(149 days)
Not Found
No
The summary describes a standard capillary electrophoresis instrument and associated kits for measuring HbA1c. There is no mention of AI or ML in the intended use, device description, or performance studies. The technology described is based on established electrophoretic separation and detection principles.
No
The device is described as an "In Vitro Diagnostic Use" product, designed for the separation and quantification of HbA1c in human whole blood to monitor long-term glycemic control in individuals with diabetes mellitus. It is used for diagnosis and monitoring, not for treating or alleviating disease.
Yes
Explanation: The device is described as an "automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of HbA1c fraction" for "monitoring long-term glycemic control in individuals with diabetes mellitus." It directly measures the HbA1c fraction, providing quantitative data used to diagnose or monitor a disease state. The "Intended Use" section explicitly states "For In Vitro Diagnostic Use."
No
The device description clearly outlines a physical instrument, the MINICAP FLEX-PIERCING instrument, which performs the analysis. The software is part of this automated analyzer, not a standalone software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- "For In Vitro Diagnostic Use." in the Intended Use / Indications for Use section for the MINICAP Hb A1c kit, the Hb A1c CAPILLARY Controls, and the Hb A1c CAPILLARY Calibrators.
- The device is designed for "Professional Use Only," which is typical for IVD devices used in clinical laboratories.
- The device is used to measure a component (HbA1c) in a human body fluid (whole blood) for monitoring a medical condition (diabetes mellitus).
N/A
Intended Use / Indications for Use
The MINICAP Hb A1c kit is designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in human whole blood, by capillary electrophoresis in alkaline buffer with the MINICAP FLEX-PIERCING instrument. Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. Results are provided in IFCC (mmol/mol) and NGSP (%Hb A1c) units.
The MINICAP Hb A1c kit is designed for Professional Use Only. For In Vitro Use.
The Hb A1c CAPILLARY Controls are designed for the quality control of human glycated hemoglobin A1c quantification with SEBIA capillary electrophoresis procedures using the MINICAP HbA1c kit with the MINICAP FLEX-PIERCING automated instrument.
The Hb A1c CAPILLARY Controls are 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 capillary electrophoresis procedures using the MINICAP HbA1c kit with the MINICAP FLEX-PIERCING automated instrument.
The Hb A1c CAPILLARY Calibrators are designed for Professional Use Only. For In Vitro Diagnostic Use.
Product codes
LCP, JIS, JJX
Device Description
The MINICAP FLEX-PIERCING instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of HbA1c fraction. The hemoglobins, separated in silica capillaries, are directly detected by their absorbance at 415 nm. The assay is performed on the hemolysate of whole blood samples collected in tubes containing K2EDTA as anticoagulant.
Quantitative determination of hemoglobin A1c is effective in monitoring middle-term blood glucose control in diabetic individuals.
The MINICAP Hb A1c procedure performed with the MINICAP 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 MINICAP 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 MINICAP 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 MINICAP FLEX-PIERCING instrument has silica capillaries functioning in parallel allowing 2 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 A1c fraction. In addition, the high resolution of MINICAP Hb A1c procedure allows the quantification of HbA1c, even in the presence of labile HbA1c, carbamylated and acetylated hemoglobins, and major hemoglobin variants such as HbS, HbC, HbD, HbE and HbF and common interfering factors such as Triglycerides, Bilirubin, Ascorbic Acid, Urea, Rheumatoid factor and Glybenclamide as outline 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.
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
Professional Use Only.
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
-
Analytical performance:
a. Precision/Reproducibility:
- Reproducibility between lots and instruments: Eight (8) different blood samples were run using the MINICAP Hb A1c procedure in both capillaries of 3 different MINICAP FLEX-PIERCING instruments and with 3 lots of MINICAP Hb A1c kits. Samples included 3 normal HbA1c level, 1 close to cut-off, and 4 elevated HbA1c level. Each sample was analyzed on both capillaries from each instrument, 60 runs over 10 working days, in duplicate within each run.
- Reproducibility within the same capillary and between capillaries from the same instrument: Eight (8) different blood samples were run using the MINICAP Hb A1c procedure in both capillaries of the same MINICAP FLEX-PIERCING instrument and with 1 lot of MINICAP Hb A1c kit. Samples included 3 normal HbA1c level, 1 close to cut-off, and 4 elevated HbA1c level. Each sample was analyzed on both capillaries from the same instrument, 40 runs over 20 working days, in duplicate within each run.
b. Linearity/assay reportable range: Evaluated based on CLSI EP6-A guideline. Two blood samples (normal at 4.8% HbA1c and elevated at 13.8% HbA1c) were mixed in different proportions and electrophoresed. Samples analyzed in duplicate. Linearity range is 4.8 - 13.8% HbA1c (29 - 127 mmol/mol). Three characteristic blood samples were serially diluted in hemolysing solution and electrophoresed. Linear within entire ranges studied from 2.5 to 31.1 g/dL total hemoglobin.
c. Detection limit: Limit of Blank (LoB) and Limit of Detection (LoD) determined according to CLSI guideline EP17-A using five zero samples (blank) and six low HbA1c samples. LoB = 0.3%, LoD = 1.1%.
d. Analytical specificity: Interference studies performed according to CLSI Guideline "EP7-A2: Interference Testing in Clinical Chemistry".
- Common substances: Tested with four different concentrations of HbA1c (~5.0%, ~8.8%, and ~11.9%). Potential interferents included Triglycerides, Bilirubin, Ascorbic acid, Urea, Rheumatoid factor, and Glybenclamide. Non-significant interference defined as ≤ 0.3% HbA1c difference.
- Carbamylated hemoglobin: Four whole blood patient samples (~5.7%, ~6.9%, ~12.4% A1c) were split, one aliquot spiked with Potassium Cyanate, incubated. Samples analyzed in triplicate. Non-significant interference defined as ≤ 0.3% HbA1c difference.
- Labile HbA1c: Four whole blood patient samples (~4.7%, ~6.8%, ~8.8%, ~12.7% A1c) were split, one aliquot spiked with glucose, incubated. Samples analyzed in triplicate. Non-significant interference defined as ≤ 0.3% HbA1c difference.
- Acetylated hemoglobin: Four whole blood patient samples (~5.2%, ~6.6%, ~9.4%, ~11.7% A1c) were split, one aliquot spiked with acetylsalicylic, incubated. Samples analyzed in triplicate. Non-significant interference defined as ≤ 0.3% HbA1c difference.
- Hemoglobin variants: Tested with samples known to contain HbS, HbE, HbD, and HbC. Non-significant interference defined as ±10% difference from NGSP reference method.
