The CAPILLARYS Hb A1c kit is designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in human blood, by capillary electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 2 FLEX-PIERCING instrument. The CAPILLARYS Hb A1c kit is designed for laboratory use. Measurement of the hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. The CAPILLARYS Hb A1c kit is designed for Professional Use Only. For In Vitro Diagnostic Use.

The Hb A1c CAPILLARY Calibrators are designed for the calibration and migration control of human glycated hemoglobin A1c quantification with SEBIA CAPILLARYS Hb A1c electrophoresis procedure performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument for capillary electrophoresis. The Hb A1c CAPILLARY Calibrators are designed for Professional Use Only. For In Vitro Diagnostic Use.

The Hb A1c CAPILLARY Controls are designed for the quality control of human glycated hemoglobin A1c quantification with CAPILLARYS Hb A1c electrophoresis procedure performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument for capillary electrophoresis. The Hb A1c CAPILLARY Controls are designed for Professional Use Only. For In Vitro Diagnostic Use.

Device Description

The CAPILLARYS Hb A1c kit, controls and calibrators are used with the CAPILLARYS 2 FLEX-PIERCING system. The CAPILLARYS 2 FLEX-PIERCING 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 also occurs according to the electrolyte pH and electroosmotic flow. The CAPILLARYS 2 FLEX-PIERCING instrument has silica capillaries functioning in parallel allowing 8 simultaneous analyses for HbA1c quantification from 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.

AI/ML Overview

This document describes the CAPILLARYS Hb A1c kit, Hb A1c CAPILLARY Calibrators, and Hb A1c CAPILLARY Controls for use with the CAPILLARYS 2 FLEX-PIERCING instrument, designed for the separation and quantification of HbA1c in human whole blood.

The information provided focuses on demonstrating substantial equivalence to a predicate device (TOSOH G8 Automated Glycohemoglobin Analyzer HLC-723G8) for HbA1c measurement.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list "acceptance criteria" in a quantitative format for the CAPILLARYS Hb A1c system's performance. Instead, it describes a "comparison" or "concordance" study against a predicate device to establish substantial equivalence.

The document highlights the following performance aspects through comparison:

Feature/Performance Aspect	Predicate Device (TOSOH G8 Automated Glycohemoglobin Analyzer HLC-723G8)	New Device (SEBIA CAPILLARYS Hb A1c with CAPILLARYS 2 FLEX-PIERCING)
Intended Use	For In Vitro Diagnostic Use for the measurement of hemoglobin A1c (HbA1c) in whole blood specimens. Used in clinical management of diabetes to assess long-term efficacy of diabetic control.	Designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in human whole blood, by capillary electrophoresis. Measurement effective in monitoring long-term glycemic control in individuals with diabetes mellitus. Designed for Professional Use Only. In Vitro Diagnostic Use.
Separation System	Ion-exchange high performance liquid chromatography (HPLC)	Free solution capillary electrophoresis (FSCE)
Instrument	TOSOH G8 instrument	SEBIA CAPILLARYS 2 FLEX-PIERCING instrument, PN 1227
Absorbance Wavelength	415 and 510 nm	415 nm
Analysis Throughput	37 analyses / hour	40 analyses / hour
Sample Type	Whole blood in capped tube	Whole blood in capped tube
Hemolysis	Performed automatically by the system	Performed automatically by the instrument
Introduction of Samples	Continuous loading	Continuous loading using sample racks
Collection Tubes	Tubes with EDTA anticoagulant	Tubes with EDTA anticoagulant
Standardization	NGSP, IFCC	NGSP, IFCC

The text explicitly states: "The SEBIA CAPILLARYS Hb A1c procedure, performed with the CAPILLARYS 2 FLEX-PIERCING system were found to be substantially equivalent in function, use, safety, effectiveness and the performance to predicate devices described above." This statement implies that the device meets the functional and performance criteria demonstrated by the predicate device. However, specific quantitative acceptance criteria (e.g., precision, accuracy ranges) and their corresponding reported values for the new device are not detailed in the provided excerpt. The comparison table focuses on defining similarities to establish equivalence rather than listing specific performance metrics against pre-defined acceptance limits.

