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 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 FDAapproved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
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.

AI/ML Overview

The provided text describes information about the ELITech Clinical Systems ELICAL 2 (calibrator) and ELITROL I & II (control sera), specifically for the addition of new constituents (IRON FERENE and MAGNESIUM XYLIDYL). It focuses on demonstrating substantial equivalence to predicate devices rather than independent clinical performance studies for complex AI/ML devices. Therefore, much of the requested information (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable or not present in this document.

However, I can extract the acceptance criteria and performance related to the stability and value assignment for these in vitro diagnostic devices. The studies conducted are primarily focused on demonstrating the equivalency of the new lots/constituents to the existing product and predicate devices, and ensuring appropriate stability and accurate value assignment.

Here's an attempt to structure the available information according to your request, with explicit notes about what information is not present:

Acceptance Criteria and Reported Device Performance

The provided document describes the acceptance criteria and testing for ELITech Clinical Systems ELICAL 2 (calibrator) and ELITech Clinical Systems ELITROL I & II (control sera). The primary performance parameters evaluated are stability and value assignment. The study aims to demonstrate substantial equivalence to predicate devices by showing comparable performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

Feature	Device: ELITech Clinical Systems ELICAL 2 (Calibrator)	Device: ELITech Clinical Systems ELITROL I & II (Control Sera)
Intended Use	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.	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.
Acceptance Criteria (Stability)	Lyophilized: Stable at 2-8°C until expiration date. After Reconstitution: - 15-25°C: 8 hours - 2-8°C: 2 days - (-25)-(-15)°C: 4 weeks (frozen once) Exceptions (when stored protected from light): - Direct Bilirubin: 15-25°C: 3 hours, 2-8°C: 8 hours, (-25)-(-15)°C: 2 weeks (frozen once) - Total Bilirubin: 15-25°C: 6 hours, 2-8°C: 1 day, (-25)-(-15)°C: 2 weeks (frozen once)	Lyophilized: Stable at 2-8°C until expiration date. After Reconstitution: - 15-25°C: 12 hours - 2-8°C: 5 days - (-25)-(-15)°C: 4 weeks (frozen once) Exceptions (when stored protected from light): - Direct Bilirubin: 15-25°C: 4 hours, 2-8°C: 8 hours, (-25)-(-15)°C: 2 weeks (frozen once) - Total Bilirubin: 15-25°C: 8 hours, 2-8°C: 1 day, (-25)-(-15)°C: 2 weeks (frozen once)
Reported Performance (Stability)	Confirmed to meet acceptance criteria (stated by "The following is claimed for stability:" and "The devices met all acceptance criteria"). The reported stability values match the acceptance criteria as they are directly stated.	Confirmed to meet acceptance criteria (stated by "The following is claimed for stability:" and "The devices met all acceptance criteria"). The reported stability values match the acceptance criteria as they are directly stated.
Acceptance Criteria (Value Assignment)	For ELICAL 2: The mean analyte value is calculated based on measurements against appropriate standard reference material. Verification is performed by calibrating with new lot's assigned values and measuring quality control material at two levels, verifying that obtained values are within the labeled range of the quality control.	For ELITROL I & II: Target value for Level I and II is the median of the observed values range. A confidence range (high and low values) is calculated after validation of the target value. The expectation is that the controls perform as expected within these ranges.
Reported Performance (Value Assignment)	Confirmed to meet acceptance criteria (stated by "The performance data...demonstrate...that they met all acceptance criteria"). The process of value assignment described implies that the assigned values and subsequent QC measurements were within acceptance.	Confirmed to meet acceptance criteria (stated by "The performance data...demonstrate...that they met all acceptance criteria"). The process of value assignment described implies that the assigned values and subsequent confidence ranges were within acceptance.
Substantial Equivalence	Demonstrated by comparison to predicate device K033501 (Roche Diagnostics Calibrator for Diagnostics Systems (C f.a.s)) showing similarities in intended use, format, level, handling, traceability, and stability.	Demonstrated by comparison to predicate device K041127 (Roche Diagnostics Precinorm U & Precipath U) showing similarities in intended use, format, levels, handling, and stability.

