ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL

K132399 · Elitechgroup · JFY · Jan 3, 2014 · Clinical Chemistry

Device Facts

• Record ID: K132399
• Device Name: ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL
• Applicant: Elitechgroup
• Product Code: JFY · Clinical Chemistry
• Decision Date: Jan 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

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 Story

Enzymatic colorimetric assay for quantitative creatinine determination in human serum, plasma, and urine; utilizes Selectra ProM analyzer. Principle: Creatininase hydrolyzes creatinine to creatine; creatine hydrolyzed to sarcosine and urea; sarcosine oxidized to H2O2; H2O2 reacts with 4-amino-antipyrine and EHSPT via peroxidase to form colored quinoneimine. Absorbance measured at 546 nm; proportional to creatinine concentration. Used in clinical laboratories; operated by trained laboratory personnel. Output provides creatinine concentration values for clinical decision-making regarding renal function and dialysis monitoring.

Clinical Evidence

Bench testing only. Precision study (n=80 per pool) showed total CV% 1.5-2.9%. Linearity confirmed 0.1-30 mg/dL (serum) and 5-450 mg/dL (urine). Method comparison (n=100 serum, n=54 urine) against Roche Creatinine plus v2 showed high correlation (r=1.000). Interference testing performed per CLSI EP-7A. No clinical data.

Technological Characteristics

Enzymatic colorimetric assay. Reagents: MOPS buffer, creatinase, sarcosine oxidase, ascorbate oxidase, 4-aminoantipyrine, peroxidase, EHSPT. Form factor: Kit for automated clinical chemistry analyzers (Selectra Pro Series). Calibration: Multi-parametric, traceable to ID-MS. Controls: Lyophilized human serum or liquid urine. Connectivity: Integrated with Selectra Pro Series Analyzers.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of creatinine in human serum, plasma, and urine to aid in diagnosis/treatment of renal diseases and monitoring renal dialysis. Not for Point of Care settings. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• Roche Diagnostics Creatinine plus ver. 2 (k024098)
• Roche Calibrator for Automated Systems (C.f.a.s.) (k033501)
• Roche Precinorm and Precipath (k041227)
• Biorad Liquichek Urine Chemistry Control Level 1 and Level 2 (k020817)

Submission Summary (Full Text)

{0}------------------------------------------------

#### 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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

1.

2.

4.

3. Contact Person:

-

Debra K. Hutson Director, QARA, North America 21720 23dd Dr SE, Suite 150 Bothell, WA 98021 Phone: [phone] Fax: [phone] Email: [e-mail]

ELITech Clinical Systems ELICAL 2

ELITech Clinical Systems CREATININE PAP SL

Device Description: Classification

> 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

5.

.

{1}------------------------------------------------

#### k020817 BIO-RAD

Liquichek Urine Chemistry Control Level 1 and Level 2

Intended Use

Reagents:

Calibrators:

Controls:

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.

#### 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.

Page 2 of 14

{2}------------------------------------------------

- 7.
#### Device Descriptions

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.

## 8.

# Substantial Equivalence Information -

- Assay (reagent) 1. Predicate Device Name
- Roche Diagnostics Creatinine plus ver 2
- 2. k024098
- 3. Comparison with predicate

