ELITech Clinical Systems CK NAC SL is intended for the quantitative in vitro determination of creatine kinase (CK) in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Creatine phosphokinase and its isoenzymes measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

Device Description

CK NAC SL is available as kit only. It consists of 2 reagents R1 & reagent R2: Reagent R1 contains: Imidazole buffer (pH 6.10), D-Glucose, N-Acetyl-L-Cysteine, Magnesium acetate, NADP, EDTA, Hexokinase (microorganisms), sodium azide. Reagent R2 contains: Creatine phosphate, ADP, AMP, Diadenosine pentaphosphate, Glucose-6-phosphate Dehydrogenase (G-6-PDH) (micro-organisms), sodium azide.

ELITech Clinical Systems ELICAL2 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 the antibodies to HCV and HIV according to FDA-approved methods.

ELITROL I and ELITROL II are two level quality control products consisting of a 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.

AI/ML Overview

Here's an analysis of the provided text regarding the ELITech Clinical Systems CK NAC SL device, focusing on acceptance criteria and supporting studies:

Preface: This document primarily details the analytical performance of the ELITech Clinical Systems CK NAC SL reagent, calibrator (ELICAL 2), and controls (ELITROL I and ELITROL II). It is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than defining novel clinical acceptance criteria. The "acceptance criteria" in this context refer to the performance metrics that the device achieved and that were deemed acceptable for substantial equivalence. There are no explicit "acceptance criteria" presented as threshold values that needed to be met; rather, the successful demonstration of performance comparable to the predicate device and established guidelines served as the de facto acceptance.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned above, explicit numerical acceptance criteria were not predefined in the document. Instead, the reported performance metrics were presented and implicitly accepted if they demonstrated substantial equivalence and adherence to CLSI guidelines. The table below summarizes the key performance characteristics reported for the ELITech Clinical Systems CK NAC SL, its calibrator, and controls.

Performance Metric Category	Specific Test/Parameter	Reported Device Performance (ELITech Clinical Systems CK NAC SL)	Notes / Implicit Acceptance Criteria Context
Precision	Within-run CV% (Level 1)	0.7% (Mean 147 U/L)	Results demonstrate good precision, aligning with typical IVD requirements for reproducibility.
	Within-run CV% (Level 2)	1.1% (Mean 406 U/L)
	Within-run CV% (Level 3)	1.1% (Mean 1154 U/L)
	Total CV% (Level 1)	1.7% (Mean 147 U/L)
	Total CV% (Level 2)	2.4% (Mean 406 U/L)
	Total CV% (Level 3)	3.9% (Mean 1154 U/L)
Linearity/Assay Range	Measuring Range	10 to 1714 U/L	Assessed per CLSI EP6-A. Considered acceptable for the intended use.
	Upper Linearity (with dilution)	17140 U/L
Detection Limit	Limit of Detection (LoD)	1 U/L	Determined per CLSI EP17-A. Represents the lowest detectable concentration.
	Limit of Quantification (LoQ)	5 U/L	Determined per CLSI EP17-A. Represents the lowest quantifiable concentration.
Interference	Unconjugated Bilirubin	No significant interference up to 30.0 mg/dL	"No significant interference" defined as within ± 10% recovery.
	Conjugated Bilirubin	No significant interference up to 29.5 mg/dL
	Triglycerides	No significant interference up to 3133 mg/dL
	Acetaminophen	No significant interference up to 30 mg/dL
	Ascorbic Acid	No significant interference up to 20.0 mg/dL
	Acetylsalicylic Acid	No significant interference up to 200 mg/dL
Method Comparison	Correlation (y = 1.012x + 2)	r = 0.998, r² = 0.995, Sy.x = 29 U/L	Compared against Roche Diagnostics CKL on cobas c111. High correlation coefficient (`r`) and `r²` indicate strong agreement, supporting substantial equivalence.
Matrix Comparison	Serum vs. Plasma (y = 0.939x + 9)	r = 1.000, r² = 1.000, Sy.x = 9 U/L	Compares serum and lithium heparin plasma samples. Extremely high correlation indicates suitability for both sample types.
Stability (CK NAC SL)	On-board stability	28 days	Established through real-time studies.
	Shelf-life	14 months (followed on 3 batches)	Established through real-time studies.
Stability (ELITROL I/II)	Shelf-life (unreconst.)	30 months at 2-8°C	Based on a commercial vendor (K041227).
	Reconstituted stability	12h (15-25°C), 5 days (2-8°C), 4 weeks (frozen once) (-25 to -15°C)	Based on a commercial vendor (K041227).
Stability (ELICAL 2)	Shelf-life (unreconst.)	Until expiration date printed on label (2-8°C)	Based on a commercial vendor (K033501).
	Reconstituted stability	8 hours (15-25°C), 2 days (2-8°C), 4 weeks (frozen once) (-25 to -15°C)	Based on a commercial vendor (K033501).

