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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study data for the CAPI 3 IMMUNOTYPING device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list predefined quantitative acceptance criteria with specific numerical thresholds for all performance metrics (e.g., repeatability, reproducibility, accuracy). Instead, for qualitative assessments, the acceptance criterion appears to be "concordant results" or "100% agreement." For sensitivity, the acceptance criterion is implicitly shown by the reported detection limits.

Performance Metric	Acceptance Criteria (Implicit from Document)	Reported Device Performance
Repeatability (Within-run and Between-capillaries)	All samples should give concordant results within run and between capillaries.	For each tested reagent (ELP, Anti-IgG, Anti-IgA, Anti-IgM, Anti-Kappa, Anti-Lambda), all 4 urine samples (including Bence Jones proteins) gave concordant results within run and between capillaries. All dilution programs were tested.
Reproducibility (Between lots and instruments)	All samples should give concordant results across different runs, instruments, and reagent lots.	All 3 urine samples (including Bence Jones proteins) gave concordant results for all 18 runs (over 5 working days, 2 times/day) on the 3 CAPILLARYS 3 TERA instruments and with the 3 lots of CAPI 3 IMMUNOTYPING kit. All dilution programs were tested.
Sensitivity (Detection Limit)	Monoclonal proteins in urine should be detectable at clinically relevant low concentrations. (No explicit numerical acceptance criterion is stated, but the ability to detect at specified g/L or mg/dL is the measure).	Detection Limits Reported:- Lambda free: 0.010 g/L (1.0 mg/dL)- Kappa free: 0.030 g/L (3.0 mg/dL)- IgG Lambda: 0.004 g/L (0.4 mg/dL)- Lambda (part of IgG Lambda): 0.004 g/L (0.4 mg/dL)
Sample Stability (2-8 °C)	Results after 1 week storage at 2-8 °C should comply with "acceptance criteria defined by SEBIA." (Specific criteria not detailed in document).	The results obtained complied with the acceptance criteria defined by SEBIA. Conclusion: Urine samples can be stored for 1 week between 2 and 8 °C.
Sample Stability (-70/-80 °C)	Results after 1 month storage at -70/-80 °C should comply with "acceptance criteria defined by SEBIA." (Specific criteria not detailed in document).	The results obtained complied with the acceptance criteria defined by SEBIA. Conclusion: Urine samples can be stored for 1 month between -70 and -80 ℃.
Kit Stability (CAPI 3 IMMUNOTYPING sample diluent)	Stable for 2 years at 2 - 30 °C. (The acceptance criterion is the claimed stability period and conditions).	2 years at 2 - 30 °C (Reported as claimed stability).
Kit Stability (CAPI 3 IMMUNOTYPING ELP solution)	Stable for 2 years at 2 - 8 °C. (The acceptance criterion is the claimed stability period and conditions).	2 years at 2 - 8 °C (Reported as claimed stability).
Kit Stability (CAPI 3 IMMUNOTYPING antisera)	Stable for 2 years at 2 - 8 °C. (The acceptance criterion is the claimed stability period and conditions).	2 years at 2 - 8 °C (Reported as claimed stability).
On-Board Stability (Sample Diluent, ELP, Antisera)	Stable for 2 months on-board the instrument. (The acceptance criterion is the claimed stability period).	2 months (Reported as claimed stability).
Accuracy/Concordance	100% agreement between the test technique (CAPI 3 IMMUNOTYPING on CAPILLARYS 3 TERA) and the reference technique (CAPILLARYS IMMUNOTYPING on CAPILLARYS 2) for qualitative results, including presence/absence and type of monoclonal component.	This study demonstrated 100% agreement between the two techniques for all 52 urine samples (8 without, 44 with monoclonal components of various types). This 100% agreement was confirmed for specific monoclonal protein types (IgG Lambda, IgG Kappa, IgG Lambda with Lambda free, IgG Kappa with Kappa free, Lambda free, Kappa free, IgM Kappa with Kappa free, IgA Lambda, IgA Lambda with Lambda free, and without Monoclonal).

2. Sample Size Used for the Test Set and Data Provenance

Repeatability: 4 different urine samples with monoclonal proteins (including Bence Jones proteins).
Reproducibility: 3 different urine samples with monoclonal proteins (including Bence Jones proteins).
Sensitivity: 3 pathological urine samples, serially diluted in normal urine.
Sample Stability (2-8 °C): 10 urine samples (normal and pathological).
Sample Stability (-70/-80 °C): 10 urine samples (normal and pathological).
Accuracy/Concordance: 52 urine samples (8 without monoclonal component, 44 with monoclonal component including Bence Jones proteins).

Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that it's a 510(k) submission from Sebia (manufacturing in France, submitter in USA), and refers to "urine samples," these are likely clinical samples, but details on their origin are not provided. The phrase "analyzed at the beginning of the study (reference) and after X storage (test)" suggests a prospective element for the stability studies on stored samples.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document states: "All electrophoregrams were evaluated visually for the qualitative results." However, it does not specify the number of experts used for ground truth establishment or their qualifications (e.g., "radiologist with 10 years of experience"). This is a significant omission from the perspective of external validation of the ground truth. It is implied that visual evaluation by trained personnel (likely laboratory professionals or experts in electrophoresis interpretation) was the method, but no further details are provided.

4. Adjudication Method for the Test Set

The document does not detail an adjudication method (such as 2+1 or 3+1 consensus) for the visual evaluation of electrophoregrams. It simply states they were "evaluated visually." This implies a single evaluator, or an internal process where disagreement (if any) was resolved, but the process is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study was described. The accuracy/concordance study compares the new device's visual interpretation results to an existing, cleared device's visual interpretation results, which is a comparison of two methods, not an assessment of human readers with and without AI assistance. The device itself is a qualitative detection and characterization system, and the evaluation stated is "electrophoregrams were evaluated visually," indicating human interpretation is still involved in the final result.

6. Standalone Performance Study

The studies described (repeatability, reproducibility, sensitivity, stability, accuracy/concordance) evaluate the performance of the integrated system (CAPI 3 IMMUNOTYPING kit on CAPILLARYS 3 TERA instrument). The "electrophoregrams are evaluated visually" suggests human-in-the-loop performance, rather than a purely standalone algorithm. The device produces a "protein profile for qualitative analysis," which is then visually interpreted. Therefore, a standalone (algorithm only) performance study, in the sense of an AI algorithm making a definitive diagnosis without human oversight, does not appear to have been performed or is not directly applicable to the described use case which involves visual evaluation.

7. Type of Ground Truth Used

The ground truth for the test sets (e.g., for accuracy, repeatability, reproducibility studies) appears to be established by the visual evaluation of electrophoregrams performed by an expert or experts using a "reference technique" or the device itself.

For the accuracy/concordance study, the "reference technique" (CAPILLARYS IMMUNOTYPING URINE procedure performed with the CAPILLARYS 2 instrument) served as the comparator for establishing ground truth, assuming the predicate device's results are considered the established truth.
For other studies like repeatability and reproducibility, the "ground truth" seems to implicitly be the correct identification of presence/absence and type of monoclonal protein based on the expected outcome for the known pathological samples, assessed by visual evaluation.
No mention of pathology, outcomes data, or independent gold standard beyond another electrophoretic method is provided.

8. Sample Size for the Training Set

The document does not mention a "training set" or explicitly describe the development of an algorithm that learns from data. This device is an immunodiagnostic test system based on capillary electrophoresis and specific antisera, producing profiles that are then visually interpreted. It is not presented as an AI/ML-driven device requiring a training set in the conventional sense. The "training" for such a system would typically involve its chemical and mechanical design, calibration, and validation against a standard.

9. How the Ground Truth for the Training Set Was Established

As no training set is described for an AI/ML algorithm, this question is not applicable. The assay's "truth" is inherent in its biochemical principle (antigen-antibody reaction, electrophoretic separation) and the expertise of interpreting the resulting electrophoregrams.

Summary

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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

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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

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Indications for Use

510(k) Number (if known)

Device Name CAPI 3 IMMUNOTYPING

Indications for Use (Describe)

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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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 400Norcross, Georgia 30093, USA
Contact	Karen Anderson, Director of RegulatoryPhone: 1-800-835-6497Fax: 770-446-8511Email: karen.anderson@sebia-usa.comMatthew C. Wagner, Ph.DScientific Affairs SpecialistEmail: Matthew.wagner@sebia-usa.comPhone: 1-800-835-6497, 3752
Date Prepared	October 7, 2019
Manufacturing	SebiaParc Technologique Léonard de VinciRue Léonard de Vinci,CP 8010 LISSES, 91008 EVRY CedexFRANCEPhone: (33) 1 69 89 80 80Fax: (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 CapillaryElectrophoresis
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 (ControlsElectrophoretic Protein Fractionation)
Establishment Registration No.	8023024

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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 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.

