AESKU PR3 by AESKU.DIAGNOSTICS | FDA 510(k) Summary

AESKULISA PR3 is a solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocytes for the semiquantitative and qualitative detection of antibodies against proteinase 3 in human serum.

The assay is an aid in the diagnosis of Wegener's granulomatosis and should be used in conjunction with other serological tests and clinical findings.

Device Description

solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocytes

AI/ML Overview

This document is a 510(k) clearance letter for the AESKULISA PR3 device, an in-vitro diagnostic (IVD) test. As such, it does not contain the detailed study information typically found in a clinical study report for other types of medical devices, especially those involving AI or imaging.

Here's an analysis based on the provided text, highlighting why most of your requested points cannot be directly answered:

The document confirms that the AESKULISA PR3 is a solid phase enzyme immunoassay for detecting antibodies against proteinase 3 in human serum, intended as an aid in diagnosing Wegener's granulomatosis. The clearance is based on substantial equivalence to predicate devices. This type of clearance generally relies on demonstrating that the new device performs comparably to a legally marketed predicate device, rather than requiring extensive de novo clinical studies to establish diagnostic performance against a ground truth in a clinical setting.

Therefore, many of the specific questions about acceptance criteria, study design, expert involvement, and AI performance are not applicable to this type of regulatory document for an IVD kit cleared via the 510(k) pathway.

However, based on the nature of IVD devices evaluated for substantial equivalence, we can infer some aspects and explicitly state where information is missing.

Overview of Device and Clearance Type:

Device Name: AESKULISA PR3
Device Type: In Vitro Diagnostic (IVD) - Solid phase enzyme immunoassay
Indications For Use: Semiquantitative and qualitative detection of antibodies against proteinase 3 in human serum, as an aid in the diagnosis of Wegener's granulomatosis (to be used with other serological tests and clinical findings).
Regulatory Pathway: 510(k) Premarket Notification, cleared based on Substantial Equivalence. This means the device's performance was compared to an existing, legally marketed predicate device, not necessarily proven against a gold standard in a large-scale clinical trial as if it were a novel therapeutic or diagnostic imaging AI.

Analysis of Requested Information:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in this clearance letter. For IVDs, acceptance criteria for substantial equivalence typically involve demonstrating comparable analytical performance (e.g., sensitivity, specificity, precision, accuracy, linearity, interfering substances) to a predicate device.
- Reported Device Performance: Not detailed in this clearance letter. The FDA's decision of substantial equivalence implies that the manufacturer submitted data demonstrating comparable performance to their chosen predicate device. This data would usually be found in the 510(k) submission itself, not the clearance letter.
Sample sizes used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in the clearance letter. For IVD submissions, test sets are typically patient samples used to evaluate analytical and clinical performance against the predicate.
- Data Provenance: Not specified in the clearance letter. For IVDs, samples might come from various sources (e.g., commercial banks, clinical laboratories, prospective collections), often representing the intended use population.
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 Applicable in this context. For an IVD, "ground truth" (or clinical truth) is typically established by a combination of clinical diagnosis, other laboratory tests, and/or reference methods, not by a panel of expert human readers evaluating the device's output. The device itself is a diagnostic test, providing a result (antibody detection) that contributes to the overall clinical diagnosis.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like '2+1' or '3+1' are typical for studies where human readers interpret medical images or complex clinical data and their interpretations need to be reconciled to form a ground truth or a consensus reading. This process is not relevant for an automated immunoassay kit.
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 is an IVD kit, not an AI-powered diagnostic imaging device or an AI assistant for human readers. Therefore, MRMC studies and "human readers improve with AI" metrics are irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The AESKULISA PR3 device itself is a "standalone" laboratory test in that it performs the assay and produces a result (qualitative or semiquantitative antibody level) based on the sample. There is no "human-in-the-loop" performance of the algorithm itself, as it's a chemical immunoassay, not an AI algorithm. Human involvement would be in running the test, interpreting the results for clinical context, and making a diagnosis.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Inferable, but not explicitly stated. For IVDs diagnosing conditions like Wegener's granulomatosis, the "ground truth" for clinical performance evaluation would generally be a well-established clinical diagnosis (often based on a combination of clinical symptoms, other laboratory tests, imaging, and sometimes biopsy/pathology). The device's results are then compared against this clinical diagnosis to determine its sensitivity and specificity in diagnosing the condition.
The sample size for the training set:
- Not Applicable/Not Specified. For an immunoassay, there isn't a "training set" in the machine learning sense. The assay is developed and optimized during its R&D phase, often using characterized samples, but this is different from an AI model's training set.
How the ground truth for the training set was established:
- Not Applicable/Not Specified. As above, the concept of a "training set" with established ground truth is not relevant for this type of IVD device.

Summary of What's Available vs. What's Not:

Available: Device name, regulatory class, product code, indications for use, regulatory pathway (510(k) substantial equivalence).
Not Available (and largely not applicable for this device type/clearance letter): Detailed acceptance criteria, specific performance metrics, sample sizes, data provenance details, expert qualifications, adjudication methods, MRMC studies, specific ground truth methodologies, or training set information. These details would be contained within the original 510(k) submission, which is not provided here.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

AESKU.DIAGNOSTICS c/o Dr. Sascha Pfeiffer Regulatory Affairs, Product Specialist Gastroenterology Mikroforum Ring 2 Wendelsheim, Rheinland Germany D-55234

JUN 0 3 2010

Re: K091859

Regulation Name:

Regulatory Class:

Product Code:

Trade/Device Name: AESKULISA PR3 Regulation Number: 21 CFR §866.5660 Multiple autoantibodies immunological test system Class II MOB May 25, 2010 June 1, 2010

Dear Dr. Pfeiffer:

Dated: Received:

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 class II (Special Controls), 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); medical device reporting (reporting of

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Page 2 – Dr. Sascha Pfeiffer

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 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

510(k) Number (if known): K091859

Device Name: AESKULISA PR3

Indications For Use:

The assay is an aid in the diagnosis of Wegener's granulomatosis and should be used in conjunction with other serological tests and clinical findings.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D) `

(21 CFR 807 Subpart C)

Biena Philip

Division Sign-Off

Office of In Vitro Diag Device Evaluatio 210K

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).