(160 days)
No
The summary describes a capillary electrophoresis system and kit for immunotyping. The analysis is based on visual evaluation of electrophoregrams and standard performance metrics are reported. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is for in vitro diagnostic use, specifically for qualitative detection and characterization of monoclonal proteins in human serum, not for treating or preventing disease.
Yes
The device is designed for the "qualitative detection and the characterization of monoclonal proteins (immunotyping) in human serum," which is a diagnostic function. It is explicitly stated "For In Vitro Diagnostic Use."
No
The device description clearly outlines a physical instrument (CAPILLARYS 3 TERA) and a kit containing reagents (sample diluent and specific antisera). While software is likely involved in controlling the instrument and processing data, the core of the device is hardware and chemical components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states "For In Vitro Diagnostic Use" for both the CAPI 3 IMMUNOTYPING kit and the IT / IF Control.
- Intended Use: The device is designed for the qualitative detection and characterization of monoclonal proteins in human serum, which is a biological sample taken from the human body.
- Laboratory Use: The device is intended for use in a laboratory setting, as indicated by "For laboratory use" for the IT / IF Control and the description of the instrument and kits used in a laboratory environment.
- Diagnostic Purpose: The detection and characterization of monoclonal proteins are used to aid in the diagnosis and monitoring of various conditions, such as multiple myeloma and other plasma cell disorders.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CAPI 3 IMMUNOTYPING kit is designed for the qualitative detection and the characterization of monoclonal proteins (immunotyping) in human serum with the CAPILLARYS 3 TERA instrument, SEBIA, for capillary electrophoresis. It is used in conjunction with the CAPI 3 PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).
The CAPILLARYS 3 TERA instrument performs all procedural sequences automatically to obtain a profile for qualitative analysis. Each serum sample is mixed with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains, respectively.
The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 mm.
The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins.
For In Vitro Diagnostic Use.
The IT / IF Control is designed to qualitative detection and characterization of human monoclonal immunoglobulins (Ig G, Ig A, Ig M, Kappa and Lambda) with the electrophoresis methods :
-
Immunotyping performed using capillary electrophoresis on SEBIA CAPILLARYS 2, CAPILLARYS 2 FLEX-PIERCING and CAPILLARYS 3 TERA instruments and on SEBIA MINICAP instrument,
-
Immunofixation methods : SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber.
The IT / IF Control is designed for laboratory use. It should be used (with its barcode label for CAPILLARYS and MINICAP procedures) like a human serum sample.
The electrophoretic pattern obtained is specific for each batch of IT / IF control.
For In Vitro Diagnostic Use.
Product codes
CFF, DFH, DEH, CEF, JJY
Device Description
CAPILLARYS 3 TERA INSTRUMENT
The CAPILLARYS 3 TERA instrument uses the principle of capillary electrophoresis in liquid 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.
CAPI 3 IMMUNOTYPING KIT
In CAPI 3 MMUNUOTYPING kit contains the sample diluent and specific antisera against gamma (Ig G), alpha (Ig A), mu (Ig M) heavy chains, and free and bound Kappa and Lambda light chains. A sample dilution is prepared and injected at the anodic end of six capillaries. The reference pattern (ELP pattern), which is a complete electrophoretic pattern of the sample's proteins, is obtained by mixing the sample with the ELP solution and injection into the 1st capillary. The antisera patterns are obtained by sample aspiration into the 5 subsequent capillaries separation is performed in a high voltage electrical field and detected using absorbance at 200 nm.
IT/IF CONTROL
The IT / IF control contains three monoclonal proteins which can be used as a qualitative control with the CAPI IMMUNOTYPING kit on the CAPILLARYS 3 TERA instrument.
Reagents:
CAPI 3 IMMUNOTYPING KIT
| ITEMS | PN 2600 |
|---|---|
| Sample diluent (ready to use) | 1 vial, 60 mL |
| Pierceable cap for the Sample diluent vial | 1 cap |
| Rack with ELP solution and antiserum tubes | |
| ELP solution (ready to use) | 1 vial, 1.2 mL |
| Mammalian immunoglobulins antihuman gamma heavy chains (ready to use) | 1 vial, 1.2 mL |
| Mammalian immunoglobulins antihuman alpha heavy chains (ready to use) | 1 vial, 1.2 mL |
| Mammalian immunoglobulins antihuman mu heavy chains (ready to use) | 1 vial, 1.2 mL |
| Mammalian immunoglobulins antihuman kappa (free and bound) light chains (ready to use) | 1 vial, 1.2 mL |
| Mammalian immunoglobulins antihuman lambda (free and bound) light chains (ready to use) | 1 vial, 1.2 mL |
Additional reagents not included in the CAPI 3 IMMUNOTYPING KIT
| ITEMS | PN | COMPONENTS |
|---|---|---|
| CAPI 3 PROTEIN(E) 6 | 2503 | 3 vials buffer, 700 mL each |
| 4 filters | ||
| 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 |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Laboratory use, Prescription Use
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
- Repeatability Study:
- Study Type: Repeatability
- Sample Size: Six (6) different serum samples (1 normal, 5 pathological with monoclonal components).
