(349 days)
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No
The summary describes a standard enzyme immunoassay (ELISA) kit, which is a biochemical test and does not involve AI/ML. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device is an in vitro diagnostic (IVD) immunoassay designed for the detection of antibodies to aid in the diagnosis of a disease, not to treat or prevent a disease.
Yes
The device is described as "an aid in the diagnosis of Wegener's granulomatosis," which directly indicates its use in diagnosing a medical condition.
No
The device description explicitly states it is a "solid phase enzyme immunoassay," which is a laboratory test method involving physical components (reagents, plates, etc.), not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "semiquantitative and qualitative detection of antibodies against proteinase 3 in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to gain information about a medical condition (Wegener's granulomatosis).
- Device Description: The description of a "solid phase enzyme immunoassay" is a common type of laboratory test performed in vitro.
- Aid in Diagnosis: The statement that the assay is an "aid in the diagnosis of Wegener's granulomatosis" further confirms its role in providing diagnostic information based on in vitro testing.
These characteristics align perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
MOB
Device Description
AESKULISA PR3 is a solid phase enzyme immunoassay.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 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
1
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
2
Indications for use
510(k) Number (if known): K091859
Device Name: AESKULISA PR3
Indications For Use:
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.
(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