). and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The You may, therefore, market the device, subject to the gentration, listing of the arguint misting and general controls provisions of the received requirementibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified (see adove) into online sits). The subjecting your device it may be subject to such additional controls. Existing marts 800 to 805. In additio it may be subject to such additional controllar controllers (CFR), Parts 800 to 895. In addition, FDA can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 can be found in Thic 21, Code of I occrain concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issuality of a subscribe with other requirements of the Act that FDA has made a determination that your device of the requirements of the Act that FDA nas made a decirimation in and regulations administered by other Federal agencies. You must or any Federal statutes and regulations dominations on registration and listing (21 comply with all the Act's requirements, including, assocting (reporting (reporting of comply with all the Act 3 requirements 801 and 809); medical device reporting of CFR Part 807); labeling (21 CFR Parts (11 and 800); and monufacturing practice CFR Part 807); labeling (21 CFR 803); and good manufacturing practice medical device-iclated adverse ovelity systems (QS) regulation (21 CFR Part 820). {5}------------------------------------------------ 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, G.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 {6}------------------------------------------------ # Indications for Use Form 510(k) Number (if known): K112029 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) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) AND/OR 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) K112029 Page 1 of {7}------------------------------------------------ # Indications for Use Form 510(k) Number (if known): K 11 JD2 ELITech Clinical Systems ELITROL I & ELITROL II Device Name: Indications for Use: ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers. Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) AND/OR Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k< 11 2029 Page 1 of

ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05

Device Facts

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Device Story

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Predicate Devices

Related Devices

Submission Summary (Full Text)

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ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05

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

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