The MINICAP IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the MINICAP and the MINICAP FLEX-PIERCING instruments, SEBIA, for capillary electrophoresis. It is used in conjunction with the MINICAP PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).

The MINICAP and MINICAP FLEX-PIERCING instruments perform 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 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 suspected monoclonal proteins.

For In Vitro Diagnostic Use.

Device Description

The MINICAP IMMUNOTYPING using the MINICAP FLEX-PIERCING instrument uses the principle of capillary electrophoresis in free solution. With this technique, charged molecules are separated by their electrophoresis mobility in an alkaline buffer. The separation occurs according to the electrolyte pH and electro-osmotic flow. In capillary electrophoresis abnormal fractions in serum protein electrophoregrams, primarily those in the beta globulin and gamma globulin zones are always suspected of being monoclonal proteins, paraproteins, monoclonal immunoglobulins) and therefore an indication of a gammopathy. The MINICAP FLEX-PIERCING instrument has 2 capillaries functioning in parallel. A sample dilution is prepared and injected simultaneously by aspiration at the anodic end of the 2 capillaries.

The Immunotyping procedure follows the steps in which the sample is mixed with an ELP solution (reference pattern), specific antisera gamma ( IgG), mu (IgM) heavy chains and free/bound Kappa and Lambda light chains.

A high voltage protein separation is then performed and direct detection of the proteins at 200 nm at the cathodic end of the capillary. The capillaries are then washed and prepared for the next analysis. The superimposition of the antisera patterns with the ELP pattern allows for the visualization of the disappearance and /or the decrease of the monoclonal fraction on the antiserum pattern and to indicate a gammopathy.

AI/ML Overview

The provided text describes a Special 510(k) submission for the MINICAP IMMUNOTYPING device, indicating a modification to allow its use with a new instrument, the MINICAP FLEX-PIERCING. The core of the submission aims to demonstrate that this modification does not change the intended use or fundamental scientific technology of the device and that the performance characteristics remain substantially equivalent to the original cleared device.

Unfortunately, the document does not contain a detailed study report with specific performance data that directly proves the device meets acceptance criteria in a quantitative manner as typically expected for medical device studies. Instead, it states that "Completed detailed sets of data are on file at Sebia manufacturing" and discusses the "results of risk analysis employing acceptance criteria" which were met. Therefore, I cannot provide a table of acceptance criteria with reported device performance or information about sample sizes, ground truth establishment, or expert adjudication as these details are not present in the provided text.

However, I can extract the acceptance criteria as stated for the modified device and explain the general approach taken for the special 510(k) submission based on the available information.

Acceptance Criteria and Study for MINICAP IMMUNOTYPING (using MINICAP FLEX-PIERCING)

The Special 510(k) submission focuses on demonstrating that the MINICAP IMMUNOTYPING procedure, when run on the new MINICAP FLEX-PIERCING instrument, maintains performance equivalent to its use on the predicate MINICAP instrument.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific quantitative performance data is not provided in the document to populate such a table. The document states that "Completed detailed sets of data are on file at Sebia manufacturing" and that "The results of risk analysis employing acceptance criteria demonstrate the predetermined performance characteristics were met and the predetermined acceptance criteria were satisfied."

However, the predetermined acceptance criteria for the modified device are explicitly stated as:

Acceptance Criteria Claimed	Reported Device Performance
1. The same intended use claim as the unmodified device	The document explicitly states: "The devices have the same intended use, detection and characterization of monoclonal proteins (immunotyping) in human serum using capillary electrophoresis." and "Modifications to the MINICAP IMMUNOTYPING using the MINICAP FLEX-PIERCING instrument do not affect the intended use of the device as describe in the labeling, nor alter the fundamental scientific technology of the device."
2. Substantial equivalency to the predicate device for detection and characterization of monoclonal proteins (immunotyping) in human serum.	The submitted documentation aims to demonstrate this: "Sebia is following the FDA guidance to demonstrate the equivalence to the original reagent and instrument performance by using the Special 510(k) notification process." and "The results indicate that the intended use, qualitative interpretation of the patterns were found substantially equivalent to the original device." Specific data is not presented.
3. Performance characteristics within predetermined criteria.	"The results of risk analysis employing acceptance criteria demonstrate the predetermined performance characteristics were met and the predetermined acceptance criteria were satisfied." Specific performance characteristics and their predetermined ranges are not presented.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided text. The document only mentions "Completed detailed sets of data are on file at Sebia manufacturing."
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The adjudication method for the "electrophoregrams are evaluated visually" is mentioned, implying human interpretation, but details about the experts or their qualifications are absent.

