CAPILLARYS IMMUNOTYPING, MODEL 2100 by SEBIA

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

The CAPILLARYS 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.

Device Description

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.

AI/ML Overview

This document is a 510(k) premarket notification approval letter for a medical device called "CAPILLARYS IMMUNOTYPING PN 2100". It establishes substantial equivalence to a predicate device, meaning it doesn't require a new PMA.

Therefore, the document does not contain the level of detail typically found in a clinical study report or a pre-market approval application regarding device performance and acceptance criteria. It primarily focuses on the regulatory approval process based on substantial equivalence.

As a result, I cannot provide the requested information in full detail from the provided text. The information below is what can be inferred or explicitly stated.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not explicitly state acceptance criteria or provide a table of performance data. An approval based on substantial equivalence implies that the device's performance is comparable to a legally marketed predicate device, but specific metrics are not detailed here.

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

This information is not present in the provided text.

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

This information is not present in the provided text.

4. Adjudication Method for the Test Set:

This information is not present in the provided text.

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 an "Immunological test system" for detecting and characterizing monoclonal proteins, which appears to be a laboratory diagnostic device, not an AI-assisted imaging or diagnostic tool relevant to MRMC studies comparing human readers with and without AI assistance. Therefore, it is highly unlikely such a study was performed or would be applicable to this device type.

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

The device description states "The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins." This indicates that human visual evaluation is part of the process, suggesting it's not a purely standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document does not specify the type of ground truth used for validation. For an immunotyping system, it would likely involve comparison to established laboratory methods or reference standards, but this is not detailed.

8. The sample size for the training set:

This information is not present in the provided text.

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

This information is not present in the provided text.

Summary of what can be extracted/inferred:

Device Name: CAPILLARYS IMMUNOTYPING, PN 2100
Intended Use: Detection and characterization of monoclonal proteins (immunotyping) in human urine and serum with the CAPILLARYS System, for capillary electrophoresis. Used with CAPILLARYS PROTEIN(E) 6 kit.
Mechanism: Performs automatic procedural sequences to obtain a protein profile. Each sample is mixed with individual antisera specific against Ig G, Ig A, Ig M heavy chains, and kappa and lambda light chains. Proteins are separated in silica capillaries and detected by absorbance at 200 nm.
Evaluation: Electrophoregrams are evaluated visually to detect specific reactions.
Regulatory Basis: Substantial equivalence to a legally marketed predicate device. This implies that the performance is considered comparable, but specific metrics are not provided in this regulatory letter itself.
Human-in-the-loop: Yes, "evaluated visually" indicates human involvement.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEBIA, Inc. c/o Ms. Karen Anderson Director of Technical and Regulatory 400-1705 Corporate Drive, Suite 400 Norcross, GA 30093

APR 1 7 2009

Re: K082085

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: April 03, 2009 Received: April 06, 2009

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.

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of

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Page 2 – Ms. Karen Anderson

substantial equivalence of your device to a legally 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 In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Maria M. Chari

Maria M. Chan, Ph.D. 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):K082085

Device name:

CAPILLARYS IMMUNOTYPING, PN 2100

Indications For Use:

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

、

Over-The Counter Use

(Optional Format 1-2-96)

Mana Mchan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 082085

-1/76

April 2009

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).