CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)

K162281 · Sebia · LCP · Feb 17, 2017 · Hematology

Device Facts

• Record ID: K162281
• Device Name: CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
• Applicant: Sebia
• Product Code: LCP · Hematology
• Decision Date: Feb 17, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The CAPI 3 HbA1c kit is designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in venous whole blood, by capillary electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 3 TERA instrument. Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. This test is not for screening or diagnosis of diabetes. The CAPI 3 HbA1c kit is designed for Professional Use Only. The Multi-system HbA1c CAPILLARY Controls (2) are designed for the migration control and quality control of human glycated hemoglobin A1c quantification with SEBIA capillary electrophoresis procedures: CAPILLARYS HbA1c performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument, CAPI 3 HbA1c performed with the CAPILLARYS 3 TERA automated instrument and MINICAP HbA1c performed with the MINICAP FLEX-PIERCING automated instrument. The HbA1c CAPILLARY Controls are designed for Professional Use Only.

Device Story

CAPI 3 HbA1c kit uses capillary electrophoresis to quantify HbA1c in venous whole blood. Input: K2/K3 EDTA whole blood samples. Process: Sample dilution, injection into silica capillaries, high-voltage separation in alkaline buffer (pH 9.4), and direct absorbance detection at 415 nm. Output: Relative quantification of HbA1c fraction in % (NGSP) and mmol/mol (IFCC). Used in clinical laboratories; operated by professional staff on CAPILLARYS 3 TERA instrument. Software automatically processes migration patterns to identify hemoglobin fractions. Results assist clinicians in monitoring long-term glycemic control. Benefits: High-resolution separation allows quantification despite presence of labile HbA1c, carbamylated/acetylated hemoglobins, and major variants.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated across three instruments (Total CV 0.7-1.3% in NGSP units). Linearity confirmed 3.8-17.3% HbA1c. Interference studies show no significant impact from endogenous substances (bilirubin, lipids, etc.), common drugs, or hemoglobin variants (S, E, D, C, F, A2). Method comparison against predicate in 392 total samples showed high correlation (r ≥ 0.997).

Technological Characteristics

Capillary electrophoresis in free solution; silica capillaries (ID <100 µm); alkaline buffer (pH 9.4); 415 nm absorbance detection; Peltier temperature control; RFID-tagged reagents/racks; 12 parallel capillaries; PC/touchscreen interface; standalone instrument.

Indications for Use

Indicated for professional use in monitoring long-term glycemic control in individuals with diabetes mellitus. Not for screening or diagnosis of diabetes. Uses venous whole human blood.

Regulatory Classification

Identification

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

Predicate Devices

• CAPILLARYS HbA1c Kit (k122101)
• HbA1c CAPILLARY Controls (k122101, k133344)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized graphic of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.

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

SEBIA, INC. KAREN ANDERSON DIRECTOR OF TECHNICAL AND QUALITY ASSURANCE 1705 CORPORATE DRIVE, SUITE 400 NORCROSS GA 30093

February 17, 2017

Re: K162281 Trade/Device Name: CAPI 3 Hb A1c MULTI-SYSTEM Hb A1c CAPILLARY Controls (2) Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP, JJX Dated: August 8, 2016 Received: August 15, 2016

Dear Karen Anderson:

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 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.

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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/ResourcesforYou/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

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#### Indications for Use

510(k) Number (if known)

Device Name CAPI 3 Hb Alc

#### Indications for Use (Describe)

The CAPI 3 Hb A 1 c kit is designed for separation and quantification of the HbA 1c glycated fraction of hemoglobin in venous whole human blood, by capillary electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 3 TERA instrument. Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. This test is not for screening or diabetes. The CAPI 3 Hb A1c kit is designed for Professional Use Only

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### Indications for Use

510(k) Number (if known)

Device Name

MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (2)

Indications for Use (Describe)

The Multi-system Hb A1c CAPILLARY Controls (2) are designed for the migration control and quality control of human glycated hemoglobin Alc quantification with SEBIA capillary electrophoresis procedures:

- CAPILLARYS Hb A1c performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument,

- CAPI 3 Hb Alc performed with the CAPILLARYS 3 TERA automated instrument and,

- MINICAP Hb A1c performed with the MINICAP FLEX-PIERCING automated instrument.

