EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM by EUROIMMUN US LLC

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.

Device Description

Not Found

AI/ML Overview

This is a premarket notification (510(k)) letter from the FDA, not a study report. Therefore, it does not contain the detailed acceptance criteria or the specifics of a study proving the device meets those criteria.

The document states that the FDA has reviewed the 510(k) submission for the EUROIMMUN ANCA IFA Granulocyte BIOCHIP MOSAIC™ Test System and determined it to be substantially equivalent to legally marketed predicate devices. This means that the device is considered as safe and effective as a device already on the market, but it doesn't provide the detailed study results that would typically include acceptance criteria and performance data.

To answer your request thoroughly, a full 510(k) submission document (which is usually much more extensive than this letter) or specific study reports would be needed.

However, based on the provided text, I can infer some general information:

1. A table of acceptance criteria and the reported device performance:

Not Available. The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) or detailed device performance metrics. The FDA's determination of "substantial equivalence" implies that the submitted data met the necessary standards for comparison to a predicate device, but the specific performance numbers are not present here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Available. This information is typically found in the clinical study section of the 510(k) submission, not in the FDA's decision letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not Available. This level of detail about ground truth establishment is not provided in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Available. The document does not describe the adjudication method used for any test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This device is an in-vitro diagnostic (IVD) test system for detecting autoantibodies, not an AI-assisted diagnostic tool interpreted by human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Implied, but details not available. As an IVD test system, its performance is inherently "standalone" in the sense that the test results are produced by the system itself, not through human interpretation of an algorithm's output. However, the specific performance metrics (sensitivity, specificity, accuracy) of this standalone operation are not detailed in this letter.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Implied to be clinical diagnosis or reference methods. For an ANCA test, ground truth typically involves a clinical diagnosis of the associated autoimmune diseases (Wegener's granulomatosis, microscopic arteriitis, Churg-Strauss syndrome, polyarteriitis nodosa) established by clinical experts, often supported by other laboratory tests or histopathology. However, the document itself does not explicitly state how the ground truth was established for the studies.

8. The sample size for the training set:

Not Available. The document does not mention anything about a training set, which is more common for machine learning-based devices. This is an immunoassay test system, which generally relies on established biochemical reactions, not a deep learning model requiring a large training set in the same way.

9. How the ground truth for the training set was established:

Not Applicable/Not Available. As above, a "training set" in the context of machine learning is not directly relevant to this type of immunoassay device. If optimization or validation runs were performed, the ground truth would likely follow similar principles to those for establishing the test set performance.

Summary

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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

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Indication of Use Statement

510(k) Number (if known):

EUROIMMUN ANCAIFA Granulocyte BIOCHIP Mosaic™ Device Name:

Indications for Use:

Intended 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

K051489

Regulation Number and Section

§ 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).