(468 days)
No
The description details a Western blot assay, a traditional laboratory technique, and makes no mention of AI or ML.
No.
This device is an diagnostic assay used to detect antibodies for Lyme disease, not to treat a condition.
Yes
The device is a Western blot assay intended for the qualitative detection of human IgG antibody to B. burgdorferi, used in testing human serum samples to aid in determining if a patient has been infected with the organism, thus making it a diagnostic device.
No
The device description clearly states it is a "Western blot device" and a "solid phase enzyme immunoassay (EIA)", which are laboratory test systems involving physical components and reagents, not software alone.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of human IgG antibody to B. burgdorferi" in "human serum samples." This involves testing samples taken from the human body in vitro (outside the body) to diagnose a condition (Lyme Disease).
- Device Description: The description further clarifies it's a "Western blot device for the detection of human IgG antibodies directed to the organism Borrelia burgdorferi." This reinforces the in vitro nature of the test.
- Performance Studies: The performance studies describe testing "sera" (plural of serum), which are samples of blood taken from humans.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
MarDx Lyme Disease (IgG) Marblot Strip Test System is a Western blot assay for the qualitative detection of human IgG antibody to B. burgdorferi. The MarDx Lyme Disease (1gG) Marblot Strip Test System is intended for use in testing human serum samples which have been found positive or equivocal using an EIA or IFA test procedure.
Product codes
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Device Description
The MarDx Lyme Disease (IgG) Marblot Strip Test System is a Western blot device for the detection of human IgG antibodies directed to the organism Borrelia burgdorferi. The device is similar in function to other solid phase enzyme immunoassays (EIA), but differs in its ability to discriminate the individual antibody specificities directed against the organism.
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
Twelve hundred and sixty eight sera were tested by reference Western blot and EIA methodologies to determine the agreement, sensitivity, specificity of the MarDx Lyme Disease (IgG) Marblot Strip Test System. The data indicates that the MarDx Marblot Lyme IgG Test has a high sensitivity and specificity relative to the Steere Western blot and the MarDx Lyme Disease IgG EIA Test System reference procedure. thus is performs at least as well as the predicate devices.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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 shows the logo for MarDx. The logo is in black and white and features the text "MarDx" in a bold, sans-serif font. The "X" in "MarDx" is stylized with a line extending from the top right of the "X" to the right of the logo. Above the text are four horizontal lines of varying lengths.
Diagnostics, Inc.,
5919 Farnsworth Ct, Carlsbad, CA 92008 • 800-331-2291 • CA: 619-929-0500 • FAX: 619-929-0124
JUN - 5 1996
Attachment A - 510K Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and proposed 21 CFR Part 807.92.
Identification of reference device:
- I. MarDx Lyme Disease IgG EIA Test System (K894224).
- The Lyne Western blot procedure developed and utilized by Dr. Allen Steere, MD, Tufts Medical Center, Boston , MA II. (Dressler et al. Journal of Infectious Diseases, 1993; 167:392-400) .
- III. The physicians diagnosis of the Academic Reference Centers (ARCS) panel maintained by the CDC, Fort Collins, CO.
Description of the new device:
The MarDx Lyme Disease (IgG) Marblot Strip Test System is a Western blot device for the detection of human IgG antibodies directed to the organism Borrelia burgdorferi. The device is similar in function to other solid phase enzyme immunoassays (EIA), but differs in its ability to discriminate the individual antibody specificities directed against the organism.
Statement of the intended use:
MarDx Lyme Disease (IgG) Marblot Strip Test System is a Western blot assay for the qualitative detection of human IgG antibody to B. burgdorferi. The MarDx Lyme Disease (1gG) Marblot Strip Test System is intended for use in testing human serum samples which have been found positive or equivocal using an EIA or IFA test procedure.
Comparison / Technology characteristics of the device:
The Western blot is very similar to the EIA in that both are enzyme immunoassays. In both assays the enzyme labeled bound patient antibodies are detected with a chromogenic substrate that is converted to a visible colored product at the reaction site. The final end product of the Western blot and the EIA do differ somewhat. The EIA end product is not stable over time and must be read by spectrophotometric methods within a few minutes. In contrast Western blot strips are stable for many years and may be read at any time. This difference does not effect the safety or effectiveness of the device.
Description and conclusions of the clinical studies:
Twelve hundred and sixty eight sera were tested by reference Western blot and EIA methodologies to determine the agreement, sensitivity, specificity of the MarDx Lyme Disease (IgG) Marblot Strip Test System. The data indicates that the MarDx Marblot Lyme IgG Test has a high sensitivity and specificity relative to the Steere Western blot and the MarDx Lyme Disease IgG EIA Test System reference procedure. thus is performs at least as well as the predicate devices.
Sincerely,
Arthur Markowitz
rthur Markovits, M.S President MarDx Diagnostics, Inc.
Barry E. Menefee, Ph.D.
Vice President Scientific Affairs MarDx Diagnostics, Inc.