The immunotyping is performed in four automated steps:

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1. 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.
1. 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.
1. 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.
1. 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 antihumangamma heavy chains (ready to use)	1 vial, 1.2 mL
Mammalian immunoglobulins antihumanalpha heavy chains (ready to use)	1 vial, 1.2 mL
Mammalian immunoglobulins antihumanmu heavy chains (ready to use)	1 vial, 1.2 mL
Mammalian immunoglobulins antihumankappa (free and bound) light chains(ready to use)	1 vial, 1.2 mL
Mammalian immunoglobulins antihumanlambda (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 each4 filters

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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 REAGENTCUPS	2581	5 units
CAPI 3 URINE KIT	2513	1 Vial , 480 mL

2. INDICATIONS FOR USE

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.

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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 usingCAPILLARYS 2 / CAPILLARYS 2 FLEXPIERCINGINSTRUMENT	K130500
CAPI 3 IMMUNOTYPING using the CAPILLARY 3TERA 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

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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 kitis designed for the detection and thecharacterization of monoclonal proteins(immunotyping) in human urine and serumwith the CAPILLARYS, the CAPILLARYS 2and the CAPILLARYS 2 FLEX-PIERCING,SEBIA, for capillary electrophoresis. It is usedin conjunction with the SEBIA CAPILLARYSPROTEIN(E) 6 kit designed for proteinsseparation into 6 major fractions in alkalinebuffer (pH 9.9).The CAPILLARYS, CAPILLARYS 2 and theCAPILLARYS 2 FLEX-PIERCING perform allprocedural sequences automatically to obtain aprotein profile for qualitative analysis. Eachurine or serum sample is mixed with individualantisera that are specific against gamma (Ig G),alpha (Ig A) and mu (Ig M) heavy chains, andkappa (free and bound) light chains andlambda (free and bound) light chains,respectively. The proteins, separated in silicacapillaries, are directly detected by theirabsorbance at 200 nm.The electrophoregrams are evaluated visuallyto detect the presence of specific reactions withthe suspect monoclonal proteins.For In Vitro Diagnostic Use.	The CAPI 3 IMMUNOTYPING kit is designed forthe qualitative detection and the characterizationof monoclonal proteins (immunotyping) in humanurine and serum with the CAPILLARYS 3 TERAinstrument, SEBIA, for capillary electrophoresis.It is used in conjunction with the CAPI 3PROTEIN(E) 6 kit, SEBIA, designed for proteinsseparation into 6 major fractions in alkaline buffer(pH 9.9).The CAPILLARYS 3 TERA instrument performsall procedural sequences automatically to obtaina protein profile for qualitative analysis. Eachurine or serum sample is mixed with individualantisera that are specific against gamma (Ig G),alpha (Ig A) and mu (Ig M) heavy chains, andkappa (free and bound) light chains and lambda(free and bound) light chains, respectively. Theproteins, separated in silica capillaries, aredirectly detected by their absorbance at 200 nm.The electrophoregrams are evaluated visually todetect the presence of specific reactions withthe suspect monoclonal proteins.For In Vitro Diagnostic Use.
Separation system	Free solution capillary electrophoresis(FSCE): protein separation in an alkalinebuffer (pH 9.9) according to their charge, to theelectrolyte pH and electroosmotic flow.Fast separation and good resolution.Electrophoregrams show separated fractionsaccording to their charge.	Same
Sample Type	Serum and Urine	Same
Results	Qualitative	Same
Reagent	CAPILLARYS IMMUNOTYPING Kit (PN 2100) :Antisera segment containing :ELP solutionmammalian immunoglobulinsantihuman gamma heavy chainsmammalian immunoglobulinsantihuman alpha heavy chainsmammalian immunoglobulinsantihuman mu heavy chainsmammalian immunoglobulinsantihuman kappa (free and bound) light chainsmammalian immunoglobulinsantihuman lambda (free and bound) light chains sample diluent	CAPI 3 IMMUNOTYPING Kit (PN 2600) :Sample diluentRack with ELP solution tube and antiserum tubes :mammalian immunoglobulinsantihuman gamma heavy chainsmammalian immunoglobulinsantihuman alpha heavy chainsmammalian immunoglobulinsantihuman mu heavy chainsmammalian immunoglobulinsantihuman kappa (free and bound) light chainsmammalian immunoglobulinsantihuman lambda (free and bound) light chains
Urine Kit	CAPILLARYS/MINICAP URINE KITPN 20131 Vial 480 mL	CAPI 3 URINE KIT*PN 25131 Vial , 480 mLReagent same,PN to reflect Capi 3 part number sequence.

