510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION .
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATIONDECISION SUMMARYASSAY ONLY TEMPLATEA. 510(k) Number:k122101B. Purpose for Submission:New DeviceC. Measurand:Whole blood hemoglobin A1c (HbA1c)D. Type of Test:Capillary ElectrophoresisE. Applicant:Sebia Inc.F. Proprietary and Established Names:CAPILLARYS Hb A1c kitHb A1c CAPILLARY CalibratorsHb A1c CAPILLARY ControlsG. Regulatory lation SectionPanelIIIIClass I, reserved21 CFR 864.747021 CFR 862.115021 CFR 862.1660Hematology (81)Chemistry (75)Chemistry (75)H. Intended Use:1
1. Intended use(s):See Indications for use below2. Indication(s) for use:The CAPILLARYS Hb A1c kit is designed for separation and quantification of theHbA1c glycated fraction of hemoglobin in human whole blood, by capillaryelectrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 2 FLEX-PIERCINGinstrument. Measurement of hemoglobin A1c is effective in monitoring long-termglycemic control in individuals with diabetes mellitus. The CAPILLARYS HbA1c kit isdesigned for Professional Use Only.The Hb A1c CAPILLARY Calibrators are designed for the calibration and migrationcontrol of human glycated hemoglobin A1c quantification with SEBIA CAPILLARYSHbA1c electrophoresis procedure performed with the CAPILLARYS 2 FLEXPIERCING automated instrument for capillary electrophoresis. The Hb A1cCAPILLARY Calibrators are designed for Professional Use Only.The Hb A1C CAPILLARY Controls are designed for the quality control of humanglycated hemoglobin A1c quantification with CAPILLARTYS Hb A1c electrophoresisprocedure performed with the CAPILLARYS 2 FLEX-PIERCING automated instrumentfor capillary electrophoresis. The Hb A1c CAPILLARY Controls are designed forProfessional Use Only.3. Special conditions for use statement(s):For Prescription Use Only4. Special instrument requirements:CAPILLARYS 2 FLEX-PIERCING instrumentI. Device Description:The CAPILLARYS Hb A1c kit, control and calibrators are to be used with theCAPILLARYS 2 FLEX- Piercing system.The components are summarized as follows:··CAPILLARYS Hb A1c kit contains a ready to use buffer ( 2 vials, 700 ml each), aready to use hemolysing solution (1 vial, 700 ml ), Wash solution (1 vial, 75 ml),Green Dilution segments (1 pack of 90) and Filters (4 filters per kit)Hb A1c CAPILLARY Calibrators consist of a HbA1c CAPILLARYS Calibrator 1(green cap) and a HbA1c CAPILLARYS Calibrator 2 (red cap), 1 vial of each, 600µL each and bar code labels for each level of calibrator.2
·Hb A1c CAPILLARY Controls consist of HbA1c CAPILLARYS Control 1 (whitecap) and HbA1c CAPILLARYS Control 2 (black cap), 1 vial of each, 600 µL each.White and Grey Dilution segments (4 each) and Barcode labels for each level ofcontrol.J. Substantial Equivalence Information:1. Predicate device name(s):TOSOH G8 Automated Glycohemoglobin Analyzer HLC-723G8TOSOH A1C Calibrator SetTOSOH Hemoglobin A1c Controls2. Predicate 510(k) number(s):k071132, k0214843. Comparison with predicate:Similarities and Differences: ReagentItemNew DevicePredicate DeviceTOSOH G8 AutomatedCAPILLARYS Hb A1c kitGlycohemoglobinAnalyzer HLC-723G8k071132IntendedThe CAPILLARYS Hb A1c kitThe Tosoh G8 AutomatedUse/Indications foris designed for separation andGlycohemoglobinUsequantification of the HbA1cAnalyzer HLC-723G8 isglycated fraction of hemoglobin in intended for In Vitrohuman whole blood, by capillarydiagnostic Use for theelectrophoresis in alkaline buffermeasurement of(pH 9.4) with the CAPILLARYS 2 hemoglobin A1c (HbA1c)FLEX-PIERCING instrument.in whole blood specimens.Measurement of hemoglobin A1cis effective in monitoring longterm glycemic control inindividuals with diabetes mellitus.The CAPILLARYS HbA1c kit isdesigned for Professional UseOnly.MethodFree solution capillaryelectrophoresisSample TypeWhole bloodIon-exchange highperformance liquidchromatography (HPLC)Whole blood3
