IBL C3D-CIC EIA TEST

K032796 · Ibl GmbH · CZW · Jan 13, 2004 · Immunology

Device Facts

• Record ID: K032796
• Device Name: IBL C3D-CIC EIA TEST
• Applicant: Ibl GmbH
• Product Code: CZW · Immunology
• Decision Date: Jan 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5240
• Device Class: Class 2

Intended Use

The IBL C3d-CIC test is a semi-quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complexes that bind C3d in human serum. The measurement is performed as an aid in the diagnosis of various autoimmune and other CIC related diseases. Levels of these complexes are one indicator in a multifactorial diagnostic regime

Device Story

The IBL C3d-CIC EIA test is an in vitro diagnostic enzyme immunoassay used in clinical laboratory settings. It detects circulating immune complexes (CIC) that bind C3d in human serum samples. The assay functions as a semi-quantitative tool to assist clinicians in diagnosing autoimmune and CIC-related conditions. Results are intended to be used as one component of a multi-factorial diagnostic evaluation. The device provides laboratory professionals with a measured level of immune complexes, which supports clinical decision-making regarding the presence or progression of autoimmune disease.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sandwich ELISA; monoclonal anti-C3d antibody coated microplates; horseradish peroxidase-labeled anti-human IgG detection; TMB substrate; optical density measurement at 450 nm. Semi-quantitative; results expressed in µg/ml. Serum matrix only.

Indications for Use

Indicated for the semi-quantitative detection of C3d-binding circulating immune complexes (CIC) in human serum as an aid in the diagnosis of autoimmune and other CIC-related diseases.

Regulatory Classification

Identification

A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Submission Summary (Full Text)

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JAN 1 3 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Immuno-Biological Laboratories (IBL)-Hamburg C/O Lehnus and Associates Consulting 150 Cherry Lanc Rd. East Stroudsburg, PA 18301

Re: K032796

Trade/Device Name: IBL C3d-CIC EIA test Regulation Number: 21 CFR 866.5240 Regulation Name: Complement Components Immunological Test System Regulatory Class: Class II Product Code: CZW Dated: September 5, 2003 Received: September 9, 2003

Dear Mr. Lchnus:

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 IDA 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 – Mr. G. Lehnus

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Pwer Autman, M.D.

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Page __1_ of __1_

510(k) Number (if known): __ K032796

Device Name: ______IBL_C3d-CIC EIA Test

## Indications For Use:

The IBL C3d-CIC test is a semi-quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C3d in human serum. The measurement is performed as an aid in the diagnosis of various autoimmune and other CIC related diseases. Levels of these complexes are one indicator in a multi-factorial diagnostic regime.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Clinical Laboratory Devices

KO32796 510(k) Number -

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)