Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the analytical method (capillary electrophoresis) and its performance characteristics (precision, linearity, interference). There is no mention of AI, ML, or any learning algorithms used in the device's operation or data analysis.

Therapeutic

No
The device is an in vitro diagnostic device used for measurement and monitoring, not for direct treatment or amelioration of a disease.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "used as an aid in diagnosis of diabetes, as an aid to identify patients who may be at risk for developing diabetes mellitus," and "The CAPILLARYS Hb A 1c kit is intended for in vitro Diagnostic Use Only."

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical instrument (CAPILLARYS 2 FLEX-PIERCING instrument) that performs capillary electrophoresis on blood samples. This involves hardware components like capillaries, a high voltage system, and a detector. While software is undoubtedly involved in controlling the instrument and processing the data, the device itself is not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The CAPILLARYS Hb A 1c kit is intended for in vitro Diagnostic Use Only."
Intended Use: The intended use is to separate and quantify HbA1c in venous whole human blood. This is a test performed on a biological sample outside of the body to provide information for medical purposes.
Clinical Purpose: The results are used as an aid in the diagnosis of diabetes, identifying risk for diabetes, and monitoring long-term blood glucose control. These are all clinical applications.
Device Description: The device description details a laboratory instrument and a kit used to perform a test on blood samples.

All of these points align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The CAPILLARYS Hb A1c kit is intended for separation and quantification of the HbA1c glycated fraction of hemoglobin (in IFCC unit (mmol/mol) and NGSP unit (%)) in venous whole human blood, by capillary electrophoresis in alkaline buffer with the CAPILLARYS 2 FLEX-PIERCING instrument. Measurement of hemoglobin A1c is used as an aid in diagnosis of diabetes, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. The CAPILLARYS Hb A1c kit is intended for in vitro Diagnostic Use Only.

Product codes (comma separated list FDA assigned to the subject device)

PDJ

Device Description

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 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 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 CAPILLLARYS 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.

The HbA1c concentrations are standardized and indicated in %HbA1c (DCCT/NGSP) and in mmol/mol (IFCC) units.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

a. Precision / Reproducibility:
The precision of the CAPILLARYS Hb A1c procedure was evaluated in a study based on the CLSI EP5-A3 guideline. Four whole blood samples (~5%, ~6.5%, ~8%, ~12% HbA1c) were used. Eight different samples (4 human blood samples, 2 controls, 2 calibrators) were run in duplicate on two capillaries per run, two runs per day over 20 days per lot of kit, using three lots, yielding a total of 1440 results over 60 days. Reproducibility between instruments and within instruments was summarized showing SD and %CV for HbA1c in mmol/mol and %.

b. Linearity / assay reportable range:
A linearity study was performed per CLSI EP06-A using low (4.4% Hb A1c / 24 mmol/mol) and high (16.7% / 159 mmol/mol) samples. Mixtures of two different blood samples (normal and elevated HbA1c) were analyzed in triplicate. The tests were determined to be linear within the entire range studied. The stated measuring range is 24 mmol/mol to 158 mmol/mol HbA1c (4.4% to 16.6% HbA1c).

c. Traceability, Stability (controls, calibrators, or methods):
The CAPILLARYS Hb A1c test standardization is traceable to the International Federation of Clinical Chemistry (IFCC) reference calibrators. The assay is NGSP certified annually.

d. Calibrators and Controls:
The Hb A1c CAPILLARY CALIBRATORS and Sebia MULTI-SYSTEM Hb A1c CAPILLARYS CONTROLS are required for use. Value assignment and stability were reviewed and cleared in K122101 for calibrators and K162281 for controls.

e. Comparison Studies:
A method comparison study of 150 variant-free whole blood samples was performed using the CAPILLARYS Hb A1c kit and CAPILLARYS 2 FLEX-PIERCING instrument. Results were compared to an NGSP reference laboratory using the cleared HPLC HbA1c method (Automated Glycohemoglobin Analyzer HLC-712G8). The samples spanned various HbA1c levels, including around decision points. Regression analysis (Ordinary linear fit, Weighted Deming, Passing Bablok) showed a correlation coefficient of 0.999. Slope was 1.027 (1.019 to 1.035) for ordinary linear fit. Average bias was -0.07 (-0.08 to -0.05). Bias at normal range (6.5%) was -0.09 (-0.11 to -0.07).

f. Total Error Calculations:
Total error (TE) was calculated for 4 concentrations (5.1%, 6.4%, 8.2%, and 12.2%) using bias estimation and coefficients of variation. TE was within the ≤ 6.0% specification for the concentration of 5.1%.

5.1% HbA1c: TE (%) = 5.9
6.4% HbA1c: TE (%) = 4.1
8.2% HbA1c: TE (%) = 2.8
12.2% HbA1c: TE (%) = 3.1

g. Interferences:
Interference studies were performed per CLSI EP07-A2. No interference was detected from various endogenous factors and drugs at tested concentrations. Hemoglobin variant studies (S, C, E, D, A2, F) were performed.

