(255 days)
None
Not Found
No
The summary focuses on a test kit for detecting antibodies and lacks any mention of AI, ML, image processing, or related concepts.
No
The device is described as a "test kit" for "in vitro diagnostics use" to determine antibodies, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states, "This test kit is designed for qualitatively or semi-quantitatively determination of anti-Neutrophil cytoplasmic antibodies (ANCA) in serum. These antibodies are associated with Wegener's granulomatosis, microscopic arteriitis, Churg-Strauss syndrome and classic polyarteriitis nodosa. For in vitro diagnostics use." This explicitly indicates its use in diagnosing diseases.
No
The device is described as a "test kit" for determining antibodies in serum, which strongly implies a physical component (reagents, test strips, etc.) and is for in vitro diagnostic use, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostics use." This is the key phrase that identifies the device as an IVD.
Additionally, the intended use describes a test performed on a biological sample (serum) to detect specific antibodies (ANCA) for diagnostic purposes related to certain medical conditions. This aligns perfectly with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This test kit is designed for qualitatively or semi-quantitatively determination of anti-Neutrophil cytoplasmic antibodies (ANCA) in serum. These antibodies are associated with Wegener's granulomatosis, microscopic arteriitis, Churg-Strauss syndrome and classic polyarteriitis nodosa. For in vitro diagnostics use.
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
Not Found
Key Metrics
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the words "HEALTH & HUMAN SERVICES USA" written around the perimeter.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 6 2006
EUROIMMUN US, LLC c/o Ms Kathryn Kohl Managing Director Operations, Scientific & Regulatory Tek Campus of Morris County 429 Rockaway Valley Rd. Boonton TWP, NJ 07005
Re: K051489
Ros I 107
Trade/Device Name: EUROIMMUN ANCA IFA Granulocyte BIOCHIP MOSAIC™ Test System Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies, immunological test system Regulatory Class: Class II Product Code: MOB Dated: May 31, 2005 Received: June 14, 2005
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 nrior 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal 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 Part 801); good manufacturing practice requirements as set forth in the quality
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systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation systems (QB) 105 (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This icher with anow you to ogen mailing of substantial equivalence of your device to a legally premits to notification: "The PDF maille sification 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 rryou desire specific at (240) 276-0484. Also, please note the regulation entitled, connact the Office of Connect notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general information on your consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert M. Becker
Robert L. Becker, Jr., M.D., Ph.D., 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
2
Indication of Use Statement
510(k) Number (if known):
EUROIMMUN ANCAIFA Granulocyte BIOCHIP Mosaic™ Device Name:
Indications for Use:
Intended use:
This test kit is designed for qualitatively or semi-quantitatively determination of anti-Neutrophil cytoplasmic antibodies (ANCA) in serum. These antibodies are associated with Wegener's granulomatosis, microscopic arteriitis, Churg-Strauss syndrome and classic polyarteriitis nodosa. For in vitro diagnostics use.
× Prescription Use (Part 21 CFR § 801 Subpart D) AND / OR
Over-the-Counter Use (21 CFR § 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mona Chan
Sign-Off
Tice of In Vitro Diagnostic Device T cluation and Safety