The CAPI 3 Hb A1c kit is designed for separation and quantification of the HbA1c 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.

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.

Device Description

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.

AI/ML Overview

The provided document describes the Sebia CAPI 3 Hb A1c kit and the MULTI-SYSTEM Hb A1c CAPILLARY Controls (2), which are devices used for the separation and quantification of the HbA1c glycated fraction of hemoglobin. The document presents performance data primarily related to analytical precision and accuracy, rather than a clinical study with human readers or ground truth established by experts in a diagnostic context.

Here's an analysis based on the categories requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria mentioned are implicitly derived from the reported performance, as specific quantitative criteria are not explicitly stated for all aspects (e.g., a target CV for precision). However, the study aims to demonstrate that the device performs within acceptable analytical limits for precision and accuracy.

Performance Characteristic	Acceptance Criteria (Implicit from Industry Standards/Predicate Device)	Reported Device Performance (CAPI 3 Hb A1c)
Precision	Low coefficient of variation (CV%) for both mmol/mol and % HbA1c across various experimental factors (within-capillary, between-capillary, between-run, between-day, between-lot, between-instrument).	Overall Total Reproducibility CV%:- mmol/mol: 0.9% - 2.3%- Percentage: 0.7% - 1.3%(Specific CVs are provided across different factors and instruments, demonstrating consistently low variability).
Linearity	Linear response across the measuring range.	Linear within the stated measuring range of 21-132 mmol/mol (4.0% - 14.7% HbA1c) and for total hemoglobin concentrations from 2.9 to 30.5 g/dL.
Accuracy (Internal Correlation)	High correlation (correlation coefficient close to 1) and a slope close to 1 with a y-intercept close to 0 when compared to a NGSP-standardized method.	Correlation Coefficient: 0.998 for both concentration and percentage.Y-Intercept: -0.238 (mmol/mol), -0.024 (%).Slope: 1.000 for both.
Accuracy (External Correlation - Study 1)	High correlation (correlation coefficient close to 1) and a slope close to 1 with a y-intercept close to 0 when compared to a NGSP-standardized method.	Correlation Coefficient: 0.998 (mmol/mol), 0.997 (%).Y-Intercept: 0.249 (mmol/mol), 0.045 (%).Slope: 0.993 (mmol/mol), 0.992 (%).
Accuracy (External Correlation - Study 2)	High correlation (correlation coefficient close to 1) and a slope close to 1 with a y-intercept close to 0 when compared to a NGSP-standardized method.	Correlation Coefficient: 0.998 (mmol/mol), 0.998 (%).Y-Intercept: 1.417 (mmol/mol), 0.205 (%).Slope: 0.970 (mmol/mol), 0.968 (%).
Interference	No significant interference from common factors.	No interference detected from high concentrations of various substances/factors (Triglycerides, Bilirubin, Ascorbic Acid, Urea, Rheumatoid factor, Glybenclamide, Total Protein, Glucose, Acetylsalicylic acid, Acetaminophen, Ibuprofen, Metformin, Acetylated hemoglobin, Carbamylated hemoglobin, Labile HbA1c, Hb A2, Hb F, Hb S, Hb C, Hb D, Hb E).

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

Precision Test Set: 8 different blood samples (3 normal HbA1c, 1 near cut-off, 4 elevated HbA1c). These samples were run extensively: each 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 provenance of these blood samples (e.g., country of origin, retrospective/prospective) is not specified in the provided text.
Linearity Test Set:
- Mixture of 2 different blood samples (normal and elevated HbA1c) in different proportions, analyzed in triplicate.
- Dilution of 4 different blood samples (1 normal, 1 near cut-off, 2 elevated HbA1c), serially diluted.
  Provenance not specified.
Accuracy (Internal Correlation) Test Set: 100 blood samples (normal and elevated HbA1c levels). Provenance not specified.
Accuracy (External Correlation - Study 1) Test Set: 175 blood samples (normal and elevated HbA1c levels). Provenance not specified.
Accuracy (External Correlation - Study 2) Test Set: 117 blood samples (normal and elevated HbA1c levels). Provenance not specified.
Combined Accuracy Study Set: 392 whole blood samples (100 internal + 175 external study 1 + 117 external study 2). Provenance not specified, but the studies were likely conducted internally or by contract labs in the company's operational regions (e.g., France, USA given the submitter and manufacturer locations). Retrospective vs. prospective is not explicitly stated, but blood samples were used for testing the device's performance retrospectively to their collection.

