(71 days)
The anti-PR3 indirect solid phase enzyme immunometric assay (ELISA) is designed for the semiquantitative measurement of IgG class autoantibodies directed against proteinase 3 (PR3) and to aid in the diagnosis of autoimmune vasculitides such as Wegener's granulomatosis.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "Orgentec Anti-PR3 (C-ANCA) ELISA" device. This type of document typically provides regulatory approval based on substantial equivalence to a predicate device, rather than detailed studies on acceptance criteria for device performance.
Therefore, the document does not contain the specific information requested regarding acceptance criteria studies, such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or the number/qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone performance.
- The type of ground truth used for test sets.
- Sample size for training sets or how ground truth for training sets was established.
The document states the device is "designed for the semi-quantitative measurement of IgG class autoantibodies directed against proteinase 3 (PR3) and to aid in the diagnosis of autoimmune vasculitides such as Wegener's granulomatosis." This is the intended use, but not detailed performance criteria.
To obtain the information requested, one would need to refer to the original 510(k) submission (K974702) by American Laboratory Products Company, which would contain the performance data and study details supporting the claims for substantial equivalence. The clearance letter itself only confirms that the FDA found the device substantially equivalent based on the submitted information.
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FEB | | 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Richard Conley American Laboratory Products Company P.O. Box 451 Windham, NH 03087
Re: K974702 Trade Name: Orgentec Anti-PR3 (C-ANCA) ELISA Regulatory Class: II Product Code: MOB Dated: December 1, 1997 Received: December 8, 1997
Dear Mr. Conley:
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 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 requirements, 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 (770)488-7655.
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 (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/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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510(k) Number (if known): K974702
Device Name: ORGenTec Anti-PR3 ELISA
Indications For Use:
ﺗﺤﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴ
The anti-PR3 indirect solid phase enzyme immunometric assay (ELISA) is designed for the semiquantitative measurement of IgG class autoantibodies directed against proteinase 3 (PR3) and to aid in the diagnosis of autoimmune vasculitides such as Wegener's granulomatosis.
IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
| Prescription Use(Per 21 CFR 801.109) | |
|---|---|
| OR Over-The-Counter Use ____(Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | X974702 |
§ 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).