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 (K151552).

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.

K151552 · Elitechgroup · JIX · Jul 8, 2015 · Clinical Chemistry

Device Facts

Record ID	K151552
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	Jul 8, 2015
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 Pro Series 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 Pro Series Analyzers.

Device Story

ELICAL 2 and ELITROL I/II are lyophilized human serum-based products used for calibration and quality control of clinical chemistry assays. ELICAL 2 serves as a multi-parametric calibrator; ELITROL I and II serve as two-level quality control sera. Used in clinical laboratories on ELITech Clinical Systems Selectra Pro Series Analyzers. Operators are trained laboratory professionals. The device is reconstituted with distilled/deionized water. Calibration values are assigned by testing against reference materials on Selectra analyzers; control values are assigned via multi-day triplicate testing. Healthcare providers use the calibrator to establish assay accuracy and the control sera to monitor precision and accuracy of patient sample testing. Proper calibration and control ensure reliable quantitative results for clinical decision-making, benefiting patients through accurate diagnostic testing.

Clinical Evidence

Bench testing only. Performance data established through value assignment protocols on Selectra ProM and ProS analyzers. Calibration values assigned based on mean of 48 measurements against reference materials. Control values assigned via triplicate testing over several days to determine median and confidence ranges. No clinical patient data included.

Technological Characteristics

Lyophilized human serum-based calibrator and control sera. Reconstituted with distilled/deionized water. Multi-parametric composition. Stability varies by analyte (e.g., bilirubin exceptions). Designed for use on ELITech Clinical Systems Selectra Pro Series Analyzers. No electronic components or software algorithms integral to the calibrator/control products themselves.