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

The document mentions "performance and comparative studies" were conducted. However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

This information is not provided in the document. As this is an in vitro diagnostic device for quantitative measurement, the "ground truth" would typically refer to reference method results or highly accurate measurements, rather than expert consensus on image interpretation. The document indicates standardization against NGSP and IFCC, which are recognized programs for HbA1c measurement, implying traceability to established reference methods, but details on how ground truth was established for this specific study's test set are absent.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where multiple experts review cases and resolve discrepancies. For a quantitative in vitro diagnostic device, the ground truth is established through analytical methods, not typically by expert adjudication of diagnoses.

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

This information is not applicable. The device is an in vitro diagnostic instrument for HbA1c quantification. It is not an AI-assisted diagnostic tool for human readers/clinicians, and thus, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

The device itself is a standalone in vitro diagnostic instrument. The performance studies mentioned refer to the analytical performance of the instrument system (CAPILLARYS Hb A1c procedure with the CAPILLARYS 2 FLEX-PIERCING instrument) in measuring HbA1c. Therefore, the entire system operates in a standalone capacity for measurement. The document states that the performance studies were performed using SEBIA's commercially available materials and standard procedures, and compared against a predicate device, which inherently implies standalone performance evaluation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this type of quantitative diagnostic device for HbA1c is typically established by reference methods traceable to internationally recognized standardization programs (NGSP and IFCC). The document explicitly states: "CAPILLARYS Hb A1c test is standardized according to NGSP and IFCC requirements/guidelines." This means that the accuracy of the device's measurements would be compared against results obtained by these highly accurate, standardized reference methods.

8. The Sample Size for the Training Set

This information is not provided. As this is a laboratory diagnostic assay, there isn't typically a "training set" in the machine learning sense. The assay is developed and validated, and its performance characterized through studies. If there were method development activities, the number of samples used for optimization is not specified.

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

This information is not provided and not directly applicable in the context of a traditional training set for an algorithmic device. For the development and validation of an in vitro diagnostic assay like this, the "ground truth" for calibrators and controls (which are used to ensure accurate measurements) is established through precise analytical methods, typically traceable to reference standards from NGSP and IFCC, as mentioned in the document for the device's standardization.

Summary

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Image /page/0/Picture/0 description: The image contains a handwritten word "K122101". The word starts with a capital letter K, followed by the number 1, then two 2's, then the number 1 again, then the number 0, and ends with the number 1. The handwriting is simple and clear.

6 2012 DEC

510(k) SUMMARY 1.

INTENDED USE AND SUMMARY OF THE PROCEDURES

For In Vitro Diagnostic Use.

The CAPILLARYS Hb A1c procedure performed with the CAPILLARYS 2 FLEX-PIERCING instrument has been certified by the National Glycohemoglobin Standardization Program (NGSP).

Electrophoresis is a well established technique routinely used in clinical laboratories for measuring components from body fluids, including HbA1c glycated fraction. The CAPILLARYS 2 FLEX-PIERCING instrument has been developed to provide complete automation of this testing with fast separation and good resolution. In many aspects, the methodology can be considered as an intermediary type of technique between classical zone electrophoresis and liquid chromatography.

The CAPILLARYS 2 FLEX-PIERCING 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 also occurs according to the electrolyte pH and electroosmotic flow.

The CAPILLARYS 2 FLEX-PIERCING instrument has silica capillaries functioning in parallel allowing 8 simultaneous analyses for HbA1c quantification from 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 Arefraction. In addition, the high resolution of CAPILLARYS Hb A1c procedure allows the quantification of HbArc, even in the presence of labile HbAxe, carbamylated hemoglobins, major hemoglobin variants such as HbS, HbC, HbD, HbE and HbF and common interfering factors such as Trialycerides, Bilirubin, Ascorbic Acid, Urea, Rheumatoid factor, and Glybenclamide as outlined in the package insert labeling.

By using 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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SUBJECTS OF THIS 510(K) PREMARKET NOTIFICATION

This submission is limited to the CAPILLARYS Hb A1c procedure (PN 2015). CAPILARYS Hb A1c calibrators (PN 4755) and CAPILLARYS HbA1c control (PN 4744) performed with the SEBIA CAPILLARYS 2 FLEX-PIERCING instrument (PN 1227).