4. Adjudication method for the test set

The document implies visual evaluation by experts: "The electrophorograms are evaluated visually to detect the presence of specific reactions with suspected monoclonal proteins." However, no specific adjudication method (e.g., 2+1, 3+1) is described for the test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This document describes a device for detecting and characterizing monoclonal proteins using capillary electrophoresis, with visual evaluation of electrophoregrams. It is a modification of an in vitro diagnostic device, not an AI-assisted diagnostic tool for Human Readers. Therefore, an MRMC comparative effectiveness study regarding human readers improving with AI vs without AI assistance is not applicable and not mentioned in this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device involves instrumental analysis and the 'PHORESIS software' for evaluation, but the final interpretation mentions "electrophoregrams are evaluated visually to detect the presence of specific reactions." This suggests a human-in-the-loop component for qualitative analysis rather than a fully standalone algorithm interpretation. A standalone performance study of the algorithm without human interpretation is not explicitly mentioned or described.

7. The type of ground truth used

The document describes the device as providing "detection and the characterization of monoclonal proteins (immunotyping) in human serum." The comparison is against the predicate device's performance. The nature of the "ground truth" for the samples used in the underlying studies (e.g., confirmed patient diagnoses, reference lab results, pathology) is not specified.

8. The sample size for the training set

The document does not detail any "training set." This is a Special 510(k) for an instrument modification to an existing device, focusing on demonstrating substantial equivalence, not a de novo submission for a novel algorithm that would typically involve distinct training and testing sets.

9. How the ground truth for the training set was established

As no training set is mentioned or described, this information is not applicable/provided.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 8, 2015

SEBIA INC. C/O MS. KAREN ANDERSON DIRECTOR OF TECHNICAL AND QUALITY ASSURANCE SUITE 400, 1705 CORPORATE DRIVE NORCROSS GA 30093

Re: K143483

Trade/Device Name: MINICAP Immunotyping Using the MINICAP and the MINICAP FLEX-PIERCING Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E immunological test system Regulatory Class: II Product Code: CFF, DFH, DEH, CEF Dated: December 8, 2014 Received: December 9, 2014

Dear Ms. Anderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require 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

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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 regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Leonthena R. Carrington -A

Leonthena Carrington, MS, MBA, MT(ASCP) Director (Acting) Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health (OIR) Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143483

Device Name

MINICAP IMMUNOTYPING USING THE MINICAP AND THE MINICAP FLEX-PIERCING

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 suspected monoclonal proteins.

For In Vitro Diagnostic Use.

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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SPECIAL 510k SUMMARY

Purpose for Submission

Sebia hereby submits this Special 510k to provide notification of the modification to our MINICAP IMMUNUNOTYPING procedure. The MINICAP IMMUNOTYPING reagent kit was originally cleared for use with the MINICAP instrument, K082388 April 14, 2009.

This modification includes a new instrument family member, MINICAP FLEX-PIERCING.

Modifications to the test system include:

New instrument family member MINICAP FLEX-PIERCING instrument using the MINICAP ● IMMUNOTYPING procedure.
A full description of the differences and similarities between performance of the MINICAP IMMUNOTYPING procedure using the MINICAP and MINICAP FLEX-PIERCING instruments is described below.

The MINICAP FLEX-PIERCING analyzer is a new member of the MINICAP family of analyzers and will use the same reagents as cleared with the MINICAP IMMUNOTYPING device.

The devices have the same intended use, detection and characterization of monoclonal proteins (immunotyping) in human serum using capillary electrophoresis.

Both devices are based on the same principles and technique following the process of:

Each serum sample is mixed with the individual antisera that are specific aqainst .. gamma ( IgG), alpha ( IgA), mu ( IgM) heavy chains and kappa and lambda ( free and bound) light chains.
The proteins are separated in silica capillaries and directly detected by their absorbance ii. at 200 nm
The electrophorograms are evaluated to detect the presence of specific reactions with iii. the suspected monoclonal proteins using PHORESIS software.

The MINICAP FLEX-PIERCING instrument was 510(k) cleared for an alternant assay MINICAP Hb A1c that has similar technical characteristic and the same software but a different sample matrix. The MINICAP Hb A1c was cleared under K133344, March 28, 2014

In accordance with the FDA policies, with this new application of the MINICAP IMMUNOTYPING assay using the MINICAP FLEX-PIERCING instrument, new labeling was added to the package insert. Sebia is following the FDA guidance to demonstrate the equivalence to the original reagent and instrument performance by using the Special 510(k) notification process.

The results of risk analysis employing acceptance criteria demonstrate the predetermined performance characteristics were met and the predetermined acceptance criteria were satisfied. The results indicate that the intended use, qualitative interpretation of the patterns were found substantially equivalent to the original device. The results demonstrate that the risk analysis demonstrates no adverse effects on the qualitative results obtained.