The Hb Alc CAPILLARY Controls are designed for Professional Use Only.

For In Vitro Use.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

#### 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 [e-mail]

"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."

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# 510K SUMMARY (Summary of Safety and Effectiveness)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

| Submitter Name | Sebia, Inc. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 1705 Corporate Drive Suite 400<br>Norcross, Georgia 30093, USA |
| Contact | Karen Anderson, Dir of Technical and QA<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br><br>Aigars Brants, Ph.D, Scientific Affairs Officer<br>Phone [phone]<br>Fax [phone]<br>Email: [e-mail] |
| Date Prepared | July 25, 2016 / Revised February 14, 2017 |
| Manufacturing | Sebia<br>Parc Technologique Léonard de Vinci<br>Rue Léonard de Vinci,<br>CP 8010 LISSES, 91008 EVRY Cedex<br>FRANCE<br>Phone: [phone]<br>Fax: [phone] |
| Product Name | CAPI 3 Hb A1c (PN 2515),<br>MULTI-SYSTEM Hb A1c CAPILLARY Controls<br>(2) (PN 4768) using CAPILLARYS 3 TERA<br>instrument (PN 1246) |
| Common Name | Whole blood hemoglobin A1c (HbA1c) by capillary<br>electrophoresis |
| Product Regulation No. | 21 CFR Part 864.7470,862.1660 |
| Product Codes | LCP, JJX |
| Device classification | Class II , Class I (general controls) |
| Establishment Registration No. | 8023024 |

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| Predicate Device Name | Predicate Device 510(k) number |
|---------------------------------------|--------------------------------|
| CAPILLARYS Hb A1c kit | K122101 |
| Hb A1c CAPILLARY Controls | K122101 and K133344 |
| CAPILLARYS 2 FLEX-PIERCING instrument | K122101 |

#### DEVICE DESCRIPTION 1.

The capillary electrophoresis provides complete automation with fast separation and good resolution. This electrokinetic separation technique is carried out in a silica glass tube (i.e., capillary) with internal diameter lower than 100 µm filled with a buffer composed of electrolytes.

The CAPILLARYS 3 TERA instrument uses the principle of capillary electrophoresis in free solution. With this technique, charged molecules are separated by their electrophoretic mobility in an alkaline buffer with a specific pH. Separation occurs according to the electrolyte pH and electroosmotic flow.

The CAPILLARYS 3 TERA instrument has silica capillaries functioning in parallel allowing 12 simultaneous analyses of HbA1c quantification in a whole blood sample. A sample dilution with hemolysing solution is prepared and injected by aspiration at the anodic end of the capillary. A high voltage protein separation is then performed and direct detection of the hemoglobins is made at the cathodic end of the capillary at 415 nm, which is the absorbance wave length specific to hemoglobins. Before each run, the capillaries are washed with a wash solution and prepared for the next analysis with buffer.

Direct detection provides accurate relative quantification of individual hemoglobin A1c fraction. In addition, the high resolution of CAPI 3 Hb A1c procedure allows the quantification of HbA1c even in the presence of labile HbA1c, carbamylated and acetylated hemoglobins, and major hemoglobin variants.

By using an alkaline pH buffer, normal and abnormal (or variant) hemoglobins are detected in the following order, from cathode to anode: A2/C, E, S/D, F, A0, other Hb (including minor Hb A1) and then A1c.

