ELITech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine on ELITech Clinical Systems Selectra Pro Series Analyzers. It is not intended for use in Point of Care settings.

Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

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 and ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

ELITech Clinical Systems URINE CONTROL BI-LEVEL is a set of 2 levels of urine controls used for in vitro diagnostic in the quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

Device Description

ELITech Clinical Systems CREATININE PAP SL is available as kit only. It consists of a bi-reagent R1 and R2 whose composition is, for R1: MOPS buffer (pH 7.50), EHSPT, Creatinase, Sarcosine oxidase, Ascorbate oxidase. For R2: MOPS buffer (pH 7.50), 4-Aminoantipyrine, Creatininase, Peroxidase, 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.

ELITech Clinical Systems 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.

ELITech Clinical Systems URINE CONTROL BI-LEVEL is a liquid solution prepared from human urine supplemented with constituents of human and animal origin, chemicals, preservatives and stabilizers. Human sera corresponding to the URINE CONTROL BI-LEVEL were tested for each urine donor and found to be negative for HbsAg and antibodies to HCV and HIV-1/HIV-2 according to FDA-approved methods.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance:

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (ELITech Clinical Systems CREATININE PAP SL)
Precision (Serum/Plasma)	CV% within acceptable clinical range	Level 1: Within-run CV 1.2%, Total CV 1.9%
		Level 2: Within-run CV 0.6%, Total CV 1.7%
		Level 3: Within-run CV 0.5%, Total CV 1.5%
Precision (Urine)	CV% within acceptable clinical range	Level 1: Within-run CV 0.8%, Total CV 2.2%
		Level 2: Within-run CV 0.7%, Total CV 2.3%
		Level 3: Within-run CV 1.9%, Total CV 2.9%
Linearity (Serum/Plasma)	Valid measuring range for clinical use	0.10 to 30 mg/dL (Manual dilution 1 to 5 allows up to 150 mg/dL)
Linearity (Urine)	Valid measuring range for clinical use	5 to 450 mg/dL
Limit of Detection (LoD) (Serum/Plasma)	Low enough for accurate diagnosis	0.02 mg/dL
Limit of Quantification (LoQ) (Serum/Plasma)	Low enough for accurate diagnosis	0.08 mg/dL
Limit of Detection (LoD) (Urine)	Low enough for accurate diagnosis	0.5 mg/dL
Limit of Quantification (LoQ) (Urine)	Low enough for accurate diagnosis	2.0 mg/dL
Interference (Serum/Plasma)	No significant interference from common substances at specified levels	No significant interference from unconjugated bilirubin (30.0 mg/dL), triglycerides (3000 mg/dL), hemoglobin (500 mg/dL), uric acid (20.0 mg/dL), glucose (500 mg/dL), ascorbic acid (20 mg/dL), creatine (5 mg/dL), conjugated bilirubin (14.8 mg/dL). Methyl-dopa, L-dopa, and Calcium dobesilate induce falsely low results at therapeutic concentrations. Monoclonal gammopathies may cause unreliable results.
Interference (Urine)	No significant interference from common substances at specified levels	No significant interference from Conjugated bilirubin (29.5 mg/dL), Hemoglobin (500 mg/dL), Ascorbic acid (20 mg/dL), Calcium dobesilate (50.0 mg/dL), Glucose (539 mg/dL), Methyldopa (10 mg/dL).
Method Comparison (Serum/Plasma)	Strong correlation with predicate device	y = 0.979x + 0.05 mg/dL, r = 1.000, r² = 1.000, Sy.x = 0.09 mg/dL
Method Comparison (Urine)	Strong correlation with predicate device	y = 1.063x + 2 mg/dL, r = 1.000, r² = 0.999, Sy.x = 4 mg/dL
Matrix Comparison (Plasma)	Strong correlation with serum samples	y = 0.981x + 0.03 mg/dL, r = 1.000, r² = 1.000, Sy.x = 0.09 mg/dL
Stability (Reagent)	On-board stability and shelf-life as claimed	On-board stability: 28 days. Shelf-life: 20 months (real-time for 3 batches).
Stability (Control Material)	Shelf-life and reconstituted stability as claimed	Shelf-life 24 months (lyophilized). Reconstituted: 12 hours (15-25°C), 5 days (2-8°C), 4 weeks (-25° to -15°C).
Stability (Calibrator Material)	Shelf-life and reconstituted stability as claimed	Shelf-life 24 months (lyophilized). Reconstituted: 8 hours (15-25°C), 2 days (2-8°C), 4 weeks (-25° to -15°C).
Stability (Urine Control)	Shelf-life and opened stability as claimed	Shelf-life 10 months. Opened: 30 days (2-8°C).

