AESKULISA MPO, MODEL 30-7303US

K091860 · Aesku Diagnostics · MOB · Feb 23, 2010 · Immunology

Device Facts

• Record ID: K091860
• Device Name: AESKULISA MPO, MODEL 30-7303US
• Applicant: Aesku Diagnostics
• Product Code: MOB · Immunology
• Decision Date: Feb 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

AESKULISA MPO is a solid phase enzyme immunoassay employing purified native myeloperoxidase (MPO) from human peripheral blood polymorphonuclear cells for the semiquantitative and qualitative detection of antibodies against MPO in human serum. The assay is an aid in the diagnosis of autoimmune systemic vasculitis such as microscopic polyangiitis, and glomerulonephritis and should be used in conjunction with other laboratory and clinical findings.

Device Story

AESKULISA MPO is a solid-phase enzyme-linked immunosorbent assay (ELISA) for detecting anti-myeloperoxidase (MPO) antibodies in human serum. The device utilizes a 96-well microtiter plate coated with purified human MPO antigen. Patient serum is added to the wells; if anti-MPO antibodies are present, they bind to the immobilized antigen. A goat polyclonal anti-human IgG HRP-conjugate is added, binding to the antigen-antibody complex. A TMB chromogenic substrate is then introduced, producing a color change proportional to the concentration of bound antibodies. The reaction is stopped with 1M HCl and measured via a microplate reader at 450 nm. The device is intended for use in clinical laboratories by trained personnel. Results assist clinicians in the differential diagnosis of autoimmune systemic vasculitis, such as microscopic polyangiitis and crescentic glomerulonephritis. The assay provides semi-quantitative (U/mL) and qualitative (positive/negative) results.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and performance characteristics typical of enzyme immunoassays.

Technological Characteristics

Solid-phase enzyme immunoassay (ELISA). Components: 96-well microtiter plate coated with purified human neutrophil MPO, HRP-conjugated goat anti-human IgG, TMB substrate, and 1M HCl stop solution. Requires microplate reader (450 nm). Calibrated in relative arbitrary units (U/mL). Stability: 24 months at 4°C.

Indications for Use

Indicated for the semiquantitative and qualitative detection of anti-MPO antibodies in human serum as an aid in the diagnosis of autoimmune systemic vasculitis (e.g., microscopic polyangiitis, glomerulonephritis). 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002

Aesku Diagnostics c/o Dr. Sascha Pfeiffer Regulatory Affairs Manager Product Specialist Gastroenterology Mikroforum Ring 2 55234 Wendelsheim, Germany

FEB 2 3 2010

Re: k091860

. . . .

Trade/Device Name: AESKULISA MPO Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MOB Dated: February 18, 2010 Received: February 22, 2010

Dear Dr. Pfeiffer:

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 medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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Page 2 - Dr. Sascha Pfeiffer

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,

Grain in Char

Maria M. Chan, Ph.D. Director Division Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Additional information request for K091860 - February 2010

## Indications for use 2.6

510(k) Number (if known): K091860

Device Name: AESKULISA MPO

Indications For Use:

AESKULISA MPO is a solid phase enzyme immunoassay employing purified native myeloperoxidase (MPO) from human peripheral blood polymorphonuclear cells for the semiquantitative and qualitative detection of antibodies against MPO in human serum.

The assay is an aid in the diagnosis of autoimmune systemic vasculitis such as microscopic polyangiitis, and glomerulonephritis and should be used in conjunction with other laboratory and clinical findings.

Mava M. Chan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

51000 Ko91860

(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 X AND/OR (Part 21 CFR 801 Subpart D)(21 CFR 807 Subpart C)

Over-The-Counter Use