2. Sample Size Used for the Test Set and Data Provenance

Precision Study:
- Sample Size: For each of the 3 levels of samples, 'n' = 80 measurements were performed (presumably 2 runs/day x 2 measures/run x 20 days).
- Data Provenance: Not explicitly stated, but typically these studies use commercially available control materials or pooled patient samples. Given the context of IVD submissions, these would be laboratory-generated data, likely in a controlled environment. The country of origin is not specified, but the submitter is ELITech Clinical Systems SEPPIM S.A.S in France, so the studies were likely conducted within their facilities or partner labs. Retrospective or prospective is not specified, but it would be prospective data collection for the study.
Linearity/Assay Reportable Range:
- Sample Size: Not explicitly stated how many samples were used, but it involved multiple dilutions across the claimed range.
- Data Provenance: Not specified, but laboratory-generated.
Detection Limit:
- Sample Size: 15 measurements of 4 samples (total 60 measurements) with low analyte concentrations.
- Data Provenance: Not specified, but laboratory-generated.
Interference Study:
- Sample Size: Not explicitly stated how many samples were initially spiked with interferents, but the results describe "concentrations up to..." of various interferents.
- Data Provenance: Not specified, but laboratory-generated using spiked samples.
Method Comparison Study:
- Sample Size: 100 patient serum samples.
- Data Provenance: "100 serum patient samples." The country of origin is not specified. This is prospective data collected for the study.
Matrix Comparison Study:
- Sample Size: 40 paired serum and lithium heparin plasma samples.
- Data Provenance: Patient samples. Country of origin not specified. This is prospective data collected for the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For this type of in vitro diagnostic device (IVD) for quantitative measurement of creatine kinase (CK), the "ground truth" for the test set is established by:

Reference Methods: The values of calibrators and control materials are traceable to the IFCC method (Schumann, 2002), which is a widely accepted international reference method for enzymes. This method itself (and its development) would involve expert consensus and established protocols.
Predicate Device Measurements: In the method comparison study, the predicate device (Roche Diagnostics CKL on a cobas c111 analyzer) essentially serves as the "ground truth" or reference for comparison, reflecting its established accuracy and validation.
Internal Validation: The value assignment for Elitrol I and II and Elical 2 involves testing against predetermined values on multiple instruments and calculation of median/mean values. This process is overseen by qualified laboratory personnel, but not typically "experts" in the sense of clinicians establishing a diagnosis.

Number of Experts: Not applicable in the traditional sense of medical experts reviewing individual cases. The ground truth relies on established analytical methods and comparisons to a legally marketed predicate device.
Qualifications of Experts: Not applicable for establishing ground truth of individual cases. The reference methods (e.g., IFCC) are developed and maintained by international bodies comprising experts in clinical chemistry and enzymology.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies where a human expert consensus is required for complex qualitative or semi-quantitative assessments (e.g., image interpretation, pathology review).

