(58 days)
KXXXXXX
Mardx Diagnostics Western Blot
No
The device description and performance studies detail a standard ELISA assay, which is a biochemical test, not an AI/ML-based system. There are no mentions of AI, ML, or related concepts.
No.
This device is an in vitro diagnostic (IVD) test for detecting antibodies related to Lyme disease and provides diagnostic information, not therapy.
Yes
The device qualitatively detects IgM antibodies to Borrelia burgdorferi for the presumptive diagnosis of Lyme disease in patients with consistent signs and symptoms, and the results are used to support a clinical diagnosis. This aligns with the definition of a diagnostic device, which is used to identify or determine the presence of a disease or condition.
No
The device is an ELISA kit, which is a laboratory-based assay involving physical reagents and a microtiter plate, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kit is for the "qualitative presumptive detection of IgM antibodies to Borrelia burgdorferi in human serum." This indicates that the device is used to examine specimens derived from the human body (serum) to provide information for diagnostic purposes (detecting antibodies related to Lyme disease).
- Device Description: The description details a laboratory test (ELISA) performed on human serum to detect specific antibodies. This aligns with the definition of an in vitro diagnostic device.
- Performance Studies: The inclusion of performance studies evaluating the device's performance using human serum samples further supports its classification as an IVD.
The core function of the device is to analyze a human biological sample (serum) outside of the body to provide information relevant to a potential diagnosis (Lyme disease). This is the defining characteristic of an In Vitro Diagnostic device.
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 human serum. This ELISA should only be used for patients with signs and symptoms that are 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 (comma separated list FDA assigned to the subject device)
LSR
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
Not Found
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics:
The CDC Lyme Disease Serum Panel Stratified by Time After Onset - serum panel obtained from the CDC.
- Total samples: 47
- Results (positive/equivocal/negative):
- Normals: 0/0/5
- 1 year: 1/0/7
- % Agreement with Clinical Diagnosis:
- Normals: 100.0%
- 1 year: 12.5%
- Overall Agreement with clinical diagnosis: 47.6% (20/42), considering equivocals as positive for 1-step agreement.
Study 2:
- Sample size: 176 sera from patients of various ages and genders submitted to a large clinical lab for B. burgdorferi antibody testing.
- Test methods: Trinity Biotech B. burgdorferi IgM ELISA and BioWhittaker LYME STAT. Samples found positive or equivocal were tested by Mardx Diagnostics Western Blot (IgG and IgM).
- Results (compared to Western Blot):
- Trinity Biotech B. burgdorferi IgM ELISA positive: 6 WB+, 10 WB-
- Trinity Biotech B. burgdorferi IgM ELISA equivocal: 0 WB+, 3 WB-
- LYME STAT positive: 6 WB+, 9 WB-
- LYME STAT equivocal: 0 WB+, 3 WB-
- Key metrics:
- 1-step (ELISA) Pos. or Eq.: Trinity: 10.8% (19/176) (95%CI: 6.1-15.5%); LYME STAT: 10.2% (18/176) (95%CI: 5.7-14.8%)
- 1-step Pos. or Eq. & 2-step (WB) pos.: Trinity: 3.41% (6/176) (95%CI: 0.7-6.1%); LYME STAT: 3.41% (6/176) (95%CI: 0.7-6.1%)
- 2-step Pos. among 1-step Pos. or Eq.: Trinity: 31.6% (6/19) (95%CI: 10.3-52.9%); LYME STAT: 33.3% (6/18) (95%CI: 11.1-55.6%)
Precision:
- Seven sera assayed ten times each on three different assays at two different sites.
- Inter-Assay (n=60) CV values for samples ranged from 8.96% to 68.0%.
- Inter-Assay CV values for controls: HPC=7.04%, Cal=4.70%, LPC=5.11%, NC=64.0%.
- A total of 492 determinations: no cases of positive result for a negative serum or negative result for a positive serum.
- Equivocal sample #3: negative 23 times, positive 19 times.
- Equivocal sample #5: negative 19 times, positive 3 times.
Cross-Reactivity:
- Tested against potentially cross-reactive sera: lipemic, bilirubinemic, RPR +, dsDNA +, RF +, EBV +, CMV +, RMS +, elevated ESR, and CRP.
- All tested cross-reactive samples showed 0 positives.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement with clinical diagnosis: 47.6% (20/42)
1-step (ELISA) Pos. or Eq.: Trinity: 10.8% (19/176); LYME STAT: 10.2% (18/176)
1-step Pos. or Eq. & 2-step (WB) pos.: Trinity: 3.41% (6/176); LYME STAT: 3.41% (6/176)
2-step Pos. among 1-step Pos. or Eq.: Trinity: 31.6% (6/19); LYME STAT: 33.3% (6/18)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Bio Whittaker's Lyme M STAT test. KXXXXXX (K number not explicitly provided)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Mardx Diagnostics Western Blot (K number not explicitly provided)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
NOV 26 2003
Summary of Safety and Effectiveness Information Borrelia burgdorferi IgM ELISA Test Kit
I. Trinity Biotech 2823 Girts Road Jamestown, NY 14701 Contact person: Bonnie B. DeJoy Telephone: 716-483-3851 Date of preparation: Nov. 20, 2003
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 human serum. This ELISA should only be used for patients with signs and symptoms that are 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.
III. Predicate Device
The Borrelia burgdorferi IgM ELISA test is substantially equivalent to Bio Whittaker's Lyme M STAT test. Equivalence is demonstrated by the following comparative results:
Performance Characteristics
The CDC Lyme Disease Serum Panel Stratified by Time After OnsetThe following information is from a serum panel obtained from the CDC and tested by Trinity Biotech. 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.
1
| Time From
Onset | positive | equivocal | negative | Total | %Agreement
with Clinical
Diagnosis |
|--------------------|----------|-----------|----------|-------|------------------------------------------|
| normals | 0 | 0 | 5 | 5 | 100.0% |
| 1 year | 1 | 0 | 7 | 8 | 12.5% |
| Total | 17 | 3 | 27 | 47 | |
Table 1 Trinity Biotech B. burgdorferi IgM ELISA Results
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 Trinity Biotech B. burgdorferi IgM ELISA demonstrated 47.6% (20/42) agreement with clinical diagnosis of Lyme disease.
Study 2
One hundred seventy-six 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 Trinity Biotech B. burgdorferi IgM ELISA and BioWhittaker LYME STAT. Any serum found positive or equivocal was tested by Mardx Diagnostics Western Blot on both IgG and IgM. The results are illustrated in Table 2.
Table 2
| Western Blot | ||||||
|---|---|---|---|---|---|---|
| + | + | - | ||||
| Trinity Biotech | + | 6 | 10 | |||
| B. burgdorferi eq. | ||||||
| IgM | 0 | 3 | ||||
| LYME STAT | + | 6 | 9 | |||
| eq. | 0 | 3 | ||||
| Type of Result | Trinity | (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. & | ||||||
| 2-step (WB) pos. | 3.41% | |||||
| (6/176) | (0.7-6.1%) | 3.41% | ||||
| (6/176) | (0.7-6.1%) | |||||
| 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%) | |||||
| CI = Confidence Interval |
2
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 Division Sign-Off |
|---|
Office of In Vitro Diagnostic DeviceOmoo tion and Safety
510(k) Ro33070