- Hemoglobin F: 16 whole blood samples with HbA1c (~5.3% and ~11.6%) and varying HbF concentrations (2.3 to 19.7%) were tested. Non-significant interference defined as ±10% difference from NGSP reference method. -
Comparison studies:
a. Method comparison with predicate device: Performed according to CLSI Guideline "EP9-A2: Method Comparison and Bias Estimation Using Patient Samples".
- Internal Study: 101 whole blood samples (HbA1c 4.8% to 13.3%) analyzed in singlicate using candidate and predicate devices.
- External study No.1: 126 whole blood samples (HbA1c 4.8% to 13.6%) analyzed in singlicate using candidate and predicate devices.
- External study No.2: 140 whole blood samples (HbA1c 4.8% to 13.1%) analyzed in singlicate using candidate and predicate devices.
b. Matrix comparison: 41 random matched sample pairs (K2 EDTA and K3 EDTA) tested on the MINICAP FLEX-PIERCING instrument using the MINICAP HbA1c assay kit.
Key Metrics
- Reproducibility between lots and instruments for HbA1c (%): Within-run CV min 0.0%, max 2.1%; Total CV min 0.0%, max 2.2%.
- Reproducibility between lots and instruments for HbA1c (mmol/mol): Within-run CV min 0.0%, max 4.0%; Total CV min 0.0%, max 4.0%.
- Reproducibility within the same capillary and between capillaries: Total CV (%) ranges from 0.8% to 1.3% for HbA1c (%).
- Linearity: HbA1c (%) first order linear regression Y=0.08982x+4.764, r2=0.998, r=0.999.
- Linearity: HbA1c (mmol/mol) first order linear regression Y=0.9855x+28.41, r2=0.999, r=0.999.
- Detection limits: LoB= 0.3%, LoD = 1.1%.
- Analytical specificity (no significant interference ≤ 0.3% HbA1c unless specified):
- Triglycerides: up to 3.07 g/dL (35.1 mM)
- Bilirubin: up to 25.8 mg/dL (442 μM)
- Ascorbic acid: up to 60 mg/dL (3.41 mM)
- Urea: up to 291 mg/dL (48.5 mM)
- Rheumatoid factor: up to 2178 IU/mL
- Glybenclamide: up to 3 mg/dL
- Carbamylated hemoglobin: up to 8.7 %
- Labile HbA1c: up to 14.8 %
- Acetylated hemoglobin: up to 3.0 %
- HbS: up to 40.5% (±10% difference criterion)
- HbE: up to 24.7% (±10% difference criterion)
- HbD: up to 41.0% (±10% difference criterion)
- HbC: up to 37.0% (±10% difference criterion)
- HbF: up to 19.7% (±10% difference criterion)
- Method comparison correlations:
- Internal Study: HbA1c (%) Correlation coefficient 0.998, y-Intercept 0.165, Slope 0.982. HbA1c (mmol/mol) Correlation coefficient 0.998, y-Intercept 1.262, Slope 0.985.
- External study No.1: HbA1c (%) Correlation coefficient 0.998, y-Intercept -0.032, Slope 0.997. HbA1c (mmol/mol) Correlation coefficient 0.998, y-Intercept -0.396, Slope 0.996.
- External study No.2: HbA1c (%) Correlation coefficient 0.998, y-Intercept -0.057, Slope 1.019. HbA1c (mmol/mol) Correlation coefficient 0.998, y-Intercept -0.316, Slope 1.023.
- Matrix comparison correlation: HbA1c (%) Correlation coefficient 0.999, y-intercept 0.039, Slope 0.998. HbA1c (mmol/mol) Correlation coefficient 0.999, y-intercept 0.091, Slope 1.001.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K133344
MAR 2 8 2014
510(K) Summary
SEBIA's manufacturing and 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 Contact person: Karen Anderson Prepared on March 26, 2014
- Product/Device Names: MINICAP Hb A1c (PN 2215), MINICAP FLEX-PIERCING (PN 1232), Hb A1c CAPILLARY Calibrators (PN 4755), Hb A1c CAPILLARY Controls (PN 4774)
Common Name: glycosylated hemoglobin
Product Regulation Name: glycosylated hemoglobin assay
The MINICAP Hb A1c type of devices/assays are classified by FDA as Class II, under Regulation 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 Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| LCP | II | 21 CFR 864.7470 | |
| Glycosylated | |||
| hemoglobin assay | Hematology (81) | ||
| JIS | II | 21 CFR 862.1150 | |
| Calibrator | Chemistry (75) | ||
| JJX | Class I, Reserved | 21 CFR 862.1660 | |
| Quality control | |||
| material (assayed | |||
| and unassayed) | Chemistry (75) |
Product Nomenclature:
HEMOGLOBINS A1C BY CAPILLARY ELECTROPHORESIS
Establishment Registration Number:
8023024
1
STANDARDS: MINICAP Hb A1c test is standardized according to NGSP and IFCC requirements/quidelines.
This submission is limited to the MINICAP Hb A1c kit (PN 2215) using the MINICAP FLEX-PIERCING instrument (PN 1232) and the performance using the Hb A1c CAPILLARY Controls (PN 4774) with the system and Hb A1c CAPILLARY Calibrators (PN 4755)
The SEBIA Hb A1c CAPILLARY Controls (PN 4774) and Hb A1c CAPILLARY Calibrators (PN 4755) were FDA cleared (K122101), December 6, 2012.
Substantial Equivalence to Predicate Devices:
For the separation and quantification of the Hb A1c glycated fraction of hemoglobin in human blood, by capillary electrophoresis in an alkaline buffer using the MINICAP Hb A1c kit with the MINICAP FLEX-PIERCING instrument.
The new device, MINICAP Hb A1c procedure using the MINICAP FLEX-PIERCING instrument, utilizes the previous cleared SEBIA Hb A1c CAPILLARY Calibrators and Hb A1c CAPILLARY Controls (K122101).
The performance of the MINICAP Hb A1c kit using the MINICAP FLEX-PIERCING instrument. Hb A1c CAPILLARY Calibrators and Hb A1c CAPILLARY Controls was compared to the predicate device, CAPILLARYS Hb A1c kit using the CAPILLARYS 2 FLEX-PIERCING instrument, the Hb A1c CAPILLARY Calibrators and the Hb A1c CAPILLARY Controls (K122101).