ItemMeasuring RangeCollection tubesAbsorbance wavelengthItemIntendedUse/Indications forUseFormatStorage TemperatureSimilarities and Differences: ReagentNew DevicePredicate DeviceTOSOH G8 AutomatedCAPILLARYS Hb A1c kitGlycohemoglobinAnalyzer HLC-723G8k0711324.0-14.7% HbA1c4.0-16.9% HbA1cK3EDTA anticoagulantEDTA anticoagulant410 and 510 nm415 nmSimilarities and Differences: CalibratorsNew DevicePredicateTOSOH A1c CalibratorHb A1c CAPILLARYSetCalibratorsk071132The HbA1c CAPILLARYThe A1c Calibrator Set isCalibrators are designed for thea reference agent designedcalibration and migration controlfor calibrating the Tosohof human glycated hemoglobinAutomatedA1c quantification with SEBIAGlycohemoglobinCAPILLARYS HbA1cAnalyzerelectrophoresis procedureperformed with the CAPILLARYS2 FLEX-PIERCING automatedinstrument for capillaryelectrophoresis. The HbA1cCAPILLARY Calibrators aredesigned for Professional UseOnly.2 levels3 years at-30 C/-18 C (-22 F/0 F).When reconstituted the in usestorage stability is 1 week at 2-8 C(36-46 F), 6 months at -22 C / 18 C (-8 F/0 F). Do not freeze andthat more than 3 timesSameUnopened: between -30 Cand -18 C until expirationdate printed on vial.Opened and reconstituted:-18 C and -22 C for 6months. Do not freeze andthaw more than 3 times.4
ItemIntendedUse/Indications forUseSimilarities and Differences: ControlsNew DevicePredicateTOSOH Hemoglobin A1CcontrolHb A1c CAPILLARY Controlsk021484The HbA1C CAPILLARYThe TOSOH HemoglobinControls are designed for theA1c Controls are intendedquality control of human glycated for use as quality controlhemoglobin A1c quantificationmaterials to monitor thewith CAPILLARTYS HbA1cprecision of laboratoryelectrophoresis proceduretesting procedures forperformed with the CAPILLARYS HbA1c quantitation. The2 FLEX-PIERCING automatedcontrols are designed forinstrument for capillaryuse with Tosohelectrophoresis. The HbA1cBioscience, Inc G7 andCAPILLARY Controls areG8 analyzers.designed for Professional UseOnly.Format2 levels; 1vial (0.6mL) per levelStorage Temperature3 years at 2-8 C (36-46 F). Whenreconstituted the controls arestable for 1 day at 2-8 C (3646 F), 6 months at -22 C/-18 C (8 F/0 F). When hemolyzed thecontrols are stable for 1 month at 22 C/-18 C (-8 F/0 F). Do notfreeze and thaw more than 3 times.2 levels; 4 vials (0.25mL)per levelHemoglobin A1c controlsare stable until the last dayof the expiration dateshown on the vial whenstored unopened at 2-8 CK. Standard/Guidance Document Referenced (if applicable):CLSI Guideline, EP9-A2: Method Comparison and Bias Estimation Using Patient Samples;Approved Guideline Second editionCLSI Guideline, EP6-A: Evaluation of the Linearity of Quantitative Analytical Methods;Approved GuidelineCLSI Guideline, EP5-A2: Evaluation of Precision Performance of Clinical ChemistryDevices; Approved Guideline Second editionCLSI Guideline, EP7-A2: Interference Testing in Clinical Chemistry; Approved GuidelineSecond edition5