Indications for Use

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

Related Devices

K130765 — ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II · Elitechgroup · Apr 4, 2013
K112029 — ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 · Elitechgroup · Aug 30, 2011
K102016 — PRECICONTROL CLINCHEM MULTI 1 AND 2 · Roche Diagnostics · Sep 1, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 8, 2015 ELITECH GROUP C/O DEBRA HUTSON VICE PRESIDENT REGULATORY AFFAIRS/ QUALITY AFFAIRS 21720 23RD DRIVE SE, SUITE 150 BOTHELL WA 98021 Re: K151552 Trade/Device Name: ELITech Clinical Systems ELICAL 2 ELITech Clinical Systems ELITROL I ELITech Clinical Systems ELITROL II Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIX, JJY Dated: June 8, 2015 Received: June 9, 2015 Dear Debra 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 Parts 801 and 809); 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 {1}------------------------------------------------ electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Katherine Serrano -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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) k151552 # Device Name ELITech Clinical Systems ELICAL 2 ## Indications for Use (Describe) 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 Pro Series Analyzers. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) k151552 ## Device Name ELITech Clinical Systems ELITROL I ELITech Clinical Systems ELITROL II ## Indications for Use (Describe) ELITech Clinical Systems 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 Pro Series Analyzers. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {4}------------------------------------------------ ## 510(k) Summary # | 1. | Date: | July 6, 2015 | |-----------|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. | Submitter: | ELITech Clinical Systems SAS Zone Industrielle 61500 SEES FRANCE | | 3. | Contact Person: | Debra K. Hutson VP RA/QA, EGI 21720 23rd Dr SE, Suite 150 Bothell, WA 98021 Phone: 425-482-5174 Fax: 425-482-5550 Email: d.hutson@elitechgroup.com | | 4. 4.a | Device Description: Classification | ELITech Clinical Systems ELICAL 2 Class II JIX Clinical Chemistry 21 CFR 862.1150 | | 4.b | Device Description: Classification | ELITech Clinical Systems ELITROL I and ELITROL I Class I JJY Clinical Chemistry 21CFR862.1660 | | 5. 5.a | Predicate Device: | K033501 Roche Diagnostics Calibrator for Diagnostics Systems (C f.a.s) | | 5.b | Predicate Device: | K041127 Roche Diagnostics Precinorm U & Precipath U | {5}------------------------------------------------ 6. 6.a 6.b Intended Use ELITech Clinical Systems ELICAL 2 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 Pro Series Analyzers. Special conditions for use statement(s): Rx ONLY This device is intended for professional use and in vitro diagnostic only. CAUTION: Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner. Special instrument requirements: For use with ELITech Clinical Systems Selectra Pro Series Analyzers. Performance data was obtained on the Selectra ProM and ProS Analyzers. Intended Use ELITech Clinical Systems ELITROL I and ELITROL II > 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 Pro Series Analyzers. Special conditions for use statement(s): Rx ONLY This device is intended for professional use and in vitro diagnostic only. CAUTION: Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner. Special instrument requirements: For use with ELITech Clinical Systems Selectra Pro Series Analyzers. Performance data was obtained on the Selectra ProM and ProS Analyzers. #### Device Descriptions 7. - ELITech Clinical Systems ELICAL 2 7.a 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 FDAapproved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A {6}------------------------------------------------ #### 7.b ELITech Clinical Systems ELITROL I and ELITROL II 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. Analyte submission history: ELITech Clinical Systems ELICAL 2. ELITech Clinical Systems ELITROL I and ELITech Clinical Systems ELITROL II were initially cleared under k093883. Additional analytes were added to the labeling in k100263, k100525, k102993, k103376, k102647, k110780, k110830, k112029, k122083 and k122858. This submission adds values for constituents to enable the devices to be used for the calibration and control of tests for IRON FERENE (exempt) and MAGNESIUM XYLIDYL (previously cleared under k040508). The new constituents' values have been added to the labeling for ELICAL 2 and ELITROL I & II. #### 8. Substantial Equivalence Information #### 8.a Calibrator - 1. Predicate Device Name - Calibrator for Diagnostics Systems (C f.a.s) - 2. K033501 - 3. Comparison with predicate ## Similarities | Parameter | New Device ELITech Clinical Systems ELICAL 2 | Predicate Device Calibrator for Diagnostics Systems (C 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 Pro Series Analyzers. | Calibrator for automated systems (C.f.a.s.) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers 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. | {7}------------------------------------------------ | Parameter | New Device ELITech Clinical Systems ELICAL 2 | Predicate Device Calibrator for Diagnostics Systems (C f.a.s), K033501 | |--------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | 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. | | Parameter | New Device ELITech Clinical Systems ELICAL 2 | Predicate Device Calibrator for Diagnostics Systems (C f.a.s), K033501 | |-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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) - 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) | 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) - 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) | #### 8.b Controls - - 1. Predicate Device Name Precinorm U & Precipath U - - 2. K041127 3. Comparison with predicate ## Similarities | Parameter | New Device ELITech Clinical Systems ELITROL I & II | Predicate Device Precinorm U & Precipath U, K041127 | |--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative | For in vitro diagnostic use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheet. | | Parameter | New Device ELITech Clinical Systems ELITROL I & II | Predicate Device Precinorm U & Precipath U, K041127 | | | ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series 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) | {8}------------------------------------------------ {9}------------------------------------------------ #### 9. Stability ELITech Clinical Systems ELICAL 2 is purchased from a commercial vendor (previously cleared under k033501). The following is claimed for stability: ELICAL 2 is stable until the expiration date printed on the label when stored at 2-8°C prior to reconstitution. After reconstitution stability is 8 hours when stored at 15-25°C, 2 days at 2-8°C or 4 weeks between (-25)-(-15) C (when frozen once). The labeling states that the ELICAL 2 should be stored tightly capped and protected from light when not in use ELITech Clinical Systems ELITROL I & II is purchased from a commercial vendor (previously cleared under k041227). The following is claimed for stability: Before reconstitution, the shelf-life of the ELITech Clinical Systems ELITROL I and ELITROL II stored at 2-8°C is until the expiry date on the label. After reconstitution the stability is 12 hours when stored at 15-25°C, 5 days when stored at 2-8°C or 4 weeks between (-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) - 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). #### 10. Value Assignment For each analyte requiring value assignment, the new lot of ELITech Clinical Systems ELICAL 2 is tested against the appropriate standard reference material on two separate ELITech Clinical Systems Selectra analyzers using the relevant ELITech Clinical Systems assay reagents. The mean analyte value is calculated and a target value is assigned on a minimum of 48 measurements taken. Verification of the value assignment is performed by calibrating with the new lot's assigned values and measuring quality control material at two levels and verifying that the values obtained are within the labeled range of the quality control. For each analyte that requires value assignment, the new lot of ELITech Clinical Systems ELITROL I & II is tested using two separate ELITech Clinical Systems Selectra analyzers. Each sample is tested in triplicate over several days. The target value of Level I and II are the median of the observed values range. After validation of the target value, a confidence range (high and low values) is then calculated. #### 11. Standard/Guidance Document Reference No applicable mandatory performance standards or special controls exist for this device. #### 12. 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.