(82 days)
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No
The provided text describes an ELISA-based laboratory test for detecting antibodies and does not mention any computational or algorithmic components indicative of AI/ML.
No
This device is an in vitro diagnostic (IVD) test system designed to detect antibodies to Borrelia burgdorferi. It is used to aid in the diagnosis of Lyme disease by providing supportive evidence for exposure, but it does not treat or cure any medical condition.
Yes
The device is described as "intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum" and "intended for testing serum samples from symptomatic patients or those suspected of having Lyme disease." While it states that "A diagnosis of Lyme disease should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data," its direct role in detecting antibodies to aid in the diagnosis of a specific disease makes it a diagnostic device.
No
The device description is not provided, but the intended use clearly describes an ELISA test system, which is a laboratory-based assay involving physical reagents and equipment, not solely software.
Yes, based on the provided text, the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System and the ZEUS ELISA Borrelia burgdorferi IgM Test System are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: Both devices are explicitly described as being intended for the "qualitative detection of IgG and IgM class antibodies to Borrelia burgdorferi in human serum." This involves testing biological samples (human serum) in vitro (outside the body) to obtain information about a person's health status (presence of antibodies related to Lyme disease).
- Purpose: The results are used as "supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi," which is directly related to diagnosing Lyme disease. This aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
The fact that they are ELISA-based assays, which are common laboratory tests performed on biological samples, further supports their classification as IVDs.
N/A
Intended Use / Indications for Use
The ZEUS ELISA Borrelia VIsE1/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 suspected of having Lyme disease.
Positive and equivocal test results with the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following approaches:
(1) Standard two-tier test methodology (STTT) using IgG or IgM Western blot testing following current interpretation guidelines;
or
(2) Modified two-tier test methodology (MTTT) using one of the following three ELISA-based assays:
- ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System
- · ZEUS ELISA Borrelia burgdorferi IgM Test System
- ZEUS ELISA Borrelia burgdorferi IgG Test System
Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data.
ZEUS ELISA Borrelia burgdorferi IgM Test System
The ZEUS ELISA Borrelia burgdorferi IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgM class antibodies to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease.
Positive and equivocal test results with the ZEUS ELISA Borrelia burgdorferi IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following approaches:
(3) Standard two-tier test methodology (STTT) using IgM Western blot testing following current interpretation guidelines; or
(4) Modified two-tier test methodology (MTTT) using the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System.
Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data.
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
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.
July 29, 2019
ZEUS Scientific Inc. Mark Kopnitsky Chief Scientific Officer P.O. Box 38 Raritan, New Jersey 08869
Re: K191240
Trade/Device Name: ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System ZEUS ELISA Borrelia burgdorferi IgM Test System Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LSR Dated: May 6, 2019 Received: May 8, 2019
Dear Mark Kopnitsky:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kristian Roth, Ph.D. Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191240
Device Name
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System ZEUS ELISA Borrelia burgdorferi IgM Test System
Indications for Use (Describe) ZEUS ELISA Borrelia VlsE1/pepC10 lgG/IgM Test System
The ZEUS ELISA Borrelia VIsE1/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 suspected of having Lyme disease.
Positive and equivocal test results with the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following approaches:
(1) Standard two-tier test methodology (STTT) using IgG or IgM Western blot testing following current interpretation guidelines;
or
(2) Modified two-tier test methodology (MTTT) using one of the following three ELISA-based assays:
- ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System
- · ZEUS ELISA Borrelia burgdorferi IgM Test System
- ZEUS ELISA Borrelia burgdorferi IgG Test System
Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data.
ZEUS ELISA Borrelia burgdorferi IgM Test System
The ZEUS ELISA Borrelia burgdorferi IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgM class antibodies to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease.
Positive and equivocal test results with the ZEUS ELISA Borrelia burgdorferi IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following approaches:
(3) Standard two-tier test methodology (STTT) using IgM Western blot testing following current interpretation guidelines; or
(4) Modified two-tier test methodology (MTTT) using the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System.
Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
3
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