MINICAP IMMUNOTYPING, MODEL: 2300

K082388 · Sebia · CFF · Apr 14, 2009 · Immunology

Device Facts

• Record ID: K082388
• Device Name: MINICAP IMMUNOTYPING, MODEL: 2300
• Applicant: Sebia
• Product Code: CFF · Immunology
• Decision Date: Apr 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

The MINICAP IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the MINICAP System, 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 performs 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), aipha (Iq 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 the suspected monoclonal proteins. For In Vitro Diagnostic Use.

Device Story

MINICAP IMMUNOTYPING is an in vitro diagnostic kit for identifying monoclonal proteins in human serum. It utilizes capillary zone electrophoresis on the SEBIA MINICAP System. The process involves mixing serum samples with specific antisera (IgG, IgA, IgM, Kappa, Lambda) and an ELP solution. The system automatically performs sample dilution, injection into silica capillaries, and high-voltage protein separation in an alkaline buffer (pH 9.9). Proteins are detected via absorbance at 200 nm. The system generates electrophoregrams; clinicians visually compare antisera patterns against a reference ELP pattern. Disappearance or decrease of a monoclonal fraction in the presence of specific antisera indicates a gammopathy. The device is intended for clinical laboratory use, providing automated, qualitative analysis to assist in diagnosing monoclonal gammopathies.

Clinical Evidence

Bench testing only. Analytical performance included precision/reproducibility studies using normal and pathological serum samples (IgG, IgA, IgM), confirming concordant results across different reagent lots. Detection limit is 25 mg/dL. Interference testing showed no effect from hemoglobin, cholesterol, or triglycerides. Method comparison study (n=69) against the predicate device demonstrated 100% qualitative agreement.

Technological Characteristics

Capillary zone electrophoresis system using silica capillaries. Reagents include specific antisera for IgG, IgA, IgM, Kappa, and Lambda. Detection via 200 nm absorbance. Operates in alkaline buffer (pH 9.9). Automated sample dilution and loading. System uses 2 parallel capillaries. Software-controlled automation for barcode reading, dilution, and analysis.

Indications for Use

Indicated for the detection and characterization of monoclonal proteins in human serum to identify monoclonal gammopathies. For prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Sebia c/o Ms Karen Anderson Director of Technical Training and Regulatory 400-1705 Corporate Drive Norcross, Georgia 30093

APR 1 4 2009

Re: k082388

Trade/Device Name: Minicap Immunotyping (PN 2300) Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins (A, G, M, D, E) Immunological Test Systems Regulatory Class: II Product Code: CFF, DFH, DEH, CEF Dated: March 30, 2009 Received: March 31, 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); 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 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.

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## Page 2 -- Ms. Karen Anderson

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office or In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Maria M Chan

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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MINICAP IMMUNOTYPING

Page 1 of 1

510(k) Number (if known):

Device name:

MINICAP IMMUNOTYPING, PN 2300

Indications For Use:

The MINICAP IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the MINICAP System, 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 performs 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), aipha (Iq 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 the suspected 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) OR

Over-The Counter Use

(Optional Format 1-2-96)

Mana M Chen
Division Chief, Of

Division Sign-Off

アンドの流れです! ではないといったらないと思います!?!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Office of In Vitro Dlagnostic Device Evaluation and Safety

510(k) K082388

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