Both the new device (MINICAP Hb A1c kit & MINICAP FLEX-PIERCING instrument using the Hb A1c CAPILLARY Calibrators and the Hb A1c CAPILLARY Controls) and the predicate device (CAPILLARYS Hb A1c kit & CAPILLARYS 2 FLEX-PIERCING instrument using the Hb A1c CAPILLARY Calibrators and the Hb A1c CAPILLARY Controls) use capillary electrophoresis technology. The devices compared were found to be substantially equivalent in function, concept, principle, technique, use, safety and effectiveness,
The 510(K) number of the predicate device, CAPILLARYS Hb A1c using CAPILLARYS 2 FLEX-PIERCING instrument, the Hb A1c CAPILLARY Calibrators and the Hb A1c CAPILLARY Controls predicate device, was FDA cleared as K122101 on December 6, 2012.
| 510K Table of Predicate Devices | ||
|---|---|---|
| Predicate Device | 510K | Clearance Date |
| CAPILLARYS Hb A1c | ||
| CAPILLARYS 2 FLEX PIERCING | K122101 | December 6, 2012 |
| Hb A1c CAPILLARY Controls | K122101 | December 6, 2012 |
| Hb A1c CAPILLARY Calibrators | K122101 | December 6, 2012 |
2
DEVICE DESCRIPTION
The MINICAP FLEX-PIERCING instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of HbA1c fraction. The hemoglobins, separated in silica capillaries, are directly detected by their absorbance at 415 nm. The assay is performed on the hemolysate of whole blood samples collected in tubes containing K2EDTA as anticoagulant.
Quantitative determination of hemoglobin A1c is effective in monitoring middle-term blood glucose control in diabetic individuals.
The MINICAP Hb A1c procedure performed with the MINICAP 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 MINICAP 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 MINICAP 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 MINICAP FLEX-PIERCING instrument has silica capillaries functioning in parallel allowing 2 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 analvsis with buffer.
Direct detection provides accurate relative quantification of individual hemoglobin Are fraction. In addition, the high resolution of MINICAP Hb A1c procedure allows the quantification of HbA1c, even in the presence of labile HbArc, carbamylated and acetylated hemoglobins, and major hemoglobin variants such as HbS, HbC, HbD, HbE and HbF and common interfering factors such as Triglycerides, Bilirubin, Ascorbic Acid, Urea, Rheumatoid factor and Glybenclamide as outline 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.
3
INTENDED USE
The MINICAP Hb A1c kit is designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in human whole blood, by capillary electrophoresis in alkaline buffer with the MINICAP FLEX-PIERCING instrument. Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. Results are provided in IFCC (mmol/mol) and NGSP (%Hb A1c) units.
The MINICAP Hb A1c kit is designed for Professional Use Only.
The Hb A1c CAPILLARY Controls are designed for the quality control of human glycated hemoglobin A1c quantification with SEBIA capillary electrophoresis procedures using the MINICAP HbA1c kit with the MINICAP FLEX-PIERCING automated instrument.
The Hb A1c CAPILLARY Controls are designed for Professional Use Only.
The Hb A1c CAPILLARY Calibrators are designed for the calibration and migration control of human glycated hemoglobin A1c quantification with SEBIA capillary electrophoresis procedures using the MINICAP HbA1c kit with the MINICAP FLEX-PIERCING automated instrument.
The Hb A1c CAPILLARY Calibrators are designed for Professional Use Only.
For In Vitro Diagnostic Use.
4
PRODUCT DESCRIPTION
1. MINICAP FLEX PIERCING instrument, Part Number 1232
2. Reagent Kit
The MINICAP Hb A1c kits, Hb A1c CAPILLARY Controls and Hb A1c CAPILLARY Calibrators are used with the MINICAP FLEX- PIERCING system.
The configurations of the components are summarized:
- . MINICAP Hb A1c kits in Table I.
- . Hb A1c CAPILLARY Calibrators in Table II.
- Hb A1c CAPILLARY 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 and instrument operators manual. Each kit, control and calibrators is supplied with a 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.
| ITEMS | PN 2215 |
|---|---|
| Buffer (ready to use) | 2 vials, 250 mL each |
| Hemolysing solution (ready to use) | 1 vial, 225 mL |
| Wash solution (stock solution) | 1 vial, 25 mL |
| Reagent Cups | 1 pack of 125 |
| Filters | 3 filters |
| Bins for used cups | 4 bins |
| Hemolysing solution bar code labels | 5 sheets of 4 labels |
TABLE I. REAGENTS AND MATERIALS SUPPLIED IN THE MINICAP Hb A1c KIT (PN 2215)
TABLE II. REAGENTS AND MATERIALS SUPPLIED WITH Hb A1c CAPILLARY CALIBRATORS (PN 4755)
| ITEMS | PN 4755 |
|---|---|
| Hb A1c CAPILLARY Calibrator 1 (green cap) | 1 vial of each, 600µL each |
| Hb A1c CAPILLARY Calibrator 2 (red cap) | |
| Barcode label Hb A1c CAPILLARY Calibrator 1 | 1 |
| Barcode label Hb A1c CAPILLARY Calibrator 2 | 1 |
5
TABLE III. REAGENTS AND MATERIALS SUPPLIED WITH Hb A1c CAPILLARY CONTROLS (PN 4774)
| ITEMS | PN 4744 |
|---|---|
| Hb A1c CAPILLARY Control 1 ( white cap ) | 1 vial of each, 600µL each |
| Hb A1c CAPILLARY Control 2 ( black cap) | |
| Barcode label HbA1c CAPILLARY Control 1 | 2 |
| Barcode label HbA1c CAPILLARY Control 2 | 2 |
| White dilution segments* | 4 |
| Grey dilution segments* | 4 |
- Not used with the MINICAP FLEX-PIERCING instrument
TABLE IV. REAGENTS AND MATERIALS REQUIRED BUT NOT SUPPLIED IN THE MINICAP HbA1c KIT, Hb A1c CAPILLARY CONTROLS OR Hb A1c CAPILLARY CALIBRATORS
| ITEMS | PN | COMPONENTS |
|---|---|---|
| CAPICLEAN | 2058 | 1 vial, 25 mL |
| CAPILLARYS / MINICAP Wash Solution | 2052 | 2 vials, 75 mL |
| Tubes and caps for controls | 9202, 9205 | 200 per box, 500 per box |
| MINICAP Reagent Cups | 2280 | 250 per box |
| Lids for bins for used reagent cups | 2286 | 12 per box |
| "AUTOMATIC LOW VOLUME" bar code labels | 9208 | 20 per box |
| "MANUAL LOW VOLUME" bar code labels | 9209 | 20 per box |
| MINICAP FLEX-PIERCING centering rings | 1612 | 27 per box |
| PHORESIS software | 1110 | |
| MINICAP | 1232 | |
| FLEX-PIERCING INSTRUMENT | ||
| Update HbA1c kit for MINICAP FLEX- | ||
| PIERCING | 1238 |
LABELING
Labeling contained in this submission includes:
- A. MINICAP Hb A1c operators manual
- B. MINICAP Hb A1c package insert
- C. Hb A1c CAPILLARY Controls package insert
- D. Hb A1c CAPILLARY Calibrators package insert
and the box labels and the product labels of the MINICAP Hb A1c kit, MINICAP Hb A1c CAPILLARY Controls, Hb A1c CAPILLARY Calibrators and of the reagents and materials required but not supplied.