CAPILLARYS 2 FLEX-PIERCING is a capillary electrophoresis instrument that has been previously cleared for CAPILLARYS HEMOGLOBIN(e) assay under K112550, issued on May 25th, 2012.

REGULATORY STATUS

The CAPILLARYS Hb A1c types of devices/assays are classified by FDA as Class II, under Requlation No. 21 CFR 864.7470, SEBIA is seeking clearance to import the assay described above, and by this submission is notifying FDA of its intent to market these products in the United States.

PRODUCT DESCRIPTION

1. Reagent Kit

The CAPILLARYS HbA1c kits, controls and calibrators are used with the CAPILLARYS 2 FLEX-PIERCING system.

The configurations of the components are summarized:

. CAPILLARYS HbA1c kits in Table I.
CAPILLARYS HbA1c Calibrators in Table II. .
CAPILLARYS HbA1c controls in Table III. .
Reagents that are required to perform the test but are sold separately in Table IV .

For additional details, see Package Inserts included in Section III, Attachment III C. Each kit, control and calibrators is supplied with Package Insert which contains instruction for use and all the necessary information on the reagents needed to run the tests. Each Package Insert also contains information on storage conditions, shelf life and signs of deterioration of the components and the reagents sold separately.

TABLE I. REAGENTS AND MATERIALS SUPPLIED IN THE CAPILLARYS HbA1c KIT (Р№ 2015)

ITEMS	PN 2015
Buffer (ready to use)	2 vials, 700 mL each
Hemolysing solution (ready to use)	1 vial, 700 mL
Wash solution (stock solution)	1 vial, 75 mL
Green Dilution segments	1 pack of 90
Filters	4 filters

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MATERIALS SUPPLIED WITH CAPILLARYS HbA1c TABLE II. REAGENTS AND CALIBRATORS (PN 4755)

ITEMS	PN 4755
Hb A1c CAPILLARYS Calibrator 1 (green cap)	1 vial of each, 600µL each
Hb A1c CAPILLARYS Calibrator 2 (red cap)	1
Barcode label HbA1c CAPILLARYS Calibrator 1	1
Barcode label HbA1c CAPILLARYS Calibrator 2	1

TABLE III. REAGENTS AND MATERIALS SUPPLIED WITH CAPILLARYS HbA1c CONTROLS (PN 4744)

ITEMS	PN 4744
HbA1c CAPILLARYS Control 1 ( white cap )	1 vial of each, 600µL each
HbA1c CAPILLARYS Control 2 ( black cap )	1 vial of each, 600µL each
Barcode label HbA1c CAPILLARYS Control 1	2
Barcode label HbA1c CAPILLARYS Control 2	2
White Dilution segments for Control 1	4
Grey Dilution segments for Control 2	4

TABLE IV. REAGENTS AND MATERIALS REQUIRED BUT NOT SUPPLIED IN THE CAPILLARYS HbA1c KIT, CONTROLS OR CALIBRATORS

ITEMS	PN	COMPONENTS
CAPICLEAN	2058	1 vial, 25 mL
CAPILLARYS / MINICAP WashSolution	2052	2 vials, 75 mL
Boxes for control storage	2082	2 boxes
Tubes and caps for controls	9205	500 per box
Wedge adapters	9203	10 per box
PHORESIS software	1110
CAPILLARYS 2 FLEX-PIERCINGINSTRUMENT	1227

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2. Accessories Required but Sold Separately

The accessory required for the CAPILLARYS HbA1c kit for the automated procedure has been identified in the preceding paragraphs. It is:

CAPILLARYS 2 FLEX-PIERCING automated capillary electrophoresis system, which is part of the 510(K) premarket notification "CAPILLARYS HEMOGLOBIN(e)", K112550, for which FDA clearance was issued May 25th, 2012.

LABELING

Proposed labeling is described in Section III.

COMPARISON (CONCORDANCE), SUBSTANTIAL EQUIVALENCE AND PERFORMANCE STUDIES

The performance and comparative studies of the CAPILLARYS Hb A1c test performed with the CAPILLARYS 2 FLEX-PIERCING system were performed using SEBIA's commercially available materials and standard procedures.

Similarly, in comparative studies, commercially available materials and standard procedures were used with the predicate device: TOSOH G8 Automated Glycohemoglobin Analyzer HLC-723G8 (K071132), which are based on high performance liquid chromatography (HPLC) of blood samples for Hb A1c analvsis.

