(71 days)
None
Not Found
No
The summary describes a standard ELISA assay for measuring antibodies and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is an in-vitro diagnostic assay used for aiding in diagnosis, not for treating or preventing a disease or condition.
Yes
The device is described as an "anti-MPO indirect solid phase enzyme immunometric assay (ELISA)" designed "to aid in the diagnosis of microscopic polyangiitis and progressive glomerulonephritis," which clearly indicates a diagnostic purpose.
No
The device description is not found, but the intended use describes an "enzyme immunometric assay (ELISA)," which is a laboratory test involving physical reagents and equipment, indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is designed for the "semiquantitative measurement of IgG class autoantibodies directed against myeloperoxidase (MPO)" and to "aid in the diagnosis of microscopic polyangiitis and progressive glomerulonephritis." This describes a test performed on biological samples (likely blood or serum) to provide information about a patient's health status and aid in diagnosis.
- Method: The description mentions an "indirect solid phase enzyme immunometric assay (ELISA)," which is a common laboratory technique used for in vitro testing of biological samples.
These characteristics clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The anti-MPO indirect solid phase enzyme immunometric assay (ELISA) is designed for the semiquantitative measurement of IgG class autoantibodies directed against myeloperoxidase (MPO) and to aid in the diagnosis of microscopic polyangiitis and progressive glomerulonephritis.
Product codes
MOB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Richard Conlev American Laboratory Products Company P.O. Box 451 Windham, NH 03087
FEB 17 1998
Re : K974701 Trade Name: Orgentec Anti-MPO(P-ANCA) ELISA Requlatory 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 Sutman
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
2
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510(k) Number (if known):_ K974701
Device Name: ALPCO ORGenTec anti-MPO (p-ANCA)
Indications For Use:
Indication Statement
The anti-MPO indirect solid phase enzyme immunometric assay (ELISA) is designed for the semiquantitative measurement of IgG class autoantibodies directed against myeloperoxidase (MPO) and to aid in the diagnosis of microscopic polyangiitis and progressive glomerulonephritis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Madsen
vision Sinn-
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OR
Over-The-Counter Use_
(Optional Format 1-2-96)