(88 days)
Not Found
No
The description focuses on the automated steps of capillary electrophoresis and visual evaluation of electrophoregrams, with no mention of AI or ML for analysis or interpretation.
No.
The device is an in vitro diagnostic (IVD) test designed for the qualitative detection and characterization of monoclonal proteins in human urine and serum, which is used for diagnostic purposes and does not directly provide therapy.
Yes
Explanation: The device is designed for "qualitative detection and the characterization of monoclonal proteins (immunotyping) in human urine and serum," which is used to diagnose conditions involving abnormal protein levels. This falls under the definition of a diagnostic device as it leads to a diagnosis of a disease or condition. The text also explicitly states "For In Vitro Diagnostic Use."
No
The device is a kit used with a physical instrument (CAPILLARYS 3 TERA) and involves chemical reactions (mixing with antisera) and physical separation techniques (capillary electrophoresis). It is not solely software.
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."
- Intended Use: The device is designed for the "qualitative detection and the characterization of monoclonal proteins (immunotyping) in human urine and serum." This is a diagnostic purpose, analyzing biological samples in vitro (outside the body).
- Device Description: The description details a laboratory instrument (CAPILLARYS 3 TERA) and a kit (CAPI 3 IMMUNOTYPING) used to perform a specific diagnostic test (immunotyping) on biological samples (urine and serum).
- Performance Studies: The document includes a "Summary of Performance Studies" which describes testing and validation of the device's performance for its intended diagnostic use (repeatability, reproducibility, sensitivity, accuracy/concordance).
- Predicate Devices: The mention of predicate devices with K numbers (indicating FDA clearance for IVDs) further supports its classification as an IVD.
All these elements align with the definition and characteristics 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 urine and 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 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.
For In Vitro Diagnostic Use.
Product codes
CEF, DEH, DFH, CFF
Device Description
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 um 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.
In capillary electrophoresis, abnormal fractions detected in serum or urine protein electrophoregrams, primarily those in the beta globulin and gamma globulin zones, are always suspect of being monoclonal proteins (M-proteins, paraproteins, monoclonal immunoglobulins). With the CAPI 3 IMMUNOTYPING procedure, the immunotyping procedure uses specific antibodies to identify these abnormal fractions.
In immunotyping 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. Previously diluted samples are mixed with specific antisera against gamma (Ig G), alpha (lg A), mu (lg M) heavy chains, and free and bound Kappa and Lambda light chains. Protein separation is performed in a high voltage electrical field. The separated proteins are detected using absorbance at 200 nm at the cathodic end of the capillary. After the analysis, the capillaries are immediately washed with a wash solution and filled with buffer which prepares the capillaries for the next analysis.
The immunotyping is performed in four automated steps:
- Dilution of serum or urine samples with a specific diluent in the pre-dilution well of the 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 without the need for extra incubation step or removal of the immune complexes.
- Injection of the prepared samples with simultaneous aspiration into 6 capillaries at the 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 and Lambda) allows characterization of suspected monoclonal component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Absorbance at 200 nm
Anatomical Site
Human urine and serum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Four (4) different urine samples with monoclonal proteins including Bence Jones proteins were run using the CAPI 3 IMMUNOTYPING URINE procedure on all capillaries of the same CAPILLARYS 3 TERA instrument and with one lot of CAPI 3 IMMUNOTYPING kit. Each sample was analyzed with each reagent (ELP solution, Anti-Ig G, Anti-Ig A, Anti-Ig M,Anti-Kappa and Anti-Lambda) on all capillaries, including 2 runs per reagent. In this study all dilution programs were tested.For each tested reagent, all samples gave concordant results within run and between capillaries.
Three (3) different urine samples with monoclonal proteins including Bence Jones proteins were run using the CAPI 3 IMMUNOTYPING URINE procedure on 3 CAPILLARYS 3 TERA instruments and 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). In this study, all dilution programs were tested.
Serial dilutions were prepared in normal urine with three pathological urine samples all exhibiting monoclonal components and analyzed using the CAPI 3 IMMUNOTYPING URINE procedure.
