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 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.

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 the regulatory submission for calibration and control devices (ELITech Clinical Systems ELICAL 2, ELITROL I, and ELITROL II) for use with Lipase testing on ELITech Clinical Systems Selectra Analyzers. The focus of the submission is to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating the device's performance in diagnosing patients.

Therefore, many of the requested points, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types related to diagnostic performance of an AI model, are not applicable to this type of device submission.

The "study" referenced in this document is a value assignment and verification process for the calibrator and control materials, not a clinical trial of a diagnostic device.

Here's the information that can be extracted from the provided text, adapted to the context of a calibrator and control material:

1. Table of Acceptance Criteria and Reported Device Performance (for Lipase value assignment):

Acceptance Criteria (for Lipase Value Assignment)	Reported Device Performance (for Lipase Value Assignment)
Calibration factor of control lots systems must be within an acceptance range.	The document states this criterion was met.
Value obtained for lipase must be ±9% of the target value.	The document states this criterion was met.

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

Test Set (for ELICAL 2 Lipase Value Assignment): "The test system" was calibrated using "a previously qualified lot of ELICAL 2 and two different approved lot of lipase reagents." The amount of lipase in the "new lot of ELICAL 2" was then measured. The exact number of measurements or samples within this process is not specified, but it involves a comparison against two different approved lots of lipase reagents.
Test Set (for ELITROL I and ELITROL II Lipase Value Assignment): "The test system" was calibrated 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 II." The exact number of measurements or samples within this process is not specified but involves a comparison against two different approved lots of lipase test reagents.
Data Provenance: The data is generated internally by ELITech Clinical Systems as part of their manufacturing and quality control process for calibrators and control materials. No country of origin for the "data" as clinical patient data is provided, as it's a lab-based calibration process. This is a prospective process for each new manufacturing lot.

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

Not Applicable. The "ground truth" here is the established value of lipase in the calibrator/control material, which is determined through internal procedures and traceability to a titrimetric manual method, not through consensus of human experts interpreting diagnostic results.

4. Adjudication method for the test set:

Not Applicable. As the "ground truth" is a measured value against a target, there is no expert adjudication involved in the typical sense of interpreting clinical data. The process involves meeting predefined numerical acceptance criteria.

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 is not a diagnostic AI device; it's a calibrator/control material. MRMC studies are not relevant here.

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

Not Applicable. This is not an algorithm or AI device. Its purpose is to ensure the accuracy of laboratory measurements by providing known reference points (calibrators) and quality control materials.

7. The type of ground truth used:

For ELICAL 2 and ELITROL I/II: The "ground truth" for the lipase values is established through a process traceable to a titrimetric manual method. This serves as the reference standard against which the device's assigned values are verified. The ultimate "ground truth" is therefore a chemical/analytical reference standard.

8. The sample size for the training set:

Not Applicable. This is not a machine learning or AI device that requires a training set. The "training" of the device is its manufacturing and formulation.

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

Not Applicable. No training set is used. The inherent "ground truth" for the calibrator and control materials is their chemical composition and the established lipase activity, which is then verified against a titrimetric manual method.

Summary

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510(k) Summary
Introduction	According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence.	APR 4 2013
	The assigned 510(k) number is: K130765
SubmitterAddressPhone numberFax 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 usewith testing LIPASE. The devices, ELITech Clinical Systems ELICAL 2 andELITech Clinical Systems ELITROL I and ELITROL II, have been clearedpreviously for use with testing other constituents. The LIPASE constituenthas always been present as part of the formulation of the devices; thedesign and composition of the devices remains the same as it was whencleared previously for uses with testing other analytes. All the otherpreviously cleared analytes remain the same for stability, value assignmentprocedure, and traceability. K numbers for the previously clearedconstituents are K110830, K112029, K122858, K093883, K110780, K102993,K122083, K112029, K100525, K100263 and K102647.
Device names:(Proprietary names)	ELITech Clinical Systems ELICAL 2ELITech 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. CALIBRATORTrade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code	ELITech Clinical Systems ELICAL 2Calibrator, multi-analyte mixtureClass IICalibrator (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 onhuman serum containing constituents to ensure optimal calibration.ELICAL 2 is prepared exclusively from the blood of donors tested individuallyand found to be negative for HbsAg and to antibodies to HCV and HIVaccording to FDA-approved methods or methods in compliance with theEuropean Directive 98/79/EC, Annex II, List A.