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# Reagents:

# CAPI 3 Hb A1c KIT

| ITEMS | PN 2515 |
|------------------------------------|----------------------|
| Buffer (ready to use) | 2 vials, 700 mL each |
| Hemolysing solution (ready to use) | 1 vial, 700 mL |
| Filters | 4 filters |

# Additional reagents not included in the CAPI 3 Hb A1c KIT

| ITEMS | PN | COMPONENTS |
|--------------------------------------|------|-------------------------------------------------------------|
| CAPICLEAN CAPILLARYS 3 | 2060 | 1 vial, 25 mL |
| CAPILLARYS 3 WASH SOLUTION | 2062 | 1 vial, 75mL |
| CAPI 3 DISPOSABLES KIT | 2580 | 10 packs of 14 reagent cups<br>5 bins for used reagent cups |
| TEST TUBES | 9214 | 200 of 100mm-tubes |
| CAPI 3 BINS FOR USED REAGENT<br>CUPS | 2581 | 5 units |
| TUBES AND CAPS FOR | 9202 | 20 units |
| CONTROLS | 9205 | 500 units |

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### 2. INDICATIONS FOR USE

#### CAPI 3 Hb A1c kit:

The CAPI 3 Hb A1c kit is designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in venous whole blood, by capillary electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 3 TERA instrument. Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. This test is not for screening or diabetes. The CAPI 3 Hb A1c kit is designed for Professional Use Only.

For In Vitro Diagnostic Use.

#### MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (2):

The Multi-system Hb A1c CAPILLARY Controls (2) are designed for the migration control and quality control of human glycated hemoglobin A1c quantification with SEBIA capillary electrophoresis procedures:

CAPILLARYS Hb A1c performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument,

-CAPI 3 Hb A1c performed with the CAPILLARYS 3 TERA automated instrument and, - MINICAP Hb A1c performed with the MINICAP FLEX-PIERCING automated instrument. The Hb A1c CAPILLARY Controls are designed for Professional Use Only.

For In Vitro Use.

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# 3. TECHNOLOGICAL CHARACTERISTICS

The CAPILLARYS 3 TERA instrument uses the principle of capillary electrophoresis in free solution which is the most common form of capillary electrophoresis. With this technique, charged molecules are separated by their electrophoretic mobility in an alkaline buffer with a specific pH. Separation also occurs according to the electrolyte pH and electroosmotic flow.

The CAPILLARYS 3 TERA instrument has silica capillaries functioning in parallel allowing 12 simultaneous analyses of Hb A1c quantification in a whole blood sample. A sample dilution with hemolysing solution is prepared and injected by aspiration at the anodic end of the capillary. A high voltage protein separation is then performed and direct detection of the hemoglobins is made at the cathodic end of the capillary at 415 nm, which is the absorbance wave length specific to hemoglobins. Before each run, the capillaries are washed with a wash solution and prepared for the next analysis with buffer.

Direct detection provides accurate relative quantification of individual hemoglobin A1cfraction. In addition, the high resolution of CAPI 3 Hb A1c procedure allows the quantification of HbA1c, and particularly, even in the presence of labile HbA1c, carbamylated and acetylated hemoglobins, and major hemoglobin variants.

By using an alkaline pH buffer, normal and abnormal (or variant) hemoglobins are detected in the following order, from cathode to anode: A2/C, E, S/D, F, A0, other Hb (including minor Hb A1) and then A1c.

#### SUBSTANTIAL EQUIVALENCE INFORMATION:

| Predicate Device Name | Predicate Device 510(k) number |
|---------------------------|--------------------------------|
| CAPILLARYS Hb A1c | K122101 |
| Hb A1c CAPILLARY Controls | K122101 and K133344 |

The technological characteristics of the CAPI 3 Hb A1c procedure using the CAPILLARYS 3 TERA instrument (candidate device) utilizes the same principles of capillary electrophoresis in an alkaline buffer reading at a wavelength of 415 nm as the CAPILLARYS Hb A1c procedure (predicate device).

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# Table A.