Ten (10) urine samples including normal and pathological urine samples were analyzed at the beginning of the study (reference) and after 1 week storage at 2 - 8℃ (test), with the CAPI 3 IMMUNOTYPING URINE procedure performed with the CAPILLARYS 3 TERA instrument.
Ten (10) urine samples including normal and pathological urine samples were analyzed at the beginning of the study (reference) and after 1 month storage at - 70 / - 80 °C (test), with the CAPI 3 IMMUNOTYPING URINE procedure performed with the CAPILLARYS 3 TERA instrument.
The accuracy study included 52 urines samples composed of 8 urine samples without monoclonal component and 44 urine samples with monoclonal component including Bence Jones proteins. The samples were tested using the CAPI 3 IMMUNOTYPING URINE procedure performed with the CAPILLARYS 3 TERA instrument (test technique) and the CAPILLARYS IMMUNOTYPING URINE procedure performed with the CAPILLARYS 2 instrument (reference technique). All electrophoregrams were evaluated visually for the qualitative results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Repeatability:
Four (4) different urine samples with monoclonal proteins including Bence Jones proteins were run using the CAPI 3 IMMUNOTYPING URINE procedure on all capillaries of the same CAPILLARYS 3 TERA instrument and with one lot of CAPI 3 IMMUNOTYPING kit. Each sample was analyzed with each reagent (ELP solution, Anti-Ig G, Anti-Ig A, Anti-Ig M, Anti-Kappa and Anti-Lambda) on all capillaries, including 2 runs per reagent. In this study all dilution programs were tested. For each tested reagent, all samples gave concordant results within run and between capillaries.
Reproducibility between lots and instruments:
Three (3) different urine samples with monoclonal proteins including Bence Jones proteins were run using the CAPI 3 IMMUNOTYPING URINE procedure on 3 CAPILLARYS 3 TERA instruments and 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). In this study, 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:
Serial dilutions were prepared in normal urine with three pathological urine samples all exhibiting monoclonal components and analyzed using the CAPI 3 IMMUNOTYPING URINE procedure.
- Sample A (Lambda free): Detection limit 0.010 g/L (1.0 mg/dL) for a monoclonal protein concentration of 2.432 g/L (243.2 mg/dL).
- Sample C (Kappa free): Detection limit 0.030 g/L (3.0 mg/dL) for a monoclonal protein concentration of 0.946 g/L (94.6 mg/dL).
- Sample D (Ig G, Lambda): Detection limit 0.004 g/L (0.4 mg/dL) for both Gamma (0.118 g/L, 11.8 mg/dL) and Lambda.
Sample Stability:
- Stability at 2-8℃: Ten (10) urine samples. Results comply with acceptance criteria. Urine samples can be stored for 1 week between 2 and 8 °C.
- Stability at -70 / - 80 °C: Ten (10) urine samples. Results comply with acceptance criteria. Urine samples can be stored for 1 month between - 70 and - 80 ℃.
Kit Stability:
- CAPI 3 IMMUNOTYPING sample diluent: 2 years at 2 - 30 °C
- CAPI 3 IMMUNOTYPING ELP solution: 2 years at 2 - 8 °C
- CAPI 3 IMMUNOTYPING antisera: 2 years at 2 - 8 °C
- On-Board Stability (Sample diluent, ELP solution, antisera): 2 months
Accuracy/Concordance:
Study included 52 urine samples (8 without monoclonal component, 44 with monoclonal component).
Tested using CAPI 3 IMMUNOTYPING URINE procedure with CAPILLARYS 3 TERA instrument (test technique) and CAPILLARYS IMMUNOTYPING URINE procedure with CAPILLARYS 2 instrument (reference technique).
All electrophoregrams were evaluated visually for qualitative results.