For this quantitative diagnostic device performing biochemical measurements, such adjudication methods are not applicable. The "adjudication" is inherent in the analytical methods themselves:

Agreement with Reference Method: Traceability to the IFCC method provides the "gold standard."
Agreement with Predicate Device: The method comparison study assesses device performance against a legally marketed, previously cleared device.
Statistical Analysis: Performance is assessed using statistical methods (e.g., regression analysis, CV%) rather than expert consensus on individual data points.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement

No, an MRMC comparative effectiveness study was not done.

MRMC studies are typically performed for devices that involve human interpretation, such as diagnostic imaging systems where multiple readers evaluate cases with and without AI assistance to measure improvements in diagnostic accuracy, efficiency, or confidence.

This submission is for a fully automated in vitro diagnostic reagent and associated calibrators/controls, where the analysis is performed by an instrument (ELITech Clinical Systems Selectra analyzers). There is no "human reader" component in the analytical process that the device assists, therefore, an MRMC study and related effect sizes are not relevant here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The entire performance evaluation described for the ELITech Clinical Systems CK NAC SL device (precision, linearity, detection limits, interference, method comparison, matrix comparison) represents standalone performance.

The device is an "algorithm only" (or rather, a reagent-based chemistry system) that provides quantitative results. There is no human intervention in the generation of the CK concentration value itself beyond the initial sample loading and instrument setup. The performance studies detailed in the submission are precisely evaluating this standalone analytical performance.

7. The Type of Ground Truth Used

The ground truth used for the performance studies is multi-faceted:

Reference Method Traceability: For calibrators and controls, the values are traceable to the IFCC method (Schumann, 2002), which is an international reference method for creatine kinase. This is a highly robust and standardized form of ground truth based on rigorously defined analytical procedures.
Predicate Device Values: For the method comparison study, the measurements obtained from the legally marketed Roche Diagnostics CKL reagent on a cobas c111 analyzer served as the comparative ground truth. This is a common approach in 510(k) submissions to demonstrate substantial equivalence.
Spiked Samples/Known Concentrations: For studies like linearity, detection limits, and interference, samples prepared with known concentrations of the analyte or interferents are used.

8. The Sample Size for the Training Set

The document describes performance studies, which are analogous to validation or test sets. It does not provide information on a "training set".

This type of device (a chemical reagent kit for measuring biomarkers) typically does not involve machine learning algorithms that require a distinct training set in the way AI/ML software devices do. Its analytical characteristics are determined by the chemical principles of the assay and optimization through traditional laboratory methods, not by training on a large dataset of results.

9. How the Ground Truth for the Training Set Was Established

As noted in section 8, there is no explicit "training set" reported for this device in the context of an AI/ML algorithm. Therefore, the question of how ground truth for a training set was established is not applicable.

Any internal development and optimization of the reagent formulation or instrument parameters would be based on established chemical principles, analytical testing, and potentially iterative refinement to meet desired performance benchmarks, rather than training on a separate labeled dataset.

Summary

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122083

510(k) Summary

ELITech Clinical Systems CK NAC SL AUG 222 2012 July 11, 2012 1. Date: ELITech Clinical Systems SEPPIM S.A.S 2. Submitter: Zone Industrielle 61500 SEES FRANCE 3. Contact Person: Debra K. Hutson Director, QARA, North America 21720 23rd Dr SE, Suite 150 Bothell, WA 98021 Phone: 425-482-5174 425-482-5550 Fax: Email: d.hutson@elitechgroup.com ELITech Clinical Systems CK NAC SL 4. Device Description: Classification Class II JHW Clinical Chemistry 21 CFR 862.1215 ELITech Clinical Systems ELICAL 2 Device Description: Classification Class II ﺍﻟﺬ Clinical Chemistry 21 CFR 862.1150 ELITech Clinical Systems ELITROL I and ELITROL II Device Description: Class I, reserved Classification JJY Clinical Chemistry 21 CFR 862.1660 K063744 5. Predicate Device: Roche Diagnostics CKL K033501 Roche Diagnostics Calibrator for Automated Systems (C.f.a.s.) K041227 Roche Diagnostics Precinorm and Precipath 6. Intended Use ELITech Clinical Systems CK NAC SL is intended for the quantitative Reagents: in vitro determination of creatine kinase (CK) in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Creatine phosphokinase and its isoenzymes measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as

