ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II

K153644 · Elitechgroup · CFR · Sep 7, 2016 · Clinical Chemistry

Device Facts

• Record ID: K153644
• Device Name: ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
• Applicant: Elitechgroup
• Product Code: CFR · Clinical Chemistry
• Decision Date: Sep 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

ELITech Clinical Systems GLUCOSE HK SL is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic diseases. 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 Analyzers. ELITech Clinical Systems ELITROL II are multiparametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers.

Device Story

Device is an in vitro diagnostic reagent kit (GLUCOSE HK SL) used with ELITech Clinical Systems Selectra Pro Series Analyzers. It utilizes an enzymatic hexokinase/G-6-PDH UV end-point method; glucose reacts with ATP to form glucose-6-phosphate, which is then oxidized by NAD+ to produce NADH; the resulting increase in absorbance is directly proportional to glucose concentration. The system includes multi-parametric calibrators (ELICAL 2) and control sera (ELITROL I/II). Operated by laboratory technicians in clinical settings; output is a quantitative glucose concentration (mg/dL). Results assist healthcare providers in diagnosing and monitoring carbohydrate metabolism disorders and pancreatic diseases. Benefits include standardized, automated glucose quantification for clinical decision-making.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP05-A2 (n=80 per level, total CV% 1.7-2.0%). Linearity established per CLSI EP06-A (range 20-720 mg/dL for serum, 10-720 mg/dL for urine). Method comparison (n=100 serum, n=40 urine) against predicate showed high correlation (r=1.000). Interference testing per CLSI EP07-A2 confirmed no significant interference for common substances up to specified concentrations. No clinical studies performed.

Technological Characteristics

Enzymatic hexokinase/G-6-PDH UV end-point assay. Reagents: Pipes buffer, NAD, ATP, Hexokinase, G-6-PDH, Magnesium salt, Sodium azide. Calibrator/Controls: Lyophilized human serum. Analyzers: Selectra Pro Series. Connectivity: Standalone analyzer system. Sterilization: N/A (reagents).

Indications for Use

Indicated for quantitative in vitro diagnostic determination of glucose in human serum, plasma, and urine to aid in diagnosis and treatment of carbohydrate metabolism disorders (diabetes mellitus, idiopathic hypoglycemia) and pancreatic diseases. Prescription use only; not for Point of Care settings.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Roche Diagnostics Cobas C111 Glucose HK (k951595)
• Roche Calibrator for Automated Systems (C.f.a.s.) (k033501)
• Roche Diagnostics Precinorm U and Precipath U (k041227)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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

September 7, 2016

ELITECHGROUP TERRY TRIMINGHAM REGULATORY ASSOCIATE 21720 23RD DRIVE SE, SUITE 150 BOTHELL, WA 98021

Re: K153644 Trade/Device Name: ELITech Clinical Systems GLUCOSE HK SL ELITech Clinical Systems ELICAL 2 ELITech Clinical Systems ELITROL I ELITech Clinical Systems ELITROL II Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II

Product Code: CFR, JIX, JJY Dated: July 25, 2016 Received: July 26, 2016

Dear Terry Trimingham:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -S

For: Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

### 510(k) Number (if known) K153644

#### Device Name

ELITech Clinical Systems GLUCOSE HK SL ELITech Clinical Systems ELICAL 2 ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II

#### Indications for Use (Describe)

ELITech Clinical Systems GLUCOSE HK SL is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic diseases.

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 Analyzers.

ELITech Clinical Systems ELITROL II are multiparametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers.