#### Similarities

| Parameter | ELITech Clinical Systems Device<br>CREATININE PAP SL | Predicate device<br>Roche Diagnostics Creatinine plus ver.2 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>/ Indication for<br>Use | Intended for the quantitative in vitro<br>diagnostic determination of creatinine<br>in human serum, plasma and urine on<br>ELITech Clinical Systems Selectra Pro<br>Series Analyzers. It is not intended for<br>use in Point of Care settings.<br>Creatinine measurements are used in<br>the diagnosis and treatment of renal<br>diseases, in monitoring renal dialysis,<br>and as a calculation basis for<br>measuring other urine analytes. | For in vitro diagnostic use in the<br>quantitative determination of creatinine<br>in serum, plasma and urine on the<br>cobas c111 system. |
| Specimen<br>Type | Serum, Plasma, Urine | Same |
| Assay<br>Technology | Enzymatic colorimetric test | Same |
| Parameter | ELITech Clinical Systems Device<br>CREATININE PAP SL | Predicate device<br>Roche Diagnostics Creatinine plus ver.2 |
| Assay Range | Serum/plasma: 0.10 - 30 mg/dL<br>Urine: 5 - 450 mg/dL. | Serum/plasma: 0.06 - 30.5 mg/dL<br>Urine: 1.1 - 452 mg/dL. |
| Instrument | Selectra ProM analyzer | cobas c111 |
| Calibrator | Recommended calibration material<br>(not included):<br>ELITech Clinical Systems ELICAL 2 | Recommended calibration material<br>(not included):<br>Roche Calibrator f.a.s. |
| Interferences- | Serum/Plasma | Serum/Plasma |
| | Unconjugated bilirubin: No significant<br>interference up to 30.0 mg/dL.<br>Conjugated bilirubin: No significant<br>interference up to 14.8 mg/dL. | Icterus: No significant influence up to I<br>Index of 20 (approximate conjugated<br>and unconjugated bilirubin<br>concentration of 20 mg/dL (342<br>µmol/L)). |
| | Hemoglobin: No significant<br>interference up to 500 mg/dL.<br>Triglycerides: No significant<br>interference up to 3000 mg/dL.<br>Uric acid: No significant interference<br>up to 20.0 mg/dL.<br>Glucose: No significant interference<br>up to 500 mg/dL.<br>Ascorbic acid: No significant<br>interference up to 20 mg/dL.<br>Methyl-dopa: Induce falsely low<br>results at therapeutic concentrations.<br>L-dopa: Induce falsely low results at<br> | Hemoglobin: No significant interference<br>up to an H Index of 800 (approximate<br>800 mg/dL).<br>Lipemia (Intralipid): No significant<br>influence up to an L index of 1000.<br>There is poor correlation between the L<br>index (corresponds to turbidity) and<br>triglycerides concentration.<br>Ascorbic acid: < 300 mg/L does not<br>interfere.<br>Drugs: No interference was found at<br>therapeutic concentrations using<br>common drug panels.<br>Exceptions: Levodopa and calcium<br>dobesilate cause artificially low<br>creatinine levels at the tested drug level<br>while DL-proline at a concentration of<br>>1mmol/L causes falsely high results.<br>2-Phenyl-1,3 indandion (Phenindion) at<br>therapeutic concentrations interference<br>with the assay. |
| | | Cyanokit (Hidroxocobalamin) may<br>cause interference with results: |
| Parameter | ELITech Clinical Systems Device<br>CREATININE PAP SL | Predicate device<br>Roche Diagnostics Creatinine plus ver.2 |
| | | Other: In very rare cases monoclonal<br>gammopathy can lead to incorrect<br>results. |
| | | No significant interference up to a<br>creatine level of 0.38 mmol/L (5 mg/dL). |
| Interferences -<br>Urine | Urine | Urine |
| | Conjugated bilirubin: No significant<br>interference up to 29.5 mg/dL. | Drugs: No interference was found at<br>therapeutic concentration using |
| | Hemoglobin: No significant<br>interference up to 500 mg/dL. | common drugs panels.<br>Exception: Levodopa causes artificially |
| | Ascorbic acid: No significant<br>interference up to 20 mg/dL. | low results. High homogentisic acid<br>concentrations in urine samples lead to<br>false results. |
| | Methyl-dopa: No significant<br>interference up to 10 mg/dL. | Other: No significant interference up to<br>a creatinine level of 3.05 mmol/L (40<br>mg/dL) |
| | Calcium dobesilate: No significant<br>interference up to 50.0 mg/dL | |
| | Glucose: No significant interference<br>up to 5000 mg/dL. | |
| | Serum/plasma: | Serum/plasma: |
| | Adults : | Adults : |
| Reference<br>Range | 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 m<br>0.16-0.39 mg/dL |
| | Males 14 - 26 | 1-< 3 y<br>0.18-0.35 mg/dL |
| | mg/kg/24h | 3-< 5 y<br>0.26-0.42 mg/dL |
| | | 5-< 7 y<br>0.29-0.47 mg/dL |
| | | 7-< 9 y<br>0.34-0.53 mg/dL |
| | | 9-< 11 y<br>0.33-0.64 mg/dL |
| | | 11-< 13 y<br>0.44-0.68 mg/dL |
| | | 13-< 15 y<br>0.46-0.77 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 Device<br>CREATININE PAP SL | Predicate device<br>Roche Diagnostics Creatinine plus ver.2 |
| Calibration<br>frequency | Serum/Plasma: 14 days<br>Urine: 14 days | Each lot and as required following<br>quality control procedures |

{3}------------------------------------------------

# Differences

·

Page 4 of 14

.

{4}------------------------------------------------

.

Page 5 of 14

.

.

.

・

.

·

:

:

. . . . . .