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	progressive. Duchenne-type muscular dystrophy.
Calibrators:	ELITech Clinical Systems ELICAL 2 is a multi-parametric calibratorfor in vitro diagnostic use in the calibration of quantitative ELITechClinical Systems methods on ELITech Clinical Systems Selectraanalyzers.
Controls:	ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use in accuracy controlof quantitative ELITech Clinical Systems methods on ELITech ClinicalSystems Selectra analyzers.

Special conditions for use statement(s):

Prescription Use Only. It is not intended for use in Point of Care settings.

Special instrument requirements: Performance was provided for the ELITech Clinical Systems Selectra ProM.

Device Description 7.

Substantial Equivalence Information -8.

Assav

1. Predicate Device Name Roche Diagnostics CKL
1. K063744
1. Comparison with predicate

Similarities

Parameter	CK NAC SL	Roche Diagnostics CKL
Intended Use	Intended for the quantitative in vitro determination of creatine kinase (CK) in human serum and plasma on ELITech Clinical Systems Selectra analyzers.It is not intended for use in Point of Care settings.	In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma on the cobas c111 system.

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Specimen Type	Serum and Plasma free ofhemolysis 1,2	Same
Assay Technology	Kinetic U.V. method	Same
Calibration frequency	28 days	Same

Differences

Parameter	CK NAC SL	Roche Diagnostics CKL
Assay Range	10 - 1714 U/L	7 — 2000 U/L
Instrument	Selectra ProM analyzer	cobas c111
Calibrator	Recommended calibrationmaterial (not included):ELITech Clinical SystemsELICAL 2	Recommended calibrationmaterial (not included):Roche Calibrator f.a.s.
Interference	Triglycerides: No significantinterference up to 3000 mg/dL.Unconjugated bilirubin: Nosignificant interference up to30.0 mg/dL (513 µmol/L).Conjugated bilirubin: Nosignificant interference up to29.5 mg/dL (504 µmol/L).Ascorbic acid: No significantinterference up to 20.0 mg/dL.Acetaminophen: Nosignificant interference up to30.0 mg/dL.Acetylsalicylic acid: Nosignificant interference up to200.0 mg/dL.	Hemoglobin: No significantinterference up to an H Indexof 100 (approximate 100mg/dL).Lipemia (Intralipid): Nosignificant influence up to an Lindex of 1000. icterus: Nosignificant influence up to iIndex of 15 (approximateconjugated and unconjugatedbilirubin concentration of 15mg/dL (257µmol/L)).
Reference Range	Serum/plasma: 3	Serum/plasma:
	Men: < 171 U/L	Men: < 191 U/L
	Women: < 145 U/L	Women: < 170 U/L

Control

1. Predicate Device Name:
- Roche Diagnostics Precinorm U and Precipath U
1. K041227
1. Comparison with predicate

1 Hørder M, Elser RC, Gerhardt W, Mathieu M. Sampson EJ.International Federation of Clinical Chemistry, Committee on Enzymes. Approved recommendation on IFCC methods for the measurement of catalytic concentration for enzymes. Part 7. IFCC method for creatine kinase. Eur.J Clin Chem Clin Biochem 1991; 29:435-56.

2 Gerhard Schumann, Roberto Bonora, Ferruccio Ceriotti, Pascale Clerc-Renaud, Carlo A. Ferrero, IFCC Primary Reference Procedures for the Measurement

of Catalytic Activity Concentrations of Enzymes at 37°C Part 2. Reference Procedure for the Measurement of Catalytic Concentration of Creatine Kinase, Clin Chem Lab Med 2002; 40(6):635-642.