Similarities and differences between the predicate device (CAPILLARYS Hb A1c) and the candidate device (CAPI 3 Hb A1c). Both are members of the Sebia CAPILLARYS family of instruments.

| Table A | SEBIA CAPILLARYS<br>Hb A1c (K) 122101 | SEBIA CAPI 3 Hb A1c |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CAPILLARYS Hb A1c kit is designed<br>for separation and quantification of the<br>HbA1c glycated fraction of hemoglobin in<br>human blood, by capillary electrophoresis<br>in alkaline buffer (pH 9.4) with the<br>CAPILLARYS 2 FLEX-PIERCING<br>instrument. Measurement of hemoglobin<br>A1c is effective in monitoring long-term<br>glycemic control in individuals with<br>diabetes mellitus. The CAPILLARYS Hb<br>A1c kit is designed for Professional Use<br>Only.<br>For In Vitro Diagnostic Use. | The CAPI 3 Hb A1c kit is designed for<br>separation and quantification of the<br>HbA1c glycated fraction of<br>hemoglobin in venous whole blood,<br>by capillary electrophoresis in alkaline<br>buffer (pH 9.4) with the CAPILLARYS<br>3 TERA instrument. Measurement of<br>hemoglobin A1c is effective in<br>monitoring long-term glycemic control<br>in individuals with diabetes<br>mellitus.This test is not for screening<br>or diagnosis of diabetes. The CAPI 3<br>Hb A1c kit is designed for<br>Professional Use Only.<br>For In Vitro Diagnostic Use. |
| Separation<br>system | Free solution capillary electrophoresis<br>(FSCE): hemoglobin separation on an<br>alkaline buffer (pH 9.4) according to their<br>charge, to the electrolyte pH<br>and<br>electroosmotic flow.<br>Fast separation and good resolution.<br>Electrophoregrams show separated<br>fractions according to their charge. | Same |
| Reagent | CAPILLARYS Hb A1c Kit (PN 2015) : | CAPI 3 Hb A1c Kit (PN 2515) : |
| Composition | Buffer (ready to use) : 2 vials, 700 mL<br>each<br>Hemolysing solution (ready to use) : 1 vial,<br>700 mL<br>Wash solution (stock solution) : 1 vial, 75<br>mL<br>Dilution segments : 1 pack of 90<br>Filters : 4 filters | Buffer (ready to use) : 2 vials, 700 mL<br>each<br>Hemolysing solution (ready to use) : 1<br>vial, 700 mL<br>Filters : 4 filters |
| Shelf life (*) | Buffer : 3 years at 2 - 8 °C | Same |
| | Hemolysing solution : 3 years at 2 – 30 °C | |
| Instrument | SEBIA CAPILLARYS 2 FLEX-PIERCING<br>instrument, PN 1227 | SEBIA CAPILLARYS 3 TERA<br>instrument, PN 1246 |
| Analysis<br>throughput | 40 analyses / hour | 62 analyses / hour |
| Interface | PC interface | PC interface + touch screen |
| Temperature<br>Control | By Peltier device | Same |
| | | |
| Detection<br>system | Deuterium lamp | Deuterium lamp and LED |
| Software for<br>data processing | SEBIA PHORESIS™ software | Same |
| Firmware | Included into the PHORESIS software | Included into the instrument |
| Number of<br>separation units | 8 parallel capillaries | 12 parallel capillaries |
| Samples tubes | Uncapped tubes or capped tubes<br>depending on the procedure | Same |
| Samples<br>identification | Yes (Bar code reading on both sample<br>racks and tubes) | Yes (Bar code reading on sample<br>tubes and RFID labels on sample<br>racks) |
| Reagent<br>identification | No | Yes (RFID labels on reagent vials) |
| Introduction of<br>the samples<br>into the<br>automatic<br>system | Primary capacity of 88 tubes for HbA1c<br>technique (i.e. 11 sample racks),<br>uninterrupted throughput on sample racks.<br>Each sample rack contains 8 sample tube. | Primary maximal capacity of 120<br>tubes (i.e. 15 sample racks),<br>uninterrupted throughput on sample<br>racks (8 positions available). |
| Reagent bay :<br>main<br>compartement | CAPILLARYS 2 FLEX-PIERCING:<br>Contains one vial of water, wash solution,<br>hemolyzing solution (for Hb and Hb A1c<br>techniques) and buffer container. | Up to 4 analysis buffers or<br>hemolysing solutions (identified by<br>RFID labels); 1 waste container, 1<br>container for water, 1 container for<br>the wash solution |
| Reagent bay :<br>secondary<br>compartment | NA | Up to 3 vials and 1 rack with<br>immunotyping reagents (all<br>RFID tagged) in temperature<br>controlled environment (< 15 °C);<br>1 RFID labeled vial and three tubes<br>(for maintenance solutions) at room<br>temperature |
| Dimensions | L. 95 cm x H. 39 cm x D. 63 cm | L. 90 cm x H. 54 cm x D. 67 cm |
| Weight | 50 kg | 75 kg |

