← Product Code [LSR](/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR) · K051071

# VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT (K051071)

_Viramed Biotech AG · LSR · Aug 11, 2005 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K051071

## Device Facts

- **Applicant:** Viramed Biotech AG
- **Product Code:** [LSR](/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR.md)
- **Decision Date:** Aug 11, 2005
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3830
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

The Viramed Biotech Borrelia B31 IgG ViraBlot® is an in vitro qualitative assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this Western blot assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyme disease. The Viramed Biotech Borrelia B31 IgG Virablot® can be used anytime after onset provided the EIA or IFA are positive or equivocal. It should also be used for follow-up when: 1) Only IgM antibodies were found positive in a Western blot, 2) IgG antibodies were found by Western blot but were not considered significant by the CDC criteria for a positive IgG Western blot, 3) previously tested seronegative individuals are shown to develop antibodies by an EIA or IFA test.

## Device Story

The Borrelia B31 IgG ViraBlot® is an in vitro diagnostic Western blot assay used to detect IgG antibodies to Borrelia burgdorferi in human serum. It serves as a confirmatory test for samples previously screened as positive or equivocal by EIA or IFA methods. The device is intended for use in clinical laboratory settings by trained laboratory personnel. The assay provides qualitative results that serve as supportive evidence of Lyme disease infection. By identifying specific IgG antibodies, the test assists clinicians in confirming diagnoses for patients who have shown initial reactivity in screening tests or require follow-up due to inconclusive prior results. The output is interpreted by healthcare providers to aid in the clinical diagnosis of Lyme disease.

## Clinical Evidence

Clinical sensitivity evaluated in 100 patients: 25% (5/20) for acute erythema migrans, 25% (5/20) for convalescent erythema migrans, 60% (12/20) for early-disseminated neuroborreliosis, and 95% (38/40) for late-stage Lyme arthritis. Specificity 100% (200/200) in normal blood donors. Correlation with CDC Lyme Disease Panel 95% (42/44). CAP 2003 proficiency panel correlation 100% (15/15).

## Technological Characteristics

Western blot assay; nitrocellulose support membrane; electrophoretically isolated B. burgdorferi antigens. Manual visual interpretation of precipitated substrate bands. No electronic sensing or energy source required. Standalone diagnostic kit.

## 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.

## Submission Summary (Full Text)

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>
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
K051071

B. Purpose for Submission:
New device

C. Measurand:
IgG antibodies to *Borrelia burgdorferi*

D. Type of Test:
Western blot test

E. Applicant:
Viramed Biotech AG

F. Proprietary and Established Names:
*Borrelia B31 IgG ViraBlot®*

G. Regulatory Information:

1. Regulation section: 21CFR 866. 3830, Treponema pallidum treponemal test reagents
2. Classification: Class: II
3. Product code: 83 LSR; Reagent, Borrelia Serological Reagent
4. Panel: 83 Microbiology

H. Intended Use:

1. Intended use(s):
The Viramed Biotech Borrelia B31 IgG ViraBlot® is an *in vitro* qualitative assay for the detection of IgG antibodies to *Borrelia burgdorferi* in human serum. It is intended for use in the testing of human serum samples which have been found

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positive or equivocal using an EIA or IFA test procedure for $B$. burgdorferi antibodies. Positive results from this Western blot assay are supportive evidence of infection with $B$. burgdorferi, the causative agent for Lyme disease. The Viramed Biotech Borrelia B31 IgG Virablot® can be used anytime after onset provided the EIA or IFA are positive or equivocal. It should also be used for follow-up when: 1) Only IgM antibodies were found positive in a Western blot, 2) IgG antibodies were found by Western blot but were not considered significant by the CDC criteria for a positive IgG Western blot, 3) previously tested seronegative individuals are shown to develop antibodies by an EIA or IFA test.

2. Indication(s) for use:

The Viramed Biotech Borrelia B31 IgG ViraBlot® is an in vitro qualitative assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for $B$. burgdorferi antibodies. Positive results from this Western blot assay are supportive evidence of infection with $B$. burgdorferi, the causative agent for Lyme disease. The Viramed Biotech Borrelia B31 IgG Virablot® can be used anytime after onset provided the EIA or IFA are positive or equivocal. It should also be used for follow-up when: 1) Only IgM antibodies were found positive in a Western blot, 2) IgG antibodies were found by Western blot but were not considered significant by the CDC criteria for a positive IgG Western blot, 3) previously tested seronegative individuals are shown to develop antibodies by an EIA or IFA test.