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

Not applicable in the context of this device. This device is an in vitro diagnostic (IVD) for quantitative measurement of HbA1c. The "ground truth" for the test set is established by a "commercially available capillary electrophoresis technique for HbA1c quantification that is NGSP standardized," which serves as the reference method. There were no human experts adjudicating diagnostic outcomes based on the device's output.

4. Adjudication Method for the Test Set

Not applicable. As this is a quantitative analytical device, the comparison is against a reference measurement method directly, not through expert adjudication of images or clinical cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This is an in vitro diagnostic device for automated quantitative measurement, not an AI-powered diagnostic imaging or decision support tool that involves human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies reported are standalone performance studies of the CAPI 3 Hb A1c procedure (kit + CAPILLARYS 3 TERA instrument). It measures HbA1c levels automatically without human interpretation of the measurement itself, beyond loading samples and reviewing the quantitative results.

7. The Type of Ground Truth Used

The ground truth for the accuracy studies was established by a "commercially available capillary electrophoresis technique for HbA1c quantification that is NGSP standardized." This is a reference method, not expert consensus, pathology, or outcomes data in the usual sense of clinical diagnostic studies. NGSP (National Glycohemoglobin Standardization Program) standardization indicates traceability to the Diabetes Control and Complications Trial (DCCT) reference method.

8. The Sample Size for the Training Set

The provided document describes performance evaluation studies (precision, linearity, accuracy, interference) for a finished diagnostic device. It does not mention a "training set" in the context of machine learning or AI algorithm development because the device is a laboratory instrument based on an electrokinetic separation technique (capillary electrophoresis), not a machine learning model that requires training data. Therefore, the concept of a training set as typically understood in AI/ML is not applicable here.

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

Not applicable, as there is no "training set" in the context of this device's analytical methodology.

Summary

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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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."

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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)

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.

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."

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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 400Norcross, Georgia 30093, USA
Contact	Karen Anderson, Dir of Technical and QAPhone: 1-800-835-6497Fax: 770-446-8511Email: karen.anderson@sebia-usa.comAigars Brants, Ph.D, Scientific Affairs OfficerPhone 1-800-835-6497Fax 770-446-8511Email: aigars.brants@sebia-usa.com
Date Prepared	July 25, 2016 / Revised February 14, 2017
Manufacturing	SebiaParc Technologique Léonard de VinciRue Léonard de Vinci,CP 8010 LISSES, 91008 EVRY CedexFRANCEPhone: (33) 1 69 89 80 80Fax: (33) 1 69 89 78 78
Product Name	CAPI 3 Hb A1c (PN 2515),MULTI-SYSTEM Hb A1c CAPILLARY Controls(2) (PN 4768) using CAPILLARYS 3 TERAinstrument (PN 1246)
Common Name	Whole blood hemoglobin A1c (HbA1c) by capillaryelectrophoresis
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 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 cups5 bins for used reagent cups
TEST TUBES	9214	200 of 100mm-tubes
CAPI 3 BINS FOR USED REAGENTCUPS	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.