3 Schumann, G., et al., Clin. Chem. Lab. Med., (2002), 40, 635-42.

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Similarities and Differences
Item	Candidate Device(ELITech Clinical SystemsELITROL I and ELITROLII)	PredicateRoche DiagnosticsPrecinorm U and Precipath U(K041227)
Intended Use/Indications forUse	ELITech Clinical SystemsELITROL I and ELITROL 11are multi-parametric controlsera for in vitro diagnosticuse in quality control ofquantitative ELITechClinical Systems methods onELITech Clinical SystemsSelectra Analyzers.	Precinorm U is for use in qualitycontrol by monitoring accuracyand precision for the quantitativemethods as specified in thevalue sheets.Precipath U is for use inquality control by monitoringaccuracy and precision forthe quantitative methods asspecified in the value sheets.
Format	Lyophilized human sera withconstituents added asrequired to obtain definedcomponent levels	Same
Levels	Two Levels (Level I andLevel II)	Same
Stability	Lyophilized: Store at 2-8°Cand protected from light untilthe expiry date. AfterReconstitution: 12 hoursbetween 15-25°C, 5 daysbetween 2-8°C, 4 weeksbetween -25 and -15°C(when frozen once)	Same

Calibrator

1. Predicate Device Name:
Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) 2. K033501
1. Comparison with predicate

Similarities and Differences
Item	Candidate Device(ELITech Clinical SystemsELICAL 2)	PredicateRoche Calibrator forAutomated Systems (C.f.a.s.)K033501
Intended Use/Indications forUse	ELITech Clinical SystemsELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in thecalibration of quantitativeELITech Clinical Systemsmethods on ELITech ClinicalSystems Selectra analyzers.	Calibrator for automated systems(C.f.a.s.) is for use in thecalibrationof quantitative Roche methodson Roche clinical chemistryanalyzersas specified in the value sheets.
Format	Lyophilized calibrator basedon human serum withconstituents added as	Same

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	requires to obtain desiredcomponent levels
Level	Single Level	Same
Stability	Lyophilized: store at 2-8°Cand protect from light until theexpiry date.After reconstitution: 8 hoursbetween 15-25°C, 2 daysbetween 2-8°C, 4 weeksbetween -25 and -15°C(when frozen once)	Same

9. Standard/Guidance Document Reference

Evaluation of Precision Performance of Quantitative Measurement Methods; . Approved Guideline-Second Edition. CLSI (NCCLS) document EP5-A2, Vol 24, No. 25, August 2004.
. Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline. CLSI (NCCLS) document EP17-A, vol 24, No. 34, October 2004.
Method Comparison and Bias estimation Using Patient Samples, Approved . Guideline-Second Edition. CLSI (NCCLS) document EP9-A2-IR, Vol 30, No. 17, July 2010.
. Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use: Guidance for Industry and FDA Staff, November 2004.
Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. . CLSI (NCCLS) document EP07-A2, Vol 25, No. 27, November 2005.
Evaluation of the Linearity of the Measurement of Quantitative Procedures: a . Statistical Approach; Approved Guideline. CLSI (NCCLS) document EP6-A, Vol 23, No. 16, April 2003.

Test Principle: 10.

UV Method.

Creatine Phosphate + ADP	Creatine kinaseCreatine + ATP
ATP + D-Glucose	HexokinaseD-Glucose-6-Phosphate + ADP
G-6-P + NADP +	G-6-PDHD-Gluconate-6-Phosphate + NADPH + H+

Where:
G-6-P: D-Glucose-6-Phosphate and G-6-PDH: Glucose-6-Phosphate Dehydrogenase.

The increase of NADPH concentration is directly proportional to the enzymatic CK activity.

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Performance Characteristics - Analytical Performance 11.

a. Precision/Reproducibility

The precision of the device was determined in accordance with Evaluation of Precision Performance of Quantitative Measurement Methods: Approved Guideline-Second Edition. CLSI (NCCLS) document EP5-A2, Vol 24, No. 25, August 2004.

