(421 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 in vitro diagnostic (IVD) test system designed for the qualitative detection of human IgM antibody to B. burgdorferi, which aids in diagnosis rather than providing direct therapy.
Yes
The device detects human IgM antibodies to B. burgdorferi, which is used to identify individuals who have been exposed to the bacteria causing Lyme disease. This information is used in conjunction with other clinical tests for diagnosis.
No
The device description clearly states it is a "Western blot device" and a "solid phase enzyme immunoassay (EIA)", indicating it is a physical test kit with reagents and strips, not software.
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 IgM antibody to B. burgdorferi" in "human serum samples." This involves testing biological samples outside of the body to gain information about a person's health status.
- Device Description: The description further clarifies that it's a "Western blot device for the detection of human IgM antibodies directed to the organism Borrelia burgdorferi." This confirms it's a test performed on a biological sample.
- Performance Studies: The performance studies involve testing "sera" (plural of serum), which are biological samples.
All of 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 diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
MarDx Lyme Disease (IgM) Marblot Strip Test System is a Western blot assay for the qualitative detection of human IgM antibody to B. burgdorferi. The MarDx Lyme Disease (IgM) 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 (IgM) Marblot Strip Test System is a Western blot device for the detection of human IgM 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
Not Found
Mentions AI, DNN, or ML
Not Found
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
Not Found
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)
Thirteen hundred and forty one sera were tested by reference Western blot and ElA methodologies to determine the agreement, sensitivity, and specificity of the MarDx Lyme Disease (1gM) Marblot Strip Test System. The data indicates that the MarDx Marblot Lyme IgM Test has a high sensitivity relative to the Steere Western blot and the MarDx Lyme Disease IgM EIA Test System reference procedure, thus performs at least as well as the predicate devices,
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 consists of three horizontal black bars above the text "MarDX". The "X" in "MarDX" is stylized with a line extending from the bottom left to the top right, creating a sense of motion or direction.
K95/709
Diagnostics, Inc.,
5919 Farnsworth Ct, Carlsbad, CA 92008 • 800-331-2291 • CA: 619-929-0500 • FAX: 619-929-0124
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:
- MarDx Lyme Disease IgM EIA Test System (K894293). ﺎ .
- The Lyme 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 (IgM) Marblot Strip Test System is a Western blot device for the detection of human IgM 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 (IgM) Marblot Strip Test System is a Western blot assay for the qualitative detection of human IgM antibody to B. burgdorferi. The MarDx Lyme Disease (IgM) 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 vears 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:
Thirteen hundred and forty one sera were tested by reference Western blot and ElA methodologies to determine the agreement, sensitivity, and specificity of the MarDx Lyme Disease (1gM) Marblot Strip Test System. The data indicates that the MarDx Marblot Lyme IgM Test has a high sensitivity relative to the Steere Western blot and the MarDx Lyme Disease IgM EIA Test System reference procedure, thus performs at least as well as the predicate devices,
Sincerely,
Lither Roberts
Arthur Markovits, M.S.P.I President MarDx Diagnostics, Inc.
Date: 4/11/45
Bd
Barry E. Menefee, Ph.D. Vice President Scientific Affairs MarDx Diagnostics, Inc.
Date: 4/11/95