2. Sample Sizes and Data Provenance:

Test Set Sample Sizes:
- Precision (Serum/Plasma and Urine): 80 measurements per level (3 levels for each matrix).
- Method Comparison (Serum/Plasma): 100 patient serum samples.
- Method Comparison (Urine): 54 patient urine samples.
- Matrix Comparison (Plasma): 43 patient plasma samples (lithium heparin).
- Detection Limit (Serum/Plasma and Urine): 15 measurements of 4 samples for LoD and LoQ for each matrix.
Data Provenance: The document does not explicitly state the country of origin for the patient samples or if the data was retrospective or prospective. However, the studies were conducted by ELITech Clinical Systems SAS, which is located in France, suggesting the data may originate from a European setting. The methodology described (e.g., patient sample testing, specific protocols) implies these were prospective studies where samples were collected and tested as part of the validation process.

3. Number of Experts and Qualifications for Ground Truth:

The document describes performance studies for an in-vitro diagnostic (IVD) reagent for creatinine measurement. For such devices, "ground truth" is typically established by reference methods or validated comparative methods.

No human experts were used to establish ground truth for the test values of the samples in the analytical performance studies (precision, linearity, detection limit, interference). These are determined by the measurements themselves and compared against established analytical criteria and industry standards.
For Traceability, ELITech Clinical Systems ELICAL 2 calibrator values are traceable to the ID-MS (Isotope Dilution -Mass Spectrometry) reference method. This is considered the "gold standard" for accuracy in many clinical chemistry analytes and represents the highest level of ground truth for calibration.
For Method Comparison, the "ground truth" for the comparative study was the results obtained from the predicate device, the Roche Diagnostics CREP2 (Creatinine Plus ver 2) reagent on a cobas c111 analyzer. The predicate device itself has undergone its own validation and regulatory clearance processes.

4. Adjudication Method:

None. Adjudication methods (like 2+1, 3+1) are typically used in image-based diagnostic studies where human interpretation of medical images generates the ground truth, and discrepancies between readers need to be resolved. This document describes an IVD device for quantitative chemical analysis, where measurements are objective and do not involve human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC comparative effectiveness study was not done. These studies are relevant for AI-powered diagnostic tools that assist human readers (e.g., radiologists interpreting images). This device is an in-vitro diagnostic reagent and does not involve human readers in the diagnostic process beyond performing the test and interpreting the quantitative result.

6. Standalone (Algorithm Only) Performance:

Yes, effectively. The performance described (precision, linearity, detection limits, interference, method comparison) represents the standalone performance of the ELITech Clinical Systems CREATININE PAP SL reagent as performed on the ELITech Clinical Systems Selectra Pro Series Analyzers, without human interpretation as part of the measurement process itself. The "algorithm" here is the enzymatic colorimetric assay methodology of the reagent combined with the automated analyzer.

7. Type of Ground Truth Used:

Primarily Expert Concensus (ID-MS Traceability) and Comparative Method (Predicate Device):
- For calibration and absolute accuracy, the calibrator (ELICAL 2) is traceable to the ID-MS (Isotope Dilution -Mass Spectrometry) reference method, which is a highly accurate, consensus-driven method used by reference laboratories to establish true values.
- For method comparison, the ground truth was established by the predicate device (Roche Diagnostics CREP2 on a cobas c111 analyzer). The performance of the new device was compared against this already legally marketed and validated method.
- For analytical performance characteristics like precision, linearity, detection limits, and interference, the "ground truth" is defined by adherence to established analytical protocols (CLSI guidelines) and the reproducibility/accuracy of the measurements themselves in controlled conditions.

8. Sample Size for the Training Set:

Not explicitly stated/Not applicable in the traditional sense. This is an in-vitro diagnostic reagent, not an AI/machine learning model that typically involves a "training set" in the computational sense.
However, the development of such reagents involves extensive research and development, including formulation, optimization, and preliminary testing, which could be considered an analogous "training" phase to refine the product. The document highlights the use of CLSI standard protocols for performance evaluation, which are used to test the final product, not to "train" it.