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

| <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-------------------------------------------------------------|
| <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# K153644

# 510(k) Summary Submitted in accordance with CFR 807.92

# ELITech Clinical Systems GLUCOSE HK SL

| 1. | Date: | August 16, 2016 |
|----|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Submitter: | ELITech Clinical Systems SAS<br>Zone Industrielle<br>61500 SEES<br>FRANCE |
| 3. | Contact Person: | Terry Trimingham<br>21720 23rd Dr SE, Suite 150<br>Bothell, WA 98021<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 4. | Device Description:<br>Classification | ELITech Clinical Systems GLUCOSE HK SL<br>Class II<br>CFR Glucose HK<br>Clinical Chemistry<br>21 CFR 862.1345 |
| | Device Description:<br>Classification | ELITech Clinical Systems ELICAL 2<br>Class II<br>JIX<br>Clinical Chemistry<br>21 CFR 862.1150 |
| | Device Description:<br>Classification | ELITech Clinical Systems ELITROL I and ELITROL II<br>Class I<br>JJY<br>Clinical Chemistry<br>21 CFR 826.1660 |
| 5. | Predicate Device: | K951595<br>Roche Diagnostics<br>Cobas C111 Glucose HK |

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

#### 6. Intended Use

| Reagent: | ELITech Clinical Systems GLUCOSE HK SL is intended<br>for the quantitative in vitro diagnostic determination of<br>glucose in human serum, plasma and urine on ELITech<br>Clinical Systems Selectra Pro Series Analyzers. Glucose<br>measurements are used in the diagnosis and treatment of<br>carbohydrate metabolism disorders including diabetes<br>mellitus and idiopathic hypoglycemia, and of pancreatic<br>diseases. |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Calibrators: | ELITech Clinical Systems ELICAL 2 is a multi-parametric<br>calibrator for in vitro diagnostic use in the calibration of<br>quantitative ELITech Clinical Systems methods on<br>ELITech Clinical Systems Analyzers. |
| Controls: | ELITech Clinical Systems ELITROL I and ELITROL II are<br>multiparametric control sera for in vitro diagnostic use in<br>quality control of quantitative ELITech Clinical Systems<br>methods on ELITech Clinical Systems Analyzers. |

#### Special conditions for use statement(s):

This device is intended for prescription use and in vitro diagnostic only.

CAUTION: Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner. It is not intended for use in Point of Care settings.

Reagent Special instrument requirements:

For use with ELITech Clinical Systems Selectra Pro Series Analyzers. Performance data was obtained on the Selectra ProM Analyzer.

#### Device Descriptions 7.

ELITech Clinical Systems GLUCOSE HK SL is available as a kit only. It consists of a Bi-reagent R1 & R2 whose composition is: R1: Pipes buffer, pH 7.60 80 mmol/L, NAD 4.1 mmol/L, ATP 2.2 mmol/L, Sodium azide < 0.1 % R2: Hexokinase ≥ 8 500 U/L, G-6-PDH ≥ 8 500 U/L, Magnesium salt 20 mmol/L, Sodium azide < 0.1 % mmol/L.

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 neqative 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.

#### 8. Substantial Equivalence Information Assay (reagent)

- 1. Predicate Device Name
- Roche Diagnostics Cobas C111 Glucose HK
- 2. K951595
- 3. Comparison with predicate

