← Product Code [LSR](/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR) · K033070

# BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM (K033070)

_Trinity Biotech USA · LSR · Nov 26, 2003 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K033070

## Device Facts

- **Applicant:** Trinity Biotech USA
- **Product Code:** [LSR](/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR.md)
- **Decision Date:** Nov 26, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3830
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Intended Use

The Trinity Biotech Captia™ 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 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.

## Device Story

ELISA kit for qualitative presumptive detection of IgM antibodies to Borrelia burgdorferi in human serum; utilizes microassay plate coated with purified B. burgdorferi antigen (strain B-31). Patient serum incubated on plate; antigen-specific antibodies bind to solid-phase antigen. After washing, goat anti-human IgM conjugated with horseradish peroxidase added; binds to antigen-antibody complexes. Chromogen/substrate (TMB) added; enzymatic reaction produces color change proportional to antibody presence. Reaction stopped with sulfuric acid; optical density measured at 450 nm using microplate reader. Results interpreted via cutoff calibrator and correction factor. Used in clinical laboratory settings by trained personnel. Output supports clinical diagnosis of Lyme disease when combined with patient history, signs, symptoms, and mandatory supplemental Western blot testing.

## Clinical Evidence

No clinical data provided. Performance characteristics were established in the predicate device (K965129).

## Technological Characteristics

Enzyme-Linked Immunosorbent Assay (ELISA) utilizing purified B. burgdorferi antigen coated on solid-phase microtiter wells. Detection via enzyme-labeled anti-human IgM conjugate and photometric measurement of substrate color change. Manual or automated laboratory processing. No specific materials or software algorithms described beyond standard ELISA biochemical principles.

## Regulatory 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), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.

## Predicate Devices

- Borrelia Burgdorferi IgM ELISA Test System ([K965129](/device/K965129.md))

## Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K033070

B. Analyte:
Borrelia burgdorferi

C. Type of Test:
Enzyme-Linked Immunosorbent Assay

D. Applicant:
Trinity Biotech USA

E. Proprietary and Established Names:
Trinity Biotech Captia Borrelia burgdorferi IgM Enzyme-Linked Immunosorbent Assay (ELISA)

F. Regulatory Information:
1. Regulation section: 866.3830
2. Classification: Class II
3. Product Code: LSR
4. Panel: 83

G. Intended Use:
1. Intended use(s):
The Trinity Biotech Captia Borrelia burgdorferi (B. burgdorferi) IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative presumptive (first-step) detection of IgM antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with history, signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western Blot (second-step) procedure. Positive supplemental (second-step) results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The diagnosis of Lyme disease must be made based on history, signs (such as erythema migrans), symptoms, and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first- or second-step) should not be used to exclude Lyme disease.

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2. **Indication(s) 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.

3. **Special condition for use statement(s):**
Not applicable

4. **Special instrument Requirements:**
Single or dual wavelength microplate reader with 450 nm filter

## H. Device Description:

This is an ELISA kit that contains purified *B. burgdorferi* (strain B-31, passed less than 15 times, washed, concentrated and detergent treated in glycine buffer) antigen coated microassay plate in a 96 well configuration containing alternating strips of inactivated antigen and control antigen, serum diluent, cutoff calibrator, a high positive, low positive, and negative control, horseradish-peroxidase conjugate, Chromogen/substrate solution, wash buffer and stop solution.

## I. Substantial Equivalence Information:

1. **Predicate device name(s):**
Borrelia Burgdorferi IgM ELISA Test System

2. **Predicate K number(s):**
K965129

3. **Comparison with predicate:**

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Intended Use | Presumptive detection of B. burgdorferi IgM antibodies in human serum | Presumptive detection of B. burgdorferi IgM antibodies in human serum  |
|  Reagents | Tris BSA Serum Diluent
Tris Tween Wash Buffer
Goat anti-human IgG (Fc) | Tris BSA Serum Diluent
Tris Tween Wash Buffer
Goat anti-human IgG (Fc)  |
|  Technology | ELISA | ELISA  |
|  Reagents | Horseradish Peroxidase Conjugate
TMB enzyme substrate
Sulfuric Acid Stop | Horseradish Peroxidase Conjugate
TMB enzyme substrate
Sulfuric Acid Stop  |
|  Procedure | Serum incubation-20 min
Conjugate incubation-20min
Substrate incubation-10min | Serum incubation-20 min
Conjugate incubation-20min
Substrate incubation-10min  |

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|   | Stop-add 100μl of stop solution
Read at 450nm | Stop-add 100μl of stop solution
Read at 450nm  |
| --- | --- | --- |
|  Calculations | 1 cutoff calibrator, high, low, and negative controls
Multiply cutoff calibrator by correction factor | 1 cutoff calibrator, high, low, and negative controls
Multiply cutoff calibrator by correction factor  |
|  Differences  |   |   |
|  Item | Device | Predicate  |
|  None | None | None  |

J. Standard/Guidance Document Referenced (if applicable):
Not applicable

K. Test Principle:
Enzyme-Linked Immunosorbent Assays (ELISA) rely on the ability of biological materials, (i.e., antigens) to adsorb to plastic surfaces such as polystyrene (solid phase). When antigens bound to the solid phase are brought into contact with a patient's serum, antigen specific antibody, if present, will bind to the antigen on the solid phase forming antigen-antibody complexes. Excess antibody is removed by washing. This is followed by the addition of goat anti-human IgG conjugated with horseradish peroxidase which then binds to the antibody-antigen complexes. The excess conjugate is removed by washing, followed by the addition of Chromogen/Substrate, Tetramethylbenzidine (TMB). If specific antibody to the antigen is present in the patient's serum, a blue color develops. When the enzymatic reaction is stopped with 1N H2SO4, the contents of the wells turn yellow. The color, which is indicative of the presence of antibody in the serum, can be read on a suitable spectrophotometer or ELISA microwell plate reader.

L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Not Applicable. This is a change in distributor only. Performance characteristics were established in K965129.
b. Linearity/assay reportable range:
Not Applicable
c. Traceability (controls, calibrators, or method):
Not Applicable
d. Detection limit:
Not Applicable
e. Analytical specificity:
Not Applicable
f. Assay cut-off:
Not Applicable

2. Comparison studies:
a. Method comparison with predicate device:

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Not Applicable

b. Matrix comparison:
Not Applicable

3. Clinical studies:
a. Clinical sensitivity:
Not Applicable
b. Clinical specificity:
Not Applicable
c. Other clinical supportive data (when a and b are not applicable):
Not Applicable

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:
Not Applicable

M. Conclusion:
The Trinity Biotech Captia Borrelia burgdorferi IgM ELISA is substantially equivalent in performance to the predicate for the presumptive detection of $B$. burgdorferi in human serum.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K033070](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K033070)

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