6
STUDY SUMMARY
-
- Analytical performance:
- a. Precision/Reproducibility:
The reproducibility studies have been performed according to CLSI Guideline "EPS-A2: Evaluation of Precision Performance of Clinical Chemistry Devices".
Reproducibility between lots and instruments
Eight (8) different blood samples were run using the MINICAP Hb A1c procedure in both capillaries of 3 different MINICAP FLEX-PIERCING instruments and with 3 lots of MINICAP Hb A1c kits. The analyzed blood samples included 3 samples with normal HbA% level (No. 1, 2 and 3), 1 sample with HbArelevel close to the cut-off value (No. 4) and 4 samples with elevated HbAre level (No. 5, 6, 7 and 8). In this study, each blood sample was analyzed on both capillaries from each instrument, including 60 runs over 10 working days (at 2 different times of the day). Within each run, samples were analyzed in duplicate.
The following tables summarize the within-run and total instrument-reagent C.V. % ranges for the HbA1c concentrations (in mmol/mol) and percentages.
| | Within-run reproducibility | | | Total reproducibility | | | Mean (HbA1c
concentration
- mmol/mol) | Within-run reproducibility | | Total reproducibility | |
|---------------|----------------------------|------------|------------|-----------------------|------------------|---------------|---------------------------------------------|----------------------------|------------|-----------------------|------------------|
| | Mean
(% HbA1c) | CV min (%) | CV max (%) | Total CV min (%) | Total CV max (%) | | | CV min (%) | CV max (%) | Total CV min (%) | Total CV max (%) |
| Sample No. 1 | 5.2 | 0.9 | 2.0 | 0.9 | 2.2 | Sample No. 1 | 33 | 0.9 | 3.5 | 0.9 | 3.5 |
| Sample No. 2 | 5.4 | 0.9 | 2.1 | 0.9 | 2.1 | Sample No. 2 | 36 | 1.1 | 4.0 | 1.2 | 4.0 |
| Sample No. 3 | 5.5 | 0.5 | 2.0 | 0.7 | 2.1 | Sample No. 3 | 37 | 0.0 | 3.0 | 1.4 | 3.3 |
| Sample No. 4 | 6.4 | 0.5 | 1.9 | 0.8 | 1.9 | Sample No. 4 | 47 | 1.2 | 2.6 | 1.3 | 2.6 |
| Sample No. 5 | 7.9 | 0.7 | 1.4 | 0.8 | 1.6 | Sample No. 5 | 63 | 0.7 | 1.6 | 0.7 | 2.2 |
| Sample No. 6 | 9.1 | 0.0 | 1.1 | 0.0 | 1.1 | Sample No. 6 | 76 | 0.0 | 1.4 | 0.0 | 1.4 |
| Sample No. 7 | 10.1 | 0.6 | 1.1 | 0.6 | 1.2 | Sample No. 7 | 87 | 0.3 | 1.3 | 0.3 | 1.4 |
| Sample No. 8 | 12.3 | 0.4 | 1.2 | 0.6 | 1.8 | Sample No. 8 | 110 | 0.4 | 1.4 | 0.6 | 2.2 |
| CV (%) ranges | | 0.0 | 2.1 | 0.0 | 2.2 | CV (%) ranges | | 0.0 | 4.0 | 0.0 | 4.0 |
Reproducibility within the same capillary and between capillaries from the same instrument
Eight (8) different blood samples were run using the MINICAP Hb A1c procedure in both capillaries of the same MINICAP FLEX-PIERCING instrument and with 1 lot of MINICAP Hb A1c kit. The analyzed blood samples included 3 samples with normal HbAic level (No. 1, 2 and 3), 1 sample with HbA . level close to the cut-off value (No. 4) and 4 samples with elevated HbA% . level (No. 5, 6, 7 and 8). In this study, each blood sample was analyzed on both capillaries from the same
7
instrument, including 40 runs over 20 working days (at 2 different times of the day). Within each run, samples were analyzed in duplicate.
The results for HbAje concentrations (in mmol/mol) and percentages are summarized in the following tables.
For reproducibility within the same capillary, maximal CV's have been calculated for each blood sample from pooled data obtained on each capillary.
| | Sample
No. 1 | Sample
No. 2 | Sample
No. 3 | Sample
No. 4 | Sample
No. 5 | Sample
No. 6 | Sample
No. 7 | Sample
No. 8 |
|-----------------------------------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|
| Mean (% HbA1c) | 5.2 | 5.2 | 5.7 | 6.4 | 7.8 | 9.0 | 10.1 | 11.9 |
| Within-run
reproducibility
(CV %) | 1.0 | 1.1 | 1.0 | 0.9 | 1.1 | 0.9 | 0.7 | 1.1 |
| Within-capillary
reproducibility
(CV %) | 1.4 | 1.4 | 1.5 | 1.1 | 0.7 | 0.8 | 0.8 | 0.9 |
| Between-run
reproducibility
(CV %) | 0.0 | 0.3 | 0.7 | 0.0 | 0.0 | 0.0 | 0.3 | 0.0 |
| Between-day
reproducibility
(CV %) | 0.7 | 0.0 | 0.5 | 0.6 | 0.2 | 0.4 | 0.3 | 0.1 |
| Total (CV%) | 1.2 | 1.1 | 1.3 | 1.1 | 1.1 | 1.0 | 0.8 | 1.1 |
8
8
| | Sample
No. 1 | Sample
No. 2 | Sample
No. 3 | Sample
No. 4 | Sample
No. 5 | Sample
No. 6 | Sample
No. 7 | Sample
No. 8 |
|-----------------------------------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|
| Mean (HbA1c
concentration –
mmol/mol) | 33 | 34 | 38 | 46 | 62 | 75 | 87 | 106 |
| Within-run
reproducibility
(CV %) | 1.7 | 1.9 | 1.7 | 1.1 | 0.8 | 1.2 | 0.8 | 1.2 |
| Within-capillary
reproducibility
(CV %) | 2.5 | 2.8 | 2.4 | 1.3 | 0.8 | 1.2 | 1.0 | 0.9 |
| Between-run
reproducibility
(CV %) | 0.0 | 1.4 | 0.3 | 0.5 | 0.0 | 0.0 | 0.4 | 0.0 |
| Between-day
reproducibility
(CV %) | 1.3 | 0.0 | 0.6 | 0.5 | 0.0 | 0.6 | 0.3 | 0.2 |
| Total (CV %) | 2.2 | 2.3 | 1.8 | 1.3 | 0.8 | 1.3 | 1.0 | 1.2 |
b. Linearity/assay reportable range:
The linearity of the MINICAP HbA1c procedure was evaluated based on CLSI EP6-A quideline "Evaluation of the Linearity Quantitative Measurement Procedures: A Statistical Approach". Two blood samples, including a normal sample with HbA1c concentration at 4.8% (29 mmol/mo)) and an elevated HbA1c level sample with HbA1c concentration at 13.8% (127 mmol/mol) were mixed within different proportions and the dilutions were electrophoresed with the MINICAP HbA1c assay kit using the MINICAP FLEX-PIERCING instrument. Samples were analyzed in duplicate.