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

# Similarities

| Parameter | New Device<br>ELITech Clinical Systems<br>GLUCOSE HK SL | Predicate Device<br>ROCHE DIAGNOSTICS GLUCOSE HK,<br>K951595 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | ELITech Clinical Systems GLUCOSE<br>HK SL is intended for the quantitative<br>in vitro diagnostic determination of<br>glucose in human serum, plasma and<br>urine on ELITech Clinical Systems<br>Selectra Pro Series Analyzers. | In vitro test for the quantitative<br>determination of glucose in human<br>serum, plasma and urine on the Cobas<br>c 111 system. |
| Indication for<br>Use | Glucose measurements are used in<br>the diagnosis and treatment of<br>carbohydrate metabolism disorders<br>including diabetes mellitus and<br>idiopathic hypoglycemia, and of<br>pancreatic diseases. | Glucose measurements are used in the<br>diagnosis and treatment of<br>carbohydrate metabolism disorders<br>including diabetes mellitus, neonatal<br>hypoglycemia, and idiopathic<br>hypoglycemia, and of pancreatic islet<br>cell tumors. |
| Sample Type | Serum, Plasma, Urine | Same |
| Assay<br>Technology | Enzymatic<br>(hexokinase).<br>UV.<br>End<br>point. | Enzymatic reference method with<br>hexokinase |
| Composition | Reagent :<br>R1: Pipes buffer, pH 7.60 80 mmol/L,<br>NAD 4.1 mmol/L, ATP 2.2 mmol/L,<br>Sodium azide < 0.1 %<br>R2: Hexokinase ≥ 8 500 U/L, G-6-PDH<br>≥ 8 500 U/L, Magnesium salt 20<br>mmol/L, Sodium azide < 0.1 %. | R1: TRIS buffer: 100 mmol/L, pH 7.8;<br>Mg2+: 4 mmol/L; ATP: ≥ 1.7 mmol/L;<br>NADP: ≥ 1.0 mmol/L; preservative.<br>SR: HEPES buffer: 30 mmol/L, pH 7.0;<br>Mg2+: 4 mmol/L; HK (yeast): ≥ 130<br>µkat/L; G-6-PDH (E. coli): ≥ 250 µkat/L;<br>preservative. |
| Appearance<br>of reagents | Liquid form, ready to use | Same |