Within-run and Total precision results were obtained by performing two runs per day, two measures per run, for 3 levels of samples on 2 instruments during twenty operating days according to CLSI EP5-A2 protocol. The results are presented in the table below:

	n	Mean (U/L)	Within-run SD	Within-run CV%
Level 1	80	147	1.0	0.7
Level 2	80	406	4.6	1.1
Level 3	80	1154	13.1	1.1

Within-Run Precision

Total Precision

	n	Mean (U/L)	Total SD	Total CV%
Level 1	80	147	2.4	1.7
Level 2	80	406	9.8	2.4
Level 3	80	1154	45.5	3.9

b. Linearity/assay reportable range

The linearity study of CK NAC SL reagent was performed according to CLSI protocol EP6-A. From this study, a measuring range from 10 to 1714 U/L has been determined. Manual dilution 1 to 10 allows an upper linearity of CK NAC SL reagent to 17140 U/L.

c. Traceability

For calibration, a multi-parametric calibrator named ELITech Clinical Systems ELICAL 2 (manufactured by SEPPIM under product code CALI-0580) must be used. Its value is traceable to the IFCC method (Schumann, 2002), by manual measurement. The values of these control materials are traceable to the IFCC method (Schumann, 2002), by manual measurement.

d. Stability

Real-time stabilities:

On board stability for the ELITech Clinical Systems CK NAC SL was established by real time studies on the ELITech Clinical Systems Selectra ProM. The on-board stability of the reagent is 28 days. The shelf-life of CK NAC SL reagent has been followed in the real time

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for 14 months on 3 different batches.

Control material 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 1 and Elitrol 11 is 30 months at 2-8°C. After reconstitution the stability is 12 hours when stored at 15-25°C, 5 days when stored at 2-8°C or 4 weeks (when frozen once) at -25° and -15° C.

Calibrator material 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 the stability is 8 hours when stored at 15-25°C, 2 days at 2-8°C or 4 weeks (when frozen once) at -25°and -15°C. The labeling stated that the Elical 2 should be stored tightly capped and protected from light when not in use.

Value Assignment

Elitrol I and II are value assigned using multiple Vital Scientific PRO M 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.

Elical 2 is tested against predetermined values on multiple Vital Scientific PRO M using the CL NAC SL reagent and 2 levels of quality control material. The mean analyte value is calculated and a target value is assigned.

e. Detection limit

Determined according to CLS! protocol EP17-A (Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline).

Limit of Detection (LoD) of CK NAC SL obtained from 15 measurements of 4 samples with a low concentration of analyte (approximately 4 x LoB ~ 2.4 U/L) is 1 U/L.

Limit of Quantification (LoQ) of CK NAC SL obtained from 15 measurements of 4 samples at nominal concentration 5 U/L is 5 U/L.

f. Interference/analytical specificity

Interferences due to unconjugated bilirubin, conjugated bilirubin, triglycerides, acetaminophen, ascorbic acid, acetylsalicylic acid were investigated following the recommended sample levels in CLSI EP7-A2 protocol (Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition).

The results of testing interferences are the following:

Concentration up to 30.0 mg/dL unconjugated bilirubin, 29.5 mg/dL unconjugated ।
bilirubin, and 3133 mg/dL triglycerides do not show any significant interference for each substance. Non-significant interference is defined as within ± 10% recovery.
Likewise, concentrations up to 30 mg/dL acetaminophen, 20.0 mg/dL ascorbic acid and เ
200 mg/dL acetyIsalicyIc acid do not show any significant interference for each

substance. Non-significant interference is defined as within ± 10% recovery.

The following statement will also be included in the labeling:

Other compounds may interfere. Users should refer to the two following literature

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references:

-Young, D. S., Effects of preanalytical variables on clinical laboratory tests, 200 Ed., AACC Press. (1997).

