(104 days)
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No
The document describes a standard in vitro diagnostic assay (Western Blot) for detecting antibodies. There is no mention of AI, ML, image processing, or any computational analysis beyond what would be typical for interpreting a Western Blot result.
No
The device is an in vitro diagnostic assay used for detection of antibodies, which aids in diagnosis and is not used to treat a disease.
Yes
The device is an in vitro qualitative assay intended for the detection of IgM antibodies to Borrelia burgdorferi in human serum, with positive results providing supportive evidence of infection. This function aligns with the definition of a diagnostic device.
No
The device is an in vitro diagnostic assay, which is a laboratory test involving physical reagents and samples, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states: "The Viramed Biotech Borrelia B31 IgM ViraBlot® is an in vitro qualitative assay for the detection of IgM antibodies to Borrelia burgdorferi in human serum."
The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism. The device is designed to analyze human serum samples to detect antibodies, which is a classic example of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Viramed Biotech Borrelia B31 IgM ViraBlot® is an in vitro qualitative assay for the detection of IgM antibodies to Borrelia burgdorferi in human serum. It is intended for use in testing human serum samples which have been found insitive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this Western Blot assay are supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease. The Viramed Biotech Borrelia B31 ViraBlot can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this early period, infected patients are usually found to be Western blot positive for IgG. A positive IgM test alone is not recommended for use in determining active disease in persons with illness of longer than one month.
Product codes (comma separated list FDA assigned to the subject device)
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
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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).
0
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines forming the body and wings.
AUG 1 1 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Viramed Biotech AG c/o Barry E. Menefee, Ph.D. Chief of Operations Viralab, Inc. 1730 South Ditmar Street Oceanside, CA 92054
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K051169 Re:
Trade/Device Name: Borrelia B31 IgM Virablot® Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema Pallidum Treponemal Test Reagents Regulatory Class: Class II Product Code: LSR Dated: June 28, 2005 Received: June 29, 2005
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 eoninered prox 8 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 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 either class II (Special Controls) or class III (PMA), 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 r read be a 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 or car) I 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
1
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter with anow you to oogin manag of substantial equivalence of your device to a legally premarket notification: "The PDF interlig on for your device and thus, permits your device to proceed to the market. > - - -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
If you desire specific information about the application of labeling requirements to your device, i If you destions on the promotion and advertising of your device, please contact the Office of In or questions on the prome Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I va may ovaill other generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sally a Forry
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Appendix C. Indication of Use Statement
510(k) Number: K051169
Device Name: Borrelia B31 IgM Virablot®
Indication for Use:
The Viramed Biotech Borrelia B31 IgM ViraBlot® is an in vitro qualitative assay for the detection of IgM antibodies to Borrelia burgdorferi in human serum. It is intended for use in testing human serum samples which have been found insitive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this Western Blot assay are supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease. The Viramed Biotech Borrelia B31 ViraBlot can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this early period, infected patients are usually found to be Western blot positive for IgG. A positive IgM test alone is not recommended for use in determining active disease in persons with illness of longer than one month.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
Office of In
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Manufactured by Viramed Biotech AG, Behringstrasse, 11, Planegg/Steinkerchen എന്നിബന്ദി സ്ഥിപ്പിച്ച 760 594-7285
KOS 116 9
Diagnostic I