# Differences

| Parameter | New Device<br>ELITech Clinical Systems<br>GLUCOSE HK SL | Predicate Device<br>ROCHE DIAGNOSTICS GLUCOSE HK,<br>K951595 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay Format | 8 x 25 mL | 4 x 100 mL |
| Storage &<br>Expiry | Store at 2-8°C and protect from light. | Shelf life at 2-8°C. |
| | The reagent is stable until the expiry<br>date stated on the label. | See expiration date on reagent. |
| Assay Range | Serum, Plasma : 20 - 720 mg/dL<br>Urine: 10 - 720 mg/dL | Serum, Plasma, Urine : 1.98 - 720<br>mg/dL |
| Instrument | Selectra Series Analyzers | Cobas C111 |
| Reference | Serum/ Plasma : | Serum / Plasma :<br>74 - 109 mg/dL (4.11 - 6.05 mmol/L) |
| Parameter | New Device<br>ELITech Clinical Systems<br>GLUCOSE HK SL | Predicate Device<br>ROCHE DIAGNOSTICS GLUCOSE HK,<br>K951595 |
| Values | 74 - 106 mg/dL<br>4.1 - 5.9 mmol/L<br>Urine :<br><0.5 g/day 1-15 mg/dL<br><2.78 mmol/day 0.1 - 0.8 mmol/L | Urine :<br>1st Morning Urine: 6 - 20 mg/dL (0.3 –<br>1.1 mmol/L)<br>24 Hour Urine: 6 - 17 mg/dL (0.3 – 0.96<br>mmol/L)<br>(Average of 1350 mL Urine/24 h) |
| Controls | Recommended quality control<br>material (not included):<br>ELITech Clinical Systems ELITROL I<br>(Normal control)<br>ELITech Clinical Systems ELITROL II<br>(Pathologic control) | Recommended quality control material<br>(not included):<br>Precinorm U or Precinorm U plus and<br>Precipath U or Precipath U plus |
| Calibrator | Recommended calibration material<br>(not included):<br>ELITech Clinical Systems ELICAL 2 | Recommended calibration material (not<br>included):<br>Calibrator f.a.s |
| Limit of<br>Detection | Serum: 0.3 mg/dL (0.02 mmol/L)<br>Urine: 0.2 mg/dL (0.01 mmol/L) | Serum, Plasma & Urine: 1.98 mg/dL<br>(0.11 mmol/L) |
| Interferences-<br>Serum | Unconjugated bilirubin: No<br>significant interference up to<br>30.0 mg/dL (513 µmol/L).<br>Conjugated bilirubin: No significant<br>interference up to 29.5 mg/dL<br>(504 µmol/L).<br>Hemoglobin: No significant<br>interference up to 500 mg/dL.<br>Triglycerides: No significant<br>interference up to 600 mg/dL (5.95<br>mmol/L). At a level of ~1300mg/dL of<br>Triglycerides, a negative bias of 32%<br>is observed at 50 mg/dL of glucose,<br>and a negative bias of 19% is<br>observed at 120mg/dL of glucose<br>Ascorbic acid: No significant<br>interference up to 20.0 mg/dL.<br>(1136 µmol/L)<br>Uric acid: No significant interference<br>up to 20.0 mg/dL.(1190 µmol/L)<br>Methyl dopa: No significant<br>interference up to 2.0 mg/dL.<br>L-dopa: No significant interference<br>up to 30.0 mg/dL.<br>Tolazamide: No significant<br>interference up to 50.0 mg/dL.<br>Acetaminophen: No significant<br>interference up to 30 mg/dL.<br>(1.98 mmol/L) | Icterus: No significant interference up<br>to an I index of 60 for conjugated and<br>unconjugated bilirubin approximate<br>conjugated and unconjugated bilirubin<br>concentration: 1026 µmol/L or<br>60 mg/dL).<br>Hemolysis: No significant interference<br>up to an H index of 1000 (approximate<br>hemoglobin concentration: 621 µmol/L<br>or 1000 mg/dL).<br>Lipemia (Intralipid): No significant<br>interference up to an L index of 2000.<br>There is poor correlation between the L<br>index (corresponds to turbidity) and<br>Triglycerides concentration.<br>Drugs: No interference was found at<br>therapeutic concentrations using<br>common drug panels. |
| Parameter | New Device<br>ELITech Clinical Systems<br>GLUCOSE HK SL | Predicate Device<br>ROCHE DIAGNOSTICS GLUCOSE HK,<br>K951595 |
| Interferences -<br>Urine | Conjugated bilirubin: No significant<br>interference up to 29.5 mg/dL<br>(504 µmol/L).<br>Hemoglobin: No significant<br>interference up to 500 mg/dL<br>Uric Acid: No significant interference<br>up to 100 mg/dL.(5.95 mmol/L)<br>Urea: No significant interference up<br>to 6000 mg/dL.(999 mmol/L)<br>pH: No significant interference<br>between 2.5 to 12.0<br>Specific gravity: No significant<br>interference between 1.000 to 1.030 | No data |
| Calibration<br>frequency | Calibration frequency: 28 days<br>Recalibrate when reagent lots<br>change, when quality control results<br>fall outside the established range,<br>and after a maintenance operation. | Each lot and as required following<br>quality control procedures. |

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

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

# Control Sera

- 1. Predicate Device Name:
- Roche Diagnostics Precinorm U and Precipath U
- 2. k041227
- 3. Comparison with predicate

# Similarities and Differences

| ltem | ELITech Clinical Systems Device<br>ELITROL I and ELITROL II | Predicate<br>Roche Diagnostics Precinorm U and<br>Precipath U (k041227) |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use/Indica<br>tions for<br>Use | ELITech Clinical Systems ELITROL I and<br>ELITROL II are multi-parametric control<br>sera for in vitro diagnostic use in quality<br>control of quantitative ELITech Clinical<br>Systems methods on ELITech Clinical<br>Systems Analyzers. | Precinorm U is for use in quality control<br>by monitoring accuracy and precision for<br>the quantitative methods as specified in<br>the value sheets.<br>Precipath U is for use in quality control<br>by monitoring accuracy and precision for<br>the quantitative methods as specified in<br>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>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 |