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

Not applicable in the traditional AI/ML sense. For an IVD reagent, the "ground truth" during its development (analogous to training) would involve:
- Chemical principle validation: Ensuring the enzymatic reaction effectively measures creatinine.
- Formulation optimization: Through numerous experiments, determining optimal concentrations of reagents for sensitivity, specificity, and stability.
- Calibration standards: Developing and validating calibrators against recognized reference materials (like ID-MS) to ensure accurate quantification across the measuring range.
- This iterative process relies on established chemical principles, analytical instrumentation, and validation against known standards and samples with established values, often aligned with international reference methods.

Summary

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510(k) Summary

JAN - 3 2014

ELITech Clinical Systems CREATININE PAP SL

Zone Industrielle

61500 SEES FRANCE

Class II JFY

Class II JIX

Clinical Chemistry 21 CFR 862.1225

Clinical Chemistry 21 CFR 862.1150

July 29, 2013 Date: Submitter: ELITech Clinical Systems SAS

Contact Person:

Debra K. Hutson Director, QARA, North America 21720 23dd Dr SE, Suite 150 Bothell, WA 98021 Phone: 425-482-5174 Fax: 425-482-5550 Email: d.hutson@elitechgroup.com

ELITech Clinical Systems ELICAL 2

ELITech Clinical Systems CREATININE PAP SL

Device Description: Classification

Device Description: Classification

Device Description: Classification

Predicate Device:

ELITech Clinical Systems ELITROL I and ELITROL II Class I. JJY Clinical Chemistry 21 CFR 826.1660

ELITech Clinical Systems URINE CONTROL BI-LEVEL Class I, JJY Clinical Chemistry 21 CFR 826.1660

K024098 Roche Diagnostics Creatinine plus ver 2

K033501 Roche Diagnostics Calibrator for Automated Systems (C.f.a.s.)

K041227 Roche Diagnostics Precinorm and Precipath

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K020817 BIO-RAD

Liquichek Urine Chemistry Control Level 1 and Level 2

Intended Use

Reagents:

Calibrators:

Controls:

Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

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 Analyzer.

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Device Descriptions

8.

Substantial Equivalence Information -

Assay (reagent) 1. Predicate Device Name
- Roche Diagnostics Creatinine plus ver 2
1. K024098
1. Comparison with predicate