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(*) The reagent shelf life (buffer and hemolysing solution) has been extended (3 years instead of 2 years)

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Table B. Similarities and differences between the candidate device (Multi-system Hb A1c CAPILLARY Controls (2)) and the predicate device (Hb A1c CAPILLARY Controls).

| TABLE C | SEBIA<br>Hb A1c CAPILLARY Controls<br>K122101 and K133344 | SEBIA<br>Multi-system Hb A1c CAPILLARY<br>Controls (2) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Hb A1c CAPILLARY Controls are<br>designed for the migration control and<br>quality control of human glycated<br>hemoglobin A1c quantification with SEBIA<br>capillary electrophoresis procedures :<br>- CAPILLARYS Hb A1c performed<br>with the CAPILLARYS 2 FLEX-PIERCING<br>automated instrument and,<br>- MINICAP Hb A1c performed with<br>the MINICAP FLEX-PIERCING automated<br>instrument.<br>The Hb A1c CAPILLARY Controls are<br>designed for Professional Use Only.<br><br>For In Vitro Use. | The Multi-system Hb A1c CAPILLARY<br>Controls (2) are<br>designed for the<br>migration control and quality control of<br>human glycated hemoglobin<br>A1c quantification with<br>SEBIA capillary electrophoresis<br>procedures:<br>- CAPILLARYS Hb A1c performed<br>with the CAPILLARYS 2 FLEX-PIERCING<br>automated instrument,<br>- CAPI 3 Hb A1c performed with the<br>CAPILLARYS 3 TERA automated<br>instrument and,<br>- MINICAP Hb A1c performed with<br>the MINICAP FLEX-PIERCING automated<br>instrument.<br>The Hb A1c CAPILLARY Controls are<br>designed for Professional Use Only.<br><br>For In Vitro Use. |
| Product Number | 4774 | 4768 |
| Format | Hb A1c CAPILLARY Control 1 :<br>1 vial<br>Hb A1c CAPILLARY Control 2 :<br>1 vial | Same |
| Preparation | Reconstitute the lyophilized control vial with<br>0.6 mL of distilled or deionized water. | Reconstitute the lyophilized control vial<br>with 0.75 mL of distilled or deionized water. |
| Storage<br>temperature | Before reconstitution, store the lyophilized<br>controls refrigerated (2 to 8 °C). They are<br>stable until the expiration date indicated on<br>the vial labels. | Same |
| Shelf life | 3 years at 2 - 8 °C | Same |
| TABLE B | SEBIA<br>Hb A1c CAPILLARY Controls<br>K122101 and K133344 | SEBIA<br>Multi-system Hb A1c CAPILLARY<br>Controls (2) |
| | - 30 °C.<br>Do not freeze and thaw the<br>reconstituted controls more than 30<br>times.<br>After hemolysis with the CAPILLARYS<br>2 FLEX-PIERCING instrument, store<br>the dilution segments with controls at<br>2 - 8 °C and use them within the day<br>(for 8 hours maximum). They may be<br>stored, without any delay, between -<br>18 °C and - 30 °C for 1 month<br>maximum. Do not freeze and thaw a<br>dilution segment with hemolyzed<br>control more than three times.<br>MINICAP Hb A1c :<br>After reconstitution, store the controls<br>at 2 - 8 °C in a closed conical tube for<br>control blood and use them within the<br>day (for 24 hours maximum). After<br>use, they must be stored without any<br>delay between - 18 °C and - 30 °C due<br>to the risk of microbial contamination<br>and denaturation. They are stable for<br>6 months maximum between - 18 °C<br>and - 30 °C.<br>Do not freeze and thaw the<br>reconstituted controls more than 30<br>times. | - 30 °C.<br>Do not freeze and thaw the<br>reconstituted controls more than 30<br>times.<br>After hemolysis with the CAPILLARYS<br>2 FLEX-PIERCING instrument, store<br>the dilution segments with controls at<br>2 - 8 °C and use them within the day<br>(for 8 hours maximum). They may be<br>stored, without any delay, between -<br>18 °C and - 30 °C for 1 month<br>maximum. Do not freeze and thaw a<br>dilution segment with hemolyzed<br>control more than three times.<br>MINICAP Hb A1c :<br>After reconstitution, store the controls<br>at 2 - 8 °C in a closed conical tube for<br>control blood and use them within the<br>day (for 24 hours maximum). After<br>use, they must be stored without any<br>delay between - 18 °C and - 30 °C due<br>to the risk of microbial contamination<br>and denaturation. They are stable for<br>6 months maximum between - 18 °C<br>and - 30 °C.<br>Do not freeze and thaw the<br>reconstituted controls more than 30<br>times.<br>CAPI 3 Hb A1c :<br>After reconstitution, store the controls<br>at 2 - 8 °C in a closed conical tube for<br>control blood and use them within the<br>day (for 24 hours maximum). After<br>use, they must be stored without any<br>delay between - 18 °C and - 30 °C due<br>to the risk of microbial contamination<br>and denaturation. They are stable for<br>6 months maximum between - 18 °C<br>and - 30 °C.<br>Do not freeze and thaw the<br>reconstituted controls more than 30<br>times. |
| Instrument | SEBIA CAPILLARYS 2 FLEX-<br>PIERCING<br>SEBIA MINICAP FLEX-PIERCING | SEBIA CAPILLARYS 2 FLEX-<br>PIERCING<br>SEBIA MINICAP FLEX-PIERCING<br>SEBIA CAPILLARYS 3 TERA |