、:

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Intended Use

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 calibratorfor in vitro diagnostic use in thecalibration of quantitative ELITechClinical Systems methods onELITech Clinical SystemsSelectra Analyzers.	For in vitro diagnostic use in thecalibration of quantitative Rochemethods on Roche clinicalchemistry analysers as specified inthe value sheets.
Format	Lyophilized calibrator based onhuman serum with constituentsadded as required to obtain desiredcomponents levels	Lyophilized calibrator based onhuman serum with constituentsadded as required to obtain desiredcomponents levels
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, avoidingthe loss of lyophilizate, and pipettein exactly 3 mL of distilled/deionizedwater. Carefully close the bottle anddissolve the contents completely byoccasional gentle swirling within 30minutes. Avoid the formation offoam.
Traceability	Traceability information is given inthe value sheet included in the box.	Traceability of the target value isgiven in the respective instructionfor use of the system reagents.
Stability	Lyophilized:To store at 2-8°C and protectedfrom light until the expiry dateAfter reconstitution, the stabilitiesare: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)	Lyophilized:Stable at 2-8°C up to expirationdate.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 (whenstored protected from light):Between 15-25 °C: 3 hoursBetween 2-8 °C: 8 hoursBetween (-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 (whenstored protected from light):Between 15-25 °C: 6 hoursBetween 2-8 °C: 1 dayBetween (-25)-(-15) °C: 2 weeks(when frozen once)	- Stability of total bilirubin (whenstored protected from light):Between 15-25 °C: 6 hoursBetween 2-8 °C: 1 dayBetween (-25)-(-15) °C: 2 weeks(when frozen once)
Traceability:	ELITech Clinical Systems ELICAL 2 is traceable to values established usinga 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 bycalibrating the test system using a previously qualified lot of ELICAL 2 andtwo different approved lot of lipase reagents and then measuring the amountof lipase in the new lot of ELICAL 2. The calibration factor of the control lotssystems must be within an acceptance range. The value obtained for lipasemust be ±9% of the target value in order for the lot to be accepted.
Device name
2. CONTROLSTrade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code	ELITech Clinical Systems ELITROL I and ELITROL IIMulti-analyte controls - all kindsClass I, reservedQuality 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 qualitycontrol products consisting of lyophilized human serum containing constituentsat desired levels.Elitrol I and Elitrol II are prepared exclusively from the blood of donors testedindividually and found to be negative for HbsAg and to antibodies to HCV andHIV according to FDA-approved methods or methods in compliance with theEuropean Directive 98/79/EC, Annex II, List A.
Intended Use	ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametriccontrol sera for in vitro diagnostic use in quality control of quantitative ELITechClinical Systems methods on EliTech Clinical Systems Selectra Analyzers.

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Comparison to Predicate device

	ELITech Clinical Systems Device(ELITROL I / ELITROL II)	Predicate Device(Roche Precinorm U / Precipath UK041227)
Intended use	ELITech Clinical Systems ELITROLI and ELITROL II are multi-parametric control sera for in vitrodiagnostic use in accuracy control	For in vitro diagnostic use in qualitycontrol by monitoring accuracy andprecision for the quantitative methodsas specified in the value sheet.
	ELITech Clinical Systems Device(ELITROL I / ELITROL II)	Predicate Device(Roche Precinorm U / Precipath UK041227)
	of quantitative ELITech ClinicalSystems methods on ELITechClinical Systems SelectraAnalyzers.
Format	Lyophilized human sera withconstituents added as required toobtain desired components levels.	Lyophilized human sera withconstituents added as required toobtain desired 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 formation offoam.	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 protectedfrom light until the expiry dateAfter reconstitution, the stabilitiesare: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 (whenstored protected 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 (whenfrozen once)*Exception for bilirubin total & directas noted in package insert:- 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 (whenstored protected 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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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.

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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.

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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.

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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

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Indications for Use Form

510(k) Number (if known): K130765

ELITech Clinical Systems ELICAL 2 Device Name:

Indications for Use:

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

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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:

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

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.