HbS: Mean relative % Bias 0.8 (0.0 to 1.6) at ~6.5% HbA1c; 0.4 (-3.1 to 3.2) at ~9.0% HbA1c.
HbC: Mean relative % Bias 0.0 (0.0 to 0.0) at ~6.5% HbA1c; 3.3 (1.0 to 5.7) at ~9.0% HbA1c.
HbD: Mean relative % Bias 0.5 (-1.4 to 1.6) at ~6.5% HbA1c; -1.9 (-2.4 to -1.2) at ~9.0% HbA1c.
HbE: Mean relative % Bias -0.4 (-3.3 to 1.5) at ~6.5% HbA1c; -0.3 (-3.7 to 2.1) at ~9.0% HbA1c.
HbA2: Mean relative % Bias -3.4 (-4.5 to -1.4) at ~6.5% HbA1c; -0.8 (-2.0 to 0.0) at ~9.0% HbA1c.
HbF: Mean relative % Bias -3.3 (-4.8 to -1.6) at ~6.5% HbA1c; -2.0 (-5.0 to 0.0) at ~9.0% HbA1c.
Levels of Hb F up to 23% and Hb A2 up to 7.7% do not interfere. No interference observed with major abnormal hemoglobins Hb S (≤ 40.8%), Hb C (≤ 37.2%), Hb D (≤ 41.3%) and Hb E (≤ 37.0%).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K131580

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K122101, K162281

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.1373 Hemoglobin A1c test system.

(a)
Identification. A hemoglobin A1c test system is a device used to measure the percentage concentration of hemoglobin A1c in blood. Measurement of hemoglobin A1c is used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by FDA.
(2) The premarket notification submission must include performance testing to evaluate precision, accuracy, linearity, and interference, including the following:
(i) Performance testing of device precision must, at a minimum, use blood samples with concentrations near 5.0 percent, 6.5 percent, 8.0 percent, and 12 percent hemoglobin A1c. This testing must evaluate precision over a minimum of 20 days using at least three lots of the device and three instruments, as applicable.
(ii) Performance testing of device accuracy must include a minimum of 120 blood samples that span the measuring interval of the device and compare results of the new device to results of a standardized test method. Results must demonstrate little or no bias versus the standardized method.
(iii) Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6 percent.
(iv) Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin S.
(3) When assay interference from Hemoglobin F or interference with other hemoglobin variants with low frequency in the population is observed, a warning statement must be placed in a black box and must appear in all labeling material for these devices describing the interference and any affected populations.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

February 7, 2018

Sebia Karen Anderson Director of Technical and Regulatory 1705 Corporate Drive Suite 400 Norcross, GA 30093

Re: K171861

Trade/Device Name: CAPILLARYS Hb A1c Regulation Number: 21 CFR 862.1373 Regulation Name: Hemoglobin A1c test system Regulatory Class: Class II Product Code: PDJ Dated: December 14, 2017 Received: December 20, 2017

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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

1

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

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kellie B. Ke

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

Enclosure

2

Indications for Use

510(k) Number (if known) K171861

Device Name CAPILLARYS Hb A1c

Indications for Use (Describe)

The CAPILLARYS Hb A1c kit is intended for separation and quantification of the HbA1c glycated fraction of hemoglobin (in IFCC unit (mmol/mol) and NGSP unit (%)) in venous whole human blood, by capillary electrophoresis in alkaline buffer with the CAPILLARYS 2 FLEX-PIERCING instrument of hemoglobin A1c is used as an aid in diagnosis of diabetes, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. The CAPILLARYS Hb A 1c kit is intended for in vitro Diagnostic 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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K171861

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
Norcross, Georgia 30093, USA
Contact	Karen Anderson, Dir of Technical and QA
Phone: 1-800-835-6497
Fax: 770-446-8511
Email: karen.anderson@sebia-usa.com
Date Prepared	February 6, 2018
Manufacturing	Sebia
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
Product Name	CAPILLARYS Hb A1c
Common Name	Whole blood hemoglobin A1c (HbA1c) by capillary
electrophoresis
Product Regulation No.	21 CFR 862.1373
Product Codes	PDJ
Device classification and Panel Classification	Class II , Clinical Chemistry(75)
Establishment Registration No.	8023024

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1. DEVICE DESCRIPTION

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 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 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 CAPILLLARYS 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.

The HbA1c concentrations are standardized and indicated in %HbA1c (DCCT/NGSP) and in mmol/mol (IFCC) units.

Reagents:

CAPILLARYS HbA1c KIT

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

Additional reagents not included in the CAPILLARYS Hb A1c KIT

ITEMS	PN	COMPONENTS
CAPICLEAN	2058	1 vial, 25 mL

5

CAPILLARYS WASH SOLUTION	2052	2 vial, 75mL
TUBES AND CAPS FOR CONTROLS	9202
9205	20 units
500 units
Wedge adapters	9203	10 per box
PHORESIS software	1110
CAPILLARYS 2 FLEX-PIERCING
INSTRUMENT	1227
Hb A1c CAPILLARY CALIBRATORS	4755
4756	1 SET
5 SETS
MULTI-SYSTEM Hb A1c
CAPILLARY CONTROLS	4767
4768	10 SETS
1 SET

2. INDICATIONS FOR USE

CAPILLARYS Hb A1c kit:

The CAPILLARYS Hb A1c kit is intended for separation and quantification of the HbA1c glycated fraction of hemoglobin (in IFCC unit (mmol/mol) and NGSP unit (%)) in venous whole human blood, by capillary electrophoresis in alkaline buffer with the CAPILLARYS 2 FLEXPIERCING instrument. Measurement of hemoglobin A1c is used as an aid in diagnosis of diabetes, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. The CAPILLARYS Hb A1c kit is intended for in vitro Diagnostic Use Only

3. SUBSTANTIAL EQUIVALENCE INFORMATION:

| Predicate Device Name | Predicate Device Product Code Regulation No.
510(k) number | | |
|-------------------------------------------------------------|-------------------------------------------------------------------|-----|----------|
| Tosho Automated
Glycohemoglobin Analyzer HLC-
723G-8 | K131580 | PDJ | 862.1373 |

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Similarities between the candidate device (CAPILLARYS Hb A1c) and the predicate device (Tosoh HLC-723G8, K131580 (Table A).

Similarities
Table A	Sebia CAPILLARYS Candidate Device Hb A1c	Tosoh HLC-723G8 Predicate Device (K131580)
Intended use	The CAPILLARYS Hb A1c kit is intended for separation and quantification of the HbA1c glycated fraction of hemoglobin (in IFCC unit (mmol/mol) and NGSP unit (%)) in venous whole human blood, by capillary electrophoresis in alkaline buffer with the CAPILLARYS 2 FLEX-PIERCING instrument. Measurement of hemoglobin A1c is used as an aid in diagnosis of diabetes, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. The CAPILLARYS Hb A1c kit is intended for in vitro Diagnostic Use Only	The Tosoh Automated Glycohemoglobin Analyzer HLC723G8 is intended for the in vitro diagnostic use for the measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and identifying patients who may be at risk of developing diabetes.
Specimen Type	Human Whole Blood	Human Whole Blood
Standardization	Traceable to the Diabetes Contraol and Complications Trial (DCCT) reference method and IFCC. Certified via the National Glycohemoglobin Standardization Program ( NGSP)	Same
Linearity
Measuring Range	4.4 – 16.6% (NGSP)
24 – 158 mmol/mol ( IFCC)	4.0 – 16.9 %
Total
Errorallowable bias
6%	Concentration
5.1
6.4
8.2
12.2	Concentration
5.0
6.5
8.0
12.0
	TE%
5.9
4.1
2.8
3.1	TE%
5.8
2.8
3.0
3.1
Hemoglobin
Variant
Interferences	HbA2, HbS, HbC, HbD, does not interfere with this assay	HbA2, HbF, HbS, HbC, HbD, does not interfere with this assay

Table B. Differences between the predicate device (CAPILLARYS Hb A1c) and the candidate device (Tosoh HLC-723G8, K131580) in (Table B).

Differences
Table B	Sebia CAPILLARYS Hb A1c
Candidate Device	Tosoh HLC-723G8
Predicate Device (K131580)
Assay Principle	Capillary electrophoresis	Ion-exchange HPLC

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| Hemoglobin
Variant
Interferences | Hb E no interference | Hb E has known interference, a HbE
flag is displayed and no Hb A1c is
reported. |

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

Performance Data:

a. Precision / Reproducibility:-

Precision

The precision of the CAPILLARYS Hb A1c procedure using the CAPILLARYS 2 FLEX-PIERCING was evaluated in a study based on the Clinical Laboratory Standards Institute (CLSI - USA) EP5A3 guideline "Evaluation of Precision of Quantitative Measurements Procedures; Approved Guideline - Third Edition".

The means, standard deviations (SD) and coefficients of variation (CV %) were calculated for HbA1c concentration (mmol/mol) and percentage (%) for each sample.

Evaluation of Precision of Quantitative Measurement Procedures. Four whole blood samples at the following targeted HbA1c concentration of ~ 5%. ~ 6.5%. ~ 8%, and ~12% were used in the study

Eight (8) different samples were run using the CAPILLARYS Hb A1c procedure on the CAPILLARYS 2 FLEX-PIERCING instrument. The analyzed samples included 4 human blood samples (blood No. 1 to 4), 2 controls and 2 calibrators. Each sample was analyzed in duplicate on two capillaries per run, two runs per day over 20 days per lot of CAPILLARYS Hb A1c kit, using three lots yielding a total of 1440 results per sample over 60 days.

The reproducibility between instruments is summarized in the following tables including withincapillary, between-capillary, between-run, between-lot, between-instrument and total reproducibility precision estimates (SD and %CV) for the HbAre percentages.

