(186 days)
Not Found
No
The description focuses on the physical and chemical principles of capillary electrophoresis and does not mention any AI or ML components for data analysis or interpretation.
No.
The device is designed for the quantification of HbA1c in blood, which is used for monitoring long-term glycemic control in individuals with diabetes; it does not provide any therapeutic intervention.
Yes
The device quantifies HbA1c, which is used for monitoring long-term glycemic control in individuals with diabetes mellitus. This process of measuring a biomarker to assess a medical condition falls under the definition of a diagnostic device.
No
The device description clearly details a physical instrument (CAPILLARYS 3 TERA) that performs capillary electrophoresis on blood samples. This involves hardware components like capillaries, a high voltage system, and a detector. The software is likely part of the instrument's operation, but the device itself is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "separation and quantification of the HbA1c glycated fraction of hemoglobin in venous whole human blood". This is a test performed on a biological sample (blood) to provide information about a person's health status (monitoring glycemic control in individuals with diabetes mellitus).
- For In Vitro Use: The description of the Multi-system Hb A1c CAPILLARY Controls explicitly states "For In Vitro Use". While this is specifically for the controls, it reinforces the nature of the overall system.
- Professional Use Only: The device is intended for use by healthcare professionals in a laboratory or clinical setting, which is typical for IVDs.
- Performance Studies: The document details performance studies (Precision, Accuracy, Linearity, Interferences) conducted to validate the analytical performance of the device, a requirement for IVDs.
- Predicate Devices: The mention of predicate devices with K numbers indicates that this device is being compared to previously cleared IVDs.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CAPI 3 Hb A 1 c kit is designed for separation and quantification of the HbA 1c glycated fraction of hemoglobin in venous whole human blood, by capillary electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 3 TERA instrument. Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. This test is not for screening or diabetes. The CAPI 3 Hb A1c kit is designed for Professional Use Only.
The Multi-system Hb A1c CAPILLARY Controls (2) are designed for the migration control and quality control of human glycated hemoglobin Alc quantification with SEBIA capillary electrophoresis procedures:
- CAPILLARYS Hb A1c performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument,
- CAPI 3 Hb Alc performed with the CAPILLARYS 3 TERA automated instrument and,
- MINICAP Hb A1c performed with the MINICAP FLEX-PIERCING automated instrument.
The Hb Alc CAPILLARY Controls are designed for Professional Use Only.
Product codes (comma separated list FDA assigned to the subject device)
LCP, JJX
Device Description
The CAPILLARYS 3 TERA instrument uses the principle of capillary electrophoresis in free solution. With this technique, charged molecules are separated by their electrophoretic mobility in an alkaline buffer with a specific pH. Separation occurs according to the electrolyte pH and electroosmotic flow.
The CAPILLARYS 3 TERA instrument has silica capillaries functioning in parallel allowing 12 simultaneous analyses of HbA1c quantification in a whole blood sample. A sample dilution with hemolysing solution is prepared and injected by aspiration at the anodic end of the capillary. A high voltage protein separation is then performed and direct detection of the hemoglobins is made at the cathodic end of the capillary at 415 nm, which is the absorbance wave length specific to hemoglobins. Before each run, the capillaries are washed with a wash solution and prepared for the next analysis with buffer.
Direct detection provides accurate relative quantification of individual hemoglobin A1c fraction. In addition, the high resolution of CAPI 3 Hb A1c procedure allows the quantification of HbA1c even in the presence of labile HbA1c, carbamylated and acetylated hemoglobins, and major hemoglobin variants.
By using an alkaline pH buffer, normal and abnormal (or variant) hemoglobins are detected in the following order, from cathode to anode: A2/C, E, S/D, F, A0, other Hb (including minor Hb A1) and then A1c.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision:
The precision of the CAPI 3 Hb A1c procedure was evaluated in a study based on the Clinical Laboratory Standards Institute (CLSI - USA) EP5-A3 quideline "Evaluation of Precision of Quantitative Measurements Procedures; Approved Guideline - Third Edition".
Eight (8) different blood samples were run using the CAPI 3 Hb A1c procedure on 3 CAPILLARYS 3 instruments. The analyzed blood samples included 3 samples with normal HbA1c level (No. 1, 2 and 3), 1 sample with HbA1c level close to the cut-off value (No. 4) and 4 samples with elevated HbA1c level (No. 5, 6, 7 and 8).
