(252 days)
The ZEUS ELISA Borrelia VLSe-1/PepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This kit is for in vitro diagnostic use.
Not Found
This FDA 510(k) clearance letter pertains to the ZEUS ELISA Borrelia VlsE-1/pepC10 IgG/IgM Test System. However, the provided document does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a 510(k) summary (which is a separate document). The letter primarily confirms substantial equivalence to a predicate device and outlines regulatory responsibilities.
Therefore, I cannot fulfill most of your request directly from the provided text. To answer your questions, I would need access to the 510(k) summary for K113397.
Based only on the provided document, here's what can be inferred or stated about what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Information in document: Not present.
- Missing: The specific clinical performance acceptance criteria (e.g., sensitivity, specificity thresholds) and the actual performance metrics achieved by the ZEUS ELISA Borrelia VlsE-1/pepC10 IgG/IgM Test System are not provided in this regulatory letter.
2. Sample Size Used for the Test Set and Data Provenance
- Information in document: Not present.
- Missing: The number of samples used in the clinical studies to evaluate the device and details about their origin (e.g., country, retrospective/prospective collection) are not included.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Information in document: Not present.
- Missing: This document does not describe the methodology for establishing ground truth, including the number or qualifications of experts involved.
4. Adjudication Method for the Test Set
- Information in document: Not present.
- Missing: Details on how discrepancies in ground truth establishment (if applicable) were resolved are not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- Information in document: Not present.
- Missing: This type of study is more common for imaging devices where human interpretation is a key component. For an ELISA diagnostic kit, a MRMC study involving human readers comparing performance with and without AI assistance is generally not applicable, as the device output is typically quantitative or qualitative (positive/negative) and does not involve human interpretation of complex images or data fields that an AI might augment. Therefore, no effect size of human readers improving with AI vs. without AI assistance would be relevant or found for this type of device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Information in document: The device is a "Test System" (ELISA kit), implying it functions as a standalone diagnostic tool.
- Implied: Yes, the performance of an ELISA kit is inherently standalone, as it produces a result based on the chemical reaction, not on human interpretation or an "algorithm" in the AI sense. Its "performance" refers to its analytical and clinical accuracy in detecting antibodies.
7. The Type of Ground Truth Used
- Information in document: The "Indications for Use" section states: "All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi." Also, "Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data."
- Inferred based on typical Lyme disease diagnostics: For validating a Lyme disease ELISA, the ground truth for patient samples would typically be established by a combination of:
- Clinical diagnosis: Based on patient history, symptoms (e.g., erythema migrans), and other clinical findings.
- Confirmatory laboratory tests: Often a 2-tier testing algorithm as described, where initial screening (like this ELISA) is followed by a Western Blot (which is a more specific confirmatory test) and potentially other specialized tests.
- Seroprevalence in endemic vs. non-endemic populations: Using panels from confirmed Lyme patients and healthy controls from both endemic and non-endemic areas.
- Reference standard panels: From organizations like the CDC or NIBSC that provide well-characterized samples.
- Missing: The specific "ground truth" definition used for the clinical study that supported this 510(k) is not detailed.
8. The Sample Size for the Training Set
- Information in document: Not present.
- Missing: ELISA kits do not typically have a "training set" in the same way machine learning algorithms do. However, during the development of the kit, a large number of characterized samples would be used to optimize the assay's cutoff values and ensure robust performance. The size of this internal optimization/development set is not mentioned.
9. How the Ground Truth for the Training Set Was Established
- Information in document: Not present.
- Missing: As explained above, the concept of a "training set" doesn't directly apply in the AI sense. For the samples used in the development and optimization of the ELISA, the ground truth would have been established through a similar combination of clinical diagnosis and confirmatory laboratory testing as described for the test set.
To obtain the specific details requested, you would need to access the 510(k) Summary (K113397) for this device, which the FDA generally makes publicly available. That document typically contains the detailed clinical and analytical study results used to support the substantial equivalence claim.
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Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
JUL 26 2012
Zeus Scientific, Inc. c/o Ewa NadoIczak Manager of Clinical Affairs 200 Evans Way Branchburg, NJ 08876
Re: K113397
Trade/Device Name: ZEUS ELISA Borrelia V1sE-1/pepC10 IgG/IgM Test System Regulation Number: 21 CFR §866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: II Product Code: LSR Dated: June 25, 2012 Received: June 26, 2012
Dear Ms. Nadolczak:
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 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
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Page 2 - Ms. Ewa Nadolczak
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,
Salazar
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
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Indications for Use
510(k) Number: K113397 Device Name: ZEUS ELISA Borrelia VLSe-1/pepC10 IgG/IgM Test System
Indications for Use:
The ZEUS ELISA Borrelia VlsE1/PepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This kit is for in vitro diagnostic use.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Sereva
Division Sign-Off
Office of In Vitro Diagnos vice Evaluation an
Page 1 of
Device Evaluation and Saf
§ 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).