L. Test Principle:The CAPILLARYS 2 FLEX Piercing HbA1c assay employs the principle of capillaryelectrophoresis in free solution. With this technique, charged molecules are separated by theirelectrophoretic mobility in an alkaline buffer with a specific pH. Separation also occursaccording to the electrolyte pH and electroosmotic flow.The assay has silica capillaries functioning in parallel allowing 8 simultaneous analyses forHbA1c quantification from a whole blood sample. A sample dilution with hemolysingsolution is prepared and injected by aspiration at the anodic end of the capillary. A highvoltage protein separation is them performed and direct detection of the hemoglobins is madeat the cathodic end of the capillary at 415 nm, which is the absorbance wavelength specific tohemoglobins. Before each run, the capillaries are washed with a wash solution and preparedfor the next analysis with buffer.Direct detection provided accurate relative quantification of individual hemoglobin A1cfraction. In addition, the high resolution of CAPILLARYS HbA1c procedure allows thequantification of HbA1c, and particularly, even in the presence of labile HbA1c,carbamylated and acetylated hemoglobins, and major hemoglobin variants.By using alkaline pH buffer, normal and abnormal (or variant) hemoglobins are detected inthe following order, from cathode to anode: A2/C, E, S/D, F, A0, other Hb (including minorHbA1) and then A1c.At the end of analysis, relative quantification of individual HbA1c fraction is performedautomatically. The HbA1c concentrations are standardized and indicated in %HbA1c(DCCT/NGSP) and in mmol/mol (IFCC) units.M. Performance Characteristics (if/when applicable):1. Analytical performance:a. Precision/Reproducibility:Precision within the same capillaryEight different blood samples were analyzed using the CAPILLARYS A1c procedurein 8 capillaries of the same CAPILLARYS 2 FLEX-PIERCING instrument. Theanalyzed blood samples included 3 samples with normal HbA1c levels ( 5.1-5.5%)(samples 1,2 and 3), 1 sample with HbA1c level close to the cut-off value (6%HbA1c) (sample 4) and 4 samples with elevated HbA1c levels ( 7.9, 8.4, 9.8 and10.0%),(samples 5, 6, 7 and 8) . Each blood sample was analyzed on the samecapillary, including 40 runs over 20 working days. Samples were analyzed induplicate. The results are shown below:6
SampleNSample No.1Sample No.2Sample No.3Sample No.4Sample No.5Sample No.6Sample No.7Sample .10.61.0Precision between capillaries from the same instrumentEight different blood samples were analyzed using the CAPILLARYS HbA1c assayin 8 capillaries of the same CAPILLARYS 2 FLEX-PIERCING instrument. Theanalyzed blood samples included 3 samples with normal HbA1c levels ( 5.1-5.5%)(samples 1, 2 and 3), 1 sample with a HbA1c value close to the cut-off value (6%HbA1c)(sample 4) and 4 samples with elevated HbA1c levels ( 7.9, 8.4, 9.8 and10.0%) (samples 5, 6, 7 and 8). Each sample was assayed on all capillaries from thesame instrument to include 40 runs over 20 working days. Samples were analyzed induplicate within each run. The results are shown below:SampleNSample No.1Sample No.2Sample No.3Sample No.4Sample No.5Sample No.6Sample No.7Sample .31.31.1Precision between lots and instrumentsEight different blood samples were analyzed using the CAPILLARYS HbA1c assayin 8 capillaries of 3 different CAPILLARYS 2 FLEX-PIERCING instruments andwith 3 lots of CAPILLARYS HbA1c kits. The analyzed blood samples included 3samples with normal HbA1c levels ( 5.0-5.5%)(samples 1, 2 and 3, 1 sample withHbA1c level close to the cut-off value (6%);(sample 4) and 4 samples with elevatedHbA1c levels ( 7.9-10.0% HbA1c) (samples 5,6,7 and 8). Each blood sample wasanalyzed on all capillaries from each instrument, including 60 runs over 24 days.Samples were analyzed in duplicate. The results are shown below:7