- Key Results: All dilution programs were tested. For each tested reagent, all samples gave concordant results within run and between capillaries.
- Reproducibility between lots and instruments Study:
- Study Type: Reproducibility
- Sample Size: Six (6) different serum samples (1 normal, 5 pathological with monoclonal components).
- Key Results: Samples were run on 3 CAPILLARYS 3 TERA instruments with 3 lots of CAPI 3 IMMUNOTYPING kit. Each sample was analyzed on 18 runs over 5 working days (at 2 different times of the day). All dilution programs were tested. All samples gave concordant results for all runs on the 3 CAPILLARYS 3 TERA instruments and with the 3 lots of CAPI 3 IMMUNOTYPING kit.
- Sensitivity Study:
- Study Type: Sensitivity (Detection Limit)
- Sample Size: Three pathological serum samples with monoclonal components.
- Key Results: Serial dilutions were prepared in normal serum.
- Sample 1 (Ig G, L, Gamma, Lambda): Detection limit 30.9 mg/dL
- Sample 2 (Ig A, K, Alpha, Kappa): Detection limit 13.3 mg/dL
- Sample 3 (Ig M, K, Mu, Kappa): Detection limit 25.0 mg/dL
- Interferences Study:
- Study Type: Interference
- Sample Size: 4 different serum samples (1 normal, 3 pathological with monoclonal component).
- Key Results: Studies were performed according to CLSI EP7-A2 guideline. No interference was detected due to high concentrations of:
- Triglycerides: 3.59 g/dL (41 mM)
- Bilirubin: 20 mg/dL (342 µM)
- Rheumatoid factor: 981 IU/mL
- Hemoglobin: 0.2 g/dL
- Method Comparison Study:
- Study Type: Method Comparison
- Sample Size: 115 serum samples (12 normal, 103 pathological).
- Key Results: Samples were analyzed using the CAPI 3 IMMUNOTYPING procedure (candidate device) and the CAPILLARYS IMMUNOTYPING procedure (predicate device).
- 100% agreement between the two techniques for all 115 serum samples.
- Complete agreement for all 12 normal serum samples.
- Complete agreement for all 103 pathological serum samples.
- Both techniques detected and characterized monoclonal proteins with complete agreement for various types (Ig G, Kappa; Ig G, Lambda; Ig A, Kappa; Ig A, Lambda; Ig M, Kappa; Ig M, Lambda; combinations; free light chains).
Key Metrics
- Sensitivity: Detection limits for different monoclonal components (e.g., 30.9 mg/dL for Ig G, L; 13.3 mg/dL for Ig A, K; 25.0 mg/dL for Ig M, K).
- Agreement (Method Comparison): 100% agreement.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three abstract shapes above them that resemble wings or flowing ribbons.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2016
SEBIA, INC. Karen Anderson, MT (ASCP) Director of Technical Training and Regulatory Suite 400, 1705 Corporate Drive Norcross, GA 30093
Re: K161928
Trade/Device Name: CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF Control Regulation Number: 21 CFR § 866.5510 Regulation Name: Immunoglobulins (A, G, M, D, E) Immunological Test Systems Regulatory Class: Class II Product Code: CFF - Immunoelectrophoretic, Immunoglobulins (G, A, M) Dated: December 15, 2016 Received: December 19, 2016
Dear Ms. 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 (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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/Resourcesfor You/Industry/default.htm. 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 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,
Image /page/1/Picture/8 description: The image shows the name "Kelly Oliner -S" in black font. The text is centered on the page and is easy to read. In the background, there is a faded blue logo that appears to be the letters "FDA".
