IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT

K971464 · Euro-Diagnostica AB · DBL · Oct 29, 1997 · Immunology

Device Facts

• Record ID: K971464
• Device Name: IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT
• Applicant: Euro-Diagnostica AB
• Product Code: DBL · Immunology
• Decision Date: Oct 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The Euro-Diagnostica Immunoscan Anti-GBM Kit is an enzyme immunoassay (EIA) kit for the in vitro diagnostic detection of anti-Glomerular Basement Membrane (GBM) antibodies in human serum. This kit is useful as an aid in the diagnosis of autoimmune renal disorders such as Goodpasture's syndrome.

Device Story

Immunoscan Anti-GBM Kit is an enzyme immunoassay (EIA) for detecting anti-GBM antibodies in human serum. Used in clinical laboratory settings by trained personnel to aid in diagnosing autoimmune renal disorders like Goodpasture's syndrome. The assay provides qualitative or semi-quantitative results to clinicians, supporting clinical assessment of patients presenting with renal symptoms.

Technological Characteristics

Enzyme immunoassay (EIA) kit for in vitro diagnostic use. Detects anti-GBM antibodies in human serum.

Indications for Use

Indicated for in vitro diagnostic detection of anti-Glomerular Basement Membrane (GBM) antibodies in human serum to aid in the diagnosis of autoimmune renal disorders, including Goodpasture's syndrome. For prescription use only.

Regulatory Classification

Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 9 1997

FDA Regulatory Consulting Services 155 Cider Mill Road Ringoes, New Jersey 08551 Re: K971464

Trade Name: Immunoscan Anti-GBM Kit Regulatory Class: II Product Code: DBL Dated: Auqust 28, 1997 Received: September 4, 1997

Dear Mr. Posselt:

Euro-Diaqnostica AB

c/o Mr. Karl A. Posselt

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in, the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CDIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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EURO-DIAGNOSTICA

Member of the FERAING Group

K971464

## 8. b). Statement Of Indications For Use

## STATEMENT OF INDICATIONS FOR USE

The Euro-Diagnostica Immunoscan Anti-GBM Kit is an enzyme immunoassay (EIA) kit for the in vitro diagnostic detection of anti-Glomerular Basement Membrane (GBM) antibodies in human serum. This kit is useful as an aid in the diagnosis of autoimmune renal disorders such as Goodpasture's syndrome.

Peter E. Maleri

(Division Sign-Off) Division of Clinical Laboratory D 510(k) Number -

Prescription ✓

Revised: 8/26/97