。

{5}------------------------------------------------

## Control Sera

1. Predicate Device Name:

- Roche Diagnostics Precinorm U and Precipath U
- 2. k041227
- 3. Comparison with predicate

### Similarities and Differences

| Item | ELITech Clinical Systems Device<br>ELITROL I and ELITROL II | Predicate<br>Roche Diagnostics Precinorm U and<br>Precipath U (k041227) |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use/Indicat<br>ions for<br>Use | ELITech Clinical Systems ELITROL I and<br>ELITROL II are multi-parametric control<br>sera for <i>in vitro</i> diagnostic use in quality<br>control of quantitative ELITech<br>Clinical Systems methods on ELITech<br>Clinical Systems Selectra Pro Series<br>Analyzers. | Precinorm U is for use in quality<br>control by monitoring accuracy and<br>precision for the quantitative methods.<br>as specified in the value sheets.<br>Precipath U is for use in quality<br>control by monitoring accuracy and<br>precision for the quantitative methods<br>as specified in the value sheets. |
| Format | Lyophilized human sera with constituents<br>added as required to obtain defined<br>component levels | Same |
| Levels | Two Levels (Level I and Level II) | Same |
| Stability | Lyophilized:<br>To store at 2-8°C and protected from light<br>until the expiry date<br><br>After reconstitution, the stabilities are :<br>- 12 hours between 15-25 °C.<br>- 5 days between 2-8 °C.<br>- 4 weeks between -25 and -15 °C (when<br>frozen once) | Same |

#### Urine Control .

1. Predicate Device Name:

Biorad Liquichek Urine Chemistry Control Level 1 and Level 2

2. k020817

3. Comparison with predicate

#### Similarities and Differences

| Item | ELITech Clinical Systems Device<br>URINE CONTROL BI -LEVEL | Predicate Device Biorad Liquichek<br>Urine Chemistry Control Level 1 and<br>Level 2 (K020817) |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Intended<br>use | ELITech Clinical Systems URINE<br>CONTROL BI - LEVEL is a set of 2 levels<br>of urine controls for <i>in vitro</i> diagnostic<br>used in the quality control of quantitative | Liquichek Urine Chemistry Control is<br>intended for use as unassayed quality<br>control urine. |

Page 6 of 14

{6}------------------------------------------------

# Similarities and Differences

| Item | ELITech Clinical Systems Device<br>URINE CONTROL BI -LEVEL | Predicate Device Biorad Liquichek<br>Urine Chemistry Control Level 1 and<br>Level 2 (K020817) |
|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ELITech Clinical Systems methods on<br>ELITech Clinical Systems Selectra Pro<br>Series Analyzers | |
| Format | Liquid ready to use, a liquid solution<br>prepared from human urine supplemented<br>with constituents of human and animal<br>origin, chemicals, preservatives and<br>stabilizers. | Liquid form, prepared from prepared<br>from human urine supplemented with<br>constituents of human and animal<br>origin, chemicals, preservatives and<br>stabilizers. |
| Levels | Two levels | Same |
| Stability | - Before opening:<br>Each control is stable until the expiry date<br>stated on the label.<br>- After opening:<br>Each control is stable for 30 days when<br>stored tightly-closed between 2-8 °C.<br>- Creatinine values may gradually<br>decrease over the product shelf life.<br>Individual laboratory means may<br>eventually fall outside of the<br>corresponding ranges indicated in the<br>value sheet included in the kit. | Same |

# Calibrator

1. Predicate Device Name:

- Roche Diagnostics Calibrator for Automated Systems (C.f.a.s)
- 2. k033501
- 3. Comparison with predicate

# Similarities and Differences

| Item | ELITech Clinical Systems Device<br>ELICAL 2 | Predicate<br>Roche Calibrator for Automated<br>Systems (C.f.a.s.) k033501 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indications for Use | ELITech Clinical Systems ELICAL 2 is a<br>multi-parametric calibrator for in vitro<br>diagnostic use in the calibration of<br>quantitative ELITech Clinical Systems<br>methods on ELITech Clinical Systems<br>Selectra Pro Series Analyzers. | For in vitro diagnostic use in the<br>calibration of quantitative Roche<br>methods on Roche clinical chemistry<br>analysers as specified in the value<br>sheets. |
| Format | Lyophilized calibrator based on human<br>serum with constituents added as<br>requires to obtain desired component<br>levels | Same |
| Level | Single Level | Same |

{7}------------------------------------------------

## Similarities and Differences

| Item | ELITech Clinical Systems Device<br>ELICAL 2 | Predicate<br>Roche Calibrator for Automated<br>Systems (C.f.a.s.) k033501 |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Stability | Lyophilized:<br>To store at 2-8°C and protected from light<br>until the expiry date<br><br>After reconstitution, the stabilities are :<br>- 8 hours between 15-25 °C.<br>- 2 days between 2-8 °C.<br>- 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.

{8}------------------------------------------------

#### 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% |

{9}------------------------------------------------

#### 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 followi…