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

# 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<br>Use/Indicat<br>ions for<br>Use | ELITech Clinical Systems ELICAL 2 is a<br>multiparametric calibrator for <i>in vitro</i><br>diagnostic use in the calibration of<br>quantitative ELITech Clinical Systems<br>methods on ELITech Clinical Systems<br>Analyzers. | Calibrator for automated systems<br>(C.f.a.s.) is for use in the calibration of<br>quantitative Roche methods on Roche<br>clinical chemistry analyzers as<br>specified in the value 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 |
| Stability | Lyophilized:<br>To store at 2-8°C and protected from<br>light 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<br>frozen once) | Same |

#### 9. Standard/Guidance Document Reference

- CLSI EP5-A2 (Evaluation of precision performance of Quantitative . MeasurementMethods: Approved Guideline - Second Edition). CLSI protocol EP6-A (Evaluation of the Linearity of Quantitative Measurement Procedure: A Statistical Approach; Approved Guideline).
- CLSI protocol EP17-A (Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline).
- . CLSI protocol EP7-A2 (Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition) used for recommended sample concentrations.
- CLSI protocol EP9-A2 (Method Comparison and Bias Estimation Using Patient . Samples ; Approved Guideline - Second edition).
- . NF EN 13640:2002 "Stability testing of in vitro diagnostic reagents
- Test Principle: 10.

The reaction of glucose with ATP produces Glucose –6-phosphate which in presence of NAD+ will produce D-Gluconate-6-phosphate + NADH + H*

The increase of absorbance is directly proportional to the glucose concentration.

#### Performance Characteristics - Analytical Performance 11.

# a. Precision/Reproducibility

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

# Precision

The precision of the device was determined in accordance to CLSI EP05-A2 protocol (Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition).

Within-run and total precision results were obtained by performing two runs per day, two measures per run, for 4 levels of samples on 2 instruments during twenty operating days according to CLSI EP05-A2 protocol. The results are presented in the table below:

| Level | n | Mean (mg/dL) | Precision % | |
|---------|----|--------------|----------------|-----------|
| | | | Within-run CV% | Total CV% |
| Level 1 | 80 | 45.5 | 1.1 | 2.0 |
| Level 2 | 80 | 119.5 | 0.9 | 1.7 |
| Level 3 | 80 | 251.5 | 0.9 | 2.0 |
| Level 4 | 80 | 522.5 | 0.4 | 1.8 |

### Serum Level 1,2 and 4 are human sera, level 3 is a control sera

# Urine

# Level 1 ,2 and 3 are urine pool

| Level | n | Mean (mg/dL) | Precision % | |
|---------|----|--------------|----------------|-----------|
| | | | Within-run CV% | Total CV% |
| Level 1 | 80 | 18.0 | 0.9 | 2.0 |
| Level 2 | 80 | 204.4 | 0.7 | 1.7 |
| Level 3 | 80 | 497.4 | 0.6 | 1.7 |

# b. Linearity/assay reportable range

The linearity study of ELITech Clinical Systems GLUCOSE HK SL was performed according to CLSI protocol EP06-A (Evaluation of the Linearity of the Measurement of Quantitative Procedures: a Statistical Approach; Approved Guideline).

# Serum:

The linearity of ELITech Clinical Systems GLUCOSE HK SL was studied by mixing a sample with high value (726.6 mg/dL) and a sample with low value (20.0 mg/dL) to obtain 11 levels with equidistant concentrations and then measuring the glucose concentration of each of the 11 levels using ECS GLUCOSE HK SL reagent.

Regression analysis of the results yielded the following: y = 1.025x - 2.0 mg/dL. r = 1.000 r2 = 1.000 Standard error of the estimate Sy.x = 2.0 mg/dL

From this study, a measuring range from 20 - 720 mg/dL has been determined.

{10}------------------------------------------------

# Urine:

The linearity of ELITech Clinical Systems GLUCOSE HK SL was studied by mixing a sample with high value (724.9 mg/dL) and a sample with low value (10.1 mg/dL) to obtain 11 levels with equidistant concentrations and then measuring the glucose concentration of each of the 11 levels using ECS GLUCOSE HK SL reagent.