A polynomial regression analysis was performed, it allows to conclude on the linearity of MINICAP Hb A1c procedure performed with the MINICAP FLEX-PIERCING instrument for HbA1c fraction within the entire range studied.
HbA1c (%) The 1st order linear regression generated is: Y=0.08982x+4.764, r2=0.998, r=0.999 The linearity range is 4.8 - 13.8% HbA1c
HbA1c (mmol/mol)
The 1st order linear regression generated is:
Y=0.9855x+28.41. r2=0.999. r=0.999
The linearity range is 29 - 127 mmol/mol HbA1c
In addition, 3 different characteristic blood samples, including a normal sample with HbA1c concentration at 5.0 % HbA1c (31 mmol/mol), a sample with HbA1c level close to the cut-off value at 6.3 % HbA1c (46 mmol/mol) and an elevated HbA1c level sample with HbA1c concentration at
9
9.3 % HbA1c (79 mmol/mol), were all serially diluted in hemolysing solution and electrophoresed with the MINICAP Hb A1c procedure. The tests were determined to be linear within the entire ranges studied from 2.5 to 31.1 g/dL total hemoglobin and HbA1c fraction concentration and percentage were not affected by the hemoglobin concentration of the samples.
c. Detection limit:
The Limit of Blank (LoB) and Limit of Detection (LoD) were determined by assaying a five zero samples (blank) and six low HbA1c samples according to CLSI quideline EP17-A . The results are as follows:
LoB= 0.3%, LoD = 1.1%
The claimed measuring range, 4.8- 13.8% (29 - 127 mmol/mol), is based on linearity.
d. Analytical specificity:
The interference studies have been performed according to the CLSI Guideline "EPT-A2: Interference Testing in Clinical Chemistry".
i) Studies were performed to assess common or known substances that could interfere with the MINICAP HbA1c assay kit. The interfering substances were evaluated in whole blood samples that contained four different concentrations of A1c (~5.0%. ~8.8% and ~11.9%). Samples containing various concentrations of potential interferents were tested and the results compared to those obtained from control samples containing no potential interfering substances. The definition of non-significant interference is ≤ 0,3% HbA1c between the tested and the control samples. The results are as follows:
| Potential interfering substance | Concentration at which no significant
interference (≤0.3%) was observed |
|---------------------------------|----------------------------------------------------------------------------|
| Triglycerides | 3.07 g/dL (35.1 mM) |
| Bilirubin | 25.8 mg/dL (442 μM) |
| Ascorbic acid | 60 mg/dL (3.41 mM) |
| Urea | 291 mg/dL (48.5 mM) |
| Rheumatoid factor | 2178 IU/mL |
| Glybenclamide | 3 mg/dL |
ii) To study interference from Carbamlyated hemoglobin, four whole blood patient samples with A1c concentrations at ~5.7%, ~6.9% and ~12.4% were split into two aliguots. One aliguot, at each A1c level, was spiked with 8.11 mg/dL (1 mmol/L) of Potassium Cyanate and incubated for 3 hours at 37°C. Another aliquot, at each A1c level, was incubated for 3 hours at 37°C. Samples were then analyzed on the MINICAP FLEX-PIERCING instrument using the MINICAP HbA1c assay kit, Samples were analyzed in triblicate. The definition of non-significant interference is ≤ 0.3 HbA1c% between the tested and the control samples.
To conclude Carbamylated hemoglobin (≤ 8.7 %) does not interfere with this assay.
iii) To study interference from Labile HbA1c, four whole blood patient samples with A1c concentrations at ~4.7%, ~6.8%, ~8.8% and ~12.7% were split into two aliguots. One aliguot. at each A1c level, was spiked with 1800 mg/dL (0,5 mol/L) of glucose and incubated for 3 hours at 37°C. Another aliquot, at each A1c level, was incubated for 3 hours at 37°C. Samples were then analyzed on the MINICAP FLEX-PIERCING instrument using the MINICAP HbA1c assay kit. Samples were analyzed in triplicate. The definition of non-significant interference is ≤ 0.3 HbA1c% between the tested and the control samples.
10
To conclude Labile Hb A1c (≤ 14.8 %) does not interfere with this assay.
iv) To study interference from Labile HbA1c, four whole blood patient samples with A1c concentrations at ~5.2%, ~6.6%, ~9.4% and ~11.7% were split into two aliguots. One aliguot, at each A1c level, was spiked with 180 mg/dL (10 mmol/L) of acetylsalicylic and incubated for 4 hours at 37°C. Another aliquot, at each A1c level, was incubated for 4 hours at 37°C. Samples were then analyzed on the MINICAP FLEX-PIERCING instrument using the MINICAP HbA1c assay kit, Samples were analyzed in triplicate. The definition of non-significant interference is ≤ 0.3 HbA1c% between the tested and the control samples.
To conclude Acetylated hemoglobin (≤ 3.0 %) does not interfere with this assay.
v) A hemoglobin variant interference study was carried out using samples known to contain Hemoglobin variants S, E, D and C. These variant samples were tested on the MINICAP FLEX-PIERCING instrument using the MINICAP HbA1c assay kit. The definition of non-significant interference is ±10% difference between the candidate method and a NGSP reference method (performed in a NGSP laboratory).
The testing results show there is no significant interference for HbS (≤ 40.5%), HbE (≤ 24.7%), HbD (≤ 41.0%) and HbC (≤ 37.0%).
vi) An additional variant interference study was carried out to study the variant interference from Hemoglobin F. 16 whole blood samples with HbA1c concentrations of ~5.3% and ~11.6% contained various concentrations of HbF (2.3 to 19.7%) were tested on the MINICAP FLEX-PIERCING instrument using the MINICAP HbA1c assay kit. The definition of non-significant interference is ±10% difference between the candidate method and a NGSP reference method (performed in a NGSP laboratory).
The testing results show there is no significant interference for HbF ≤ 19.7%.
-
- Comparison studies:
- a. Method comparison with predicate device:
The correlation studies have been performed according to CLSI Guideline "EP9-A2: Method Comparison and Bias Estimation Using Patient Samples".