Similarities

Parameter	ELITech Clinical Systems DeviceCREATININE PAP SL	Predicate deviceRoche Diagnostics Creatinine plus ver.2
Intended Use/ Indication forUse	Intended for the quantitative in vitrodiagnostic determination of creatininein human serum, plasma and urine onELITech Clinical Systems Selectra ProSeries Analyzers. It is not intended foruse in Point of Care settings.Creatinine measurements are used inthe diagnosis and treatment of renaldiseases, in monitoring renal dialysis,and as a calculation basis formeasuring other urine analytes.	For in vitro diagnostic use in thequantitative determination of creatininein serum, plasma and urine on thecobas c111 system.
SpecimenType	Serum, Plasma, Urine	Same
AssayTechnology	Enzymatic colorimetric test	Same
Parameter	ELITech Clinical Systems DeviceCREATININE PAP SL	Predicate deviceRoche Diagnostics Creatinine plus ver.2
Assay Range	Serum/plasma: 0.10 - 30 mg/dLUrine: 5 - 450 mg/dL.	Serum/plasma: 0.06 - 30.5 mg/dLUrine: 1.1 - 452 mg/dL.
Instrument	Selectra ProM analyzer	cobas c111
Calibrator	Recommended calibration material(not included):ELITech Clinical Systems ELICAL 2	Recommended calibration material(not included):Roche Calibrator f.a.s.
Interferences-	Serum/Plasma	Serum/Plasma
	Unconjugated bilirubin: No significantinterference up to 30.0 mg/dL.Conjugated bilirubin: No significantinterference up to 14.8 mg/dL.	Icterus: No significant influence up to IIndex of 20 (approximate conjugatedand unconjugated bilirubinconcentration of 20 mg/dL (342µmol/L)).
	Hemoglobin: No significantinterference up to 500 mg/dL.Triglycerides: No significantinterference up to 3000 mg/dL.Uric acid: No significant interferenceup to 20.0 mg/dL.Glucose: No significant interferenceup to 500 mg/dL.Ascorbic acid: No significantinterference up to 20 mg/dL.Methyl-dopa: Induce falsely lowresults at therapeutic concentrations.L-dopa: Induce falsely low results at	Hemoglobin: No significant interferenceup to an H Index of 800 (approximate800 mg/dL).Lipemia (Intralipid): No significantinfluence up to an L index of 1000.There is poor correlation between the Lindex (corresponds to turbidity) andtriglycerides concentration.Ascorbic acid: < 300 mg/L does notinterfere.Drugs: No interference was found attherapeutic concentrations usingcommon drug panels.Exceptions: Levodopa and calciumdobesilate cause artificially lowcreatinine levels at the tested drug levelwhile DL-proline at a concentration of>1mmol/L causes falsely high results.2-Phenyl-1,3 indandion (Phenindion) attherapeutic concentrations interferencewith the assay.
		Cyanokit (Hidroxocobalamin) maycause interference with results:
Parameter	ELITech Clinical Systems DeviceCREATININE PAP SL	Predicate deviceRoche Diagnostics Creatinine plus ver.2
		Other: In very rare cases monoclonalgammopathy can lead to incorrectresults.
		No significant interference up to acreatine level of 0.38 mmol/L (5 mg/dL).
Interferences -Urine	Urine	Urine
	Conjugated bilirubin: No significantinterference up to 29.5 mg/dL.	Drugs: No interference was found attherapeutic concentration using
	Hemoglobin: No significantinterference up to 500 mg/dL.	common drugs panels.Exception: Levodopa causes artificially
	Ascorbic acid: No significantinterference up to 20 mg/dL.	low results. High homogentisic acidconcentrations in urine samples lead tofalse results.
	Methyl-dopa: No significantinterference up to 10 mg/dL.	Other: No significant interference up toa creatinine level of 3.05 mmol/L (40mg/dL)
	Calcium dobesilate: No significantinterference up to 50.0 mg/dL
	Glucose: No significant interferenceup to 5000 mg/dL.
	Serum/plasma:	Serum/plasma:
	Adults :	Adults :
ReferenceRange	Females 0.55 - 1.02 mg/dL	Females 0.51 - 0.95 mg/dL
	Males 0.72 - 1.18 mg/dL	Males 0.67 - 1.17 mg/dL
		Children:
	Urine:	Neonates(premat.) 0.33-0.98 mg/dL
	Females 11 - 20	Neonates(full term) 0.31-0.88 mg/dL
	mg/kg/24h	2-12 m0.16-0.39 mg/dL
	Males 14 - 26	1-< 3 y0.18-0.35 mg/dL
	mg/kg/24h	3-< 5 y0.26-0.42 mg/dL
		5-< 7 y0.29-0.47 mg/dL
		7-< 9 y0.34-0.53 mg/dL
		9-< 11 y0.33-0.64 mg/dL
		11-< 13 y0.44-0.68 mg/dL
		13-< 15 y0.46-0.77 mg/dL
		Urine
		1st morning urine
		Females 29 - 226 mg/dL
		Males 40 - 278 mg/dL
		24h Urine
		Females 720 - 1510 mg/ 24 h
		Males 980 - 2200 mg/ 24 h
Parameter	ELITech Clinical Systems DeviceCREATININE PAP SL	Predicate deviceRoche Diagnostics Creatinine plus ver.2
Calibrationfrequency	Serum/Plasma: 14 daysUrine: 14 days	Each lot and as required followingquality control procedures

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Differences

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・

. . . . . .

。

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Control Sera

Predicate Device Name:

Roche Diagnostics Precinorm U and Precipath U
1. K041227
1. Comparison with predicate

Similarities and Differences

Item	ELITech Clinical Systems DeviceELITROL I and ELITROL II	PredicateRoche Diagnostics Precinorm U andPrecipath U (K041227)
IntendedUse/Indications forUse	ELITech Clinical Systems ELITROL I andELITROL II are multi-parametric controlsera for in vitro diagnostic use in qualitycontrol of quantitative ELITechClinical Systems methods on ELITechClinical Systems Selectra Pro SeriesAnalyzers.	Precinorm U is for use in qualitycontrol by monitoring accuracy andprecision for the quantitative methods.as specified in the value sheets.Precipath U is for use in qualitycontrol by monitoring accuracy andprecision for the quantitative methodsas specified in the value sheets.
Format	Lyophilized human sera with constituentsadded as required to obtain definedcomponent levels	Same
Levels	Two Levels (Level I and Level II)	Same
Stability	Lyophilized:To store at 2-8°C and protected from lightuntil the expiry dateAfter reconstitution, the stabilities are :- 12 hours between 15-25 °C.- 5 days between 2-8 °C.- 4 weeks between -25 and -15 °C (whenfrozen once)	Same

Urine Control .