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The Objectives of the modification was to:

Enable the MINICAP IMMUNOTYPING procedure to be run on another instrument (i) family member the MINICAP FLEX-PIERCING instrument was adapted for capped tube whole blood testing for MINICAP HbA1c technique and was cleared as K133344, March 28, 2014.
This objective was achieved by demonstrating the modifications that were adapted for the capped tube whole blood testing for MINICAP HbA1c testing at 415 nm did not affect the performance of the MINICAP IMMUNOTYPING procedure that uses serum and testing at 200 nm using uncapped tubes.

Acceptance criteria for the modified device were predetermined as follows:

1. The same intended use claim as the unmodified device
1. Substantial equivalency to the predicate device for the detection and characterization of the monocloncal proteins (immunotyping) in human serum.
1. Performance characteristics within predetermined criteria.

Completed detailed sets of data are on file at Sebia manufacturing

Device Name and Classification

Proprietary name: MINICAP IMMUNOTYPING using the MINICAP FLEX-PIERCING

Common name : Monoclonal Immunoglobulins by Capillary Electrophoresis

Classification: Class II

Product Regulation 21 CFR Part 866.5510 Immunoglobulins (A, G, M, D, E) Immunoglobulin test system 21 CFR Part 866.5550 Immunoglobulin (light chain specific) immunoglobulin test system 21 CFR Part 862.1630 Electrophoretic, Protein Fractionation

Product Code: CFF- Immunoelectrophoretic, Immunoglobulines ( G, A, M) DFH- Kappa. Antigen. Antiserum Control DEH- Lambda, Antigen, Antiserum Control CEF- Electrophoreic, Protein Fractionation

Establishment Registration: Sebia is registration with the FDA is 8023024

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Device Description

Performance Standards

To date, no performance standards exist for this device

Intended Use

The MINICAP and MINICAP FLEX-PIERCING instruments perform 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 (Ig M) heavy chains, and kappa 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 suspected monoclonal proteins.

For In Vitro Diagnostic Use.

Predicate device

We claim substantial equivalence to the MINICAP IMMUNOTYPING using the MINICAP instrument cleared as K082388.

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Substantial equivalency Similarities

The table below demonstrates the similarities and differences between the MINICAP IMMUNOTYPING using the MINICAP instrument as compared to the MINICAP IMMUNOTYPING using the MINICAP FLEX-PIERCING instrument.

Feature	Predicate Device K082388MINICAP IMMUNOTYPING using the MINICAPInstrument	Modified DeviceMINICAP IMMUNOTYPING usingMINICAP FLEX-PIERCING Instrument
Intended Use	The MINICAP IMMUNOTYPING kit is designed for thedetection and the characterization of monoclonal proteins( immunotyping) in human serum with the MINICAP System,SEBIA, for capillary electrophoresis. It is used in conjunctionwith the MINICAP PROTEIN(E) 6 kit, SEBIA, designed forprotein separation into 6 major fractions in alkaline buffer (pH9.9).The MINICAP performs all procedural sequencesautomatically to obtain a protein profile for qualitativeanalysis. Each serum sample is mixed with individual antiserathat are specific against gamma (IgG), alpha (IgA) and mu(IgM) heavy chains, and kappa and lambda ( free and bound)light chains, respectively.The proteins, separated in silica capillaries are directlydetected bythe absorbance at 200 nm. Theelectrophoregrams are evaluated visually to detect thepresence of specific reactions with the suspected monoclonalproteins.For In Vitro Diagnostic Use	The MINICAP IMMUNOTYPING kit isdesigned for the detection and thecharacterization of monoclonal proteins( immunotyping) in human serum with theMINICAP and MINICAP FLEX- PIERCINGinstruments, SEBIA, for capillaryelectrophoresis. It is used in conjunctionwith the MINICAP PROTEIN(E) 6 kit,SEBIA, designed for protein separation into6 major fractions in alkaline buffer (pH 9.9).The MINICAP and MINICAP FLEX-PIERCING instruments perform allprocedural sequences automatically toobtain a protein profile for qualitativeanalysis. Each serum sample is mixed withindividual antisera that are specific againstgamma (IgG), alpha (IgA) and mu (IgM)heavy chains, and kappa and lambda ( freeand bound) light chains, respectively.The proteins, separated in silica capillariesare directly detected by the absorbance at200 nm. The electrophoregrams areevaluated visually to detect the presence ofspecific reactions with the suspectedmonoclonal proteins.For In Vitro Diagnostic Use
Methodology	Capillary electrophoresis	Same
Technology	Capillary electrophoretic migration with Immunofixation bySubtraction( Immunotyping)	Same
AbsorbanceWavelength	200 nm	Same
Sample Type	Serum	Same
InstrumentName	MINICAP PN 1230	MINICAP FLEX-PIERCING PN 1232
Instrument	Image: Blue MINICAP instrument	Image: Green MINICAP FLEX-PIERCING instrument
	Blue Cover	Green Cover
Instrumentdimensions	22.6 X 16.2 X 16.9	17.3 X 16.3 X 22.8
Probe	Uncapped tubes only	Cap piercing