Regression analysis of the results yielded the following: y = 1.0155x - 1.6 mg/dL. r = 0.999 r2 = 0.998 Standard error of the estimate Sy.x = 3.5 mg/dL

From this study, a measuring range from 10 - 720 mg/dL has been determined.

Auto-dilution 1 to 5 allows the use of the ELITech Clinical Systems GLUCOSE HK SL with analyte activities up to 3600 mg/dL.

### c. Traceability

For calibration, a multi-parametric calibrator, most recently cleared under k151552, named ELITech Clinical Systems ELICAL 2 (manufactured by ELITech Clinical Systems SAS under product code CALI-0580) must be used. Traceability of the assigned value for all constituents in this calibrator, including the qlucose value assigned to calibrate ELITech Clinical Systems GLUCOSE HK SL. is included in its labeling. ELITech Glucose Hexokinase method is traceable to Isotope-dilution/Mass spectrometry, validated through the testing of SRM 965b of National Institute of Standards and Technology (NIST).

### d. Stability

On board stability for the ELITech Clinical Systems GLUCOSE HK SL was established by real time studies on the ELITech Clinical Systems Selectra ProM Analyzer. The on-board stability of the reagent is 28 days. The shelf-life of GLUCOSE HK SL reagent has been followed in real time for 36 months on 3 different batches; a real-time stability of 27 months is claimed.

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°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: 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 states 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 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 GLUCOSE HK SL reagent and 2 levels of quality control material. The mean analyte value is calculated and a target value is assigned.

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

# e. Detection limit

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

# Serum

Limit of Detection:

The limit of Detection was obtained from 15 measurements of 4 samples prepared from 4 patient samples measured using ELITech Clinical Systems GLUCOSE HK SL and diluted with NaCI 0.9% to obtain a concentration of approximately 5 mg/dL.

The data are not Gaussian, so LoD= LoB + Dsg (where Dsg is determined by calculating the median minus the 5th percentile of the low activity sample distribution).

Limit of Detection = 0.3 mg/dL.

# Limit of Quantification:

The limit of Quantification was obtained from 15 measurements of 4 samples prepared from 4 patient samples measured using ELITech Clinical Systems GLUCOSE HK SL and diluted with NaCl 0.9% to obtain a concentration of 5.0 mg/dL.

Acceptance criteria: The acceptable Total Error for the determination Limit of Quantification is ≤ 0.32 mg/dL. If the confidence Interval is within the acceptable total error limits, then the Limit of Quantification is acceptable. The value must be equal or higher than the Limit of Detection.

Limit of Quantification = 5.00 mg/dL.

# Urine

Limit of Detection:

The limit of Detection was obtained from 15 measurements of 4 samples prepared from 4 patient samples measured using ELITech Clinical Systems GLUCOSE HK SL and diluted with NaCl 0.9% to obtain a concentration of 5.0 mg/dL.

The data are not Gaussian, so LoD= LoB + Ds (where Ds & is determined by calculating the median minus the 5th percentile of the low activity sample distribution).

Limit of Detection = 0.2 mg/dL.

# Limit of Quantification

The limit of Quantification was obtained from 15 measurements of 4 samples prepared from 4 patient samples measured using ELITech Clinical Systems GLUCOSE HK SL and diluted with NaCl 0.9% to obtain a concentration of 1.50 mg/dL.

Acceptance criteria: The acceptable Total Error for the determination Limit of Quantification is ≤ 0.8 mg/dL. If the confidence Interval is within the acceptable total error limits, then the Limit of Quantification is acceptable. The value must be equal or higher than the Limit of Detection.

Limit of Quantification =5.00 mg/dL.

# f. Interference/analytical specificity

# Serum

Interferences due to unconjugated bilirubin, conjugated bilirubin, hemoglobin, triglycerides, ascorbic acid, uric acid, methyl dopa, L-dopa, Tolazamide and acetaminophen were investigated following the recommended sample levels in CLSI EP07-A2 protocol

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

(Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition).