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Table A (continued)	SEBIA CAPILLARYS IMMUNOTYPING(K) 130500	SEBIA CAPI 3 IMMUNOTYPING
Instrument	SEBIA CAPILLARYS 2 FLEX-PIERCING instrument, PN 1227SEBIA CAPILLARYS 2 instrument, PN 1222	SEBIA CAPILLARYS 3 TERA instrument, PN 1246
Analysisthroughput	16 analyses / 2hour	21 anlaysis / 2hours
Interface	PC interface	PC interface + touch screen
TemperatureControl	By Peltier device	Same
Detection system	Deuterium lamp	Deuterium lamp and LED
Software for dataprocessing	SEBIA PHORESIS™ software	Same
Firmware	Included into the PHORESIS software	Included into the instrument

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Number ofseparation units	8 parallel capillaries	12 parallel capillaries
Samples tubes	uncapped tubes or capped tubes depending onthe procedure	Same
Samplesidentification	Yes (Bar code reading on both sample racksand tubes)	Yes (Bar code reading on sample tubes andRFID labels on sample racks)
Reagentidentification	No	Yes (RFID labels on reagent vials)
Introduction ofthe samples intothe automaticsystem	Primary capacity of 13 tubes for IT technique(i.e. 13 sample racks), uninterruptedthroughput on sample racks. Only position 1 onthe sample rack contains sample tube.	Primary maximal capacity of 120 tubes (i.e. 15sample racks), uninterrupted throughput onsample racks (8 positions available).
Reagent bay :maincompartement	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 A1ctechniques) 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 washsolution
Reagent bay :secondarycompartement	NA	Up to 3 vials and 1 rack with immunotypingreagents (all RFID tagged) in temperaturecontrolled environment (< 15 °C); 1 RFIDlabeled vial and three tubes (formaintenance solutions) at roomtemperature
Dimensions	L. 95 cm x H. 39 cm x D. 63 cm	L. 90 cm x H. 54 cm x D. 67 cm
Weight	50 kg	75 kg

3. Performance Data:

a. 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.

b. 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.

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c. 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.

The results are summarized below:

Sample	Monoclonal protein		Monoclonal protein concentration		Detection limit
	Type		g/L	mg/dL	g/L	mg/dL
A	Lambda free	Lambda	2.432	243.2	0.010	1.0
C	Kappa free	Kappa	0.946	94.6	0.030	3.0
D	Ig G, Lambda	Gamma	0.118	11.8	0.004	0.4
		Lambda			0.004	0.4

d. Sample Stability Stability at 2-8 ℃

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. The results obtained comply with the acceptance criteria defined by SEBIA of the CAPI 3 IMMUNOTYPING URINE procedure performed with the CAPILLARYS 3 TERA instrument. Urine samples can be stored for 1 week between 2 and 8 °C.

Stability - 70 / - 80 °C

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 results obtained comply with the acceptance criteria defined by SEBIA of the CAPI 3 IMMUNOTYPING URINE procedure performed with the CAPILLARYS 3 TERA instrument.

Urine samples can be stored for 1 month between - 70 and - 80 ℃.

e. 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

{12}------------------------------------------------

On- Board Stability
CAPI 3 IMMUNOTYPING sample diluentCAPI 3 IMMUNOTYPING ELP solutionCAPI 3 IMMUNOTYPING antisera	2 months

f. Accuracy/Concordance

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.

This study demonstrated a 100 % agreement between the two techniques.

Qualitative Results	Number of urinesamples	Complete Agreement
lgG Lambda	5	Complete Agreement
IgG Kappa	2	Complete Agreement
lgG Lambda with Lambda free	4	Complete Agreement
IgG Kappa with Kappa free	2	Complete Agreement
Lambda free	19	Complete Agreement
Kappa free	8	Complete Agreement
IgM Kappa with Kappa free	2	Complete Agreement
IgA Lambda	1	Complete Agreement
IgA Lambda with Lambda free	1	Complete Agreement
Without Monoclonal	8	Complete Agreement
Grand Total	52	Complete Agreement

4. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

Regulation Number and Section

§ 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).