(252 days)
The EUROIMMUN Anti-PR3-hn-hr ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of IgG class autoantibodies against proteinase 3 (PR3) in human serum, EDTA plasma, lithium heparin plasma and citrate plasma. It is used as an aid in the differential diagnosis of Wegener's granulomatosis and other autoimmune vasculitides, in conjunction with other laboratory and clinical findings.
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This document is a 510(k) clearance letter from the FDA for a medical device. It does not contain the detailed information necessary to complete the requested table and study description. The letter states that the device is substantially equivalent to a legally marketed predicate device but does not provide specific acceptance criteria or the study details that prove the device meets these criteria. Such information is typically found in the 510(k) summary or the full submission, which are often available separately.
Therefore, I cannot fulfill your request with the provided text.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
EUROIMMUN US, LLC c/o Ms. Kathryn Kohl Managing Director 95 Washington St Morristown, NJ 07960
APR - 7 2009
Re: K082130
Trade/Device Name: EUROIMMUN Anti-PR3-hn-hr ELISA (IgG) Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test systems Regulatory Class: Class II Product Code: MOB Dated: February 19, 2009 Received: February 23, 2009
Dear Ms. Kohl,
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 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); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket
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Page 2 – Ms. Kathryn Kohl
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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 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 STATEMENT
510(k) Number (if known): K082130
Anti-PR3-hn-hr ELISA (IgG) Device Name:
Indications For Use:
The EUROIMMUN Anti-PR3-hn-hr ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of IgG class autoantibodies against proteinase 3 (PR3) in human serum, EDTA plasma, lithium heparin plasma and citrate plasma. It is used as an aid in the differential diagnosis of Wegener's granulomatosis and other autoimmune vasculitides, in conjunction with other laboratory and clinical findings.
Prescription Use _ X Use (Part 21 CFR 801 Subpart D) C)
AND/OR
Over-The-Counter
(21 CFR 801 Subpart
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Cases of the state and the state and the states
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
Kaven K. Smaaff
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
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).(b)
Classification. Class II (performance standards).