← Product Code [LSR](/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR) · K172254

# Lyme B. burgdorferi (IgM) MarStripe Test (K172254)

_Trinity Biotech · LSR · Oct 23, 2017 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K172254

## Device Facts

- **Applicant:** Trinity Biotech
- **Product Code:** [LSR](/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR.md)
- **Decision Date:** Oct 23, 2017
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3830
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Intended Use

Lyme B. burgdorferi (IgM) MarStripe Test is an immunoblot assay for the in vitro qualitative detection of human IgM antibody to individual proteins of Borrelia burgdorferi in human serum or plasma (K₂-EDTA) in samples which have been found positive or equivocal using an EIA or IFA test procedure to provide supportive evidence of infection with B. burgdorferi.

## Device Story

The Lyme B. burgdorferi (IgM) MarStripe Test is an immunoblot assay used to detect human IgM antibodies against specific B. burgdorferi antigens. The device utilizes nitrocellulose test strips containing purified B. burgdorferi antigens and quality control lines. Patient serum or plasma samples are diluted and incubated with the strips; reactive IgM antibodies bind to the antigens. An IgM-HRP conjugate is added, followed by a substrate that produces a colorimetric reaction for visual interpretation of bound antibodies. The test is performed in a clinical laboratory setting by trained personnel. The output is a qualitative visual assessment of antibody presence, which provides supportive evidence of B. burgdorferi infection. Results are used by clinicians in conjunction with patient history and other clinical findings to aid in the diagnosis of Lyme disease.

## Clinical Evidence

Prospective study (n=676) comparing subject device to predicate IgM Western blot on EIA-positive specimens showed 93.5% positive and 93.5% negative agreement. Sensitivity evaluated on 87 characterized clinical specimens (18.4% vs 19.5% for predicate). CDC panel testing (n=42) showed 23.8% sensitivity vs 31.0% for predicate. Analytical specificity 99.5% (n=220). Precision and reproducibility studies (n=576) demonstrated high qualitative agreement.

## Technological Characteristics

Immunoblot assay; nitrocellulose strips with purified B. burgdorferi antigens; HRP-conjugated anti-human IgM; TMB substrate/chromogen; visual read-out. Compatible with human serum and K2-EDTA plasma. Manual test procedure.

## 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

- MarDx B. burgdorferi IgM MarBlot Strip Test System ([K951709](/device/K951709.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

1

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
K172254

B. Purpose for Submission:
To obtain a substantial equivalence determination and FDA clearance for a new device.

C. Measurand:
Anti-Borrelia burgdorferi (IgM) antibodies

D. Type of Test:
Enzyme Immunoassay

E. Applicant:
Immco Diagnostics

F. Proprietary and Established Names:
Lyme B. burgdorferi (IgM) MarStripe Test

G. Regulatory Information:

1. Regulation section:
21 CFR 866.3830; Treponema pallidum treponemal test reagents

2. Classification:
Class II

3. Product code:
LSR; Reagent, Borrelia Serological Reagent

4. Panel:
Microbiology

{1}

H. Intended Use:

1. Intended use(s):

Lyme B. burgdorferi (IgM) MarStripe Test is an immunoblot assay for the in vitro qualitative detection of human IgM antibody to individual proteins of Borrelia burgdorferi in human serum or plasma (K₂-EDTA) in samples which have been found positive or equivocal using an EIA or IFA test procedure to provide supportive evidence of infection with B. burgdorferi.

2. Indication(s) for use:

Same as Intended Use

3. Special conditions for use statement(s):

For prescription use only

4. Special instrument requirements:

Not applicable (N/A)

I. Device Description:

The kit is an immunoblot method to detect IgM antibodies against B. burgdorferi antigens. The test kit contains:

- Test strips. Purified B. burgdorferi antigens (3) and quality control lines (3) on nitrocellulose are present in specific positions
- Diluent. Provided for specimen dilutions
- Positive Control
- Negative Control
- Conjugate. IgM-HRP Conjugate binds reactive antibodies to the Substrate
- Substrate. Provides colorimetric reaction for visual read of bound antibodies
- Wash Buffer. Removes reagents and unbound antibodies after incubation steps