For
Leonthena Carrington, MBA, MS, MT(ASCP) Director Division of Immunology and Hematology 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) K161928
Device Name CAPI 3 IMMUNOTYPING
Indications for Use (Describe)
The CAPI 3 IMMUNOTYPING kit is designed for the qualitative detection and the characterization of monoclonal proteins (immunotyping) in human serum with the CAPILLARYS 3 TERA instrument, SEBIA, for capillary electrophoresis. It is used in conjunction with the CAPI 3 PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).
The CAPILLARYS 3 TERA instrument performs all procedural sequences automatically to obtain a profile for qualitative analysis. Each serum sample is mixed with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains, respectively.
The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 mm.
The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins.
For In Vitro Diagnostic Use.
Type of Use (Select one or both, as applicable)
X 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) K161928
Device Name
IT / IF Control
Indications for Use (Describe)
The IT / IF Control is designed to qualitative detection and characterization of human monoclonal immunoglobulins (Ig G, Ig A, Ig M, Kappa and Lambda) with the electrophoresis methods :
-
Immunotyping performed using capillary electrophoresis on SEBIA CAPILLARYS 2, CAPILLARYS 2 FLEX-PIERCING and CAPILLARYS 3 TERA instruments and on SEBIA MINICAP instrument,
-
Immunofixation methods : SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber.
The IT / IF Control is designed for laboratory use. It should be used (with its barcode label for CAPILLARYS and MINICAP procedures) like a human serum sample.
The electrophoretic pattern obtained is specific for each batch of IT / IF control.
For In Vitro Diagnostic Use.
Type of Use (Select one or both, as applicable)
X 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 | |
| Karen Anderson, Dir of Technical and QA | |
| Phone: 1-800-835-6497 | |
| Fax: 770-446-8511 | |
| Email: karen.anderson@sebia-usa.com | |
| Contact | Aigars Brants, Ph.D, Scientific Affairs Officer |
| Phone 1-800-835-6497 | |
| Fax 770-446-8511 | |
| Email: aigars.brants@sebia-usa.com | |
| Date Prepared | October 6, 2016 / Revision Dec 14, 2016 |
| 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 IMMUNOTYPING (PN 2600) |
| IT / IF Control (PN 4788) | |
| using CAPILLARYS 3 TERA instrument (PN 1246) | |
| Common Name | Monoclonal Immunoglobulins by Capillary |
| Electrophoresis | |
| Product Regulation No. | 21 CFR Part 866.5510, 866.5550, 866.1630, |
| 862.1660 | |
| Product Codes | CFF, DFH, DEH, CEF, JJY |
| Device classification | Class II (Test System), Class I (Controls |
| Electrophoretic Protein Fractionation) | |
| Establishment Registration No. | 8023024 |
5
| Predicate Device Name | Predicate Device 510(k) number |
|---|---|
| CAPILLARYS IMMUNOTYPING | K130500 |
| CAPILLARYS 2 / CAPILLARYS 2 FLEX-PIERCING | K130500 |
| IT / IF CONTROL | K130500 |
1. DEVICE DESCRIPTION
CAPILLARYS 3 TERA INSTRUMENT
The CAPILLARYS 3 TERA instrument uses the principle of capillary electrophoresis in liquid 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.
CAPI 3 IMMUNOTYPING KIT
In CAPI 3 MMUNUOTYPING kit contains the sample diluent and specific antisera against gamma (Ig G), alpha (Ig A), mu (Ig M) heavy chains, and free and bound Kappa and Lambda light chains. A sample dilution is prepared and injected at the anodic end of six capillaries. The reference pattern (ELP pattern), which is a complete electrophoretic pattern of the sample's proteins, is obtained by mixing the sample with the ELP solution and injection into the 1st capillary. The antisera patterns are obtained by sample aspiration into the 5 subsequent capillaries separation is performed in a high voltage electrical field and detected using absorbance at 200 nm.
IT/IF CONTROL
The IT / IF control contains three monoclonal proteins which can be used as a qualitative control with the CAPI IMMUNOTYPING kit on the CAPILLARYS 3 TERA instrument.