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#### Performance Data:

#### a. Precision

The precision of the CAPI 3 Hb A1c procedure was evaluated in a study based on the Clinical Laboratory Standards Institute (CLSI - USA) EP5-A3 quideline "Evaluation of Precision of Quantitative Measurements Procedures; Approved Guideline - Third Edition".

The means, standard deviations (SD) and coefficients of variation (CV %) were calculated for HbA1e concentration (mmol/mol) and percentage (%) for each sample.

Eight (8) different blood samples were run using the CAPI 3 Hb A1c procedure on 3 CAPILLARYS 3 instruments. The analyzed blood samples included 3 samples with normal

HbA1c level (No. 1, 2 and 3), 1 sample with HbAre level close to the cut-off value (No. 4) and 4 samples with elevated HbA1c level (No. 5, 6, 7 and 8).

Each sample was analyzed in duplicate on two capillaries per run, two runs per day over six days per lot of CAPI 3 Hb A1c kit, using three lots yielding a total of 432 results per sample over 18 days.

The Overall analysis is summarized in the following tables including within-capillary, betweencapillary, between-run, between-day, between-instrument and total reproducibility precision estimates (%CV) for the HbAre concentrations (in mmol/mol) and percentages.

| Within capillary | | Between capillary | | Between run | | Between day | | Between lot | | Between instrument | | Total<br>reproducibility (*) | | | |
|------------------|--------------------|-------------------|------|-------------|------|-------------|------|-------------|------|--------------------|------|------------------------------|------|-----|------|
| | Mean<br>(mmol/mol) | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| Blood No. 1 | 29 | 0,5 | 1,6% | 0,3 | 0,9% | 0,0 | 0,0% | 0,2 | 0,8% | 0,3 | 1,0% | 0,0 | 0,0% | 0,7 | 2,3% |
| Blood No. 2 | 33 | 0,5 | 1,5% | 0,4 | 1,2% | 0,0 | 0,0% | 0,3 | 0,8% | 0,1 | 0,4% | 0,2 | 0,5% | 0,7 | 2,2% |
| Blood No. 3 | 35 | 0,5 | 1,5% | 0,3 | 0,8% | 0,0 | 0,0% | 0,3 | 0,8% | 0,0 | 0,0% | 0,1 | 0,3% | 0,7 | 1,9% |
| Blood No. 4 | 46 | 0,6 | 1,4% | 0,2 | 0,5% | 0,0 | 0,0% | 0,2 | 0,5% | 0,2 | 0,5% | 0,1 | 0,1% | 0,8 | 1,6% |
| Blood No. 5 | 67 | 0,4 | 0,7% | 0,3 | 0,5% | 0,0 | 0,0% | 0,3 | 0,4% | 0,0 | 0,0% | 0,8 | 1,2% | 1,0 | 1,5% |