The SEBIA CAPILLARYS Hb A1c procedure, performed with the CAPILLARYS 2 FLEX-PIERCING system were found to be substantially equivalent in function, use, safety, effectiveness and the performance to predicate devices described above.

The following tables presents the similarities and the differences between the SEBIA CAPILLARYS Hb A1c test, calibrators and controls performed with the CAPILLARYS 2 FLEX-PIERCING as compared to the TOSOH G8 automated divcohemoglobin analyzer HLC-723G8 (K071132) both used for qualitative and quantitative analysis of Hb A1c .

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TOSOH G8 AUTOMATEDGLYCOHEMOGLOBIN ANALYZERHLC-723G8 (K071132)	SEBIA CAPILLARYS Hb A1c techniquewith CAPILLARYS 2 FLEX-PIERCINGinstrument
Intended Use	The G8 Automated GlycohemoglobinAnalyzer HLC-723G8 is intended for InVitro Diagnostic Use for themeasurement of hemoglobin A1c(HbA1c) in whole blood specimens. HbA1c measurements are used in theclinical management of diabetes toassess the long-term efficacy of diabeticcontrol.	The CAPILLARYS Hb A1c kit is designedfor separation and quantification of theHbA1c glycated fraction of hemoglobin inhuman whole blood, by capillaryelectrophoresis in alkaline buffer (pH 9.4)with the CAPILLARYS 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.
SeparationSystem	Ion-exchange high performance liquidchromatography (HPLC): proteinseparation on the column based on theirionic interactions with the cartridgematerial and elution by buffer gradientwith increasing ionicstrength. Chromatograms show retentiontimes of eluted fractions.	Free solution capillary electrophoresis(FSCE): protein separation in an alkalinebuffer (pH 9.4) according to their charge, tothe electrolyte pH and electroosmotic flow.Fast separation and good resolution.Electrophoregrams show separatedfractions according to their charge.
Instrument	TOSOH G8 instrumentImage: TOSOH G8 instrument	SEBIA CAPILLARYS 2 FLEX-PIERCINGinstrument, PN 1227Image: SEBIA CAPILLARYS 2 FLEX-PIERCING instrument
Interface	Touch screen interface	PC interface
	TOSOH G8 AUTOMATEDGLYCOHEMOGLOBIN ANALYZERHLC-723G8 (K071132)	SEBIA CAPILLARYS Hb A1c techniquewith CAPILLARYS 2 FLEX-PIERCINGinstrument
Absorbancewave length	415 and 510 nm	415 nm
Software	Tosoh Piano EVO3 software	SEBIA PHORESIS™ software
Number ofseparation units	1 column	8 parallel capillaries (total capillaries onCAPILLARYS 2 FLEX-PIERCINGinstrument: 8 capillaries)
Calibration	Yes	Yes
Sample type	Whole blood in capped tube	Whole blood in capped tube
Samplesidentification	Yes (Bar code on sample tube)	Yes (Bar code reading on both sample racksand tubes)
Hemolysis	Performed automatically by the system	Performed automatically by the instrument
Introduction ofthe samples intothe automaticsystem	Continuous loading	Continuous loading using sample racks
Analysisthroughput	37 analyses / hour	40 analyses / hour
Collection tubes	Tubes with EDTA anticoagulant	Tubes with EDTA anticoagulant
Reagent	G8 Variant Elution Buffer HsiHbA1c Calibrator setHemoglobin A1c ControlTSKgel G8 Variant HsiHsi Hemolysis & Wash Solution	CAPILLARYS Hb A1c Kit :BufferHemolyzing solutionWash solutionDilution segmentsFiltersCAPILLARYS Hb A1c CALIBRATORS:CAPILLARYS Hb A1c Calibrator 1CAPILLARYS Hb A1c Calibrator 2CAPILLARYS Hb A1c CONTROLS :CAPILLARYS Hb A1c Control 1CAPILLARYS Hb A1c Control 2
Standartization	NGSPIFCC	NGSPIFCC
	TOSOHHemoglobin A1c Calibrator SetK071132	SEBIAHbA1c CAPILLARY CALIBRATORS
Intended Use	The Hemoglobin A1c Calibrator Set is areference agent designed for calibrating theTosoh Automated GlycohemoglobinAnalyzer HCL-723G8.	The Hb A1c CAPILLARY Calibrators aredesigned for the calibration and migrationcontrol of human glycated hemoglobin A1cwith the SEBIA CAPILLARYS Hb A1celectrophoresis procedure performed with theCAPILLARYS 2 FLEX-PIERCING automatedinstrument for capillary electrophoresis.For In Vitro Diagnostic Use.
Format	2 levels5 vials (4 mL) per level	2 levels1 vial (0.6 mL) per level
Preparation	Reconstitute calibrators (1) and (2) byadding 4 mL of distilled water to each.	Reconstitute each lyophilized calibrator vialwith 0.6 mL of distilled or deionized water.
Storagetemperature	The Hemoglobin A1c Calibrator set shouldbe stored at 2 to 8 °C while unopened. It willremain stable for use up to the expirationdate listed on the vial.	Before reconstitution, the lyophilizedcalibrators must be stored between - 30 °Cand - 18 °C. They are stable until theexpiration date indicated on the vial labels.
In use storage	After being opened, the hemoglobin A1cCalibrator Set will remain stable for use forup to one week at 2 to 8°C.	After reconstitution, store the calibrators at 2 -8 °C in a closed conical tube for control bloodand use them within the day (for 8 hoursmaximum). After use, they must be storedwithout any delay between - 18 °C and - 22°C due to the risk of microbial contaminationand denaturation. They are stable for 6months maximum between - 18 °C and -22 °C.Do not freeze and thaw the reconstitutedcalibrators more than 3 times.
Traceability	The assigned values are traceable to IFCC.	Same
Instrument	Tosoh Automated GlycohemoglobinAnalyzer HCL-723G8	SEBIA CAPILLARYS 2 FLEX-PIERCING

