IMMUNOSCAN PR3-ANCA

K971690 · Euro-Diagnostica AB · MOB · Oct 29, 1997 · Immunology

Device Facts

• Record ID: K971690
• Device Name: IMMUNOSCAN PR3-ANCA
• Applicant: Euro-Diagnostica AB
• Product Code: MOB · 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 PR3-ANCA Kit is an enzyme immunoassay (EIA) kit for the in vitro detection in human serum of the subclass of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) directed against proteinase-3 to be used as an aid in the diagnosis of Wegener's granulomatosis.

Device Story

The Immunoscan PR3-ANCA Kit is an enzyme immunoassay (EIA) used in clinical laboratories. It detects PR3-ANCA in human serum samples. The assay utilizes standard EIA principles to identify specific autoantibodies. Results are interpreted by clinicians as an aid in diagnosing Wegener's granulomatosis. The device provides diagnostic support to physicians managing patients suspected of having this condition.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Enzyme immunoassay (EIA) kit for in vitro diagnostic use. Detects autoantibodies in human serum.

Indications for Use

Indicated for the in vitro detection of proteinase-3 (PR3) specific Anti-Neutrophil Cytoplasmic Antibodies (ANCA) in human serum as an aid in the diagnosis of Wegener's granulomatosis.

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

Euro-Diagnostica AB c/o Mr. Karl A. Posselt FDA Regulatory Consulting Services 155 Cider Mill Road Ringoes, New Jersey 08222

OCT 2 9 1997

Re: K971690 Trade Name: Immunoscan PR3-ANCA Regulatory Class: II Product Code: мов Dated: September 2, 1997 Received: September 4, 1997

Dear Mr. 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, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, 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 Register. 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 (CLIA-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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301)-------594-4588. 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.qov/cdrh/dsmamain.html"

Sincerely yours,

Steven Putman

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 FERRING Group

K971690

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

## STATEMENT OF INDICATIONS FOR USE

The Euro-Diagnostica Immunoscan PR3-ANCA Kit is an enzyme immunoassay (EIA) kit for the in vitro detection in human serum of the subclass of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) directed against proteinase-3 to be used as an aid in the diagnosis of Wegener's granulomatosis.

Peter E. Makin

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

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