6
Reagents:
CAPI 3 IMMUNOTYPING KIT
| ITEMS | PN 2600 |
|---|---|
| Sample diluent (ready to use) | 1 vial, 60 mL |
| Pierceable cap for the Sample diluent vial | 1 cap |
| Rack with ELP solution and antiserum tubes | |
| ELP solution (ready to use) | 1 vial, 1.2 mL |
| Mammalian immunoglobulins antihuman | |
| gamma heavy chains (ready to use) | 1 vial, 1.2 mL |
| Mammalian immunoglobulins antihuman | |
| alpha heavy chains (ready to use) | 1 vial, 1.2 mL |
| Mammalian immunoglobulins antihuman | |
| mu heavy chains (ready to use) | 1 vial, 1.2 mL |
| Mammalian immunoglobulins antihuman | |
| kappa (free and bound) light chains | |
| (ready to use) | 1 vial, 1.2 mL |
| Mammalian immunoglobulins antihuman | |
| lambda (free and bound) light chains | |
| (ready to use) | 1 vial, 1.2 mL |
Additional reagents not included in the CAPI 3 IMMUNOTYPING KIT
| ITEMS | PN | COMPONENTS |
|---|---|---|
| CAPI 3 PROTEIN(E) 6 | 2503 | 3 vials buffer, 700 mL each |
| 4 filters | ||
| 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 |
7
2. INDICATIONS FOR USE
The CAPI 3 IMMUNOTYPING kit is designed for the qualitative detection and the characterization of monoclonal proteins (immunotyping) in human serum with the CAPILLARYS 3 TERA instrument, SEBIA, for capillary electrophoresis. It is used in conjunction with the CAPI 3 PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 maior fractions in alkaline buffer (pH 9.9).
The CAPILLARYS 3 TERA instrument performs all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each serum sample is mixed with individual antisera that are specific against gamma (lg G), alpha (lg A) and mu (lg M) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains, respectively. The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 nm.
The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins.
For In Vitro Diagnostic Use.
The IT / IF Control is designed to qualitative detection and characterization of human monoclonal immunoglobulins (lg G, lg A, lg M, Kappa and Lambda) with the electrophoresis methods:
Immunotyping performed using capillary electrophoresis on SEBIA CAPILLARYS 2, -CAPILLARYS 2 FLEX-PIERCING and CAPILLARYS 3 TERA instruments and on SEBIA MINICAP instrument,
Immunofixation methods: SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, HYDRAGEL . BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber.
The IT / IF Control is designed for laboratory use. It should be used (with its barcode label for CAPILLARYS and MINICAP procedures) like a human serum sample.
The electrophoretic pattern obtained is specific for each batch of IT / IF control.
For In Vitro Diagnostic Use.
3. TECHNOLOGICAL CHARACTERISTICS
The CAPILLARYS 3 TERA instrument uses the principle of capillary electrophoresis in liquid solution. With this technique, charged molecules are separated by their electrophoretic mobility in an alkaline buffer with a specific pH. Protein separation is performed in a high voltage electrical field. The separated proteins are directly detected using absorbance at 200 nm at the cathodic end of the capillary. Separation occurs according to the electrolyte pH and is driven by electroosmotic flow. The CAPILLARYS 3 TERA instrument has silica capillaries functioning in parallel allowing 12 simultaneous analyses.
With the CAPI 3 IMMUNOTYPING procedure, the immunotyping using specific antibodies is performed to identify abnormal fractions in serum profiles. The immunotyping is performed in four automated steps:
8
Dilution of serum samples with a specific diluent in the pre-dilution well of the 1. reagent cup. This dilution is made according to the sample's immunoglobulin concentration.
-
Mixing diluted serum sample with specific antisera. The antigen - antibody complex is formed rapidly in liquid medium.
-
Injection of prepared samples with simultaneous aspiration into 6 capillaries at their anodic end. Protein separation occurs when a high voltage field is applied to the alkaline buffer. The separated proteins are detected using absorbance at 200 nm at the cathodic end of the capillary.
Overlay of the ELP pattern on the antisera patterns (Ig G, Ig A, Ig M, Kappa 4. and Lambda) allows characterization of suspected monoclonal component.
2. SUBSTANTIAL EQUIVALENCE INFORMATION:
| Predicate Device Name | Predicate Device 510(k) number |
|---|---|
| CAPILLARYS IMMUNOTYPING | K130500 |
| CAPILLARYS 2 / CAPILLARYS 2 FLEX- | |
| PIERCING | K130500 |
| IT / IF CONTROL | K130500 |
The technological characteristics of the CAPI 3 IMMUNOTYPING 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 200nm as the CAPILLARYS IMMUNOTYPING procedure (predicate device). The CAPILLARYS 3 TERA using the CAPI 3 IMMUNOTYPING procedure follow the FDA guidance document, Replacement Reagent and Instrument Family Policy.
