(93 days)
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No
The device description details a standard ELISA assay, which is a biochemical test. There is no mention of AI or ML in the intended use, device description, performance studies, or key metrics. The analysis of the results is based on photometric measurement and comparison to controls, not algorithmic learning.
No
This device is an in-vitro diagnostic test used to detect antibodies for diagnostic purposes, not to provide therapy.
Yes
The device is an ELISA kit designed to detect antibodies to Borrelia burgdorferi in human serum, which is used to support a clinical diagnosis of Lyme disease for patients with consistent signs and symptoms. This process of identifying disease markers for diagnostic purposes classifies it as a diagnostic device.
No
The device description clearly outlines a physical ELISA kit involving reagents, microtiter wells, and photometric measurement, indicating it is a hardware-based diagnostic test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a disease state (Lyme disease).
- Device Description: The description details a laboratory test procedure (ELISA) performed on a human specimen (diluted test sera) using reagents and a solid phase. This is a classic description of an in vitro diagnostic test.
- Performance Studies: The inclusion of performance studies (sensitivity, precision, cross-reactivity) is typical for IVD devices to demonstrate their analytical and clinical performance.
- Predicate Device: The mention of a predicate device (BioWhittaker's Lyme STAT test) which is also an IVD, further supports that this device falls into the same category.
The core function of the device is to analyze a biological sample in vitro to aid in the diagnosis of a disease, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Borrelia burgdorferi IgG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and patients with symptoms that are consistent with Lyme disease. Equivocal or positive results should be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
Product codes
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Device Description
The Borrelia burgdorferi IgG/IgM ELISA test is an enzyme linked immunosorbent assay to detect IgGM antibodies to Borrelia burgdorferi. Purified Borrelia burgdorferi antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, thev will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibodv. An enzyme labeled anti-human IgG/IgM is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
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
The following information is from a serum panel obtained from the CDC and tested by Wampole. The results are presented as a means to convey further information on the performance of this assay with a masked, characterized serum panel. This does not imply an endorsement of the assay by the CDC.
- Study 1: CDC Lyme Disease Serum Panel Stratified by Time After Onset. Serum panel obtained from the CDC, tested by Wampole. The Wampole Borrelia burgdorferi IgGflgM ELISA demonstrated 71% (30/42) agreement (sensitivity) with clinical diagnosis of Lyme disease.
- Study 2: 176 fresh sera from patients of various ages and genders that were submitted to a large clinical lab for B. burgdorferi antibody testing were tested on the Wampole B. burgdorferi IgG/IgM ELISA and Lyme Stat. Any serum found positive or equivocal was tested by Mardx Diagnostics Western Blot on both IgG and IgM.
- Precision: Seven sera were assayed ten times each on three different plates at three different sites. An additional three serum were assayed ten times each on three different plates at two different sites. The intersite precision is shown in Table 3. With appropriate technique the user should obtain precision of
§ 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
Summary of Safety and Effectiveness Information Borrelia burgdorferi IgG/IgM ELISA Test Kit
I. Immuno Probe Inc. 1306 Bailes Lane, Suite F Frederick, Maryland 21701 Contact person: William Boteler Telephone: 301-695-7920 Date of preparation: March 4, 1997
MAR 26 1997
II. Description of Device
The Borrelia burgdorferi IgG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and patients with symptoms that are consistent with Lyme disease. Equivocal or positive results should be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
The Borrelia burgdorferi IgG/IgM ELISA test is an enzyme linked immunosorbent assay to detect IgGM antibodies to Borrelia burgdorferi. Purified Borrelia burgdorferi antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, thev will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibodv. An enzyme labeled anti-human IgG/IgM is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
III. Predicate Device
The Borrelia burgdorferi IgG/IgM ELISA test is substantially equivalent to BioWhittaker's Lyme STAT test. Equivalence is demonstrated by the following comparative results:
1
Performance Characteristics
Table 1 The CDC Lyme Disease Serum Panel Stratified by Time After Onset.
The following information is from a serum panel obtained from the CDC and tested by Wampole. The results are presented as a means to convey further information on the performance of this assay with a masked, characterized serum panel. This does not imply an endorsement of the assay by the CDC.
| Time From
Onset | + | Equivocal | - | Total | % Agreement
with Clinical
Diagnosis |
|--------------------|----|-----------|----|-------|-------------------------------------------|
| normals | 0 | 0 | 5 | 5 | 100% |
| 1yr | 8 | 0 | 0 | 8 | 100.0% |
| Total | 25 | 5 | 17 | 47 | |
Wampole B. burgdorferi IgG/IgM ELISA Result
Because the equivocals would have been tested bv immunoblotting in a 2-step test system, they were considered 1-step positive for purposes of calculating % agreement. The Wampole Borrelia burgdorferi IgGflgM ELISA demonstrated 71% (30/42) agreement (sensitivity) with clinical diagnosis of Lyme disease.
2
Study 2: 176 fresh sera from patients of various ages and genders that were submitted to a large clinical lab for B. burgdorferi antibody testing were tested on the Wampole B. burgdorferi IgG/IgM ELISA and Lyme Stat. Any serum found positive or equivocal was tested by Mardx Diagnostics Western Blot on both IgG and IgM.
Table 2: Western blot results
| Western Blot | |||
|---|---|---|---|
| + | - | ||
| Wampole | + | 6 | 3 |
| eq. | 1 | 6 | |
| Lyme Stat | + | 5 | 3 |
| eq. | 0 | 5 |
| Type of Result | Wampole (95%CI) | Lyme Stat (95%CI) |
|---|---|---|
| 1-step (ELISA) pos. or eq. | 9.1% (4.8%-13.4%) | |
| (16/176) | 7.4% (3.4%-11.3%) | |
| (13/176) | ||
| 1-step pos. or eq. & | ||
| 2-step (WB) pos. | 4% (1.0%-6.9%) | |
| (7/176) | 2.8% (0.3%-5.3%) | |
| (5/176) | ||
| 2-step pos. among | ||
| 1-step pos. or eq. | 44% (18.9%-68.6%) | |
| (7/16) | 39% (11.5%-65.4% | |
| (5/13) |
3
- Precision. Seven sera were assayed ten times each on three different plates at three different sites. An additional three serum were assayed ten times each on three different plates at two different sites. The intersite precision is shown in Table 3. With appropriate technique the user should obtain precision of