Internal Study :
101 whole blood samples with HbA1c ranging from 4.8% (29 mmol/mol) to 13.3% (122 mmol/mol) were analyzed in singlicate using the MINICAP HbA1c assay kit on the MINICAP FLEX-PIERCING instrument (candidate device) and on the CAPILLARYS Hb A1c assay on the CAPILLARYS 2 FLEX-PIERCING instrument. The linear regression correlation was calculated as follows:
| HbA1c | Correlation coefficient | y-Intercept | Slope | Range of values
MINICAP Hb A1c |
|-----------------------------|-------------------------|-------------|-------|-----------------------------------|
| Percentage
(%) | 0.998 | 0.165 | 0.982 | 4.8 - 13.3 |
| Concentration
(mmol/mol) | 0.998 | 1.262 | 0.985 | 29 - 122 |
External study No.1
126 whole blood samples with HbA1c ranaing from 4.8% (29 mmol/mol) to 13.6% (125 mmo//mol) were analyzed in singlicate using the MINICAP HbA1c assay kit on the MINICAP FLEX-PIERCING
11
instrument (candidate device) and on the CAPILLARYS Hb A1c assay on the CAPILLARYS 2 FLEX-PIERCING instrument. The linear regression correlation was calculated as follows:
| HbA1c | Correlation coefficient | y-Intercept | Slope | Range of values
MINICAP Hb A1c |
|-----------------------------|-------------------------|-------------|-------|-----------------------------------|
| Percentage
(%) | 0.998 | - 0.032 | 0.997 | 4.8 - 13.6 |
| Concentration
(mmol/mol) | 0.998 | - 0.396 | 0.996 | 29 - 125 |
External study No. 2
140 whole blood samples with HbA1c ranging from 4.8% (29 mmol/mol) to 13.1% (119 mmol/mol) were analyzed in singlicate using the MINICAP HbA1c assay kit on the MINICAP FLEX-PIERCING instrument (candidate device) and on the CAPILLARYS Hb A1c assay on the CAPILLARYS 2 FLEX-PIERCING instrument. The linear regression correlation was calculated as follows:
| HbA₁c | Correlation coefficient | y-Intercept | Slope | Range of values
MINICAP Hb A1c |
|-----------------------------|-------------------------|-------------|-------|-----------------------------------|
| Percentage
(%) | 0.998 | - 0.057 | 1.019 | 4.8 - 13.1 |
| Concentration
(mmol/mol) | 0.998 | - 0.316 | 1.023 | 29 - 119 |
b. Matrix comparison:
A total of 41 random matched sample pairs (K2 EDTA and K3 EDTA) were tested on the MINICAP FLEX-PIERCING instrument using the MINICAP HbA1c assay kit. The linear regression is presented in the table below:
| Fraction | Number of
samples | Correlation
coefficient | y-intercept | Slope | Range of
HbA1c
fractions
(test) |
|---------------------|----------------------|----------------------------|-------------|-------|------------------------------------------|
| HbA1c (%) | 41 | 0,999 | 0,039 | 0,998 | 4,9 - 13,3 |
| HbA1c
(mmol/mol) | 41 | 0,999 | 0,091 | 1,001 | 30 - 122 |
12
SUBSTANTIAL EQUIVALENCE
The performance and comparative studies of the MINICAP Hb A1c test with the MINICAP FLEX-PIERCING instrument were performed using SEBIA's commercially available materials and standard procedures.
In the comparative studies, commercially available materials and standard procedures were used with the predicate device: CAPILLARYS Hb A1c using the CAPILLARYS 2 FLEX-PIERCING instrument (K122101).
Both the new device MINICAP Hb A1c with the MINICAP FLEX-PIERCING and the predicate method, CAPILLARYS Hb A1c with the CAPILLARYS 2 FLEX-PIERCING instrument use the same technology of capillary electrophoresis of blood samples for Hb A1c analysis. The MINICAP HbA1c kit using the MINICAP FLEX-PIERCING instrument and the predicate device the CAPILLARYS Hb A1c kit used with the CAPILLARYS 2 FLEX-PIERCING instrument utilize EDTA collection tubes of (K2 and K3).
The SEBIA MINICAP Hb A1c procedure, performed with the MINICAP FLEX-PIERCING system was found to be substantially equivalent in function, use, safety, effectiveness and the performance to predicate devices described above.
The following tables A, B, C and D present the similarities and the differences.
Table A : SEBIA MINICAP Hb A1c kit used with the MINICAP FLEX PIERCING instrument as compared to the predicate CAP!LLARYS Hb A1c kit used with the CAPILLARYS 2 FLEX-PIERCING instrument
Table B: SEBIA Hb A1c CAPILLARY Calibrators used with the MINICAP Hb A1C kit and MINICAP FLEX-PIERCING Instrument to the predicate CAPILLARYS Hb A1c kit used with the CAPILLARYS 2 FLEX-PIERCING instrument.
Table C: SEBIA Hb A1c CAPILLARY Controls used with the MINICAP Hb A1c kit and MINICAP FLEX-PIERCING instrument as compared to the predicate devices CAPILLARYS Hb A1c kit used with the CAPILLARYS 2 FLEX-PIERCING instrument.
Table D: SEBIA MINICAP FLEX-PIERCING Instrument to the predicate the CAPILLARYS 2 FLEX-PIERCING instrument.
13
Table A
SEBIA MINICAP Hb A1c kit used with the MINICAP FLEX PIERCING instrument as compared to the predicate CAPILLARYS Hb A1c kit used with the CAPILLARYS 2 FLEX-PIERCING instrument.
| | SEBIA CAPILLARYS Hb A1c technique with
CAPILLARYS 2 FLEX-PIERCING instrument | SEBIA MINICAP Hb A1c technique with MINICAP
FLEX-PIERCING instrument |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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.
Measurement of 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 MINICAP 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
MINICAP FLEX-PIERCING instrument.
Measurement of hemoglobin A1c is effective in
monitoring long-term glycemic control in individuals
with diabetes mellitus. The MINICAP Hb A1c kit is
designed for Professional Use Only.
For In Vitro Diagnostic Use. |
| Separation
system | Free solution capillary electrophoresis (FSCE):
protein separation in an alkaline buffer (pH 9.4)
according to their charge, to the electrolyte pH and
electroosmotic flow.
Fast separation and good resolution.