SampleSample No.1Sample No.2Sample No.3Sample No.4Sample No.5Sample No.6Sample No.7Sample No.8Mean(%A1c)5.05.55.56.07.98.49.810.0Within-Run reproducibility% CV% 0.61.3Total reproducibility% CV% 0.71.4An additional precision study was performed in order to demonstrate the precision ofthe CAPILLARYS HbA1c assay on the CAPILLARYS 2 FLEX-PIERCINGinstrument for samples with elevated HbA1c levels. The analyzed blood samplesincluded 4 samples with high HbA1c levels ( 11.0, 12.0, 13.0 and 14.1%) Each bloodsample was analyzed in duplicate using all capillaries from each of two instruments,and 2 lots of reagent. The results are shown below:SampleSample No.1Sample No.2Sample No.3Sample No.4Mean(%A1c)11.012.013.014.1Within-Run reproducibility% CV% CVminmax0.91.31.21.31.11.21.01.0Total reproducibility% CV% CVminmax1.21.31.21.31.31.41.11.1b. Linearity/assay reportable range:The linearity of the CAPILLARYS HbA1c procedure was evaluated based on CLSIEP6-A guideline “Evaluation of the Linearity Quantitative Measurement Procedures:A Statistical Approach”. Two blood samples, including a normal sample with HbA1cconcentration at 4.0% and an elevated HbA1c level sample with HbA1cconcentration at 14.7% were mixed within different proportions and the dilutionswere electrophoresed with the CAPILLARYS HbA1c assay kit using theCAPILLARYS 2 FLEX-PIERCING instrument. Samples were analyzed in duplicate.A polynomial regression analysis was performed and the sponsor determined that the3rd order regression provided the best fit. However, the % difference between 1st orderregression and the best fit 3rd order regression is less than 0.3%(A1c units) at alllinearity levels tested as summarized in the table below.8
Comparison of 1st Order and 3rd Order (best fit) regressionsExpected value (%)1st Order value (%)3rd Order Value (%)1st – 3rd Difference The 1st order linear regression generated is:Y -0.108x 15.027, r² 0.997, r 0.998The sponsor claims a linearity range of 4.0 – 14.7% HbA1cIn addition, 2 blood samples, including a normal sample with HbA1c concentration at5.4% HbA1c and an elevated HbA1c level sample with HbA1c concentration at 7.8%HbA1c were both serially diluted in hemolysing solution and electrophoresed withthe CAPILLARYS HbA1c procedure. According to the sponsor, the tests weredetermined to be linear within the entire ranges studied from 1.4 to 31.0 g/dL totalhemoglobin concentration of the samples.c. Traceability, Stability, Expected values (controls, calibrators, or methods):Traceability: The CAPILLARYS HbA1c assay is certified with the NationalGlycohemoglobin Standardization Program (NGSP). The NGSP ce
A1c quantification with SEBIA CAPILLARYS HbA1c electrophoresis procedure performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument for capillary electrophoresis. The HbA1c CAPILLARY Calibrators are designed for Professional Use Only. The A1c Calibrator Set is a reference agent designed for calibrating the Tosoh Automated Glycohemoglobin
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tions for the basic design properties of gravitational wave detectors. . idea enshrined in the principle of equivalence. 1.2 The equivalence principles The principle of equivalence is often presented in two distinct forms: the weak equivalence principle
a dual equivalence graph is isomorphic to one of the standard dual equivalence graphs constructed in Section 3.1. In terms of symmetric functions, this gives Corollary 3.12, which states that the generating function of a dual equivalence graph is Schur positive. The proof of Theorem 3.11 is
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