| | Mean
(mmol/mol) | Within-capillary | | Between-capillary | | Between-run | | Between-day | | Between-lot | | Between-instrument | | Total reproducibility (*) | |
|--------------|--------------------|------------------|------|-------------------|------|-------------|------|-------------|------|-------------|------|--------------------|------|---------------------------|------|
| Sample | | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| Blood No. 1 | 32 | 0,60 | 1,9% | 0,67 | 2,1% | 0,00 | 0,0% | 0,26 | 0,8% | 0,35 | 1,1% | 0,00 | 0,0% | 0,99 | 3,1% |
| Blood No. 2 | 46 | 0,76 | 1,7% | 0,40 | 0,9% | 0,00 | 0,0% | 0,27 | 0,6% | 0,38 | 0,8% | 0,00 | 0,0% | 0,98 | 2,1% |
| Blood No. 3 | 66 | 0,78 | 1,2% | 0,58 | 0,9% | 0,00 | 0,0% | 0,32 | 0,5% | 0,36 | 0,6% | 0,00 | 0,0% | 1,09 | 1,6% |
| Blood No. 4 | 109 | 0,89 | 0,8% | 0,88 | 0,8% | 0,00 | 0,0% | 0,51 | 0,5% | 1,18 | 1,1% | 0,00 | 0,0% | 1,79 | 1,6% |
| Control 1 | 33 | 0,64 | 2,0% | 0,57 | 1,8% | 0,00 | 0,0% | 0,36 | 1,1% | 0,57 | 1,8% | 0,03 | 0,1% | 1,10 | 3,4% |
| Control 2 | 63 | 0,73 | 1,2% | 0,99 | 1,6% | 0,00 | 0,0% | 0,79 | 1,2% | 0,17 | 0,3% | 0,91 | 1,4% | 1,73 | 2,7% |
| Calibrator 1 | 37 | 0,76 | 2,0% | 0,41 | 1,1% | 0,00 | 0,0% | 0,32 | 0,8% | 0,44 | 1,2% | 0,00 | 0,0% | 1,02 | 2,7% |
| Calibrator 2 | 87 | 0,94 | 1,1% | 0,67 | 0,8% | 0,00 | 0,0% | 0,23 | 0,3% | 0,62 | 0,7% | 0,00 | 0,0% | 1,33 | 1,5% |

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

| Sample | Mean
(%) | Within-capillary | | Between-capillary | | Between-run | | Between-day | | Between-lot | | Between-instrument | | Total reproducibility (*) | |
|--------------|-------------|------------------|------|-------------------|------|-------------|------|-------------|------|-------------|------|--------------------|------|---------------------------|------|
| | | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| Blood No. 1 | 5,1 | 0,06 | 1,1% | 0,06 | 1,2% | 0,00 | 0,0% | 0,03 | 0,6% | 0,03 | 0,5% | 0,00 | 0,0% | 0,09 | 1,8% |
| Blood No. 2 | 6,4 | 0,07 | 1,1% | 0,04 | 0,6% | 0,00 | 0,0% | 0,03 | 0,4% | 0,04 | 0,6% | 0,00 | 0,0% | 0,09 | 1,4% |
| Blood No. 3 | 8,2 | 0,07 | 0,9% | 0,05 | 0,7% | 0,00 | 0,0% | 0,03 | 0,3% | 0,03 | 0,4% | 0,00 | 0,0% | 0,10 | 1,2% |
| Blood No. 4 | 12,2 | 0,08 | 0,7% | 0,08 | 0,6% | 0,00 | 0,0% | 0,04 | 0,4% | 0,10 | 0,9% | 0,00 | 0,0% | 0,16 | 1,3% |
| Control 1 | 5,1 | 0,06 | 1,1% | 0,05 | 1,1% | 0,00 | 0,0% | 0,03 | 0,7% | 0,05 | 1,0% | 0,01 | 0,3% | 0,10 | 2,0% |
| Control 2 | 8,0 | 0,07 | 0,9% | 0,09 | 1,1% | 0,00 | 0,0% | 0,07 | 0,9% | 0,01 | 0,2% | 0,08 | 1,1% | 0,16 | 2,0% |
| Calibrator 1 | 5,6 | 0,07 | 1,3% | 0,04 | 0,7% | 0,00 | 0,0% | 0,03 | 0,5% | 0,05 | 0,9% | 0,00 | 0,0% | 0,10 | 1,8% |
| Calibrator 2 | 10,1 | 0,08 | 0,8% | 0,06 | 0,6% | 0,00 | 0,0% | 0,02 | 0,2% | 0,07 | 0,7% | 0,00 | 0,0% | 0,13 | 1,3% |

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

8

The reproducibility within the same instrument is summarized in the following tables :

including within-capillary, between-capillary, between-day, between-day, between-lot and total reproducibility precision estimates (SD and %CV) for the HbA% concentrations (in mmol/mol) and percentages for each instrument.

including the within-lot precision estimates (SD and %CV) for the HbA1ം concentrations (in mmol/mol) and percentages for each lot on each instrument.