Electrophoregrams show separated fractions
according to their charge. | Same |
| Instrument | SEBIA CAPILLARYS 2 FLEX-PIERCING instrument,
PN 1227 | SEBIA MINICAP FLEX-PIERCING instrument, PN
1232 |
| Picture | Image: SEBIA CAPILLARYS 2 FLEX-PIERCING instrument | Image: SEBIA MINICAP FLEX-PIERCING instrument |
| Interface | PC interface | Same |
| Absorbance wave
length | 415 nm | Same |
| Software | SEBIA PHORESIS™ software | Same |
| Number of
separation units | 8 parallel capillaries | 2 parallel capillaries |
| Calibration | Yes | Yes |
| Sample type | Whole blood in capped tube | Same |
| Samples
identification | Yes (Bar code reading on both sample racks and
tubes) | Yes (Bar code reading on sample tubes) |
| Hemolysis | Performed automatically by the instrument | Same |
| Introduction of
the samples into
the automatic
system | Continuous loading using sample racks | Continuous loading on the rotating sampler |
| Analysis
throughput | 40 analyses / hour | 7.6 analyses / hour |
| Collection tubes | Tubes with K2EDTA or K3EDTA anticoagulant | Same |
| | SEBIA CAPILLARYS Hb A1c technique with
CAPILLARYS 2 FLEX-PIERCING instrument | SEBIA MINICAP Hb A1c technique with MINICAP
FLEX-PIERCING instrument |
| Reagent | CAPILLARYS Hb A1c Kit (PN 2015) : | MINICAP Hb A1c Kit (PN 2215) : |
| | Buffer | Buffer |
| | Hemolyzing solution | Hemolyzing solution |
| | Wash solution | Wash solution |
| | Dilution segments | Reagent cups |
| | Filters | Filters |
| | | Bins for used cups |
| | | Hemolysing solution bar code labels |
| | CAPILLARY Hb A1c CALIBRATORS (PN 4755) : | CAPILLARY Hb A1c CALIBRATORS (PN 4755) : |
| | CAPILLARY Hb A1c Calibrator 1 | CAPILLARY Hb A1c Calibrator 1 |
| | CAPILLARY Hb A1c Calibrator 2 | CAPILLARY Hb A1c Calibrator 2 |
| | CAPILLARY Hb A1c CONTROLS (PN 4774) : | CAPILLARY Hb A1c CONTROLS (PN 4774) : |
| | CAPILLARY Hb A1c Control 1 | CAPILLARY Hb A1c Control 1 |
| | CAPILLARY Hb A1c Control 2 | CAPILLARY Hb A1c Control 2 |
| Standardization | NGSP | NGSP |
| | IFCC | IFCC |
| | SEBIA
HbA1c CAPILLARY CALIBRATORS
K122101 | SEBIA
HbA1c CAPILLARY CALIBRATORS |
| Intended 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 Calibrators are
designed for the calibration and migration
control of human glycated hemoglobin
A1c quantification with SEBIA capillary
electrophoresis procedures:
- CAPILLARYS Hb A1c performed
with the CAPILLARYS 2 FLEX-PIERCING
automated instrument and, - MINICAP Hb A1c performed with
the MINICAP FLEX-PIERCING
automated instrument.
The Hb A1c CAPILLARY Calibrators are
designed for Professional Use Only.
For In Vitro Diagnostic Use |
| Product Number | 4755 | 4755 |
| Format | 2 levels
1 vial (0.6 mL) per level | Same |
| Preparation | Reconstitute each lyophilized calibrator
vial with 0.6 mL of distilled or deionized
water. | Same |
| Storage
temperature | Before reconstitution, the lyophilized
calibrators must be stored between - 30
oC and - 18 oC. They are stable until the
expiration date indicated on the vial
labels. | Same |
| In use storage | After reconstitution, store the calibrators
at 2 - 8 oC in a closed conical tube for
control blood and use them within the day
(for 8 hours maximum). After use, they
must be stored without any delay between
- 18 oC and - 22 oC due to the risk of
microbial contamination and denaturation.
They are stable for 6 months maximum
between - 18 oC and - 22 oC.
Do not freeze and thaw the reconstituted
calibrators more than 3 times. | CAPILLARYS 2 FLEX-PIERCING:
After reconstitution, store the calibrators
at 2 - 8 oC in a closed conical tube for
control blood and use them within the day
(for 8 hours maximum). After use, they
must be stored without any delay between - 18 oC and - 22 oC due to the risk of
microbial contamination and denaturation.
They are stable for 22 months maximum
between - 18 oC and - 22 oC.
Do not freeze and thaw the reconstituted
calibrators more than 3 times.
MINICAP FLEX-PIERCING:
After reconstitution, prepare 2 aliquots
with equivalent volumes (≈ 0.4 mL) of the
whole amount of each calibrator in conical
tubes for control blood, for use and / or
storage. Store the aliquoted calibrators at
2 - 8 oC in a closed conical tube for
control blood and use them within the day
(for 8 hours maximum). After use, they
must be stored without any delay between - 18 oC and - 22 oC due to the risk of
microbial contamination and denaturation.
They are stable for 22 months maximum
between - 18 oC and - 22 oC.
Do not freeze and thaw the reconstituted
calibrators more than 5 times. |
| Traceability | The assigned values are traceable to
IFCC. | Same |
| Instrument | SEBIA CAPILLARYS 2 FLEX-PIERCING | SEBIA CAPILLARYS 2 FLEX-PIERCING |
| | SEBIA
HbA1c CAPILLARY CONTROLS
K122101 | SEBIA
HbA1c CAPILLARY CONTROLS |
| Intended 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.
They should be used like any biological
samples.
The values obtained must fall within the
range determined for each batch.
For In Vitro Diagnostic Use. | The Hb A1c CAPILLARY Controls are
designed for the 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 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 Diagnostic Use. |
| Product Number | 4774 | 4774 |
| Format | 2 levels
1 vial (0.6 mL) per level | Same |
| Preparation | Reconstitute each lyophilized control vial
with 0.6 mL of distilled or deionized
water. | Same |
| Storage
temperature | Before reconstitution, the lyophilized
controls must be stored refrigerated (2 to
8 °C). They are stable until the expiration
date indicated on the vial labels. | Same |
| In use storage | After reconstitution, store the controls at 2
- 8 °C in a closed conical tube for control
blood and use them within the day (for 8
hours maximum). After use, they must be
stored without any delay between - 18 °C
and - 22 °C due to the risk of microbial
contamination and denaturation. They are
stable for 6 months maximum between - 18 °C and - 22 °C.
Do not freeze and thaw the reconstituted
controls more than 30 times.
After hemolysis with the CAPILLARYS 2
FLEX-PIERCING instrument, store the
dilution segments with controls at 2-8°C
and use them within the day (for 8 hours
maximum). They may be stored, without
any delay, between - 18 °C and - 22 °C
for 1 month maximum. Do not freeze and
thaw a dilution segment with hemolyzed
control more than three times. | CAPILLARYS 2 FLEX-PIERCING :
After reconstitution, store the controls at 2 - 8 °C in a closed conical tube for control
blood and use them within the day (for 8
hours maximum). After use, they must be
stored without any delay between - 18 °C
and - 22 °C due to the risk of microbial
contamination and denaturation. They are
stable for 6 months maximum between - 18 °C and - 22 °C.
Do not freeze and thaw the reconstituted
controls more than 30 times.
