(93 days)
While there isn't a specific "Predicate Device(s) K/DEN number" listed, the text refers to another device in the "Summary of Performance Studies" section under "Study 2":
Lyme Stat
Not Found
No
The device description and performance studies describe a standard ELISA assay, which is a biochemical test, not a software-based or image processing technology that would typically incorporate AI/ML. There is no mention of AI, ML, or related concepts in the provided text.
No
The device is an ELISA kit designed for the qualitative presumptive detection of IgM antibodies to Borrelia burgdorferi in human serum to aid in the diagnosis of Lyme disease. It does not provide any treatment or therapeutic benefit.
Yes
The device is explicitly stated as an "Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative presumptive detection of IgM antibodies to Borrelia burgdorferi in human serum" and is used to "support a clinical diagnosis of Lyme disease," which are functions of a diagnostic device.
No
The device is a laboratory assay kit involving physical reagents, incubation steps, and photometric measurement, which are all hardware and chemical components, not software.
Based on the provided text, 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 IgM antibodies to Borrelia burgdorferi in human serum." This involves testing a biological sample (human serum) outside of the body to gain information about a patient's health status (presence of antibodies related to Lyme disease).
- Device Description: The description details a laboratory test (ELISA) performed on a patient specimen (serum) using reagents and a specific procedure to detect a biological marker (IgM antibodies). This is a hallmark of an in vitro diagnostic test.
- Performance Studies: The performance studies involve testing patient serum samples and comparing the results to clinical diagnoses and other laboratory tests (Western blot), which is typical for evaluating the performance of an IVD.
The core function of the device is to analyze a biological sample in vitro (outside the living organism) to provide diagnostic information.
N/A
Intended Use / Indications for Use
The Borrelia burgdorferi IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative presumptive detection of IgM antibodies to Borrelia burgdorferi in This ELISA should only be used for patients with signs and symptoms that are human serum. consistent with Lyme disease. Equivocal or positive results must 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 IgM ELISA test is an enzyme linked immunosorbent assay to detect IgM antibodies to Borrelia burgdorferi. Purified Borrelia burgdorferi antigen is attached to a solid phase microtiter well. Pretreated test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
patients of various ages
Intended User / Care Setting
Not Found
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 1: The CDC Lyme Disease Serum Panel Stratified by Time After Onset. The 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. The panel included 5 normals, and patients with Lyme disease with symptom onset: 1 year (8 samples).
Wampole B. burgdorferi IgM ELISA Results: % Agreement with Clinical Diagnosis (sensitivity) for normals was 100%, 1 year was 12.5%. The Wampole Borrelia burgdorferi IgM ELISA demonstrated 47.6% (20/42) 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 IgM ELISA and Lyme Stat. Any serum found positive or equivocal was tested by Mardx Diagnostics Western Blot on both IgG and IgM.
Western blot results for Wampole showed 6 positive and 10 negative, with 0 equivocal. For Lyme Stat, 6 positive and 9 negative, with 0 equivocal.
1-step (ELISA) pos. or eq. for Wampole was 10.8% (19/176) (95% CI: 6.1-15.5%). For Lyme Stat was 10.2% (18/176) (95% CI: 5.7-14.8%).
1-step pos. or eq. & 2-step (WB) pos. for Wampole was 3.41% (6/176) (95% CI: 0.7-6.1%). For Lyme Stat was 3.41% (6/176) (95% CI: 0.7-6.1%).
2-step pos. among 1-step pos. or eq. for Wampole was 31.6% (6/19) (95% CI: 10.3-52.9%). For Lyme Stat was 33.3% (6/18) (95% CI: 11.1-55.6%).
Precision Study: Seven sera were assayed ten times each on three different assays 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 IgM ELISA Test Kit
MAR 26 1997
- I. Immuno Probe Inc. 1306 Bailes Lane, Suite F Frederick, Maryland 21701 Contact person: William Boteler Telephone: 301-695-7920 Date of preparation: March 17, 1997
II. Description of Device
The Borrelia burgdorferi IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative presumptive detection of IgM antibodies to Borrelia burgdorferi in This ELISA should only be used for patients with signs and symptoms that are human serum. consistent with Lyme disease. Equivocal or positive results must 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 IgM ELISA test is an enzyme linked immunosorbent assay to detect IgM antibodies to Borrelia burgdorferi. Purified Borrelia burgdorferi antigen is attached to a solid phase microtiter well. Pretreated test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human 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.
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 | 1 | 0 | 7 | 8 | 12.5% |
| Total | 17 | 3 | 27 | 47 | |
Wampole B. burgdorferi IgM ELISA Result
Because the equivocals would have been tested by immunoblotting in a 2-step test system, they were considered 1-step positive for purposes of calculating % agreement. The Wampole Borrelia burgdorferi IgM ELISA demonstrated 47.6% (20/42) 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 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 | 10 |
| eq. | 0 | 3 | |
| Lyme Stat | + | 6 | 9 |
eq. 0 3
| Type of Result | Wampole | (95%CI) | Lyme Stat | (95%CI) |
|---|---|---|---|---|
| 1-step (ELISA) pos. or eq. | 10.8% | |||
| (19/176) | (6.1-15.5%) | 10.2% | ||
| (18/176) | (5.7-14.8%) | |||
| 1-step pos. or eq. & | 3.41% | (0.7-6.1%) | 3.41% | (0.7-6.1%) |
| 2-step (WB) pos. | 3.41% | |||
| (6/176) | 3.41% | |||
| (6/176) | ||||
| 2-step pos. among | ||||
| 1-step pos. or eq. | 31.6% | |||
| (6/19) | (10.3-52.9%) | 33.3% | ||
| (6/18) | (11.1-55.6%) |
3
- Precision. Seven sera were assayed ten times each on three different assays at two different sites. The intersite precision is shown in Table 3. With appropriate technique the user should obtain precision of