Predicate Device Name:

Biorad Liquichek Urine Chemistry Control Level 1 and Level 2

K020817
Comparison with predicate

Similarities and Differences

Item	ELITech Clinical Systems DeviceURINE CONTROL BI -LEVEL	Predicate Device Biorad LiquichekUrine Chemistry Control Level 1 andLevel 2 (K020817)
Intendeduse	ELITech Clinical Systems URINECONTROL BI - LEVEL is a set of 2 levelsof urine controls for in vitro diagnosticused in the quality control of quantitative	Liquichek Urine Chemistry Control isintended for use as unassayed qualitycontrol urine.

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Similarities and Differences

Item	ELITech Clinical Systems DeviceURINE CONTROL BI -LEVEL	Predicate Device Biorad LiquichekUrine Chemistry Control Level 1 andLevel 2 (K020817)
	ELITech Clinical Systems methods onELITech Clinical Systems Selectra ProSeries Analyzers
Format	Liquid ready to use, a liquid solutionprepared from human urine supplementedwith constituents of human and animalorigin, chemicals, preservatives andstabilizers.	Liquid form, prepared from preparedfrom human urine supplemented withconstituents of human and animalorigin, chemicals, preservatives andstabilizers.
Levels	Two levels	Same
Stability	- Before opening:Each control is stable until the expiry datestated on the label.- After opening:Each control is stable for 30 days whenstored tightly-closed between 2-8 °C.- Creatinine values may graduallydecrease over the product shelf life.Individual laboratory means mayeventually fall outside of thecorresponding ranges indicated in thevalue sheet included in the kit.	Same

Calibrator

Predicate Device Name:

Roche Diagnostics Calibrator for Automated Systems (C.f.a.s)
1. K033501
1. Comparison with predicate

Similarities and Differences

Item	ELITech Clinical Systems DeviceELICAL 2	PredicateRoche Calibrator for AutomatedSystems (C.f.a.s.) K033501
Intended Use/Indications for Use	ELITech Clinical Systems ELICAL 2 is amulti-parametric calibrator for in vitrodiagnostic use in the calibration ofquantitative ELITech Clinical Systemsmethods on ELITech Clinical SystemsSelectra Pro Series Analyzers.	For in vitro diagnostic use in thecalibration of quantitative Rochemethods on Roche clinical chemistryanalysers as specified in the valuesheets.
Format	Lyophilized calibrator based on humanserum with constituents added asrequires to obtain desired componentlevels	Same
Level	Single Level	Same

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Similarities and Differences

Item	ELITech Clinical Systems DeviceELICAL 2	PredicateRoche Calibrator for AutomatedSystems (C.f.a.s.) K033501
Stability	Lyophilized:To store at 2-8°C and protected from lightuntil the expiry dateAfter reconstitution, the stabilities are :- 8 hours between 15-25 °C.- 2 days between 2-8 °C.- 4 weeks between -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 EP05-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 EP09-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 EP06-A, Vol 23, No. 16, April 2003.

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10. Test Principle:

Creatininase hydrolyzes creatinine in sample to creatine is hydrolyzed by creatinase to sarcosine and urea. Sarcosine is then oxidized by sarcosine oxidase to produce hydrogen peroxide (H2O2). H2O2 reacts with 4-amino-antipyrine (4-AAP) and EHSPT (N-Ethyl-N-2(-Hydroxy-3-Sulfopropyl)-m- Toluidine) under the catalytic action of peroxidase to form a colored quinoneimine. The absorbance of the quinoneimine at 546 nm is proportional to the concentration of creatinine in the sample.