Each sample was analyzed in duplicate on two capillaries per run, two runs per day over six days per lot of CAPI 3 Hb A1c kit, using three lots yielding a total of 432 results per sample over 18 days.
Linearity:
Mixture of 2 different blood samples: 2 characteristic blood samples, including a normal sample and an elevated HbA1c level sample were mixed within different proportions and the mixtures were electrophoresed with the CAPI 3 Hb A1c procedure. For each mixture, samples were analyzed in triplicate. The tests were determined to be linear within the entire range studied for HbA1c, hemoglobin fraction. The stated measuring range is 21 mmol/mol HbA1c (4.0 % to 14.7 % HbA1c).
Dilution of 4 different blood samples in hemolysing solution: 4 different characteristic blood samples, including 1 normal sample with HbA1c concentration at 21 mmol/mol (4.1 % HbA1c), 1 sample with HbA1c level close to the cut-off value with HbA1c concentration at 47 mmol/mol (6.4 % HbA1c) and 2 elevated HbA1c level samples with HbA1c concentrations at 82 mmol/mol (9.6 % HbA1c) and at 134 mmol/mol (14.4 % HbA1c), were all serially diluted in hemolysing solution and electrophoresed with the CAPI 3 Hb A1c procedure. The tests were determined to be linear within the entire ranges studied from 2.9 to 30.5 g/dL total hemoglobin and HbA1c fraction concentration and percentage were not affected by the hemoglobin concentration of the samples.
Accuracy - Internal correlation:
The levels of HbA1c were measured in 100 blood samples with normal and elevated HbA1c levels, both by electrophoretic separations obtained with the CAPI 3 Hb A1c procedure on the CAPILLARYS 3 TERA instrument and a commercially available capillary electrophoresis technique for HbA1c quantification that is NGSP standardized. The measured values of HbA1c concentrations and percentages from both procedures were analyzed by a linear regression statistical procedure.
Accuracy - External correlations:
Study No. 1: HbA1c levels were measured in 175 blood samples, including samples with normal and elevated HbA1c levels, both by electrophoretic separations obtained with CAPI 3 Hb A1c procedure with the CAPILLARYS 3 TERA instrument and a commercially available capillary electrophoresis technique for HbA1c quantification that is NGSP standardized. The measured values of HbA1c concentrations and percentages from both procedures were analyzed by a linear regression statistical procedure.
Study No. 2: HbA1c levels were measured in 117 blood samples, including samples with normal and elevated HbA1c levels, both by electrophoretic separations obtained with CAPI 3 Hb A1c procedure with the CAPILLARYS 3 TERA instrument and a commercially available capillary electrophoresis technique for HbA1c quantification that is NGSP standardized. The measured values of HbA1c concentrations and percentages from both procedures were analyzed by a linear regression statistical procedure.
Internal and External studies combined of 392 whole blood samples (normal and elevated HbA1c levels) spanning a HbA1c measuring range of 4.1 - 14.7 % with the CAPI 3 Hb A1c procedure using the CAPILLARYS 3 TERA instrument.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision (Overall analysis, HbA1c concentration in mmol/mol):
Blood No. 1 (Mean 29): Total reproducibility SD 0.7, CV 2.3%
Blood No. 2 (Mean 33): Total reproducibility SD 0.7, CV 2.2%
Blood No. 3 (Mean 35): Total reproducibility SD 0.7, CV 1.9%
Blood No. 4 (Mean 46): Total reproducibility SD 0.8, CV 1.6%
Blood No. 5 (Mean 67): Total reproducibility SD 1.0, CV 1.5%
Blood No. 6 (Mean 73): Total reproducibility SD 0.7, CV 1.0%
Blood No. 7 (Mean 85): Total reproducibility SD 0.8, CV 0.9%
Blood No. 8 (Mean 108): Total reproducibility SD 0.9, CV 0.9%
Precision (Overall analysis, HbA1c percentage %):
Blood No. 1 (Mean 4.8): Total reproducibility SD 0.06, CV 1.2%
Blood No. 2 (Mean 5.1): Total reproducibility SD 0.06, CV 1.3%
