(280 days)
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Not Found
No
The summary describes an ELISA test kit, which is a laboratory assay for detecting antibodies. There is no mention of AI or ML in the intended use or any other section.
No
The device is an ELISA test kit intended for the qualitative determination of antibodies to aid in the diagnosis of Lyme disease. It does not provide any treatment or therapy.
Yes
The device is used for the qualitative determination of antibodies to aid in the diagnosis of Borrelia burgdorferi infection.
No
The device is a test kit intended for the qualitative determination of antibodies, which implies it is a physical kit containing reagents and other materials, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the test kit is for the "qualitative determination of IgC and/or IgM class antibodies against Borrelia burgdorferi in human serum and plasma". This involves testing samples taken from the human body (in vitro) to provide information about a person's health status (diagnostic).
- Sample Type: The test uses "human serum and plasma", which are biological samples taken from a patient.
- Purpose: The test is used "as an aid in the disease", specifically in the diagnosis of Borrelia burgdorferi infection (Lyme disease).
These characteristics clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EUROIMMUN Lyme ELISA (IgG/IgM) test kit is intended for the qualitative determination of IgC and/or IgM class antibodies against Borrelia burgdorferi in human serum and plasma (K++EDTA, Li+-heparin) from symptomatic patients or people suspected of B. burgdorferi infection. It is used as an aid in the disease, in conjunction with other laboratory and clinical findings. All positive and borderline results should be supplemented by a second step testing method such as Western blot.
Product codes
LSR
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
Not Found
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
Not Found
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
Not Found
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health and Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 4, 2015
EUROIMMUN US MICHAEL LOCKE DIRECTOR OF REGULATORY AFFAIRS 1100 THE AMERICAN ROAD MORRIS PLAINS NJ 07950
Re: K142038
Trade/Device Name: EUROIMMUN Lyme ELISA (IgG/IgM) Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: II Product Code: LSR Dated: July 24, 2014 Received: July 28, 2014
Dear Mr. Locke:
This letter corrects our substantially equivalent letter of May 4, 2015.
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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
1
Page 2 - Mr. Locke
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Sally A. Hoivat -S
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142038
Device Name
EUROIMMUN Lyme ELISA (IgG/IgM)
Indications for Use (Describe)
The EUROIMMUN Lyme ELISA (IgG/IgM) test kit is intended for the qualitative determination of IgC and/or IgM class antibodies against Borrelia burgdorferi in human serum and plasma (K++EDTA, Li+-heparin) from symptomatic patients or people suspected of B. burgdorferi infection. It is used as an aid in the disease, in conjunction with other laboratory and clinical findings. All positive and borderline results should be supplemented by a second step testing method such as Western blot.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sally A. Hojvat -S 2015.05.04 15:27:12 -04'00'
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