3. Special conditions for use statement(s):

For prescription use

4. Special instrument requirements:

None

I. Device Description:

Electrophoretically isolated antigens are bound to a solid phase nitrocellulose support membrane called an immunoblot strip. For each test to be performed, the immunoblot strip and diluted test sera are placed in a well to react. If specific antibodies that recognize an antigen are present, they will bind to the specific antigens on the strip. After incubation the immunoblot strip is washed to remove unbound antibody. An enzyme labeled anti-human IgG is then added to each strip and incubated. If antibody is present, the conjugate will bind to the antibody attached to the specific antigens. The strip is washed to remove unbound conjugate and a substrate solution is added. If the enzyme/antibody complex is present, the substrate will undergo a precipitation and color change. After an incubation period, the reaction is stopped and the presence of precipitated substrate is visualized at specific locations on the strip. The presence of a colored precipitation at various

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locations on the Virastripe strip is an indirect measurement of Borrelia burgdorferi specific antibody in the patient specimen. A lot specific band locator (reacted immunoblot strip) is supplied and used to locate and identify specific Borrelia burgdorferi B31 antibodies on the test strip.

Positivity: The criteria for a positive Western blot result defined by the CDC are followed. For B. burgdorferi IgG positivity, the blot should be positive for at least 5 of the 10 protein bands: p18, p23, p28, p30, p39, p41, p45, p58, p66, and p93 kilodaltons.

## J. Substantial Equivalence Information:

1. Predicate device name(s):
B. burgdorferi (IgG) Marblot Strip Test System from MarDx

2. Predicate 510(k) number(s):
k950829

3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Procedure | Qualitative; B. burgdorferi IgG antibodies to specific protein bands. | Qualitative; B. burgdorferi IgG antibodies to specific protein bands.  |
|  Assay | Western blot | Western blot  |
|  Specimen Type | Serum | Serum  |
|  Differences  |   |   |
|  Item | Device | Predicate  |
|  Not applicable | Not applicable | Not applicable  |

## K. Standard/Guidance Document Referenced (if applicable):

Not applicable

## L. Test Principle:

Western blot

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M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:
As a measure of kit precision, 6 blind coded specimens (2 strongly positive, 2 weakly positive and 2 negative) and kit controls were tested at three laboratory sites using the same kit lot number. For this study, two different readers within the three different laboratories assessed the band identification for each sample on the same blot. Six qualified technicians at the three sites assessed the Western blot bands from the same master lot kit number of Western blot kit. All samples were correctly interpreted by the 3 laboratories and 6 readers with 100% concordance in 34 of 38 bands for IgG.

b. Linearity/assay reportable range:
Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Not applicable

d. Detection limit:
Not applicable

e. Analytical specificity:
For determination of specificity, two hundred sera from normal blood donor individuals representing endemic and non-endemic geographic regions of the United States were tested for IgG Borrelia burgdorferi antibodies by the Viramed Borrelia B31 IgG Virablot®.

Negativity = 100% (200/200)

f. Assay cut-off:
Not applicable

2. Comparison studies:

a. Method comparison with predicate device:
Western blot testing was compared to a predicate device at two sites on routinely submitted specimens. At site 1, of a total 132 specimen tested, 8 were found to be EIA positive. At site 2, of a total of 109 specimens tested, 40 were found to be EIA positive.

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|  EIA Positive / IgG WB |  | BBI Western Blot  |   |   |
| --- | --- | --- | --- | --- |
|  Prospective Site 1 |  | Pos | Neg | Total  |
|  Viramed Biotech | Pos | 3 | 0 |   |
|  Virablot® | Neg | 0 | 5 |   |
|   |  |  |  | 8  |
|  Agreement (8/8) =100%  |   |   |   |   |
|  Prospective Site 2 |  | Trinity/MarDx Western Blot  |   |   |
|   |  | Pos | Neg | Total  |
|  Viramed Biotech | Pos | 17 | 4 |   |
|  Virablot® | Neg | 2 | 17 |   |
|   |  |  |  | 40  |
|  Agreement (34/40)=85%  |   |   |   |   |

## Correlations to the CDC Lyme Disease Panel

A Lyme Disease Clinical panel containing 45 clinically defined positives and negative samples was obtained from the Center for Disease Control and Prevention, Fort Collins, Colorado.

|  Viramed Borrelia B31
IgG Western blot | CDC National
Lyme Disease Panel  |
| --- | --- |
|  Positive | 17/19  |
|  Negative | 25/25  |
|   | Correlation = 95%(42/44)  |

## College of American Pathologists 2003 Tick-borne Disease Proficiency Panel

The CAP Tick-borne Proficiency samples for the year 2003 were tested.

Samples tested: Positive 2  Negative 13

Correlation to Published CAP results proficiency = 100% (15/15)

b. Matrix comparison:

Not applicable

3. Clinical studies:

a. Sensitivity:

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One hundred sera were obtained from patients that were clinically diagnosed with Lyme borreliosis. Of these 100 sera, forty were paired (20 acute and 20 convalescent) sera from patients diagnosed with erythema migrans, 20 with early-disseminated neuroborreliosis and 40 with late stage Lyme arthritis.

|  Clinical Stage | Sensitivity  |
| --- | --- |
|  Acute/Erythema Migrans
(Sampled 8-10 days after onset) | 25% (5/20)  |
|  Convalescent/Erythema Migrans
(Sampled 4 weeks after onset) | 25% (5/20)  |
|  Early disseminated neuroborreliosis | 60% (12/20)  |
|  Late Stage Lyme Arthritis | 95% (38/40)  |

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

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K051071](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K051071)

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