-Young, D. S., Effects of drugs on clinical laboratory tests, 40 Ed., AACC Press, (1995). -Berth, M. & Delanghe, J. Protein precipitation as a possible important pitfall in the clinical chemistry analysis of blood samples containing monoclonal immunoglobulins: 2 case reports and a review of literature, Acta Clin Belg., (2004), 59, 263.

Performance Characteristics - Comparison Studies 12.

a. Method comparison

A correlation study was performed between CK NAC SL reagent on a Selectra ProM analyzer and Roche Diagnostics CKL (Creatine kinase) reagent on a cobas c111 analyzer according to CLSI EP9-A2 protocol (Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline - Second edition).

This study was performed using 100 serum patient samples from 10 to 1712 U/L over a span of 5 days.

Regression analysis of the results yielded the following:

v = 1.012 x + 2 U/L r = 0.998 r² = 0.995 Standard error of the estimate Sy.x = 29 U/L.

b. Comparison study: Matrix comparison

40 paired serum and plasma (in lithium heparin samples, ranging from 11 to 1672 U/L, were tested on Selectra ProM analyzer according to CLSI protocol EP9-A2 (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition). Regression analysis of the results yielded the following: y = 0.939 x + 9 U/L

r = 1.000 r2 = 1.000 Standard error of the estimate Sy.x = 9 U/L.

c. Expected values/Reference Range

As indicated in the instructions for use for CK NAC SL, each laboratory should establish and maintain its own reference values. The values given are used as guidelines only.

Men:	Women:
< 171 U/L	< 145 U/L

These values are from "Schumann, G., et al., Clin. Chem. Lab. Med., (2002), 40, 635-42."

d. Clinical Studies:

Not applicable

e. Clinical Cut-off:

Not applicable

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13. Conclusion

ﺮ ﺍﻟﻤﺮﺍﺟﻊ

The information on the principle and performance of our device that is contained in this premarket notification is complete and supports a decision that our device is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

ELITechgroup c/o Debra K. Hutson Epoch Biosciences 21720 23td Dr. SE Suite 150 Bothell, WA 98021

・・・・

AUG 222 2012

K122083 Re:

Trade Name: ELITech Clinical Systems CK NAC SL ELITech Clinical Systems ELICAL2 ELITech Clinical Systems ELITROL I ELITech Clinical Systems ELITROL II Regulation Number: 21 CFR §862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system

Regulatory Class: Class II

Product Codes: JHW, JIX, JJY Dated: July 13, 2012 Received: July 16, 2012

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 approvisions 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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. or the ret or ary I vact is requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device and ilscing (21 or re-resily) device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours.

Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{11}------------------------------------------------

Indications for Use Form

510(k) Number (if known): _ < 1 2 208 3

ELITech Clinical Systems CK NAC SL Device Name:

Indications for Use:

ELITech Clinical Systems CK NAC SL is intended for the quantitative in vitro determination of creatine kinase (CK) in human serum and plasma on ELITech Clinical Systems Selectra analyzers.

It is not intended for use in Point of Care settings.

Creatine phosphokinase and its isoenzymes measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Prescription Use × (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 Diagnostic Devices (OIVD)

isung Chan

Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K122083

Page 1 of 3

{12}------------------------------------------------

Indications for Use Form

510(k) Number (if known): _ K 122083

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 on ELITech Clinical Systems Selectra analyzers.

Prescription Use × (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 Diagnostic Devices (OIVD)

Yung Chan

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

长122083 510(k)

Page Lof 3

{13}------------------------------------------------

Indications for Use Form

510(k) Number (if known): _ 长122083

Device Name: ·

ELITech Clinical Systems ELITROL I ELITech Clinical Systems ELITROL II

Indications for Use:

ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

Prescription Use × (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 Diagnostic Devices (OIVD)

Yung Chân

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K122083

Page 1 of 3

Regulation Number and Section

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.

(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.