For each potential interferent tested, 2 serum sample pools at two glucose levels close to those specified in Appendix B of EP7-A2 we
-1* pool: low activity at nominal 50.0 mg/d
-200 pool: high activity at nominal 120.0 mg/ those specified in Appendix B of EP7-A2 were prepared:

- 1st pool: low activity at nominal 50.0 mg/dL

pool: high activity at nominal 120.0 mg/dL

Aliquots of each of the serum sample pools were spiked with increasing interferent concentration. Test ranges covered at least the interferent level specified in Appendix D of EP7-A2. Thus, there were two series of interferent spike for each potential interferent tested. A control sample was prepared from the sample pool diluted in the appropriate diluent.

| Interferent | Test range | Number of different<br>concentrations tested |
|------------------------|------------------|----------------------------------------------|
| Triglycerides | up to 3000 mg/dL | 9 |
| Unconjugated bilirubin | up to 30.0 mg/dL | 7 |
| Conjugated bilirubin | up to 29.5 mg/dL | 7 |
| Hemoglobin | up to 500 mg/dL | 9 |
| Uric acid | up to 20.0 mg/dL | 7 |
| L-dopa | up to 30 mg/dL | 7 |
| Ascorbic acid | up to 20 mg/dL | 7 |
| Methyl dopa | up to 2.0 mg/dL | 6 |
| Tolazamide | up to 50 mg/dL | 6 |
| Acetaminophen | up to 30 mg/dL | 7 |

Two (2) levels of control (Serum control Level 1 (ELITROL I) and Serum control Level 2 (ELITROL II)) were tested to check the calibration.

For both sample pools for each interferent, each point was measured in triplicate per run. Acceptance criteria: an accepted bias of ±10% in sample pools with low (50.0 mg/dL) or high (120.0 mg/dL) nominal activity.

The results of testing interferences are the following:

- Concentration up to 30.0 mg/dL unconjugated bilirubin, 29.5 mg/dL conjugated bilirubin, -500 mg/dL hemoglobin, 600 mg/dL triglycerides (At a level of ~1300mg/dL of Triglycerides, a negative bias of 32% is observed at 50 mg/dL of glucose, and a negative bias of 19% is observed at 120mg/dL of glucose), 20.0 mg/dL ascorbic acid, 20.0 mg/dL uric acid. 2.0 mg/dL methyl dopa, 30.0 Tolazamide and 30 mg/dL acetaminophen do not show any significant interference for each substance.
- In very rare cases, monoclonal gammopathies (multiple myeloma), in particular IgM type (Waldenstrom's macroglobulinemia) can cause unreliable results.

# The following statement will also be included in the labeling:

Many other substances and drugs may interfere. Some of them are listed in Young. -Young, D. S., Effects of preanalytical variables on clinical laboratory tests, 20° Ed., AACC Press, (1997).

- Young, D. S., Effects of drugs on clinical laboratory tests, 4th 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.

# Urine

Interferences due to Conjugated bilirubin, Hemoglobin, Uric Acid and Urea were investigated following the recommended sample levels in CLSI EP07-A2 protocol (Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition). Also tested were pH and specific gravity.

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

For each potential interferent tested, 2 urine sample pools at two glucose levels close to those specified in Appendix B of EP7-A2 were prepared:

- -18t pool: low activity at nominal 18.0 mg/dL
-20d pool: high activity at nominal 200.0 mg/dL

Aliquots of each of the urine sample pools were spiked with increasing interferent concentration. Test ranges covered at least the interferent level specified in Appendix D of EP7-A2. Thus, there were two series of interferent spike for each potential interferent tested. A control sample was prepared from the sample pool diluted in the appropriate diluent.

| Interferent | Test range | Number of different<br>concentrations tested |
|----------------------|------------------------|----------------------------------------------|
| Conjugated bilirubin | up to 29.5 mg/dL | 7 |
| Hemoglobin | up to 500 mg/dL | 9 |
| Uric acid | up to 100 mg/dL | 6 |
| Urea | up to 6000 mg/dL | 6 |
| pH | between 2.5 to 12.0 | 7 |
| Specific Gravity | between 1.000 to 1.030 | 6 |

Two (2) levels of control (Serum control Level 1 (ELITROL I) and Serum control Level 2 (ELITROL II)) were tested to check the reagents.