This study demonstrated a 100 % agreement between the two techniques.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity (Detection Limit):
- Sample A (Lambda free): Detection limit 0.010 g/L (1.0 mg/dL)
- Sample C (Kappa free): Detection limit 0.030 g/L (3.0 mg/dL)
- Sample D (Ig G, Lambda): Detection limit 0.004 g/L (0.4 mg/dL)
Accuracy/Concordance:
100 % agreement between the test technique and the reference technique for qualitative results across different monoclonal protein types and samples without monoclonal proteins.
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/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
November 1, 2019
Sebia Karen Anderson Director of Regulatory 1705 Corporate Drive Suite 400 Norcross, Georgia 30093
Re: K192095
Trade/Device Name: CAPI 3 Immunotyping, Capillarys 3 Tera Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A. G. M. D. and E immunological test system Regulatory Class: Class II Product Code: CEF, DEH, DFH, CFF Dated: July 31, 2019 Received: August 5, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Takeesha Taylor-Bell Acting Deputy Director Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
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 urine and 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 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.
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)
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3
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, Director of Regulatory |
| Phone: 1-800-835-6497 | |
| Fax: 770-446-8511 | |
| Email: karen.anderson@sebia-usa.com | |
| Matthew C. Wagner, Ph.D | |
| Scientific Affairs Specialist | |
| Email: Matthew.wagner@sebia-usa.com | |
| Phone: 1-800-835-6497, 3752 | |
| Date Prepared | October 7, 2019 |
| 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) |
| 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, |
| Classification Product Code | CFF |
| Subsequent Product Codes | DFH, DEH, CEF |
| Device classification | Class II (Test System), Class I (Controls |
| Electrophoretic Protein Fractionation) | |
| Establishment Registration No. | 8023024 |
4
This submission is to support the additional of new matrix (Urine) to Sebia's previously cleared reagent/ instrument combination CAPI 3 IMMUNOTYPING using the CAPILLARYS 3 TERA, K161928.
The predicate device used in this submission is Sebia's CAPILLARYS IMMUNOTYPING using the CAPILLARYS 2, K130500
1. DEVICE DESCRIPTION
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 um 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.
In capillary electrophoresis, abnormal fractions detected in serum or urine protein electrophoregrams, primarily those in the beta globulin and gamma globulin zones, are always suspect of being monoclonal proteins (M-proteins, paraproteins, monoclonal immunoglobulins). With the CAPI 3 IMMUNOTYPING procedure, the immunotyping procedure uses specific antibodies to identify these abnormal fractions.
In immunotyping 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. Previously diluted samples are mixed with specific antisera against gamma (Ig G), alpha (lg A), mu (lg M) heavy chains, and free and bound Kappa and Lambda light chains. Protein separation is performed in a high voltage electrical field. The separated proteins are detected using absorbance at 200 nm at the cathodic end of the capillary. After the analysis, the capillaries are immediately washed with a wash solution and filled with buffer which prepares the capillaries for the next analysis.
The immunotyping is performed in four automated steps:
5
-
- Dilution of serum or urine samples with a specific diluent in the pre-dilution well of the 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 without the need for extra incubation step or removal of the immune complexes.
-
- Injection of the prepared samples with simultaneous aspiration into 6 capillaries at the 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 and Lambda) allows characterization of suspected monoclonal component.
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 |
6
| CAPICLEAN CAPILLARYS 3 | 2060 | 1 vial, 25 mL |
|---|---|---|
| CAPILLARYS 3 WASH SOLUTION | 2062 | 1 vial, 75mL |
| CAPI 3 DISPOSABLES KIT | 2582 | 24 packs of 14 reagent cups |
| TEST TUBES | 9214 | 200 of 100mm-tubes |
| CAPI 3 BINS FOR USED REAGENT | ||
| CUPS | 2581 | 5 units |
| CAPI 3 URINE KIT | 2513 | 1 Vial , 480 mL |
2. INDICATIONS FOR USE
The CAPI 3 IMMUNOTYPING kit is designed for the qualitative detection and the characterization of monoclonal proteins (immunotyping) in human urine and 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 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.
For In Vitro Diagnostic Use.