4-AAP: Amino-4-antipyrine EHSPT : N-Ethyl-N-2(-Hydroxy-3-Sulfopropyl)-m-Toluidine

11. Performance Characteristics - Analytical Performance

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 EP05-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 EP05-A2 protocol. The results are presented in the table below:

Precision

Serum/Plasma

Level	n	Mean (mg/dL)	Precision %
			Within-run CV%	Total CV%
Level 1	80	0.76	1.2%	1.9%
Level 2	80	1.52	0.6%	1.7%
Level 3	80	5.52	0.5%	1.5%

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Urine

Level	n	Mean (mg/dL)	Precision %
			Within-run CV%	Total CV%
Level 1	80	83	0.8%	2.2%
Level 2	80	159	0.7%	2.3%
Level 3	80	308	1.9%	2.9%

b. Linearity/assay reportable range

The linearity study of CREATININE PAP SL reagent was performed according to CLSI protocol EP06-A.

Serum/Plasma: From this study, a measuring range from 0.10 to 30 mg/dL has been determined.

Manual dilution 1 to 5 allows an upper linearity of CREATININE PAP SL reagent to 150 mg/dL.

Urine: From this study, a measuring range from 5 to 450 mg/dL has been determined.

c. Traceability

For calibration, a multi-parametric calibrator named ELITech Clinical Systems ELICAL 2 (manufactured by ELITech Clinical Systems SAS under product code CALI-0580) must be used. Its value is traceable to the ID-MS (Isotope Dilution -Mass Spectrometry) reference method.

d. Stability

Real-time stabilities:

On board stability for the ELITech Clinical Systems CREATININE PAP SL was established by real time studies on the ELITech Clinical Systems Selectra Analyzer. The on-board stability of the reagent is 28 days. The shelf-life of CREATININE PAP SL reagent has been followed in the real time for 20 months on 3 different batches.

Serum 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 I and ELITROL II is 24 months at 2-8°C. After reconstitution the stability is 12 hours when stored at 15-25℃, 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: Before reconstitution, the shelf-life of ELITech Clinical Systems Elical 2 is stable 24 months at 2-8°C. 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.

Urine control material is purchased from commercial vendor (preciously cleared under K020817). The following is claimed for stability: ELITech Clinical Systems URINE CONTROL BI-LEVEL is stable 10 months at 2-8°C. After opening, each control is stable for 30 days when stored tightly closed at 2-8°C.

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d. Stability (continued)

Creatinine values may gradually decrease over the product shelf life. Individual laboratory means may eventually fall outside of the corresponding ranges indicated in the value sheet included in the kit.

Value Assignment

Elitrol I and II are value assigned using multiple ELITech Clinical Systems Selectra ProM Series 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 one ELITech Clinical Systems Selectra ProM Series Analyzers using the CREATININE PAP SL reagent and 2 levels of quality control material. The mean analyte value is calculated and a target value is assigned.

URINE CONTROL BI-LEVEL value is assigned using multiple ELITech Clinical Systems Selectra Series Analyzers. 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.

e. Detection limit

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

Serum/Plasma

Limit of Detection (LoD) of CREATININE PAP SL obtained from 15 measurements of 4 samples with a low concentration of analyte (approximately 4 x LoB = 0.04 mg/dL) is 0.02 mg/dL.

Limit of Quantification (LoQ) of CREATININE PAP SL obtained from 15 measurements of 4 samples at nominal concentration 0.08 md/dL is 0.08 mg/dL.

Urine

Limit of Detection (LoD) of CREATININE PAP SL obtained from 15 measurements of 4 samples with a low concentration of analyte is 0.5 mg/dL.

Limit of Quantification (LoQ) of CREATININE PAP SL obtained from 15 measurements of 4 samples is 2.0 mg/dL.

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f. Interference/analytical specificity

Interferences due to unconjugated bilirubin, conjugated bilirubin, triglycerides, hemoglobin, ascorbic acid, uric acid, glucose, methyl-dopa, L-dopa, calcium dobesilate and creatine were investigated following the recommended sample levels in CLSI EP07-A2 protocol (Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition). The results of testing interferences are the following:

Serum/Plasma

Concentration up to 30.0 mg/dL unconjugated bilirubin, 3000 mg/dL triglycerides, 500 mg/dL hemoglobin, 20.0 mg/dL Uric acid, 500 mg/dL Glucose, 20 mg/dL Ascorbic acid, 5 mg/dL Creatine, 14.8 mg/dL Conjugated bilirubin do not show any significant interference for each substance.
Methyl-dopa, L-dopa and Calcium dobesilate induce falsely low results at therapeutic concentrations.
In very rare cases, monoclonal gammopathies (multiple myeloma), in particular IgM type (Waldenstrom's macroglobulinemia) can cause unreliable results.