Blood No. 3 (Mean 5.3): Total reproducibility SD 0.06, CV 1.2%
Blood No. 4 (Mean 6.4): Total reproducibility SD 0.07, CV 1.1%
Blood No. 5 (Mean 8.3): Total reproducibility SD 0.09, CV 1.1%
Blood No. 6 (Mean 8.9): Total reproducibility SD 0.07, CV 0.8%
Blood No. 7 (Mean 9.9): Total reproducibility SD 0.07, CV 0.7%
Blood No. 8 (Mean 12.0): Total reproducibility SD 0.09, CV 0.7%
Accuracy - Internal correlation (y = CAPI 3 Hb A1c):
HbA1c Concentration (mmol/mol): Correlation coefficient 0.998, y-Intercept - 0.238, Slope 1.000, Range 22 - 132
HbA1c Percentage (%): Correlation coefficient 0.998, y-Intercept - 0.024, Slope 1.000, Range 4.1 - 14.2
Accuracy - External correlations (y = CAPI 3 Hb A1c):
Study No. 1:
HbA1c Concentration (mmol/mol): Correlation coefficient 0.998, y-Intercept 0.249, Slope 0.993, Range 23 - 138
HbA1c Percentage (%): Correlation coefficient 0.997, y-Intercept 0.045, Slope 0.992, Range 4.3 - 14.7
Study No. 2:
HbA1c Concentration (mmol/mol): Correlation coefficient 0.998, y-Intercept 1.417, Slope 0.970, Range 22 - 127
HbA1c Percentage (%): Correlation coefficient 0.998, y-Intercept 0.205, Slope 0.968, Range 4.2 - 13.7
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.
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.
Not Found
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
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized graphic of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SEBIA, INC. KAREN ANDERSON DIRECTOR OF TECHNICAL AND QUALITY ASSURANCE 1705 CORPORATE DRIVE, SUITE 400 NORCROSS GA 30093
February 17, 2017
Re: K162281 Trade/Device Name: CAPI 3 Hb A1c MULTI-SYSTEM Hb A1c CAPILLARY Controls (2) Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP, JJX Dated: August 8, 2016 Received: August 15, 2016
Dear Karen Anderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name CAPI 3 Hb Alc
Indications for Use (Describe)
The CAPI 3 Hb A 1 c kit is designed for separation and quantification of the HbA 1c glycated fraction of hemoglobin in venous whole human blood, by capillary electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 3 TERA instrument. Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. This test is not for screening or diabetes. The CAPI 3 Hb A1c kit is designed for Professional Use Only
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known)
Device Name
MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (2)
Indications for Use (Describe)
The Multi-system Hb A1c CAPILLARY Controls (2) are designed for the migration control and quality control of human glycated hemoglobin Alc quantification with SEBIA capillary electrophoresis procedures:
-
CAPILLARYS Hb A1c performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument,
-
CAPI 3 Hb Alc performed with the CAPILLARYS 3 TERA automated instrument and,
-
MINICAP Hb A1c performed with the MINICAP FLEX-PIERCING automated instrument.
The Hb Alc CAPILLARY Controls are designed for Professional Use Only.
For In Vitro Use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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 |
Aigars Brants, Ph.D, Scientific Affairs Officer
Phone 1-800-835-6497
Fax 770-446-8511
Email: aigars.brants@sebia-usa.com |
| Date Prepared | July 25, 2016 / Revised February 14, 2017 |
| 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 | CAPI 3 Hb A1c (PN 2515),
MULTI-SYSTEM Hb A1c CAPILLARY Controls
(2) (PN 4768) using CAPILLARYS 3 TERA
instrument (PN 1246) |
| Common Name | Whole blood hemoglobin A1c (HbA1c) by capillary
electrophoresis |
| Product Regulation No. | 21 CFR Part 864.7470,862.1660 |
| Product Codes | LCP, JJX |
| Device classification | Class II , Class I (general controls) |
| Establishment Registration No. | 8023024 |
5
| Predicate Device Name | Predicate Device 510(k) number |
|---|---|
| CAPILLARYS Hb A1c kit | K122101 |
| Hb A1c CAPILLARY Controls | K122101 and K133344 |
| CAPILLARYS 2 FLEX-PIERCING instrument | K122101 |
DEVICE DESCRIPTION 1.
