IBL C1Q-CIC CIA TEST

K032254 · Ibl GmbH · DAK · Aug 29, 2003 · Immunology

Device Facts

• Record ID: K032254
• Device Name: IBL C1Q-CIC CIA TEST
• Applicant: Ibl GmbH
• Product Code: DAK · Immunology
• Decision Date: Aug 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5240
• Device Class: Class 2

Intended Use

The IBL-C1q-CIC test is a quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C1q in 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.

Device Story

The IBL C1q-CIC EIA is a quantitative enzyme immunoassay (EIA) used to detect circulating immune complexes (CIC) in human serum. The device functions by measuring the binding of CIC to C1q. It is intended for use in clinical laboratory settings by trained laboratory personnel. The output is a quantitative measurement of CIC levels, which serves as one indicator within a multi-factorial diagnostic regime for autoimmune and CIC-related diseases. The test assists clinicians in the diagnostic process by providing objective data on immune complex levels.

Clinical Evidence

No clinical studies were performed. Evidence consists of analytical performance and method comparison. Precision studies (intra-assay CV 7.6-10.7%, inter-assay CV 5.4-15.5%) and method comparison against the predicate (N=80) showed 93.7% relative sensitivity, 98.4% relative specificity, and 97.5% overall agreement. Analytical specificity confirmed no interference from bilirubin, hemoglobin, or EDTA. Detection limit is 10 ug/mL.

Technological Characteristics

Solid-phase ELISA; sandwich principle. Components: monoclonal anti-C1q antibody-coated microtiter plates, monoclonal anti-human IgG-HRP conjugate, TMB substrate. Requires microtiter plate reader (450 nm). Manual assay format. Serum sample matrix.

Indications for Use

Indicated for the in vitro diagnostic detection of circulating immune complexes (CIC) that bind C1q in human serum to 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is surrounded by the words "U.S. Department of Health & Human Services" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Immuno-Biological Laboratories, Hamburg c/o Mr. Gary Lehnus Lehnus & Associates Consulting 150 Cherry Lane Road East Stroudsburg, PA 18301

AUG 2 9 2003

Re: k032254

> Trade/Device Name: IBL C1q-CIC EIA Test Regulation Number: 21 CFR § 866.5240 Regulation Name: Complement C1q, Antigen, Antiserum, Control Regulatory Class: II Product Code: DAK Dated: July 15, 2003 Received: July 22, 2003

Dear Mr. Lehnus:

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 vour 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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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,

steven Sutman

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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510(k) Number (if known): K032254

Device Name:

Indications For Use:

The IBL C1q-CIC test is a quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C1q 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)

A.L. Reeves for T. O'leary
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 15032254

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

OR

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