2. Sample size used for the test set and the data provenance:

ELICAL 2 (Calibrator):
- For Value Assignment: "a target value is assigned on a minimum of 48 measurements taken." This is the number of measurements used to establish the value for each analyte.
- Data Provenance: Not explicitly stated (e.g., country of origin). The submitter, ELITech Clinical Systems SAS, is located in France. The predicate devices are Roche Diagnostics (a global company). The data is presented as prospective testing of new lots/constituents to establish their values and stability.
ELITROL I & II (Control Sera):
- For Value Assignment: "Each sample is tested in triplicate over several days using two separate ELITech Clinical Systems Selectra analyzers." A specific total number of measurements is not provided, but it implies multiple triplicate measurements.
- Data Provenance: Not explicitly stated (e.g., country of origin). The submitter, ELITech Clinical Systems SAS, is located in France. The predicate devices are Roche Diagnostics. The data is presented as prospective testing of new lots/constituents to establish their values and stability.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is an in vitro diagnostic device for calibrators and control sera. The "ground truth" for these types of devices is established through analytical methods and reference materials, not expert consensus (e.g., radiologists interpreting images). The values are determined by analytical measurement against appropriate standards.

4. Adjudication method for the test set:

Not Applicable. As the "ground truth" is established by analytical methods and reference materials, there is no expert adjudication process involved. The results are quantitative measurements compared against established standards or internal criteria.
- For ELICAL 2, value assignment verification involved checking if measurements of quality control material fell within a labeled range.
- For ELITROL I & II, the target value was the median of observed values, and a confidence range was calculated, indicating an analytical determination rather than adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This document describes in vitro diagnostic calibrators and control sera, not AI-powered image analysis or diagnostic systems that involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This document describes in vitro diagnostic calibrators and control sera. These devices are reagents used in automated analytical instruments (Selectra Pro Series Analyzers), and their performance is inherent to the chemical properties and manufacturing process, not an algorithm. The "performance" is how accurately and reproducibly they can be used to calibrate and control other assays, which is assessed analytically.

7. The type of ground truth used:

Analytical Standards/Reference Materials & Internal Consistency:
- For ELICAL 2 (Calibrator): The ground truth for value assignment is established by testing against "appropriate standard reference material" on two separate analyzers. This means the values are traced to known, highly accurate reference standards.
- For ELITROL I & II (Control Sera): The "target value" is determined as "the median of the observed values range" from multiple measurements on two analyzers. This indicates an internal analytical consensus approach based on repetitive testing and statistical methods to establish the expected control range.

8. The sample size for the training set:

Not Applicable / Not provided. These are in vitro diagnostic reagents, not AI/ML algorithms that require training sets in the computational sense. The document describes processes for establishing performance characteristics of a manufactured product (calibrators and control sera).

9. How the ground truth for the training set was established:

Not Applicable. (See point 8).

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K151552

Device Name

ELITech Clinical Systems ELICAL 2

Indications for Use (Describe)

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.

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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."

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.

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510(k) Summary

1.	Date:	July 6, 2015
2.	Submitter:	ELITech Clinical Systems SASZone Industrielle61500 SEESFRANCE
3.	Contact Person:	Debra K. HutsonVP RA/QA, EGI21720 23rd Dr SE, Suite 150Bothell, WA 98021Phone: 425-482-5174Fax: 425-482-5550Email: d.hutson@elitechgroup.com
4.4.a	Device Description:Classification	ELITech Clinical Systems ELICAL 2Class IIJIXClinical Chemistry21 CFR 862.1150
4.b	Device Description:Classification	ELITech Clinical Systems ELITROL I and ELITROL IClass IJJYClinical Chemistry21CFR862.1660
5.5.a	Predicate Device:	K033501Roche DiagnosticsCalibrator for Diagnostics Systems (C f.a.s)
5.b	Predicate Device:	K041127Roche DiagnosticsPrecinorm U & Precipath U

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6.b

Intended Use

ELITech Clinical Systems ELICAL 2

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

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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)
1. K033501
1. Comparison with predicate

Similarities

Parameter	New DeviceELITech Clinical SystemsELICAL 2	Predicate DeviceCalibrator for Diagnostics Systems(C f.a.s), K033501
Intended use	ELITech Clinical Systems ELICAL 2 isa multi-parametric calibrator for in vitrodiagnostic use in the calibration ofquantitative ELITech Clinical Systemsmethods on ELITech Clinical SystemsSelectra Pro Series Analyzers.	Calibrator for automated systems(C.f.a.s.) is for use in the calibration ofquantitative Roche methods on Rocheclinical chemistry analyzers as specifiedin the value sheets.
Format	Lyophilized calibrator based on humanserum with constituents added asrequired to obtain desired componentslevels	Lyophilized calibrator based on humanserum with constituents added asrequired to obtain desired componentslevels
Level	Single level	Single level
Handling	Carefully open the vial, avoiding theloss of lyophilizate, and pipette inexactly 3 mL of distilled/deionizedwater. Carefully close the vial anddissolve the contents completely byoccasional gentle swirling within 30minutes avoiding the formation offoam.	Carefully open one bottle, avoiding theloss of lyophilizate, and pipette inexactly 3 mL of distilled/deionizedwater. Carefully close the bottle anddissolve the contents completely byoccasional gentle swirling within 30minutes. Avoid the formation of foam.