The capillary electrophoresis provides complete automation with fast separation and good resolution. This electrokinetic separation technique is carried out in a silica glass tube (i.e., capillary) with internal diameter lower than 100 µm filled with a buffer composed of electrolytes.
The CAPILLARYS 3 TERA instrument uses the principle of capillary electrophoresis in free solution. With this technique, charged molecules are separated by their electrophoretic mobility in an alkaline buffer with a specific pH. Separation occurs according to the electrolyte pH and electroosmotic flow.
The CAPILLARYS 3 TERA instrument has silica capillaries functioning in parallel allowing 12 simultaneous analyses of HbA1c quantification in a whole blood sample. A sample dilution with hemolysing solution is prepared and injected by aspiration at the anodic end of the capillary. A high voltage protein separation is then performed and direct detection of the hemoglobins is made at the cathodic end of the capillary at 415 nm, which is the absorbance wave length specific to hemoglobins. Before each run, the capillaries are washed with a wash solution and prepared for the next analysis with buffer.
Direct detection provides accurate relative quantification of individual hemoglobin A1c fraction. In addition, the high resolution of CAPI 3 Hb A1c procedure allows the quantification of HbA1c even in the presence of labile HbA1c, carbamylated and acetylated hemoglobins, and major hemoglobin variants.
By using an alkaline pH buffer, normal and abnormal (or variant) hemoglobins are detected in the following order, from cathode to anode: A2/C, E, S/D, F, A0, other Hb (including minor Hb A1) and then A1c.
6
Reagents:
CAPI 3 Hb A1c KIT
| ITEMS | PN 2515 |
|---|---|
| Buffer (ready to use) | 2 vials, 700 mL each |
| Hemolysing solution (ready to use) | 1 vial, 700 mL |
| Filters | 4 filters |
Additional reagents not included in the CAPI 3 Hb A1c KIT
| ITEMS | PN | COMPONENTS |
|---|---|---|
| CAPICLEAN CAPILLARYS 3 | 2060 | 1 vial, 25 mL |
| CAPILLARYS 3 WASH SOLUTION | 2062 | 1 vial, 75mL |
| CAPI 3 DISPOSABLES KIT | 2580 | 10 packs of 14 reagent cups |
| 5 bins for used reagent cups | ||
| TEST TUBES | 9214 | 200 of 100mm-tubes |
| CAPI 3 BINS FOR USED REAGENT | ||
| CUPS | 2581 | 5 units |
| TUBES AND CAPS FOR | 9202 | 20 units |
| CONTROLS | 9205 | 500 units |
7
2. INDICATIONS FOR USE
CAPI 3 Hb A1c kit:
The CAPI 3 Hb A1c kit is designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in venous whole blood, by capillary electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 3 TERA instrument. Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. This test is not for screening or diabetes. The CAPI 3 Hb A1c kit is designed for Professional Use Only.
For In Vitro Diagnostic Use.
MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (2):
The Multi-system Hb A1c CAPILLARY Controls (2) are designed for the migration control and quality control of human glycated hemoglobin A1c quantification with SEBIA capillary electrophoresis procedures:
CAPILLARYS Hb A1c performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument,
-CAPI 3 Hb A1c performed with the CAPILLARYS 3 TERA automated instrument and, - MINICAP Hb A1c performed with the MINICAP FLEX-PIERCING automated instrument. The Hb A1c CAPILLARY Controls are designed for Professional Use Only.
For In Vitro Use.
8
3. TECHNOLOGICAL CHARACTERISTICS
The CAPILLARYS 3 TERA instrument uses the principle of capillary electrophoresis in free solution which is the most common form of capillary electrophoresis. With this technique, charged molecules are separated by their electrophoretic mobility in an alkaline buffer with a specific pH. Separation also occurs according to the electrolyte pH and electroosmotic flow.
The CAPILLARYS 3 TERA instrument has silica capillaries functioning in parallel allowing 12 simultaneous analyses of Hb A1c quantification in a whole blood sample. A sample dilution with hemolysing solution is prepared and injected by aspiration at the anodic end of the capillary. A high voltage protein separation is then performed and direct detection of the hemoglobins is made at the cathodic end of the capillary at 415 nm, which is the absorbance wave length specific to hemoglobins. Before each run, the capillaries are washed with a wash solution and prepared for the next analysis with buffer.
