AESKU PR3

K091859 · Aesku Diagnostics · MOB · Jun 3, 2010 · Immunology

Device Facts

• Record ID: K091859
• Device Name: AESKU PR3
• Applicant: Aesku Diagnostics
• Product Code: MOB · Immunology
• Decision Date: Jun 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

AESKULISA PR3 is a solid phase enzyme immunoassay employing purified native human proteinase 3 (PR3) from human neutrophil granulocytes for the semi-quantitative and qualitative detection of antibodies against proteinase 3 in human serum. The assay is an aid in the diagnosis of Wegener’s granulomatosis and should be used in conjunction with other serological tests and clinical findings.

Device Story

AESKULISA PR3 is a solid-phase enzyme-linked immunosorbent assay (ELISA) for detecting anti-PR3 antibodies in human serum. The device uses a microtiter plate coated with purified human PR3 antigen. Patient serum is added; if anti-PR3 antibodies are present, they bind to the antigen. A secondary HRP-conjugated anti-human IgG antibody is added, forming an enzyme-labeled complex. A TMB chromogenic substrate is introduced, and the resulting color intensity, measured at 450 nm via a microplate reader, is proportional to the antibody concentration. The assay provides semi-quantitative and qualitative results. It is intended for use in clinical laboratories by trained personnel to assist in diagnosing Wegener’s granulomatosis alongside other clinical and serological findings.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Solid-phase enzyme immunoassay; 96-well microtiter plate coated with purified human PR3 antigen; HRP-conjugated goat anti-human IgG; TMB chromogenic substrate; 1M HCl stop solution. Requires microplate reader (450 nm). Calibrated in arbitrary U/mL. Stability: 24 months at 4°C.

Indications for Use

Indicated for the semiquantitative and qualitative detection of anti-proteinase 3 (PR3) antibodies in human serum as an aid in the diagnosis of Wegener's granulomatosis. For use in conjunction with other serological tests and clinical findings.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

AESKU.DIAGNOSTICS c/o Dr. Sascha Pfeiffer Regulatory Affairs, Product Specialist Gastroenterology Mikroforum Ring 2 Wendelsheim, Rheinland Germany D-55234

JUN 0 3 2010

Re: k091859

Regulation Name:

Regulatory Class:

Product Code:

Trade/Device Name: AESKULISA PR3 Regulation Number: 21 CFR §866.5660 Multiple autoantibodies immunological test system Class II MOB May 25, 2010 June 1, 2010

Dear Dr. Pfeiffer:

Dated: Received:

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 class II (Special Controls), 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); medical device reporting (reporting of

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Page 2 – Dr. Sascha Pfeiffer

medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

-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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## Indications for use

510(k) Number (if known): K091859

Device Name: AESKULISA PR3

Indications For Use:

AESKULISA PR3 is a solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocytes for the semiquantitative and qualitative detection of antibodies against proteinase 3 in human serum.

The assay is an aid in the diagnosis of Wegener's granulomatosis and should be used in conjunction with other serological tests and clinical findings.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D) `

(21 CFR 807 Subpart C)

Biena Philip

Division Sign-Off

Office of In Vitro Diag Device Evaluatio 210K