| Blood No. 6 | 73 | 0,5 | 0,6% | 0,3 | 0,5% | 0,1 | 0,1% | 0,3 | 0,4% | 0,3 | 0,5% | 0,0 | 0,0% | 0,7 | 1,0% |
| Blood No. 7 | 85 | 0,6 | 0,7% | 0,2 | 0,3% | 0,0 | 0,0% | 0,3 | 0,4% | 0,1 | 0,1% | 0,3 | 0,4% | 0,8 | 0,9% |
| Blood No. 8 | 108 | 0,5 | 0,5% | 0,5 | 0,5% | 0,0 | 0,0% | 0,5 | 0,5% | 0,2 | 0,2% | 0,2 | 0,2% | 0,9 | 0,9% |

(*) Total reproducibility includes ; within-capillary, between-run, between-day, between-ot and between-instrum

| | Within capillary | | Between capillary | | Between run | | Between day | | Between lot | | Between<br>instrument | | Total<br>reproducibility (*) | | |
|-------------|------------------|------|-------------------|------|-------------|------|-------------|------|-------------|------|-----------------------|------|------------------------------|------|------|
| | Mean<br>(%) | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| Blood No. 1 | 4,8 | 0,04 | 0,9% | 0,02 | 0,5% | 0,00 | 0,0% | 0,02 | 0,4% | 0,02 | 0,5% | 0,00 | 0,0% | 0,06 | 1,2% |
| Blood No. 2 | 5,1 | 0,05 | 0,9% | 0,03 | 0,6% | 0,00 | 0,0% | 0,02 | 0,4% | 0,01 | 0,1% | 0,02 | 0,3% | 0,06 | 1,3% |
| Blood No. 3 | 5,3 | 0,05 | 0,9% | 0,03 | 0,6% | 0,00 | 0,0% | 0,03 | 0,5% | 0,00 | 0,0% | 0,01 | 0,2% | 0,06 | 1,2% |
| Blood No. 4 | 6,4 | 0,06 | 0,9% | 0,02 | 0,4% | 0,00 | 0,0% | 0,02 | 0,3% | 0,02 | 0,3% | 0,00 | 0,0% | 0,07 | 1,1% |
| Blood No. 5 | 8,3 | 0,04 | 0,5% | 0,04 | 0,4% | 0,00 | 0,0% | 0,02 | 0,2% | 0,00 | 0,1% | 0,07 | 0,9% | 0,09 | 1,1% |
| Blood No. 6 | 8,9 | 0,05 | 0,5% | 0,04 | 0,4% | 0,00 | 0,0% | 0,03 | 0,3% | 0,03 | 0,4% | 0,00 | 0,0% | 0,07 | 0,8% |
| Blood No. 7 | 9,9 | 0,06 | 0,6% | 0,03 | 0,3% | 0,00 | 0,0% | 0,03 | 0,3% | 0,00 | 0,0% | 0,03 | 0,3% | 0,07 | 0,7% |
| Blood No. 8 | 12,0 | 0,05 | 0,4% | 0,04 | 0,3% | 0,00 | 0,0% | 0,04 | 0,4% | 0,04 | 0,3% | 0,02 | 0,2% | 0,09 | 0,7% |

(") Total reproducibility includes : within-capillary, between-run, between-day, between-lot and between-instru

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

The Instrument by Instrument analysis is summarized in the following tables:

- including within-capillary, between-capillary, between-day, between-lot and total reproducibility precision estimates (%CV) fo…