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 CAPILLARYSHb A1c (K) 122101	SEBIA CAPI 3 Hb A1c
Intended Use	The CAPILLARYS Hb A1c kit is designedfor separation and quantification of theHbA1c glycated fraction of hemoglobin inhuman blood, by capillary electrophoresisin alkaline buffer (pH 9.4) with theCAPILLARYS 2 FLEX-PIERCINGinstrument. Measurement of hemoglobinA1c is effective in monitoring long-termglycemic control in individuals withdiabetes mellitus. The CAPILLARYS HbA1c kit is designed for Professional UseOnly.For In Vitro Diagnostic Use.	The CAPI 3 Hb A1c kit is designed forseparation and quantification of theHbA1c glycated fraction ofhemoglobin in venous whole blood,by capillary electrophoresis in alkalinebuffer (pH 9.4) with the CAPILLARYS3 TERA instrument. Measurement ofhemoglobin A1c is effective inmonitoring long-term glycemic controlin individuals with diabetesmellitus.This test is not for screeningor diagnosis of diabetes. The CAPI 3Hb A1c kit is designed forProfessional Use Only.For In Vitro Diagnostic Use.
Separationsystem	Free solution capillary electrophoresis(FSCE): hemoglobin separation on analkaline buffer (pH 9.4) according to theircharge, to the electrolyte pHandelectroosmotic flow.Fast separation and good resolution.Electrophoregrams show separatedfractions 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 mLeachHemolysing solution (ready to use) : 1 vial,700 mLWash solution (stock solution) : 1 vial, 75mLDilution segments : 1 pack of 90Filters : 4 filters	Buffer (ready to use) : 2 vials, 700 mLeachHemolysing solution (ready to use) : 1vial, 700 mLFilters : 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-PIERCINGinstrument, PN 1227	SEBIA CAPILLARYS 3 TERAinstrument, PN 1246
Analysisthroughput	40 analyses / hour	62 analyses / hour
Interface	PC interface	PC interface + touch screen
TemperatureControl	By Peltier device	Same