| Sample | Mean
(mmol/mol) | Within-capillary | | Between-capillary | | Between-run | | Between-day | | Between-lot | | Total reproducibility () | |
|--------------------------------------------------------------------------------------------------------------------|--------------------|------------------|------|-------------------|------|-------------|------|-------------|------|-------------|------|---------------------------|------|
| | | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| Blood No. 1 | 32 | 0,60 | 1,9% | 0,49 | 1,5% | 0,00 | 0,0% | 0,22 | 0,7% | 0,42 | 1,3% | 0,91 | 2,8% |
| Blood No. 2 | 46 | 0,80 | 1,7% | 0,37 | 0,8% | 0,00 | 0,0% | 0,22 | 0,5% | 0,38 | 0,8% | 0,99 | 2,1% |
| Blood No. 3 | 66 | 0,77 | 1,2% | 0,50 | 0,8% | 0,00 | 0,0% | 0,44 | 0,7% | 0,36 | 0,6% | 1,08 | 1,6% |
| Blood No. 4 | 109 | 0,90 | 0,8% | 0,79 | 0,7% | 0,00 | 0,0% | 0,53 | 0,5% | 1,11 | 1,0% | 1,72 | 1,6% |
| Control 1 | 33 | 0,64 | 2,0% | 0,49 | 1,5% | 0,00 | 0,0% | 0,40 | 1,2% | 0,51 | 1,6% | 1,04 | 3,2% |
| Control 2 | 63 | 0,75 | 1,2% | 1.36 | 2,2% | 0,00 | 0,0% | 0,40 | 0,6% | 0,29 | 0,5% | 1,63 | 2,6% |
| Calibrator 1 | 37 | 0,80 | 2,1% | 0,29 | 0,8% | 0,00 | 0,0% | 0,40 | 1,1% | 0,32 | 0,8% | 0,99 | 2,7% |
| Calibrator 2 | 87 | 0,91 | 1,1% | 0,77 | 0,9% | 0,00 | 0,0% | 0,13 | 0,2% | 0,65 | 0,7% | 1,36 | 1,6% |
| () Total reproducibility includes : within-capillary, between-capillary, between-run, between-day and between-lot | | | | | | | | | | | | | |

Instrument No. 1

withi Within-lot (*)

| Sample | Mean
(mmol/mol) | Lot No. 1 | | Lot No. 2 | | Lot No. 3 | |
|--------------|--------------------|-----------|------|-----------|------|-----------|------|
| | | SD | CV | SD | CV | SD | CV |
| Blood No. 1 | 32 | 0,88 | 2,7% | 0,67 | 2,1% | 0,87 | 2,7% |
| Blood No. 2 | 46 | 0,91 | 2,0% | 0,96 | 2,1% | 0,89 | 1,9% |
| Blood No. 3 | 66 | 0,87 | 1,3% | 1,08 | 1,6% | 1,10 | 1,7% |
| Blood No. 4 | 109 | 1,33 | 1,2% | 1,36 | 1,2% | 1,24 | 1,1% |
| Control 1 | 33 | 0,81 | 2,5% | 0,99 | 3,1% | 0,89 | 2,7% |
| Control 2 | 63 | 1,25 | 2,0% | 1,59 | 2,5% | 1,91 | 3,0% |
| Calibrator 1 | 37 | 0,87 | 2,3% | 0,99 | 2,7% | 1,02 | 2,7% |
| Calibrator 2 | 87 | 0,95 | 1,1% | 1,40 | 1,6% | 1,25 | 1,4% |

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

	Mean	Within-capillary		Between-capillary		Between-run		Between-day		Between-lot		Total reproducibility (*)
Sample	(%)	SD	CV	SD	CV	SD	CV	SD	CV	SD	CV	SD	CV
Blood No. 1	5,1	0,06	1,3%	0,04	0,7%	0,00	0,0%	0,03	0,5%	0,03	0,7%	0,09	1,7%
Blood No. 2	6,4	0,07	1,1%	0,04	0,5%	0,00	0,0%	0,03	0,4%	0,03	0,5%	0,09	1,4%
Blood No. 3	8,2	0,08	0,9%	0,05	0,6%	0,00	0,0%	0,04	0,4%	0,04	0,5%	0,10	1,3%
Blood No. 4	12,2	0,08	0,7%	0,08	0,6%	0,00	0,0%	0,05	0,4%	0,10	0,8%	0,16	1,3%
Control 1	5,1	0,06	1,2%	0,04	0,7%	0,00	0,0%	0,04	0,7%	0,04	0,8%	0,09	1,8%
Control 2	8,0	0,07	0,9%	0,12	1,5%	0,00	0,0%	0,03	0,4%	0,02	0,3%	0,14	1,8%
Calibrator 1	5,6	0,07	1,2%	0,04	0,7%	0,00	0,0%	0,04	0,7%	0,04	0,7%	0,10	1,7%
Calibrator 2	10,1	0,09	0,9%	0,07	0,7%	0,00	0,0%	0,02	0,2%	0,07	0,7%	0,14	1,3%
(*) Total reproducibility includes : within-capillary, between-capillary, between-run, between-day and between-lot.
Sample	Mean (%)	Within-lot (*)

9

		Lot No. 1		Lot No. 2		Lot No. 3
		SD	CV	SD	CV	SD	CV
Blood No. 1	5,1	0,07	1,5%	0,07	1,4%	0,09	1,8%
Blood No. 2	6,4	0,07	1,1%	0,08	1,3%	0,09	1,4%
Blood No. 3	8,2	0,08	1,0%	0,10	1,2%	0,10	1,2%
Blood No. 4	12,2	0,13	1,1%	0,12	1,0%	0,12	0,9%
Control 1	5,1	0,07	1,4%	0,09	1,7%	0,08	1,6%
Control 2	8,0	0,11	1,4%	0,13	1,6%	0,17	2,2%
Calibrator 1	5,6	0,07	1,3%	0,09	1,7%	0,10	1,7%
Calibrator 2	10,1	0,09	0,9%	0,14	1,3%	0,11	1,1%