After hemolysis with the CAPILLARYS 2
FLEX-PIERCING instrument, store the
dilution segments with controls at 2-8 °C
and use them within the day (for 8 hours
maximum). They may be stored, without
any delay, between - 18 °C and - 22 °C for
1 month maximum. Do not freeze and
thaw a dilution segment with hemolyzed
control more than three times.
MINICAP FLEX-PIERCING :
After reconstitution, store the controls at 2
- 8 °C in a closed conical tube for control
blood and use them within the day (for 8
hours maximum). After use, they must be
stored without any delay between - 18 °C
and - 22 °C due to the risk of microbial
contamination and denaturation. They are
stable for 6 months maximum between - 18 °C and - 22 °C.
Do not freeze and thaw the reconstituted
controls more than 30 times. |
| Instrument | SEBIA
HbA1c CAPILLARY CONTROLS
K122101
SEBIA CAPILLARYS 2 FLEX-PIERCING | SEBIA
HbA1c CAPILLARY CONTROLS
SEBIA CAPILLARYS 2 FLEX-PIERCING |
14
and the control of the country
、
:
.
.
:
15
Table B
SEBIA Hb A1c CAPILLARY Calibrators used with the MINICAP Hb A1c kit and MINICAP FLEX-PIERCING Instrument to the predicate CAPILLARYS Hb A1c kit used with the CAPILLARYS 2 FLEX-PIERCING instrument.
16
Table C
SEBIA Hb A1c CAPILLARY Controls used with the MINICAP Hb A1c kit and MINICAP FLEX-PIERCING instrument as compared to the predicate devices CAPILLARYS Hb A1c kit used with the CAPILLARYS 2 FLEX-PIERCING instrument.
·
17
TABLE D
SEBIA MINICAP FLEX-PIERCING Instrument to the predicate the CAPILLARYS 2 FLEX-PIERCING instrument.
| | SEBIA CAPILLARYS 2 FLEX-PIERCING
instrument | SEBIA MINICAP FLEX-PIERCING instrument |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CAPILLARYS 2 FLEX-PIERCING instrument is
designed and intended for the human protein and
hemoglobin separation by capillary electrophoresis
on 8 parallel capillaries. The analysis is performed
using uncapped tubes or capped tubes with a cap
piercing function according to the procedure. The
CAPILLARYS 2 FLEX-PIERCING instrument is
intended to be used with the SEBIA CAPILLARYS
reagent kits.
The CAPILLARYS 2 FLEX-PIERCING instrument is
designed for Professional Use Only.
For In Vitro Use. | The MINICAP FLEX-PIERCING instrument is
designed and intended for the human protein and
hemoglobin separation by capillary electrophoresis
on 2 parallel capillaries. The analysis is performed
using uncapped tubes or capped tubes with a cap
piercing function according to the procedure. The
MINICAP FLEX-PIERCING instrument is intended to
be used with the SEBIA MINICAP reagent kits.
The MINICAP FLEX-PIERCING instrument is
designed for Professional Use Only.
For In Vitro Use. |
| Separation | Free solution capillary electrophoresis (FSCE):
protein separation in an alkaline buffer according to
their charge, to the electrolyte pH and electroosmotic
flow.
Fast separation and good resolution.
Electrophoregrams show separated fractions
according to their charge. | Same |
| system | | |
| Product Number | PN 1227 | PN 1232 |
| Picture | Image: SEBIA CAPILLARYS 2 FLEX-PIERCING instrument | Image: SEBIA MINICAP FLEX-PIERCING instrument |
| Interface | PC interface | Same |
| Detection system | Deuterium lamp | Deuterium lamp and LED |
| Software | SEBIA PHORESIS™ software | Same |
| Number of | 8 parallel capillaries | 2 parallel capillaries |
| separation units | | |
| Samples tubes | uncapped tubes or capped tubes depending on the
procedure | Same |
| Samples
identification | Yes (Bar code reading on both sample racks and
tubes) | Yes (Bar code reading on sample tubes) |
| Introduction of
the samples into
the automatic
system | Continuous loading using sample racks | Continuous loading on the rotating sampler |
| Dimensions | L. 95 cm x H. 39 cm x D. 63 cm | L. 44 cm x H. 41.5 cm x D. 58 cm |
| Weight | 50 kg | 32 kg |
18
Image /page/18/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. The logo is black and white.
DEPARTMENT OF HEALTH & IIUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2014
SEBIA C/O KAREN ANDERSON DIRECTOR OF TECHNICAL AND QUALITY ASSURANCE 1705 CORPORATE DRIVE SUITE 400 NORCROSS GA 30093
Re: K133344
Trade/Device Name: Minicap HbA Ic kit, Hb Alc Capillary Controls, Hb Alc Capillary Calibrators Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP, JIS. JJX Dated: February 18, 2014 Received: February 20, 2014
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 upproval 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 docs 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); medical device reporting (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 Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
19
Page 2-Ms. Anderson
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/Cl)RHOffices/ucm | 15809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ruth A. Chesler -S
for
Courtney H. Lias Director, Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
20
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K133344
Device Name
9
Hb A Ic CAPILLARY Calibrators using the MINICAP FLEX-PIERCING instrument
Indications for Use (Describe)
The Ho AIc CAPILLARY Calibrators are designed for the calibration control of human glycated hemoglobin Alc quantification with SEBIA capillary electrophoresis procedures using the MINICAP Hb A 1c kit with the MINICAP FLEX-PIERCING automated instrument.
The Hb Alc CAPILLARY Calibrators are designed for Professional Use Only. For In Vitro Diagnostic 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
21
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."
22
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K133344
Device Name
Hb Alc CAPILLARY Controls using the MINICAP FLEX-PIERCING instrument
Indications for Use (Describe)
The Hb AIc CAPILLARY Controls are designed for the quality control of human glycated hemoglobin AIc quantification with SEBIA capillary electrophoresis procedures using the MINICAP Hb A1c kit with the MINICAP FLEX-PIERCING automated instrument.
The Hb Alc CAPILLARY Controls are designed for Professional Use Only. For In Vitro Diagnostic 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
arraster for the more of the Form FDA USE ONLY - FOR FDA USE ONLY - FOR FOR FOR SEASE - LE - FOR FOR FOR SEASE - LE -Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
23
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."
24
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133344
Device Name MINICAP Hb Alc kit
Indications for Use (Describe)
The MINICAP Hb A 1c kit is designed for separation and quantification of the HbA 1c glycated fraction of hemoglobin in human whole blood, by capillary electrophoresis in alkaline buffer with the MINICAP FLEX-PIERCING instrument. Measurement of hemoglobin Alc is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. Results are provided in IFCC (mmol/mol) and NGSP (%Hb A Ic) units.
The MINICAP Hb Alc kit is designed for Professional Use Only. For In Vitro Use.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
PSC Publishing Services (30)) 443-6740
25
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."