Detectionsystem	Deuterium lamp	Deuterium lamp and LED
Software fordata processing	SEBIA PHORESIS™ software	Same
Firmware	Included into the PHORESIS software	Included into the instrument
Number ofseparation units	8 parallel capillaries	12 parallel capillaries
Samples tubes	Uncapped tubes or capped tubesdepending on the procedure	Same
Samplesidentification	Yes (Bar code reading on both sampleracks and tubes)	Yes (Bar code reading on sampletubes and RFID labels on sampleracks)
Reagentidentification	No	Yes (RFID labels on reagent vials)
Introduction ofthe samplesinto theautomaticsystem	Primary capacity of 88 tubes for HbA1ctechnique (i.e. 11 sample racks),uninterrupted throughput on sample racks.Each sample rack contains 8 sample tube.	Primary maximal capacity of 120tubes (i.e. 15 sample racks),uninterrupted throughput on sampleracks (8 positions available).
Reagent bay :maincompartement	CAPILLARYS 2 FLEX-PIERCING:Contains one vial of water, wash solution,hemolyzing solution (for Hb and Hb A1ctechniques) and buffer container.	Up to 4 analysis buffers orhemolysing solutions (identified byRFID labels); 1 waste container, 1container for water, 1 container forthe wash solution
Reagent bay :secondarycompartment	NA	Up to 3 vials and 1 rack withimmunotyping reagents (allRFID tagged) in temperaturecontrolled environment (< 15 °C);1 RFID labeled vial and three tubes(for maintenance solutions) at roomtemperature
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	SEBIAHb A1c CAPILLARY ControlsK122101 and K133344	SEBIAMulti-system Hb A1c CAPILLARYControls (2)
Intended Use	The Hb A1c CAPILLARY Controls aredesigned for the migration control andquality control of human glycatedhemoglobin A1c quantification with SEBIAcapillary electrophoresis procedures :- CAPILLARYS Hb A1c performedwith the CAPILLARYS 2 FLEX-PIERCINGautomated instrument and,- MINICAP Hb A1c performed withthe MINICAP FLEX-PIERCING automatedinstrument.The Hb A1c CAPILLARY Controls aredesigned for Professional Use Only.For In Vitro Use.	The Multi-system Hb A1c CAPILLARYControls (2) aredesigned for themigration control and quality control ofhuman glycated hemoglobinA1c quantification withSEBIA capillary electrophoresisprocedures:- CAPILLARYS Hb A1c performedwith the CAPILLARYS 2 FLEX-PIERCINGautomated instrument,- CAPI 3 Hb A1c performed with theCAPILLARYS 3 TERA automatedinstrument and,- MINICAP Hb A1c performed withthe MINICAP FLEX-PIERCING automatedinstrument.The Hb A1c CAPILLARY Controls aredesigned for Professional Use Only.For In Vitro Use.
Product Number	4774	4768
Format	Hb A1c CAPILLARY Control 1 :1 vialHb A1c CAPILLARY Control 2 :1 vial	Same
Preparation	Reconstitute the lyophilized control vial with0.6 mL of distilled or deionized water.	Reconstitute the lyophilized control vialwith 0.75 mL of distilled or deionized water.
Storagetemperature	Before reconstitution, store the lyophilizedcontrols refrigerated (2 to 8 °C). They arestable until the expiration date indicated onthe vial labels.	Same
Shelf life	3 years at 2 - 8 °C	Same
TABLE B	SEBIAHb A1c CAPILLARY ControlsK122101 and K133344	SEBIAMulti-system Hb A1c CAPILLARYControls (2)
	- 30 °C.Do not freeze and thaw thereconstituted controls more than 30times.After hemolysis with the CAPILLARYS2 FLEX-PIERCING instrument, storethe dilution segments with controls at2 - 8 °C and use them within the day(for 8 hours maximum). They may bestored, without any delay, between -18 °C and - 30 °C for 1 monthmaximum. Do not freeze and thaw adilution segment with hemolyzedcontrol more than three times.MINICAP Hb A1c :After reconstitution, store the controlsat 2 - 8 °C in a closed conical tube forcontrol blood and use them within theday (for 24 hours maximum). Afteruse, they must be stored without anydelay between - 18 °C and - 30 °C dueto the risk of microbial contaminationand denaturation. They are stable for6 months maximum between - 18 °Cand - 30 °C.Do not freeze and thaw thereconstituted controls more than 30times.	- 30 °C.Do not freeze and thaw thereconstituted controls more than 30times.After hemolysis with the CAPILLARYS2 FLEX-PIERCING instrument, storethe dilution segments with controls at2 - 8 °C and use them within the day(for 8 hours maximum). They may bestored, without any delay, between -18 °C and - 30 °C for 1 monthmaximum. Do not freeze and thaw adilution segment with hemolyzedcontrol more than three times.MINICAP Hb A1c :After reconstitution, store the controlsat 2 - 8 °C in a closed conical tube forcontrol blood and use them within theday (for 24 hours maximum). Afteruse, they must be stored without anydelay between - 18 °C and - 30 °C dueto the risk of microbial contaminationand denaturation. They are stable for6 months maximum between - 18 °Cand - 30 °C.Do not freeze and thaw thereconstituted controls more than 30times.CAPI 3 Hb A1c :After reconstitution, store the controlsat 2 - 8 °C in a closed conical tube forcontrol blood and use them within theday (for 24 hours maximum). Afteruse, they must be stored without anydelay between - 18 °C and - 30 °C dueto the risk of microbial contaminationand denaturation. They are stable for6 months maximum between - 18 °Cand - 30 °C.Do not freeze and thaw thereconstituted controls more than 30times.
Instrument	SEBIA CAPILLARYS 2 FLEX-PIERCINGSEBIA MINICAP FLEX-PIERCING	SEBIA CAPILLARYS 2 FLEX-PIERCINGSEBIA MINICAP FLEX-PIERCINGSEBIA 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		Totalreproducibility (*)
	Mean(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		Betweeninstrument		Totalreproducibility (*)
	Mean(%)	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) for the HbA1c concentrations (in mmol/mol) and percentages for each instrument.
including the within-laboratory precision estimates (%CV) for the HbA1c concentrations (in mmol/mol) and percentages for each lot on each instrument.