(1) Within-lot reproducibility includes : within-capillary, between-run and between-run and between-day.
Instrument No. 2

| Sample | Mean
(mmol/mol) | Within-capillary | | Between-capillary | | Between-run | | Between-day | | Between-lot | | Total reproducibility (*) | |
|--------------|--------------------|------------------|------|-------------------|------|-------------|------|-------------|------|-------------|------|---------------------------|------|
| | | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| Blood No. 1 | 32 | 0,60 | 1,9% | 0,25 | 0,8% | 0,00 | 0,0% | 0,23 | 0,7% | 0,23 | 0,7% | 0,73 | 2,3% |
| Blood No. 2 | 46 | 0,68 | 1,5% | 0,36 | 0,8% | 0,00 | 0,0% | 0,35 | 0,8% | 0,48 | 1,0% | 0,97 | 2,1% |
| Blood No. 3 | 66 | 0,72 | 1,1% | 0,32 | 0,5% | 0,21 | 0,3% | 0,26 | 0,4% | 0,52 | 0,8% | 1,00 | 1,5% |
| Blood No. 4 | 109 | 0,85 | 0.8% | 0,72 | 0,7% | 0,00 | 0,0% | 0,44 | 0,4% | 1,40 | 1,3% | 1,84 | 1,7% |
| Control 1 | 33 | 0,62 | 1,9% | 0,48 | 1,4% | 0,00 | 0,0% | 0,26 | 0,8% | 0,63 | 1,9% | 1,04 | 3,2% |
| Control 2 | 63 | 0,60 | 0,9% | 0,92 | 1,4% | 0,00 | 0,0% | 0,63 | 1,0% | 0,25 | 0,4% | 1,30 | 2,0% |
| Calibrator 1 | 37 | 0,69 | 1,8% | 0,31 | 0,8% | 0,00 | 0,0% | 0,28 | 0,7% | 0,55 | 1,5% | 0,97 | 2,6% |
| Calibrator 2 | 87 | 0,89 | 1,0% | 0,46 | 0,5% | 0,30 | 0,3% | 0,32 | 0,4% | 0,74 | 0,9% | 1,32 | 1,5% |

(*) Total reproducibility includes : within-capillary, between-capillary, between-run, between-day and between-lot.
Sample	Mean
(mmol/mol)	Lot No. 1		Lot No. 2		Lot No. 3
		SD	CV	SD	CV	SD	CV
Blood No. 1	32	0,67	2,0%	0,63	2,0%	0,81	2,5%
Blood No. 2	46	0,83	1,8%	0,89	1,9%	0,85	1,8%
Blood No. 3	66	0,82	1,2%	0,85	1,3%	0,91	1,4%
Blood No. 4	109	1,08	1,0%	1,19	1,1%	1,30	1,2%
Control 1	33	0,88	2,6%	0,79	2,4%	0,81	2,4%
Control 2	63	1,39	2,2%	1,04	1,6%	1,36	2,1%
Calibrator 1	37	0,87	2,3%	0,77	2,1%	0,81	2,2%
Calibrator 2	87	0,92	1,1%	1,14	1,3%	1,18	1,4%
(*) Within lot reproducibility includes : within-capillary, between-capillary, between-run and between-day.

| Sample | Mean
(%) | Within-capillary | | Between-capillary | | Between-run | | Between-day | | Between-lot | | Total reproducibility (*) | |
|--------------|-------------|------------------|------|-------------------|------|-------------|------|-------------|------|-------------|------|---------------------------|------|
| | | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| Blood No. 1 | 5,1 | 0,05 | 1,0% | 0,02 | 0,4% | 0,00 | 0,0% | 0,02 | 0,5% | 0,01 | 0,2% | 0,06 | 1,2% |
| Blood No. 2 | 6,4 | 0,07 | 1,1% | 0,04 | 0,6% | 0,00 | 0,0% | 0,03 | 0,4% | 0,05 | 0,8% | 0,10 | 1,5% |
| Blood No. 3 | 8,2 | 0,07 | 0,8% | 0,02 | 0,3% | 0,02 | 0,2% | 0,03 | 0,3% | 0,05 | 0,6% | 0,09 | 1,1% |
| Blood No. 4 | 12,2 | 0,08 | 0,7% | 0,06 | 0,5% | 0,00 | 0,0% | 0,03 | 0,3% | 0,12 | 1,0% | 0,16 | 1,3% |
| Control 1 | 5,1 | 0,05 | 1,1% | 0,05 | 1,0% | 0,00 | 0,0% | 0,03 | 0,5% | 0,06 | 1,1% | 0,10 | 1,9% |
| Control 2 | 8,0 | 0,05 | 0,7% | 0,09 | 1,1% | 0,00 | 0,0% | 0,06 | 0,7% | 0,02 | 0,3% | 0,12 | 1,5% |
| Calibrator 1 | 5,6 | 0,07 | 1,3% | 0,03 | 0,6% | 0,00 | 0,0% | 0,02 | 0,4% | 0,06 | 1,1% | 0,10 | 1,8% |
| Calibrator 2 | 10,1 | 0,08 | 0,8% | 0,05 | 0,5% | 0,03 | 0,3% | 0,02 | 0,2% | 0,08 | 0,7% | 0,12 | 1,2% |

