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The Viramed Biotech AG Borrelia All-In-One ViraChip is an in vitro qualitative microarray assay for the detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease. It is intended to detect antibodies to VIsE and multiple other B. burgdorferi antigens following a modified two-tier test methodology. Positive results from the Viramed Biotech AG Borrelia All-In-One ViraChip are supportive evidence for the presence of antibodies and exposure to B. burgdorferi, the causative agent for Lyme disease. Negative results do not preclude infection with B. burgdorferi. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures as an aid in diagnosis of Lyme disease.

The Viramed Biotech AG Borrelia All-In-One ViraChip Test must be used with a ViraChip Reader and the ViraChip Software.

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This document is an FDA 510(k) clearance letter for a medical device. It does not contain the detailed performance study results, acceptance criteria, or ground truth establishment methods as requested. The letter only states that the device is substantially equivalent to a predicate device and provides its indications for use.

Therefore, I cannot extract the information to complete the table and answer your questions directly from the provided text. The document clearly states "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...". This implies that the detailed study information would be in the 510(k) submission itself, not in the clearance letter.

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The Viramed Biotech AG Borrelia B31 Viro qualitative protein nicroaray assay for the detection of IgM antibodies to Borreia burgdorfer in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EA or FFA test procedure for B. burgdorferi antibodies. Positive essay are supportive evidence of infection with B. burgdorfer, the causative agent for Lyme disease.

The Viramed Biotech AG Borrelia B31 ViraChip® IgM Test must be used with a ViraChip® Reader and the ViraChip® Software.

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I am sorry, but the provided text does not contain the information necessary to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter for a medical device (Borrelia B31 ViraChip IgM Test Kit), which confirms that the FDA has determined the device is substantially equivalent to a legally marketed predicate device.

However, it does not contain the following specific details required to answer your request:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth establishment.
• Adjudication method.
• Information on Multi-Reader Multi-Case (MRMC) studies or effect sizes.
• Information on standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

This document is an administrative clearance letter, not a clinical study report or a summary of performance data. To get the requested information, you would typically need to review the device's 510(k) submission summary or a separate clinical study publication.

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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.

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.

The provided text is an FDA 510(k) clearance letter for the "Borrelia B31 ViraChip IgG Test Kit." This document does not contain the detailed acceptance criteria and performance study results as it is an approval letter, not the submission itself. The letter states that the FDA has "reviewed your Section 510(k) premarket notification" and "determined the device is substantially equivalent" to a predicate device.

Therefore, I cannot provide the requested information based on the provided text. The information requested, such as specific acceptance criteria for performance metrics (sensitivity, specificity), sample sizes, ground truth establishment methods, or details about comparative effectiveness studies, would typically be found in the manufacturer's 510(k) submission, which is not provided here.

The document does include the "Indications for Use" for the device, which describes its intended purpose.

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The Viramed Biotech AG Borrelia B31 IgG ViraStripe® is an in vitro qualitative 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 line blot assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyme discasc. The Viramed Biotech AG Borrelia B31 IgG ViraStripe® can be used anytime after onset of symptoms provided the EIA or IFA are positive or equivocal. It should also be used for follow-up when: 1) Only IgM antibodies were found positive in an line blot assay or Western blot, 2) IgG antibodies were found by line blot or Western blot but were not considered significant by the CDC criteria for a positive IgG Western blot, 3) previously tested sero-negative individuals are shown to develop antibodies by an EIA or IFA test.

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This document is a 510(k) premarket notification FDA approval letter for the Borrelia B31 IgG ViraStripe device. It does not contain the detailed study results, acceptance criteria, or performance data that would allow a complete answer to your request. The letter confirms substantial equivalence but does not provide the underlying data.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes, ground truth establishment, or multi-reader multi-case studies based solely on the provided text.

To answer your questions thoroughly, I would need access to the actual 510(k) summary document (K092693) which typically contains the study design, results, and acceptance criteria for in vitro diagnostic devices.

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The Viramed Biotech AG Borrelia B31 IgM ViraStripe® is an in vitro qualitative assay for the detection of IgM antibodies against 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 ElA or IFA test procedure for B. burgdorferi antibodies. Positive results from this line blot assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyme disease. The Viramed Biotech AG Borrelia B31 IgM ViraStripe® can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. Patients who are positive by IgM but not IgG should have the test repeated a few weeks later if they remain ill. If they are still positive only by IgM and have been ill longer than one month, this is likely a false positive.

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The document provided is a 510(k) clearance letter from the FDA for a device called "Borrelia B31 IgM ViraStripe®." It primarily details the regulatory approval process and includes the Indications for Use. However, it does not contain the specific information required to answer your request about acceptance criteria, reported device performance, study details (sample sizes, data provenance, expert involvement, adjudication, MRMC studies, standalone performance), or ground truth methodology.

This type of document typically references the studies conducted, but does not present their detailed findings or methodologies within the letter itself. To obtain that information, one would generally need to review the original 510(k) submission or supporting documents, which are not included here.

Therefore, I cannot provide the requested information based solely on the provided text.

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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.

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Acceptance Criteria and Device Performance for Borrelia B31 IgM Virablot®

The provided document describes the FDA's substantial equivalence determination for the Borrelia B31 IgM Virablot®, stating it is substantially equivalent to legally marketed predicate devices. However, the document does not include specific acceptance criteria or details of a study that proves the device meets those criteria. It is a regulatory clearance letter rather than a detailed performance study report.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance from the provided text. The document outlines the "Indication for Use" (refer to page 2 and 3) which broadly defines the intended application of the device, but this is distinct from specific performance metrics and their associated acceptance thresholds.

Without that specific information, I cannot answer the remaining points of your request regarding:

• Sample size and data provenance for the test set
• Number and qualifications of experts for ground truth
• Adjudication method
• MRMC comparative effectiveness study details
• Standalone performance details
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

In summary, the provided FDA 510(k) clearance letter acknowledges the device's substantial equivalence but does not contain the detailed performance data, acceptance criteria, or study design information requested.

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The Viramed Biotech Borrelia B31 IgG ViraBlot® is an in vitro qualitative 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 Western blot assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyme disease. The Viramed Biotech Borrelia B31 IgG Virablot® can be used anytime after onset provided the EIA or IFA are positive or equivocal. It should also be used for follow-up when: 1) Only IgM antibodies were found positive in a Western blot, 2) IgG antibodies were found by Western blot but were not considered significant by the CDC criteria for a positive IgG Western blot, 3) previously tested seronegative individuals are shown to develop antibodies by an EIA or IFA test.

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The user is asking for information about the acceptance criteria and study details for the "Borrelia B31 IgG Virablot®" device as outlined in the provided FDA 510(k) submission document. However, the provided text does not contain any information about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document is an FDA clearance letter for a 510(k) submission, confirming that the device, Borrelia B31 IgG Virablot®, is substantially equivalent to legally marketed predicate devices. It also includes the "Indication for Use" statement.

Therefore, I cannot fulfill the request using only the provided text.

To provide the requested information, I would need access to the actual 510(k) submission document, specifically the sections detailing the clinical and analytical studies, performance data, and validation methods.

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