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Parameter	New DeviceELITech Clinical SystemsELICAL 2	Predicate DeviceCalibrator for Diagnostics Systems(C f.a.s), K033501
Traceability	Traceability information is given in thevalue sheet included in the box.	Traceability of the target value is givenin the respective instruction for use ofthe system reagents.

Parameter	New DeviceELITech Clinical SystemsELICAL 2	Predicate DeviceCalibrator for Diagnostics Systems(C f.a.s), K033501
Stability	Lyophilized:To store at 2-8°C and protected fromlight until the expiry dateAfter reconstitution, the stabilities are :Between 15-25 °C : 8 hoursBetween 2-8 °C : 2 daysBetween (-25)-(-15) °C : 4 weeks(when frozen once)Exceptions :- Stability of direct bilirubin (whenstored protected from light):Between 15-25 °C: 3 hoursBetween 2-8 °C: 8 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once)- Stability of total bilirubin (when storedprotected from light):Between 15-25 °C: 6 hoursBetween 2-8 °C: 1 dayBetween (-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 storedprotected from light):Between 15-25 °C: 3 hoursBetween 2-8 °C 8 hoursBetween (-25)-(-15) °C: 2 weeks (whenfrozen once)- Stability of total bilirubin (when stored protected from light):Between 15-25 °C: 6 hoursBetween 2-8 °C: 1 dayBetween (-25)-(-15) °C: 2 weeks(when frozen once)

8.b Controls

1. Predicate Device Name
  Precinorm U & Precipath U
1. K041127

Comparison with predicate

Similarities

Parameter	New DeviceELITech Clinical SystemsELITROL I & II	Predicate DevicePrecinorm U & Precipath U, K041127
Intended use	ELITech Clinical Systems ELITROL I &ELITROL II are multi-parametriccontrol sera for in vitro diagnostic usein quality control of quantitative	For in vitro diagnostic use in qualitycontrol by monitoring accuracy andprecision for the quantitative methodsas specified in the value sheet.
Parameter	New DeviceELITech Clinical SystemsELITROL I & II	Predicate DevicePrecinorm U & Precipath U, K041127
	ELITech Clinical Systems methods onELITech Clinical Systems Selectra ProSeries Analyzers.
Format	Lyophilized human sera withconstituents added as required toobtain desired components levels.	Lyophilized human sera withconstituents added as required to obtaindesired components levels.
Levels	Two levels	Two levels
Handling	Carefully open the vial, avoiding theloss of lyophilizate, and pipette inexactly 5 mL of distilled/deionizedwater. Carefully close the vial anddissolve the contents completely byoccasional gentle swirling within 30minutes avoiding the formationoffoam.	Carefully open the bottle, avoiding theloss of lyophilizate, and pipette inexactly 5 mL of distilled/deionizedwater. Carefully close the bottle anddissolve the contents completely byoccasional gentle swirling within 30minutes. Avoid the formation of foam.
Stability	Lyophilized:To store at 2-8°C and protected fromlight until the expiry dateAfter reconstitution, the stabilities are :Between 15-25 °C :12 hoursBetween 2-8 °C :5 daysBetween (-25)-(-15) °C : 4 weeks(when frozen once)Exceptions:- Stability of direct bilirubin (whenstored protected from light):Between 15-25 °C:4 hoursBetween 2-8 °C:8 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once)- Stability of total bilirubin (when storedprotected from light):Between 15-25 °C:8 hoursBetween 2-8 °C:1 dayBetween (-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 frozenonce)*Exception for bilirubin total & direct asnoted in package insert:- Stability of direct bilirubin (when storedprotected from light):Between 15-25 °C:4 hoursBetween 2-8 °C:8 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once)- Stability of total bilirubin (when storedprotected from light):Between 15-25 °C:8 hoursBetween 2-8 °C:24 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once)

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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.

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
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.)(b)
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.