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

10

		Within-lot (*)
Sample	Mean
(%)	Lot No. 1		Lot No. 2		Lot No. 3
		SD	CV	SD	CV	SD	CV
Blood No. 1	5,1	0,05	1,1%	0,06	1,2%	0,07	1,3%
Blood No. 2	6,4	0,08	1,2%	0,08	1,3%	0,08	1,3%
Blood No. 3	8,2	0,07	0,9%	0,08	0,9%	0,08	1,0%
Blood No. 4	12,2	0,09	0,7%	0,11	0,9%	0,12	1,0%
Control 1	5,1	0,08	1,6%	0,09	1,7%	0,08	1,5%
Control 2	8,0	0,13	1,6%	0,10	1,3%	0,12	1,4%
Calibrator 1	5,6	0,08	1,4%	0,08	1,4%	0,09	1,6%
Calibrator 2	10,1	0,08	0,8%	0,11	1,1%	0,10	1,0%

(*) Within-lot reproducibility includes : within-capillary, between-run and between-run and between-day.
Instrument No. 3

| Sample | Mean
(mmol/mol) | Within-capillary | | Between-capillary | | Between-run | | Between-day | | Between-lot | | Total reproducibility (*) | |
|--------------|--------------------|------------------|------|-------------------|------|-------------|------|-------------|------|-------------|------|---------------------------|------|
| | | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| Blood No. 1 | 32 | 0,60 | 1,9% | 1,01 | 3,2% | 0,00 | 0,0% | 0,31 | 1,0% | 0,36 | 1,1% | 1,27 | 3,9% |
| Blood No. 2 | 46 | 0,81 | 1,7% | 0,45 | 1,0% | 0,14 | 0,3% | 0,21 | 0,5% | 0,24 | 0,5% | 0,99 | 2,1% |
| Blood No. 3 | 66 | 0,85 | 1,3% | 0,82 | 1,2% | 0,00 | 0,0% | 0,22 | 0,3% | 0,00 | 0,0% | 1,20 | 1,8% |
| Blood No. 4 | 109 | 0,92 | 0,8% | 1,08 | 1,0% | 0,00 | 0,0% | 0,54 | 0,5% | 0,98 | 0,9% | 1,81 | 1,7% |
| Control 1 | 33 | 0,66 | 2,1% | 0,72 | 2,2% | 0,00 | 0,0% | 0,41 | 1,3% | 0,56 | 1,7% | 1,20 | 3,7% |
| Control 2 | 63 | 0,83 | 1,3% | 0,49 | 0,8% | 0,00 | 0,0% | 1,13 | 1,8% | 0,00 | 0,0% | 1,49 | 2,4% |
| Calibrator 1 | 37 | 0,78 | 2,1% | 0,57 | 1,5% | 0,00 | 0,0% | 0,25 | 0,7% | 0,41 | 1,1% | 1,08 | 2,9% |
| Calibrator 2 | 87 | 1,02 | 1,2% | 0,73 | 0,8% | 0,00 | 0,0% | 0,19 | 0,2% | 0,43 | 0,5% | 1,34 | 1,5% |

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

Sample	Mean (mmol/mol)	Within-lot (*)
		Lot No. 1		Lot No. 2		Lot No. 3
		SD	CV	SD	CV	SD	CV
Blood No. 1	32	0,90	2,8%	1,24	3,9%	1,44	4,4%
Blood No. 2	46	0,76	1,6%	0,94	2,0%	1,16	2,5%
Blood No. 3	66	1,19	1,8%	1,12	1,7%	1,39	2,1%
Blood No. 4	109	1,45	1,3%	1,26	1,1%	1,80	1,7%
Control 1	33	0,92	2,8%	0,99	3,1%	1,25	3,8%
Control 2	63	1,50	2,4%	1,42	2,3%	1,53	2,4%
Calibrator 1	37	1,10	2,9%	0,91	2,5%	1,09	2,9%
Calibrator 2	87	1,18	1,4%	1,21	1,4%	1,42	1,6%

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

		Within-capillary		Between-capillary		Between-run		Between-day		Between-lot		Total reproducibility (*)
Sample	Mean
(%)	SD	CV	SD	CV	SD	CV	SD	CV	SD	CV	SD	CV
Blood No. 1	5,1	0,06	1,1%	0,10	1,9%	0,00	0,0%	0,04	0,7%	0,03	0,6%	0,12	2,4%
Blood No. 2	6,4	0,07	1,2%	0,04	0,6%	0,00	0,0%	0,02	0,3%	0,02	0,3%	0,09	1,4%
Blood No. 3	8,2	0,08	0,9%	0,08	0,9%	0,00	0,0%	0,02	0,2%	0,00	0,0%	0,11	1,3%
Blood No. 4	12,2	0,08	0,7%	0,09	0,8%	0,00	0,0%	0,05	0,4%	0,09	0,7%	0,16	1,3%
Control 1	5,1	0,06	1,2%	0,07	1,3%	0,00	0,0%	0,04	0,7%	0,05	1,0%	0,11	2,1%
Control 2	8,0	0,08	1,0%	0,05	0,6%	0,00	0,0%	0,10	1,3%	0,00	0,0%	0,13	1,7%
Calibrator 1	5,6	0,08	1,4%	0,05	0,9%	0,00	0,0%	0,03	0,5%	0,05	0,9%	0,11	1,9%
Calibrator 2	10,1	0,09	0,9%	0,07	0,7%	0,00	0,0%	0,02	0,2%	0,05	0,5%	0,13	1,2%

