(428 days)
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No
The summary describes an ELISA test kit, which is a laboratory assay for detecting antibodies. There is 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 test used for diagnosis, not for treating a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test kit "is used as an aid in the diagnosis" of specific medical conditions (pemphigus foliaceus and pemphigus vulgaris).
No
The device described is an ELISA test kit, which is a laboratory assay involving physical reagents and biological samples, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The description explicitly states that the test kits are intended for the "qualitative or semi-quantitative determination of IgG class autoantibodies against desmoglein 1/3 in human serum and plasma." This involves testing biological samples in vitro (outside the body).
- Purpose: The kits are used "as an aid in the diagnosis of pemphigus foliaceus (PF)" and "as an aid in the diagnosis of pemphigus vulgaris (PV)." This clearly indicates a diagnostic purpose.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes. The provided text aligns perfectly with this definition.
N/A
Intended Use / Indications for Use
The EUROIMMUN Anti-Desmoglein 1 ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgG class autoantibodies against desmoglein 1 in human serum and plasma. It is used as an aid in the diagnosis of pemphigus .foliaceus (PF), in conjunction with other laboratory and clinical findings.
The EUROIMMUN Anti-Desmoglein 3 ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IqG class autoantibodies against desmoqiein 3 in human serum and plasma. It is used as an aid in the diagnosis of pemphigus vulgaris (PV), in conjunction with other laboratory and clinical findings.
Product codes
NBO
Device Description
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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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring. MD 20993
EUROIMMUN US INC. c/o Ms. Kathryn Kohl Managing Director 429 Rockaway Valley Road Unit 1200 Boonton Township, NJ 07005
SEP 0 2 2010
Re: K091969
Trade/Device Name: EUROIMMUN Anti- Desmoglein 1 ELISA (IgG) EUROIMMUN Anti- Desmoglein 3 ELISA (IgG) Regulation Number: 21 CFR§866.5660 Regulation Name: Multiple autoantibodies Immunological Test System Regulatory Class: Class II Product Code: NBO Dated: August 2, 2010 Received: August 9, 2010
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 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
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Page 2 - Ms. Kathryn Kohl
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 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,
ia 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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EUROIMMUN US INC.
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ATTACHMENT 2
SEP 0 2 2010
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K091969
Anti-Desmoglein 1 ELISA (IgG) Device Name: Anti-Desmoglein 3 ELISA (IgG)
Indications For Use:
The EUROIMMUN Anti-Desmoglein 1 ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgG class autoantibodies against desmoglein 1 in human serum and plasma. It is used as an aid in the diagnosis of pemphigus .foliaceus (PF), in conjunction with other laboratory and clinical findings.
The EUROIMMUN Anti-Desmoglein 3 ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IqG class autoantibodies against desmoqiein 3 in human serum and plasma. It is used as an aid in the diagnosis of pemphigus vulgaris (PV), in conjunction with other laboratory and clinical findings.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
Bena Philip
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and S
510K K091969