		Within capillary		Between capillary		Between run		Between day		Between lot		Totalreproducibility (*)
	Mean(mmol/mol)	SD	CV	SD	CV	SD	CV	SD	CV	SD	CV	SD	CV
Blood No. 1	29	0,5	1,7%	0,3	1,0%	0,0	0,0%	0,2	0,7%	0,2	0,7%	0,6	2,2%
Blood No. 2	33	0,5	1,6%	0,5	1,4%	0,0	0,0%	0,2	0,7%	0,2	0,5%	0.7	2,3%
Blood No. 3	35	0,5	1,5%	0,3	1,0%	0,0	0,0%	0,2	0,7%	0,0	0,0%	0,7	1,9%
Blood No. 4	46	0,6	1,4%	0,3	0,6%	0,0	0,0%	0,4	0,9%	0,2	0,4%	0,8	1,8%
Blood No. 5	67	0,5	0,7%	0,1	0,2%	0,2	0,3%	0,2	0,4%	0,1	0,1%	0,6	0,9%
Blood No. 6	73	0,5	0,7%	0,3	0,4%	0,0	0,0%	0,4	0,5%	0,3	0,4%	0,7	1,0%
Blood No. 7	85	0,5	0,6%	0,2	0,2%	0,2	0,3%	0,5	0,6%	0,0	0,0%	0,7	0,9%
Blood No. 8	108	0,5	0.4%	0,5	0,5%	0,0	0,0%	0,6	0,5%	0,0	0,0%	0,9	0,9%

Instrument No. 1

(*) Total reproducibility includes : within-capillary, between-run, between-day and between-lot.

	Mean(mmol/mol)	Within-laboratory (*)Lot No. 1		Lot No. 2		Lot No. 3
		SD	CV	SD	CV	SD	CV
Blood No. 1	29	0,6	2,0%	0,7	2,4%	0,6	2,1%
Blood No. 2	33	0,6	1,8%	0,8	2,4%	0,8	2,5%
Blood No. 3	35	0,7	1,9%	0,7	1,9%	0,7	1,9%
Blood No. 4	46	0,9	2,0%	0,7	1,6%	0,8	1,8%
Blood No. 5	67	0,6	0,9%	0,6	0,9%	0,6	1,0%
Blood No. 6	73	0,7	0,9%	0,9	1,2%	0,4	0,6%
Blood No. 7	85	0,6	0,7%	0,7	0,9%	0,9	1,1%
Blood No. 8	108	0,7	0,6%	1,0	0,9%	1,2	1,1%

(*) Within laboratory reproducibility includes : within-capillary, between-run and between-day.

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

		Within capillary		Between capillary		Between run		Between day		Between lot		Totalreproducibility (*)
	Mean(%)	SD	CV	SD	CV	SD	CV	SD	CV	SD	CV	SD	CV
Blood No. 1	4,8	0,05	1,0%	0,03	0,5%	0,00	0,0%	0,02	0,3%	0,02	0,4%	0,06	1,2%
Blood No. 2	5,1	0,05	1,0%	0,03	0,5%	0,00	0,0%	0,02	0,5%	0,00	0,0%	0,06	1,2%
Blood No. 3	5,3	0,05	0,9%	0,04	0,7%	0,00	0,0%	0,02	0,5%	0,00	0,0%	0,06	1,2%
Blood No. 4	6,4	0,06	1,0%	0,03	0,4%	0,00	0,0%	0,02	0,2%	0,02	0,4%	0,07	1,1%
Blood No. 5	8,3	0,04	0,5%	0,03	0,4%	0,00	0,0%	0,00	0,0%	0,01	0,1%	0,05	0,6%
Blood No. 6	8,9	0,05	0,6%	0,03	0,4%	0,00	0,0%	0,04	0,4%	0,03	0,3%	0,08	0,9%
Blood No. 7	9,9	0,04	0,4%	0,03	0,3%	0,01	0,1%	0,04	0,4%	0,00	0,0%	0,07	0,7%
Blood No. 8	12,0	0,05	0,4%	0,04	0,4%	0,00	0,0%	0,05	0,4%	0,02	0,2%	0,08	0,7%

(*) Total reproducibility includes : within-capillary, between-run, between-day and between-lot.