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: ・

The predicate device for the Hb A1c CAPILLARY calibrators is the Tosoh Hemoglobin A1c calibrators, it has been FDA cleared (K071132).

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The predicate device for the Hb A1c CAPILLARY controls is Tosoh Hemoglobin A1c Controls, it has been FDA cleared by the manufacturer Canterbury Scientific under (K021484).

	TOSOHHemoglobin A1c ControlsK021484	SEBIAHbA1c CAPILLARY CONTROLS
Intended Use	The Hemoglobin A1c Control are intendedfor use as quality control materials to monitorthe precision of laboratory testingprocedures for HbA1c quantitation. Thecontrols are designed for use with TosohBioscience, Inc G7and G8 analyzers.	The Hb A1c CAPILLARY Controls aredesigned for the quality control of humanglycated hemoglobin A1c quantification withCAPILLARYS Hb A1c electrophoresisprocedure performed with the CAPILLARYS 2FLEX-PIERCING automated instrument forcapillary electrophoresis. The HbA1cCAPILLARYS Controls are designed forProfessional Use Only.
		For In Vitro Diagnostic Use.
Format	2 levels4 vials (0.25 mL) per level	2 levels1 vial (0.6 mL) per level
Preparation	Each vial must be reconstituted with 250 µLof reagent grade type I water.	Reconstitute each lyophilized control vial with0.6 mL of distilled or deionized water.
Storagetemperature	Hemoglobin A1c controls are stable until thelast day of the expiration date shown on thevial when stored unopened at 2 - 8°C.	Before reconstitution, the lyophilized controlsmust be stored refrigerated (2 to 8 °C). Theyare stable until the expiration date indicatedon the vial labels.
In use storage	Once the control is reconstituted it can beused for 60 days when stored tightly cappedat 2-8°C. The reconstituted control shouldnot be stored uncapped. Aliquots can befrozen at -15°C for up to 4-6 months (nomultiple thawing and re-freezing). Dilutedcontrols should not be frozen.	After reconstitution, store the controls at 2 - 8°C in a closed conical tube for control bloodand use them within the day (for 8 hoursmaximum). After use, they must be storedwithout any delay between - 18 °C and - 22°C due to the risk of microbial contaminationand denaturation. They are stable for 6months maximum between - 18 °C and -22 °C.Do not freeze and thaw the reconstitutedcontrols more than 30 times.After hemolysis with the CAPILLARYS 2FLEX-PIERCING instrument, store thedilution segments with controls at 2 - 8 °C anduse them within the day (for 8 hoursmaximum). They may be stored, without anydelay, between - 18 °C and - 22 °C for 1month maximum. Do not freeze and thaw adilution segment with hemolyzed control morethan three times.
Instrument	TosohAutomatedAnalyzer HCL-723G8Glycohemoglobin	SEBIA CAPILLARYS 2 FLEX-PIERCING

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STANDARDS

CAPILLARYS Hb A1c test is standardized according to NGSP and IFCC requirements/guidelines (Section VII).