Urine

Concentration up to 29.5 mg/dL Conjugated bilirubin, 500 mg/dL Hemoglobin, 20 mg/dL ı Ascorbic acid, 50.0 mg/dL Calcium dobesilate, 539 mg/dL Glucose, 10 mg/dL Methyldopa do not show any significant interference for each substance.

The following statement will also be included in the labeling:

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

Serum/Plasma

A correlation study was performed between CREATININE PAP SL reagent on a Selectra Pro Series Analyzer and Roche Diagnostics CREP2 (Creatinine Plus ver 2) reagent on a cobas c111 analyzer according to CLSI EP09-A2 protocol (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition).

This study was performed using 100 serum patient samples from 0.10 to 30.1 mg/dL over a span of 5 days.

Regression analysis of the results vielded the following:

y = 0.979x + 0.05 mg/dL.

r = 1.000

r2 = 1.000

Standard error of the estimate Sy.x = 0.09 mg/dL.

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Urine

54 urine patient samples ranging from 3 to 413 mg/dL, were tested on Selectra Pro Series Analyzer according to CLSI protocol EP09-A2 (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition). Regression analysis of the results yielded the following:

y = 1.063x + 2 mg/dL r = 1.000 r² = 0.999 Standard error of the estimate Sy.x = 4 mg/dL

b. Comparison study: Matrix comparison

43 plasma patients (in lithium heparin samples, ranging from 0.11 to 30.23 mg/dL), were a tested on a Selectra Pro Series Analyzer according to CLSI protocol EP09-A2 (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition).

Regression analysis of the results yielded the following:

y = 0.981x + 0.03 mg/dL r = 1.000 r2 = 1.000 Standard error of the estimate Sy x = 0.09 mg/dL.

c. Expected values/Reference Range

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

	Men	Woman
Serum/ Plasma	0.72 - 1.18	0.55 - 1.02	mg/dL
	64 - 104	49 - 90	μmol/L
Urine	14 - 26	11 - 20	mg/dL/kg/24h
	124 - 230	97 - 177	μmol/L/kg/24h

These reference values are from:

Newman, D.J., Price C.P., Tietz Fundamentals of Clinical Chemistry, 5th Ed., Burtis, C.A. & Ashwood, E.R. (W.B. Saunders eds. Philadelphia USA), (2001), 414.

Ceriotti, F., Reference Intervals for Serum Creatinine Concentrations: Assessment of Available Data for Global Application. Clin. Chem., (2008), 54, 559.

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and the comments of

d. Clinical Studies:
Not applicable

e. Clinical Cut-off:

Not applicable

1. Conclusion
  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.

Page 14 of 14

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/14/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 its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 3, 2014

ELITECH GROUP DEBRA K. HUTSON DIRECTOR, RA/QA, NORTH AMERICA 21720 23RD DR S.E., SUITE 150 BOTHELL WA 98021

Re: K132399

Trade/Device Name: ELITech Clinical Systems Creatinine PAP SL

ELITech Clinical Systems ELICAL 2

ELITech Clinical Systems ELITROL I and ELITech Clinical Systems ELITROL II

ELITech Clinical Systems URINE CONTROL BI-LEVEL

Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: II Product Code: JFY, JIX, JJY Dated: December 4, 2013 Received: December 5, 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements,

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Page 2-Ms. Hutson

as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the 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 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. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132399

Device Name

ELITech Clinical Systems CREATININE PAP SL ELITech Clinical Systems ELICAL 2 ELITech Clinical Systems ELITROL I and ELITech Clinical Systems ELITROL II ELITech Clinical Systems URINE CONTROL BI-LEVEL

・

Indications for Use (Describe)

ELITech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determination of creatinine in huntan serum, plasma and urine on ELITech Clinical Systems Selectra Pro Series Analyzers. It is not intended for use in Point of Care settings.

Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in the callbration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

ELITech Clinical Systems ELITROL I are multi-parameric control sera for in vitro diagnosic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

ELITech Clinical Systems URINE CONTROL BI- LEVEL is a set of 2 levels of urine controls used for in virro diagnostic in the quality control of quantitative ELITech Clinical Systems methods on ELITical Systems Selectra Pro Series Analyzers.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Regulation Number and Section

§ 862.1225 Creatinine test system.

(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.