Probe Shapeand Coating	Flat, Stainless SteelTeflon	Pointed, Stainless Steelslightly modified to enhance the hardinessof the sample probe (addition of ceramic)
Detection	Deuterium lamp, network, U.V detector, optical fibers	Deuterium lamp, LED, network, U.Vdetector, optical fibers
Lamp	Deuterium lamp	Deuterium lamp with shape changed toallow space in the instrument for LED lamp(not used with this technique)
Tuberequirement forImmunotyping	Uncapped	Uncapped
Capped andUncappedTubes (testdependent)	Not available for capped tubes	Yes
Loading ofsample tubes	Sample tubes loaded onto rotating sampler wheel	Same
Sampling	Samples taken directly from the tubes (8 to 16 mm indiameter, 50 to 100 mm high)or from 1.5 ml microtubes positioned on the primary sampletubes.Sample volume: 10 to 20 µL	Same
Number ofseparation Units	2 parallel capillaries	Same
Sampleidentification	Yes, ( Bar code reading of sample tubes)	Same
Introduction ofsamples into theautomaticsystem	Continuous loading on the rotation sampler wheel	Same
Migration	Liquid-flow capillary electrophoresis in 2 silica capillary tubes.Migrations takes place in fully controlled temperatureconditions using a Peltier device.	Same
Analysisthroughput	2 samples/hour	Same
Software	PHORESIS	Same

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	ITEMS	PN 2300
ReagentLabeling andcomposition	Sample diluent (ready to use)Rack with ELP solution and antiserum tubesELP solution (ready to use)Mammalian Immunoglobulins anti-human gamma heavy chains (ready to use)Mammalian Immunoglobulins anti-human alpha heavy chains (ready to use)Mammalian Immunoglobulins anti-human mu heavy chains (ready to use)Mammalian Immunoglobulins anti-human kappa (free and bound) light chains (ready to use)Mammalian Immunoglobulins anti-human lambda (free and bound) light chains (ready to use)	6 vials, 4.0 mL each1 vial, 1.2 mL1 vial, 1.2 mL1 vial, 1.2 mL1 vial, 1.2 mL1 vial, 1.2 mL1 vial, 1.2 mL		Same
AntiseraSpecificity	Antibody specificity to heavy chains (IgG, IgA, IgM) and to light chains (Kappa, Lambda)			Same
	SAMPLE No.		MONOCLONAL COMPONENTTYPE	CONCENTRATION (g/dL)(in the original serum)	DETECTION LIMIT (mg/dL)
Sensitivity	1	Ig A, L	AlphaLambda	2.7	25	Same
	2	Ig G, K	GammaKappa	2.9	25
	3	Ig M, K	MuKappa	1.7	25
Buffer pH	pH 9.9					Same
Serum Samplevolume requiredfor dilution:dependants ontheimmunoglobulinconcentration	< 0.8 g/dL Ig: 40 µL of serum required to make 1:10 dilution0.8 -2.0 g/dL Ig: 20 µL of serum to make 1:20 dilution; and> 2.0 g/dL Ig: 20 µL of serum to make 1:40 dilution					Same
Results	Qualitative Interpretation					Same

Proposed Labeling

The proposed labeling is attached in this submission. It includes:

1. MINICAP IMMUNOTYPING using the MINICAP FLEX-PIERCING instrument
1. MINICAP FLEX-PIERCING Instrument manual

Modifications to the MINICAP IMMUNOTYPING using the MINICAP FLEX-PIERCING instrument do not affect the intended use of the device as describe in the labeling, nor alter the fundamental scientific technology of the device. We trust that the information provided with this Special 510K will support the decision of substantial equivalence to the MINICAP IMMUNOTYPING using the MINICAP FLEX-PIERCING instrument.

If additional questions or information is required please contact: Karen Anderson, MT (ASCP)

Director of Technical and Quality Assurance Phone 1-800-835-6497 Fax 770 446 8511 or Aigars Brants , Ph,D Scientifc Affairs Officer 1-800-835-6497

Karen Anderson

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).