STATEMENT OF MANUFACTURE AND MANUFACTURING CONTROLS

The CAPILLARYS Hb A1c kits and accessories are manufactured by SEBIA in accordance with applicable GLP and GMP / Quality System practices and SEBIA's own specifications, in their entirety at its manufacturing facility located at:

Parc Technologique Léonard de Vinci, Rue Léonard de Vinci CP 8010 LISSES 91008 EVRY Cedex, FRANCE

All raw materials are obtained by SEBIA from qualified suppliers.

SEBIA adheres to a system of incoming, in process and finished product quality control procedures.

The manufacturing and quality control procedures are documented in Section VI of this 510(K) submission.

SEBIA has been certified against ISO 9001 / ISO 13485.

The CAPILLARYS Hb A1c devices are for In Vitro Diagnostic Use.

SEBIA's corporate office is located at:

Parc Technologique Léonard de Vinci, Rue Léonard de Vinci CP 8010 LISSES 91008 EVRY Cedex, FRANCE

Phone: (33) 1 69 89 80 80 : Fax: (33) 1 69 89 78 78

In the United States, the product will be distributed by:

SEBIA Inc. Suite 400 - 1705 Corporate drive NORCROSS GA 30093, USA

Phone 770 446 - 3707 ; Fax 770 446 - 8511

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Image /page/9/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" arranged around the perimeter. Inside the circle is a stylized design featuring three curved lines that resemble a caduceus or a stylized representation of human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 6, 2012

SEBIA c/o Karen Anderson 1705 Corporate Drive Suite 400 Duluth, Georgia 30093

Re: K122101

Trade/Device Name: CAPILLARYS Hb Alc Kit, Hb Alc CAPILLARY Calibrators Hb Alc CAPILLARY Controls

Regulation Number: 21 CFR §864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, JIS, JJX Dated: November 19, 2012 Received: November 20, 2012

Dear Ms. 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.

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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Karen Anderson

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benson 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): K | ZZ10|

Device Name: CAPILLARYS Hb A1c using the CAPILLARYS 2 FLEX-PIERCING instrument

Indications for Use:

The CAPILLARYS Hb Alc kit is designed for separation and quantification of the glycated fraction of hemoglobin in human whole blood, by capillary HbAic electrophoresis in alkaline buffer (pH 9.4) with the CAPILARYS 2 FLEX-PIERCING instrument. Measurement of hemoglobin A10 is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. The CAPILLARYS Hb Alc kit is designed for Professional Use Only.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Kattlus sust

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) L122101

Page 1 of

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Indications for Use

510(k) Number (if known): K(ZZ10 |

Device Name: Hb A1c CAPILLARY CALIBRATORS using the CAPILLARYS 2 FLEX-PIERCING instrument

Indications for Use:

The Hb Alc CAPILLARY Calibrators are designed for the calibration and migration control of human glycated hemoglobin Are quantification with SEBIA CAPILLARYS Hb Alc electrophoresis procedure performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument for capillary electrophoresis. The Hb Alc CAPILLARY Calibrators are designed for Professional Use Only.

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Division Sign-Off

Office of In Vitro Blagnostics and Radiological Health

16122101 510(k)

Page 2 of 3

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Indications for Use

510(k) Number (if known): K12-Z101

Device Name: Hb A1c CAPILLARY CONTROLS using the CAPILLARYS 2 FLEX-PIERCING instrument

Indications for Use:

The Hb Alc CAPILLARY Controls are designed for the quality control of human glycated hemoglobin Are quantification with CAPILLARYS Hb Alc electrophoresis grocedure performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument for capillary electrophoresis. The Hb Alc CAPILLARY Controls are designed for Professional Use Only.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Patlu Sinius

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K122101

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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).