9
Table A.
Similarities and differences between the candidate device (CAPI 3 IMMUNOTYPING and the predicate device (CAPILLARYS IMMUNOTYPING. Both are members of the Sebia CAPILLARYS family of instruments.
| Table A | SEBIA CAPILLARYS IMMUNOTYPING
(K) 130500 | SEBIA CAPI 3 IMMUNOTYPING |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CAPILLARYS IMMUNOTYPING kit is
designed for the detection and the
characterization of monoclonal proteins
(immunotyping) in human urine and serum with
the CAPILLARYS, the CAPILLARYS 2 and the
CAPILLARYS 2 FLEX-PIERCING, SEBIA, for
capillary electrophoresis. It is used in conjunction
with the SEBIA CAPILLARYS PROTEIN(E) 6 kit
designed for proteins separation into 6 major
fractions in alkaline buffer (pH 9.9).
The CAPILLARYS, CAPILLARYS 2 and the
CAPILLARYS 2 FLEX-PIERCING perform all
procedural sequences automatically to obtain a
protein profile for qualitative analysis. Each urine
or serum sample is mixed with individual antisera
that are specific against gamma (Ig G), alpha (Ig
A) and mu (Ig M) heavy chains, and kappa (free
and bound) light chains and lambda (free and
bound) light chains, respectively.
The proteins, separated in silica capillaries, are
directly detected by their absorbance at 200 nm.
The electrophoregrams are evaluated visually to
detect the presence of specific reactions with the
suspect monoclonal proteins. | The CAPI 3 IMMUNOTYPING kit is designed for
the qualitative detection and the characterization
of monoclonal proteins (immunotyping) in human
serum with the CAPILLARYS 3 TERA instrument,
SEBIA, for capillary electrophoresis. It is used in
conjunction with the CAPI 3 PROTEIN(E) 6 kit.
SEBIA, designed for proteins separation into 6
major fractions in alkaline buffer (pH 9.9).
The CAPILLARYS 3 TERA instrument performs
all procedural sequences automatically to obtain
a protein profile for qualitative analysis. Each
serum sample is mixed with individual antisera
that are specific against gamma (Ig G), alpha (Ig
A) and mu (Ig M) heavy chains, and kappa (free
and bound) light chains and lambda (free and
bound) light chains, respectively.
The proteins, separated in silica capillaries, are
directly detected by their absorbance at 200 nm.
The electrophoregrams are evaluated visually to
detect the presence of specific reactions with the
suspect monoclonal proteins. |
| | For In Vitro Diagnostic Use. | For In Vitro Diagnostic Use. |
| Separation system | Free solution capillary electrophoresis (FSCE);
protein separation in an alkaline buffer (pH 9.9)
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 |
| | CAPILLARYS IMMUNOTYPING Kit (PN 2100) : | CAPI 3 IMMUNOTYPING Kit (PN 2600) : |
| Reagent | Antisera segment containing :
ELP solution
mammalian immunoglobulins anti-
human gamma heavy chains
mammalian immunoglobulins anti-
human alpha heavy chains
mammalian immunoglobulins anti-
human mu heavy chains
mammalian immunoglobulins anti-
human kappa (free and bound) light
chains
mammalian immunoglobulins anti-
human lambda (free and bound) light
chains | Sample diluent
Rack with ELP solution tube and antiserum
tubes :
mammalian immunoglobulins anti-
human gamma heavy chains
mammalian immunoglobulins anti-
human alpha heavy chains
mammalian immunoglobulins anti-
human mu heavy chains
mammalian immunoglobulins anti-
human kappa (free and bound) light
chains
mammalian immunoglobulins anti-
human lambda (free and bound) light
chains |
| Table A | SEBIA CAPILLARYS IMMUNOTYPING (K) 130500 | SEBIA CAPI 3 IMMUNOTYPING |
| Instrument | SEBIA CAPILLARYS 2 FLEXPIERCING instrument, PN 1227
SEBIA CAPILLARYS 2 instrument, PN 1222 | SEBIA CAPILLARYS 3 TERA instrument, PN 1246 |
| Sample throughput | 8 analyses / hour | 21 (samples) analysis/ 2 hours |
| 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 13 tubes for IT technique (i.e. 13 sample racks), uninterrupted throughput on sample racks. Only position 1 on the sample rack contains 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 : Contains one vial of water, wash solution and buffer container.
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, 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 (