Direct detection provides accurate relative quantification of individual hemoglobin A1cfraction. In addition, the high resolution of CAPI 3 Hb A1c procedure allows the quantification of HbA1c, and particularly, even in the presence of labile HbA1c, carbamylated and acetylated hemoglobins, and major hemoglobin variants.
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.
SUBSTANTIAL EQUIVALENCE INFORMATION:
| Predicate Device Name | Predicate Device 510(k) number |
|---|---|
| CAPILLARYS Hb A1c | K122101 |
| Hb A1c CAPILLARY Controls | K122101 and K133344 |
The technological characteristics of the CAPI 3 Hb A1c procedure using the CAPILLARYS 3 TERA instrument (candidate device) utilizes the same principles of capillary electrophoresis in an alkaline buffer reading at a wavelength of 415 nm as the CAPILLARYS Hb A1c procedure (predicate device).
9
Table A.
Similarities and differences between the predicate device (CAPILLARYS Hb A1c) and the candidate device (CAPI 3 Hb A1c). Both are members of the Sebia CAPILLARYS family of instruments.
| Table A | SEBIA CAPILLARYS
Hb A1c (K) 122101 | SEBIA CAPI 3 Hb A1c |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 CAPI 3 Hb A1c kit is designed for
separation and quantification of the
HbA1c glycated fraction of
hemoglobin in venous whole blood,
by capillary electrophoresis in alkaline
buffer (pH 9.4) with the CAPILLARYS
3 TERA instrument. Measurement of
hemoglobin A1c is effective in
monitoring long-term glycemic control
in individuals with diabetes
mellitus.This test is not for screening
or diagnosis of diabetes. The CAPI 3
Hb A1c kit is designed for
Professional Use Only.
For In Vitro Diagnostic Use. |
| Separation
system | Free solution capillary electrophoresis
(FSCE): hemoglobin separation on 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 |
| Reagent | CAPILLARYS Hb A1c Kit (PN 2015) : | CAPI 3 Hb A1c Kit (PN 2515) : |
| Composition | 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
Dilution segments : 1 pack of 90
Filters : 4 filters | Buffer (ready to use) : 2 vials, 700 mL
each
Hemolysing solution (ready to use) : 1
vial, 700 mL
Filters : 4 filters |
| Shelf life (*) | Buffer : 3 years at 2 - 8 °C | Same |
| | Hemolysing solution : 3 years at 2 – 30 °C | |
| Instrument | SEBIA CAPILLARYS 2 FLEX-PIERCING
instrument, PN 1227 | SEBIA CAPILLARYS 3 TERA
instrument, PN 1246 |
| Analysis
throughput | 40 analyses / hour | 62 analyses / hour |
| Interface | PC interface | PC interface + touch screen |
| Temperature
Control | By Peltier device | Same |
| | | |
| Detection
system | Deuterium lamp | Deuterium lamp and LED |
| Software for
data processing | SEBIA PHORESIS™ software | Same |
| Firmware | Included into the PHORESIS software | Included into the instrument |
| Number of
separation units | 8 parallel capillaries | 12 parallel capillaries |
| 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 and RFID labels on sample
racks) |
| Reagent
identification | No | Yes (RFID labels on reagent vials) |
| Introduction of
the samples
into the
automatic
system | Primary capacity of 88 tubes for HbA1c
technique (i.e. 11 sample racks),
uninterrupted throughput on sample racks.
Each sample rack contains 8 sample tube. | Primary maximal capacity of 120
tubes (i.e. 15 sample racks),
uninterrupted throughput on sample
racks (8 positions available). |
| Reagent bay :
main
compartement | CAPILLARYS 2 FLEX-PIERCING:
Contains one vial of water, wash solution,
hemolyzing solution (for Hb and Hb A1c
techniques) and buffer container. | Up to 4 analysis buffers or
hemolysing solutions (identified by
RFID labels); 1 waste container, 1
container for water, 1 container for
the wash solution |
| Reagent bay :
secondary
compartment | NA | Up to 3 vials and 1 rack with
immunotyping reagents (all
RFID tagged) in temperature
controlled environment (