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

11

		Within-lot (*)
Sample	Mean
(%)	Lot No. 1		Lot No. 2		Lot No. 3
		SD	CV	SD	CV	SD	CV
Blood No. 1	5,1	0,09	1,8%	0,12	2,3%	0,14	2,7%
Blood No. 2	6,4	0,07	1,1%	0,09	1,4%	0,10	1,6%
Blood No. 3	8,2	0,10	1,3%	0,10	1,2%	0,13	1,6%
Blood No. 4	12,2	0,12	1,0%	0,11	0,9%	0,16	1,3%
Control 1	5,1	0,09	1,7%	0,09	1,8%	0,11	2,2%
Control 2	8,0	0,13	1,7%	0,12	1,6%	0,14	1,8%
Calibrator 1	5,6	0,10	1,8%	0,09	1,6%	0,11	2,0%
Calibrator 2	10,1	0,11	1,1%	0,12	1,1%	0,12	1,2%

b. Linearity / assay reportable range

A linearity study was performed per CLSI EP06-A: Evaluation of Quantitative Measuring Procedures; A Statistical Approach. Linearity across the reportable range was performed using low 4.4% Hb A1c (24 mmol/mol) and high 16.7% (159 mmol/mol).

Mixture of 2 different blood samples:

This linearity study of the CAPILLARYS Hb A1c procedure was evaluated in a study based on the Clinical Laboratory Standards Institute (CLSI - USA) EP6-A guideline "Evaluation of the Linearity of Quantitative Measurement Procedures: A statistical Approach: Approved Guideline". The results for HbA . concentration (mmol/mol) and percentage (%) were analyzed using statistical tools recommended by CLSI.

2 characteristic blood samples, including a normal sample and an elevated HbAre level sample were mixed within different proportions and the mixtures were electrophoresed with the CAPILLARYS Hb A1c procedure. For each mixture, samples were analyzed in triplicate. The tests were determined to be linear within the entire range studied for HbAit hemoglobin fraction. The stated measuring range is 24 mmol/mol to 158 mmol/mol HbAre (4.4 % to 16.6 % HbA«¿).

c. Traceability, Stability (controls, calibrators, or methods)

The CAPILLARYS Hb A1c test standardization is traceable to the International Federation of Clinical Chemistry (IFCC) reference calibrators.

The CAPILLARYS Hb A1c assay is NGSP certified. The NGSP certification expires in one year. See the NGSP website for current certification at http://www.ngsp.org

Hb A1c results are provided in two different units: NGSP equivalent units (%) and IFCC equivalent units (mmol/mol).

12

d. Calibrators and Controls

The Hb A1c CAPILLARY CALIBRATORS are required for use with this device. Value assignment and stability protocol and acceptance criteria were previously reviewed and cleared in K122101.

Sebia MULTI-SYSTEM Hb A1c CAPILLARYS CONTROLS are required for use with this device and cleared in submission K162281.

e. Comparison Studies

A method comparison study of 150 variant-free whole blood samples covering the measuring range were evaluated using the CAPILLARYS Hb A1c kit and the CAPILLARYS 2 FLEXPIERCING instrument. The results were compared to the testing performed at a NGSP reference laboratory using the cleared HPLC HbA1c method (Automated Glycohemoglobin Analyzer HLC-712G8).

To support the diagnostic claim for HbA1c the samples spanned around the decision points as follows:

HbA1c level	Number of samples	% of samples
HbA1c ≤ 5,0 %	7	5
5,0 % 9,0 %	17	11
Total	150	100

Samples distribution

13

HbA1c results given as a NGSP unit (%)

Fraction	Regression Analysis	Correlation coefficient	y-intercept	Slope	Range of HbA1c % value CAPILLARYS Hb A1c
HbA1c	Ordinary linear fit	0.999	-0.265	1.027	4.4 - 16.6

150 samples

HbA1c results given as a NGSP unit (%)

	Regression Analysis (HbA1c fraction)
	Ordinary linear fit	Weighed Deming	Passing Bablok
	95 % Confidence Intervals are shown in parentheses
Points (Plotted/Total)	150/150
Results Ranges	4,4 to 16,6
Normal range	23 %". It is recommended to analyze the sample with CAPILLARYS HEMOGLOBIN(E) procedure to verity the Hb F percentage and to study the patient's clinical data.

Levels of Hb A2 up to 7.7 % in the blood sample do not interfere with HbA1c fraction quantification.
No interference has been observed with HbA1c fraction quantification due to the presence of major abnormal hemoglobins Hb S (≤ 40.8 %), Hb C (≤ 37.2 %), Hb D (≤ 41.3 %) and Hb E (≤ 37.0 %).

16

h. Expected Values/ Reference Range

Hemoglobin A1c expected value range was cited from the American Diabetes Association (Standards of Medical Care in Diabetes 2016, 39 (Suppl 1)

The American Diabetes Association's (ADA) most recent Clinical Practice are:

Category	HbA1c Range (IFCC)	HbA1c Range (NGSP/DCCT)
Normal