3. TECHNOLOGICAL CHARACTERISTICS
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. 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 or urine protein profiles. The immunotyping is performed in four automated steps:
Dilution of serum or dialyzed urine samples with a specific diluent in the 1. predilution well of the reagent cup. This dilution is made according to the sample's immunoqlobulin concentration.
7
- Mixing diluted serum or urine sample with specific antisera. The antigen antibody complex is formed rapidly in liquid medium without the need for extra incubation step or removal of the immune complexes.
Injection of prepared samples with simultaneous aspiration into 6 capillaries at 3. 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, Iq A, Ig M, Kappa and Lambda) allows characterization of suspected monoclonal component.
2. SUBSTANTIAL EQUIVALENCE INFORMATION:
| Predicate Device Name | Predicate Device 510(k) number |
|---|---|
| CAPILLARYS IMMUNOTYPING using | |
| CAPILLARYS 2 / CAPILLARYS 2 FLEXPIERCING | |
| INSTRUMENT | K130500 |
| CAPI 3 IMMUNOTYPING using the CAPILLARY 3 | |
| TERA INSTRUMENT (SERUM MATRIX) | K161928 |
This submission is to support the additional of new matrix (Urine) to Sebia's previously cleared reagent/ instrument combination CAPI 3 IMMUNOTYPING using the CAPILLARYS 3 TERA, K161928.
The predicate device used in this submission is Sebia's CAPILLARYS IMMUNOTYPING using the CAPILLARYS 2, K130500
8
Table A.
.
Similarities and differences between the candidate device (CAPI 3 IMMUNOTYPING and the predicate device (CAPILLARYS IMMUNOTYPING).
| Table A | SEBIA CAPILLARYS IMMUNOTYPING
(K) 130500 | SEBIA CAPI 3 IMMUNOTYPING
(Additional of Urine) |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.
For In Vitro Diagnostic Use. | The CAPI 3 IMMUNOTYPING kit is designed for
the qualitative detection and the characterization
of monoclonal proteins (immunotyping) in human
urine and 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
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.
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 |
| Sample Type | Serum and Urine | Same |
| Results | Qualitative | Same |
| Reagent | CAPILLARYS IMMUNOTYPING Kit (PN 2100) :
Antisera segment containing :
ELP solution
mammalian immunoglobulins
antihuman gamma heavy chains
mammalian immunoglobulins
antihuman alpha heavy chains
mammalian immunoglobulins
antihuman mu heavy chains
mammalian immunoglobulins
antihuman kappa (free and bound) light chains
mammalian immunoglobulins
antihuman lambda (free and bound) light chains sample diluent | CAPI 3 IMMUNOTYPING Kit (PN 2600) :
Sample diluent
Rack with ELP solution tube and antiserum tubes :
mammalian immunoglobulins
antihuman gamma heavy chains
mammalian immunoglobulins
antihuman alpha heavy chains
mammalian immunoglobulins
antihuman mu heavy chains
mammalian immunoglobulins
antihuman kappa (free and bound) light chains
mammalian immunoglobulins
antihuman lambda (free and bound) light chains |
| Urine Kit | CAPILLARYS/MINICAP URINE KIT
PN 2013
1 Vial 480 mL | CAPI 3 URINE KIT
*PN 2513
1 Vial , 480 mL
Reagent same,
PN to reflect Capi 3 part number sequence. |
9
| Table A (continued) | SEBIA CAPILLARYS IMMUNOTYPING
(K) 130500 | SEBIA CAPI 3 IMMUNOTYPING |
|---------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------|
| Instrument | SEBIA CAPILLARYS 2 FLEX-PIERCING instrument, PN 1227
SEBIA CAPILLARYS 2 instrument, PN 1222 | SEBIA CAPILLARYS 3 TERA instrument, PN 1246 |
| Analysis
throughput | 16 analyses / 2hour | 21 anlaysis / 2hours |
| 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 |
10
| 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 | ||
| compartement | NA | Up to 3 vials and 1 rack with immunotyping |
| reagents (all RFID tagged) in temperature | ||
| controlled environment ( |