For both sample pools for each interferent, each point was measured in triplicate per run. Acceptance criteria: an accepted bias of ±10% in sample pools with low (18.0 mg/dL) or high (200.0 mg/dL) nominal activity.

The results of testing interferences are the following:

- Concentration up to 29.5 mg/dL conjugated bilirubin, 500 mg/dL hemoglobin, 100 mg/dL uric acid and 6000 mg/dL urea do not significant interference for each substance.
# The following statement will also be included in the labeling:

Many other substances and drugs may interfere. Some of them are listed in Young. -Young, D. S., Effects of preanalytical variables on clinical laboratory tests, 20° Ed., AACC Press, (1997).

-Young, D. S., Effects of drugs on clinical laboratory tests, 40 Ed., AACC Press, (1995).

#### Performance Characteristics - Comparison Studies 11.

### a. Method comparison

### Serum

A correlation study was performed between ELITech Clinical Systems GLUCOSE HK SL reagent on a Selectra ProM Analyzer and GLUC2 (Glucose HK) reagent on 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 20.5 to 707.5 mg/dL over a span of 5 days.

Regression analysis of the results vielded the following: v = 1.008 x + 0.4 ma/dL. r = 1.000 r2 = 1.000 Standard error of the estimate Sy.x = 2.7 mg/dL.

{14}------------------------------------------------

# Urine

A correlation study was performed between ELITech Clinical Systems GLUCOSE HK SL reagent on a Selectra ProM Analyzer and GLUC2 (Glucose HK) reagent on 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 40 urine patient samples (with glacial acetic acid as preservative) from 10.1 to 703.9 mg/dL over a span of 2 days.

Regression analysis of the results yielded the following: y = 0.996 x - 0.4 mg/dL r = 1.000 r2 = 1.000 Standard error of the estimate Sy.x = 3.5 mg/dL

### b. Comparison study: Matrix comparison

40 plasma patients (in lithium heparin samples, ranging from 24.3 to 710.1 mg/dL), were tested on ELITech Clinical Systems Selectra ProM 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 = 1.001x - 0.7 mg/dL r = 1.000 r2 = 1.000 Standard error of the estimate Sy.x = 1.9 mg/dL

40 plasma patients (in sodium fluoride/ oxalate, ranging from 21.2 to 701.4 mg/dL), were tested on ELITech Clinical Systems Selectra ProM 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 = 1.016x - 0.9 mg/dL r = 0.999 r2 = 0.998 Standard error of the estimate Sy.x = 7.0 mg/dL

### c. Expected values/Reference Range

As indicated in the instructions for use for ELITech Clinical Systems GLUCOSE HK SL, each laboratory should establish and maintain its own reference values. The values given are used as guidelines only.

# Serum/ Plasma :

74 - 106 mg/dL 4.1 – 5.9 mmol/L

# Urine :

<0.5 g/day 1-15 mg/dL <2.78 mmol/day 0.1 - 0.8 mmol/L

{15}------------------------------------------------

# These reference values are from:

Wu, A. H. B., Clinical quide to laboratory tests, 4006 Ed., (W.B. Saunders eds. Philadelphia USA), (2006), 444

# d. Clinical Studies:

Not applicable

# e. Clinical Cut-off:

Not applicable

#### 12. Conclusion

Versus the predicate, the new device has the same indications for use on the same specimen types. The information on the principle and performance of the test device shown in the above table, gained in laboratory evaluation of the device and contained in this premarket notification, shows no deviation in safety or effectiveness, and supports a decision that the test device is substantially equivalent to the predicate device.