	Mean(%)	Within-laboratory (*)
		Lot No. 1		Lot No. 2		Lot No. 3
		SD	CV	SD	CV	SD	CV
Blood No. 1	4,8	0,06	1,2%	0,06	1,2%	0,05	1,1%
Blood No. 2	5,1	0,05	0,9%	0,07	1,4%	0,06	1,2%
Blood No. 3	5,3	0,06	1,1%	0,06	1,2%	0,07	1,3%
Blood No. 4	6,4	0,08	1,3%	0,06	1,0%	0,06	1,0%
Blood No. 5	8,3	0,05	0,6%	0,07	0,9%	0,05	0,7%
Blood No. 6	8,9	0,07	0,8%	0,08	0,9%	0,06	0,7%
Blood No. 7	9,9	0,06	0,6%	0,06	0,6%	0,08	0,8%
Blood No. 8	12,0	0,06	0,5%	0,09	0,7%	0,09	0,7%

(*) Within laboratory reproducibility includes : within-capillary, between-run and between-day.

{16}------------------------------------------------

Instrument No. 2

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

(*) Total reproducibility includes : within-capillary, between-run, between-run, between-day and between-lot.

	Mean(mmol/mol)	Within-laboratory (*)
		Lot No. 1		Lot No. 2		Lot No. 3
		SD	CV	SD	CV	SD	CV
Blood No. 1	29	0,6	1,9%	0,7	2,3%	0,5	1,9%
Blood No. 2	33	0,5	1,6%	0,6	1,9%	0,6	1,9%
Blood No. 3	35	0,3	0,9%	0,5	1,5%	0,7	1,9%
Blood No. 4	46	0,7	1,6%	0,8	1,8%	0,8	1,7%
Blood No. 5	67	0,7	1,1%	0,6	0,9%	0,5	0,8%
Blood No. 6	73	0,8	1,1%	0,6	0,8%	0,7	1,0%
Blood No. 7	85	0,6	0,7%	0,7	0,9%	0,9	1,1%
Blood No. 8	108	0,9	0,8%	1,1	1,1%	0,9	0,8%

(*) Within laboratory reproducibility includes : within-capillary, between-run and between-day.

Within capillary		Between capillary		Between run		Between day		Between lot		Totalreproducibility (*)
	Mean(%)	SD	CV	SD	CV	SD	CV	SD	CV	SD	CV	SD	CV
Blood No. 1	4,8	0,04	0,9%	0,01	0,2%	0,00	0,0%	0,02	0,5%	0,03	0,7%	0,06	1,3%
Blood No. 2	5,1	0,05	0,9%	0,03	0,6%	0,00	0,0%	0,02	0,4%	0,02	0,3%	0,06	1,2%
Blood No. 3	5,3	0,04	0,7%	0,03	0,6%	0,00	0,0%	0,03	0,5%	0,01	0,3%	0,06	1,1%
Blood No. 4	6,4	0,06	1,0%	0,00	0,0%	0,01	0,2%	0,02	0,4%	0,02	0,4%	0,07	1,1%
Blood No. 5	8,3	0,04	0,5%	0,05	0,6%	0,00	0,0%	0,02	0,2%	0,00	0,0%	0,07	0,8%
Blood No. 6	8,9	0,04	0,5%	0,05	0,5%	0,00	0,0%	0,02	0,2%	0,04	0,4%	0,08	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%	0,07	0,7%
Blood No. 8	12,0	0,05	0,5%	0,03	0,3%	0,01	0,1%	0,04	0,3%	0,03	0,2%	0,08	0,7%

(*) Total reproducibility includes : within-capillary, between-run, between-run, between-day and between-lot.

