CAPILLARY'S IMMUNOTYPING (PN 2100) by Sebia, Inc.

The CAPILLARYS IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the SEBIA CAPILLARYS System, for capillary electrophoresis. It is used in conjunction with the CAPILLARYS PROTEIN(E) 6 or CAPILLARYS ß1-S2" kits designed for serum proteins separation into 6 major fractions in alkaline buffer (pH 9.9). Identification of Monoclonal immunoglobulins is essential for the classification of monoclonal gammopathies by the class and type of involved immunoglobulins. "For In Vitro Diagnostic Use."

Device Description

The CAPILLARYS system performs all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each sample is mixed with individual antisera that are specific against gamma (IgG), alpha (IgA) and mu (IgM) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains. The proteins fractions, separated in silica capillaries, are directly detected by their absorbance at 200 nm. The electrophoregrams are evaluated visually by comparing the profile of the untreated sample with the individual profiles treated with the respective antisera. Monoclonal immunoglobulins are thus detected and identified.

AI/ML Overview

This document does not contain the information required to populate all sections of the requested table and study description. It is a 510(k) clearance letter for the CAPILLARYS IMMUNOTYPING device, indicating substantial equivalence to a predicate device, but does not detail the specific acceptance criteria or the study data used to demonstrate performance.

Here's a breakdown of what can be extracted and what is missing:

Information Present:

Device Name: CAPILLARYS IMMUNOTYPING, PN 2100
Intended Use: Detection and characterization of monoclonal proteins (immunotyping) in human serum with the SEBIA CAPILLARYS System for capillary electrophoresis. It is used in conjunction with CAPILLARYS PROTEIN(E) 6 or CAPILLARYS ß1-S2 kits for serum protein separation.
Mechanism: Automatic procedural sequences to obtain a protein profile for qualitative analysis. Samples are mixed with individual antisera (IgG, IgA, IgM heavy chains, kappa and lambda light chains). Proteins are separated in silica capillaries and detected by absorbance at 200 nm. Electrophoregrams are evaluated visually by comparing untreated and antisera-treated profiles to detect and identify monoclonal immunoglobulins.

Information NOT Present in the Provided Document:

A table of acceptance criteria and reported device performance.
Sample size used for the test set.
Data provenance (e.g., country of origin, retrospective/prospective).
Number of experts used to establish ground truth for the test set.
Qualifications of those experts.
Adjudication method for the test set.
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
Effect size of human reader improvement with AI vs. without AI assistance.
Whether a standalone (algorithm only) performance study was done.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the test set.
Sample size for the training set.
How the ground truth for the training set was established.

Conclusion:

This document is a regulatory clearance letter. It confirms the FDA's determination of substantial equivalence for the device. However, it does not provide the detailed study results, acceptance criteria, or methodological specifics of the performance studies that would have been submitted to the FDA to support this clearance. Such details are typically found in the full 510(k) submission document, which is not provided here.

Summary

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 7 2005

Sebia, Inc. c/o Mr. Borek Janik 400-1705 Corporate Drive Norcross, GA 30093

Re: K042939

Trade/Device Name: CAPILLARYS IMMUNOTYPING, PN 2100 Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins (A,G,M,D,E) Immunological Test System Regulatory Class: Class II Product Code: CFF, DFH, DEH, CEF Dated: October 12,2004 Received: October 25, 2004

Dear Mr. Janik:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to legally

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Page 2 – Mr. Borek Janik

marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0131. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Robert Beckerf

Robert L. Becker, Jr., M.D., PhD Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 042939

Device name:

CAPILLARYS IMMUNOTYPING, PN 2100

Indications For Use:

The proteins fractions, separated in silica capillaries, are directly detected by their absorbance at 200 nm. The electrophoregrams are evaluated visually by comparing the profile of the untreated sample with the individual profiles treated with the respective antisera. Monoclonal immunoglobulins are thus detected and identified.

Identification of Monoclonal immunoglobulins is essential for the classification of monoclonal gammopathies by the class and type of involved immunoglobulins. "For In Vitro Diagnostic Use."

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Over-The Counter Use

(Optional Format 1-2-96)

Mana M. Chan

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_KO42939

Regulation Number and Section

§ 866.5550 Immunoglobulin (light chain specific) immunological test system.

(a)
Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.(b)
Classification. Class II (performance standards).