(210 days)
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No
The summary describes a standard in vitro diagnostic assay and associated hardware/software for reading the results, with no mention of AI or ML capabilities.
No
This device is an in vitro diagnostic (IVD) test kit used to detect antibodies for Borrelia burgdorferi, which helps in the diagnosis of Lyme disease. It does not directly treat or prevent a disease, which are characteristics of a therapeutic device.
Yes
The device is an in vitro diagnostic (IVD) test kit used to detect IgG antibodies to Borrelia burgdorferi in human serum, providing supportive evidence of infection with B. burgdorferi, which is characteristic of a diagnostic device.
No
The device description explicitly states that the Borrelia B31 ViraChip® IgG Test Kit is an in vitro qualitative protein microarray assay and must be used with a ViraChip® Reader and the ViraChip® Software. This indicates the device includes hardware components (the test kit and the reader) in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- "in vitro qualitative protein microarray assay": This explicitly states that the test is performed outside of the body ("in vitro").
- "for the detection of IgG antibodies to Borrelia burgdorferi in human serum": This indicates that the test is analyzing a biological sample (human serum) to detect a specific substance (IgG antibodies to Borrelia burgdorferi).
- "It is intended for use in the testing of human serum samples": This further reinforces the use of biological samples for diagnostic purposes.
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The Viramed Biotech AG Borrelia B31 ViraChip® IgG Test Kit is an in vitro qualitative protein microarray assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyne disease.
The Borrelia B31 ViraChip® IgG Test Kit must be used with a ViraChip® Reader and the ViraChip® Software.
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
human serum
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, layered on top of each other.
July 12, 2017
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
VIRAMED BIOTECH AG BARRY MENEFEE OPERATIONS MANAGER 105 COPPERWOOD WAY SUITE H OCEANSIDE CA 92058
Re: K163504
Trade/Device Name: Borrelia B31 Virachip IgG Test Kit Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: II Product Code: LSR Dated: June 14, 2017 Received: June 16, 2017
Dear Dr. Menefee:
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. 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 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.
1
If you desire specific advice for your device on our labeling regulations (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/Resourcesfor You/Industry/default.htm. 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 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,
Steven R. Gitterman -S for
Uwe Scherf, 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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Indications for Use
510(k) Number (if known) K163504
Device Name Borrelia B31 ViraChip IgG Test Kit
Indications for Use (Describe)
The Viramed Biotech AG Borrelia B31 ViraChip® IgG Test Kit is an in vitro qualitative protein microarray assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyne disease.
The Borrelia B31 ViraChip® IgG Test Kit must be used with a ViraChip® Reader and the ViraChip® Software.
| 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) |
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