		Within-laboratory (*)
	Mean(%)	Lot No. 1		Lot No. 2		Lot No. 3
		SD	CV	SD	CV	SD	CV
Blood No. 1	4,8	0,06	1,2%	0,06	1,2%	0,04	0,9%
Blood No. 2	5,1	0,06	1,2%	0,06	1,2%	0,05	1,0%
Blood No. 3	5,3	0,05	1,0%	0,06	1,0%	0,07	1,2%
Blood No. 4	6,4	0,07	1,1%	0,08	1,2%	0,07	1,1%
Blood No. 5	8,3	0,07	0,9%	0,06	0,7%	0,06	0,7%
Blood No. 6	8,9	0,07	0,8%	0,07	0,8%	0,06	0,7%
Blood No. 7	9,9	0,06	0,6%	0,07	0,7%	0,08	0,8%
Blood No. 8	12,0	0,07	0,6%	0,09	0,8%	0,07	0,6%

(*) Within laboratory reproducibility includes : within-capillary, between-run and between-day.

510(k) Summary 13

{17}------------------------------------------------

Instrument No. 3

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

(*) Total reproducibility includes : within-capillary, between-run, between-run, between-day and between-lot.

	Mean(mmol/mol)	Within-laboratory (*)
		Lot No. 1		Lot No. 2		Lot No. 3
		SD	CV	SD	CV	SD	CV
Blood No. 1	29	0,5	1,8%	0,7	2,4%	0,6	2,1%
Blood No. 2	33	0,6	1,7%	0,8	2,3%	0,7	2,3%
Blood No. 3	35	0,6	1,8%	1,0	2,8%	0,6	1,8%
Blood No. 4	46	0,6	1,3%	0,7	1,4%	0,7	1,6%
Blood No. 5	67	0,6	0,9%	0,7	1,0%	0,6	0,9%
Blood No. 6	73	0,6	0,8%	0,7	0,9%	0,6	0,8%
Blood No. 7	85	0,5	0,5%	0,9	1,1%	0,5	0,6%
Blood No. 8	108	0,7	0,7%	1,0	0,9%	0,7	0,6%

(*) Within laboratory reproducibility includes : within-capillary, between-run and between-day.

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

(*) Total reproducibility includes : within-capillary, between-run, between-run, between-day and between-lot.

	Mean(%)	Within-laboratory (*)
		Lot No. 1	Lot No. 2	Lot No. 3
		SD	CV	SD	CV	SD	CV
Blood No. 1	4,8	0,05	1,1%	0,07	1,4%	0,05	1,1%
Blood No. 2	5,1	0,05	1,0%	0,08	1,5%	0,07	1,3%
Blood No. 3	5,3	0,06	1,1%	0,09	1,7%	0,05	1,0%
Blood No. 4	6,4	0,06	0,9%	0,07	1,1%	0,07	1,1%
Blood No. 5	8,3	0,05	0,7%	0,06	0,7%	0,06	0,7%
Blood No. 6	8,9	0,06	0,7%	0,07	0,8%	0,05	0,6%
Blood No. 7	9,9	0,05	0,5%	0,08	0,8%	0,07	0,7%
Blood No. 8	12,0	0,07	0,6%	0,08	0,7%	0,07	0,6%

(*) Within laboratory reproducibility includes : within-capillary, between-run and between-run and between-day.

510(k) Summary 14

{18}------------------------------------------------

b. Linearity

Mixture of 2 different blood samples:

2 characteristic blood samples, including a normal sample and an elevated HbA10 level sample were mixed within different proportions and the mixtures were electrophoresed with the CAPI 3 Hb A1c procedure. For each mixture, samples were analyzed in triplicate.

The tests were determined to be linear within the entire range studied for HbAy, hemoglobin fraction. The stated measuring range is 21 mmol/mol HbArc (4.0 % to 14.7 % HbA1c).

Dilution of 4 different blood samples in hemolysing solution:

4 different characteristic blood samples, including 1 normal sample with HbA1c concentration at 21 mmol/mol (4.1 % HbA1c), 1 sample with HbA1c level close to the cut-off value with HbA1c concentration at 47 mmol/mol (6.4 % HbA1c) and 2 elevated HbA1c level samples with HbA1c concentrations at 82 mmol/mol (9.6 % HbA1c) and at 134 mmol/mol (14.4 % HbA1c), were all serially diluted in hemolysing solution and electrophoresed with the CAPI 3 Hb A1c procedure. The tests were determined to be linear within the entire ranges studied from 2.9 to 30.5 g/dL total hemoglobin and HbA1c fraction concentration and percentage were not affected by the hemoglobin concentration of the samples.

c. Accuracy - Internal correlation

The levels of HbA .. were measured in 100 blood samples with normal and elevated HbA1e levels, both by electrophoretic separations obtained with the CAPI 3 Hb A1c procedure on the CAPILLARYS 3 TERA instrument and a commercially available capillary electrophoresis technique for HbArc quantification that is NGSP standardized. The measured values of HbA1c concentrations and percentages from both procedures were analyzed by a linear regression statistical procedure. The results of linear regression analysis are tabulated below (y = CAPI 3 Hb A1c):

HbA1c	Correlationcoefficient	y-Intercept	Slope	Range ofvalues CAPI 3Hb A1c
Concentration(mmol/mol)	0.998	- 0.238	1.000	22 - 132
Percentage (%)	0.998	- 0.024	1.000	4.1 - 14.2

{19}------------------------------------------------

d. Accuracy - External correlations

In study No. 1, the levels of HbA« were measured in 175 blood samples, including samples with normal and elevated HbAn levels, both by electrophoretic separations obtained with CAPI 3 Hb A1c procedure with the CAPILLARYS 3 TERA instrument and a commercially available capillary electrophoresis technique for HbA « quantification that is NGSP standardized.

The measured values of HbA1c concentrations and percentages from both procedures were analyzed by a linear regression statistical procedure. The results of linear regression analysis are tabulated below (y = CAPI 3 Hb A1c):

HbA1c	Correlation coefficient	y-Intercept	Slope	Range of values CAPI 3 Hb A1c
Concentration (mmol/mol)	0.998	0.249	0.993	23 - 138
Percentage (%)	0.997	0.045	0.992	4.3 - 14.7

In study No. 2, the levels of HbA« were measured in 117 blood samples, including samples with normal and elevated HbAre levels, both by electrophoretic separations obtained with CAPI 3 Hb A1c procedure with the CAPILLARYS 3 TERA instrument and a commercially available capillary electrophoresis technique for HbArc quantification that is NGSP standardized.

HbA1c	Correlationcoefficient	y-Intercept	Slope	Range ofvalues CAPI 3Hb A1c
Concentration(mmol/mol)	0.998	1.417	0.970	22 - 127
Percentage (%)	0.998	0.205	0.968	4.2 - 13.7

Internal and External studies combined of 392 whole blood samples (normal and elevated HbA1c levels) spanning a HbA1c measuring range of 4.1 - 14.7 % with the CAPI 3 Hb A1c procedure using the CAPILLARYS 3 TERA instrument.

{20}------------------------------------------------

Interferences

No interference with the CAPI 3 Hb A1c procedure was detected due to the blood sample's high concentration of the following interfering factors tested at levels equal to the concentrations listed below:

Interfering Factor	Concentration
Triglycerides	3.85 g/dL (43.97mM)
Bilirubin	35.9 mg/dL (614 mM)
Ascorbic Acid	60 mg/dL (3.41 mM)
Urea	277 mg/dL (46.1 mM)
Rheumatoid factor	2178 IU/mL
Glybenclamide	3 mg/dL
Total Protein	149.5 g/L
Glucose	1000 mg/dL (55 mM)
Acetylsalicylic acid	1000 mg/dL (55.56 mM)
Acetaminophen	20 mg/dL (1325 μM)
Ibuprofen	50 mg/dL (2427 μM)
Metformin	5 mg/dL (387 μM)
Acetylated hemoglobin	≤ 2.1%
Carbamylated hemoglobin	≤ 5.6%
Labile HbA1c	≤ 12.7%
Hb A2	Up to 11.3%
Hb F	Up to 23%
Hb S	≤ 40.4%
Hb C	≤ 36.9%
Hb D	≤ 44.2%
Hb E	≤ 26.6%

3. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

Regulation Number and Section

§ 864.7470 Glycosylated hemoglobin assay.

(a)
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.(b)
Classification. Class II (performance standards).