J. Substantial Equivalence Information:

1. Predicate device name(s):

MarDx B. burgdorferi IgM MarBlot Strip Test System

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

K951709

{2}

3. Comparison with predicate:

|  Parameter | New device Lyme B. burgdorferi (IgM) MarStripe Test | Predicate device MarDx B. burgdorferi IgM MarBlot Strip Test System (K951709)  |
| --- | --- | --- |
|  Similarities |  |   |
|  Intended Use | Lyme B. burgdorferi (IgM) MarStripe Test is an immunoblot assay for the in vitro qualitative detection of human IgM antibody to individual proteins of Borrelia burgdorferi in human serum or plasma (K2-EDTA) in samples which have been found positive or equivocal using an EIA or IFA test procedure to provide supportive evidence of infection with B. burgdorferi. | MarDx B. burgdorferi (IgM) MarBlot Strip Test System is a immunoblot assay for the in vitro qualitative detection of human IgM antibody to individual proteins of Borrelia burgdorferi in human serum or plasma (K2-EDTA) in samples which have been found positive or equivocal using an EIA or IFA test procedure to provide supportive evidence of infection with B. burgdorferi.  |
|  Detection of antibodies | 3 antibodies directed against Borrelia burgdorferi IgM antigens associated with Lyme disease | 3 antibodies directed against Borrelia burgdorferi IgM antigens associated with Lyme disease  |
|  Quantitation | Qualitative | Qualitative  |
|  Component set | Includes B. burgdorferi MarStripe test strips, B. burgdorferi IgM Positive Control, B. burgdorferi Negative Control, Conjugate (Anti- Human IgM), Substrate, Diluent and Wash Buffer | Includes B. burgdorferi Marblot strips, B. burgdorferi WB IgM Serum Band Locator, B. burgdorferi WB Weakly Reactive IgM Control, B. burgdorferi Negative Control, Alkaline Phosphatase Conjugate (Anti-Human IgM), Alkaline Phosphatase Developing Solution, 10x Sample Diluent Wash Solution  |
|  Positive control | Anti-B. burgdorferi IgM antibodies | Anti-B. burgdorferi IgM antibodies  |
|  Screening dilution | 1:101 | 1:101  |
|  Reading | Visual | Visual  |
|  Storage | 2-8°C | 2-8°C  |
|  Calibrators | Single control | Single control  |
|  |   |   |
|  Differences |  |   |
|  Methodology | ImmunoBlot/LIA | ImmunoBlot/Western blot  |
|  Conjugate | Horseradish peroxidase | Alkaline Phosphatase  |
|  Substrate/Chromogen | Tetramethylbenzidine (TMB) | BCIP/NBT  |
|  Cutoff | Cutoff Control line | 41kD band of Weakly Reactive Control Strip  |
|  Matrix | Serum or Plasma | Serum  |

{3}

4

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

FDA Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi, published July, 2013.

CLSI M34-A: Western Blot Assay for Antibodies to Borrelia burgdorferi

CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures

CLSI EP12-A2: User Protocol for Evaluation of Qualitative Test Performance

CLSI EP7-A2: Interference Testing in Clinical Chemistry

CLSI EP9-A2: Method Comparison Bias Estimation Using Patient Samples

L. Test Principle:

Enzyme Immunoassay

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Precision. A panel of eight specimens were tested. Each specimen was tested in 4 replicates on each run, two runs per day over 12 days for a total of 96 tests for each specimen. Samples were selected based on FDA cleared B. burgdorferi ELISA results, including 2 low negative samples, 2 high negative samples, 1 cutoff sample, 1 low positive sample and 2 moderate positive samples. The cutoff specimen presented reactions near the cutoff control for two bands.

Qualitative agreement was 100% for the results of seven specimens; the cutoff specimen produced a positive result in 78/96 replicates (81.3%). A summary of results by antibody line is provided in Table 1 below:

{4}

Table 1. Summary of Precision Results by Antibody Line

|  Sample |  | EIA Value | pH | pH | pH  |
| --- | --- | --- | --- | --- | --- |
|  1 | Low Negative | 0.22 |  |  |   |
|   |  Band Type |  | Neg. | Neg. | Neg.  |
|   |  Positives |  | 0 | 0 | 0  |
|   |  Negatives |  | 96 | 96 | 96  |
|   |  % Positive |  | 0.0% | 0.0% | 0.0%  |
|  2 | Low Negative | 0.20 |  |  |   |
|   |  Band Type |  | Neg. | Neg. | Neg.  |
|   |  Positives |  | 0 | 0 | 3  |
|   |  Negatives |  | 96 | 96 | 93  |
|   |  % Positive |  | 0.0% | 0.0% | 3.1%  |
|  3 | High Negative | 0.80 |  |  |   |
|   |  Band Type |  | Neg. | Neg. | Neg.  |
|   |  Positives |  | 0 | 0 | 0  |
|   |  Negatives |  | 96 | 96 | 96  |
|   |  % Positive |  | 0.0% | 0.0% | 0.0%  |
|  4 | High Negative | 0.87 |  |  |   |
|   |  Band Type |  | Neg. | Neg. | Cut.  |
|   |  Positives |  | 0 | 0 | 3  |
|   |  Negatives |  | 96 | 96 | 93  |
|   |  % Positive |  | 0.0% | 0.0% | 3.1%  |
|  5 | Low Positive | 1.31 |  |  |   |
|   |  Band Type |  | Pos. | Neg. | Pos.  |
|   |  Positives |  | 96 | 0 | 96  |
|   |  Negatives |  | 0 | 96 | 0  |
|   |  % Positive |  | 100.0% | 0.0% | 100.0%  |
|  6 | Cutoff | 1.37 |  |  |   |
|   |  Band Type |  | Cut. | Neg. | Wpos.  |
|   |  Positives |  | 88 | 0 | 79  |
|   |  Negatives |  | 8 | 96 | 17  |
|   |  % Positive |  | 91.7% | 0.0% | 82.3%  |
|  7 | Moderate Positive | 3.36 |  |  |   |
|   |  Band Type |  | Pos. | Neg. | Pos.  |
|   |  Positives |  | 96 | 0 | 96  |
|   |  Negatives |  | 0 | 96 | 0  |
|   |  % Positive |  | 100.0% | 0.0% | 100.0%  |
|  8 | Moderate Positive | 2.92 |  |  |   |
|   |  Band Type |  | Pos. | Pos. | Pos.  |
|   |  Positives |  | 96 | 96 | 96  |
|   |  Negatives |  | 0 | 0 | 0  |
|   |  % Positive |  | 100.0% | 100.0% | 100.0%  |

Pos = positive band. Neg = negative band. Wpos = weak positive band. Cut = equivocal band.

Reproducibility. A panel of eight specimens was tested at three laboratories (2 external, 1 internal). At each site, each specimen was tested in 4 replicates per run, two runs per day over 12 days for a total of 288 tests. Results were read by 2 human operators at each site, equaling a total of 576 read-outs. Samples were selected based on FDA cleared B. burgdorferi ELISA results The cutoff specimen was chosen so that two bands were near the cutoff control.

{5}

Final positive or negative agreement was 100% for both low negative samples, one high negative and one moderate positive sample. One high negative sample produced a 99.7% negative agreement. One low positive and one moderate positive sample produced a 99.3% positive agreement. The cut off sample produced a 68.4% positive agreement. A summary of results by antibody line is provided in Table 2 below.

Table 2. Summary of Reproducibility Results by Antibody Line

|   | Sample | EIA Value | pH | pH | ΔT  |
| --- | --- | --- | --- | --- | --- |
|  1 | Low Negative | 0.22 |  |  |   |
|   |  Band Type |  | Neg. | Neg. | Neg.  |
|   |  Positives |  | 0 | 0 | 1  |
|   |  Negatives |  | 576 | 576 | 575  |
|   |  % Positive |  |  |  |   |
|  2 | Low Negative | 0.20 | 0.0% | 0.0% | 0.2%  |
|   |  Band Type |  | Neg. | Neg. | Neg.  |
|   |  Positives |  | 0 | 0 | 26  |
|   |  Negatives |  | 576 | 576 | 550  |
|   |  % Positive |  |  |  |   |
|  3 | High Negative | 0.80 | 0.0% | 0.0% | 4.5%  |
|   |  Band Type |  | Neg. | Neg. | Neg.  |
|   |  Positives |  | 0 | 0 | 0  |
|   |  Negatives |  | 576 | 576 | 576  |
|   |  % Positive |  |  |  |   |
|  4 | High Negative | 0.87 | 0.0% | 0.0% | 0.0%  |
|   |  Band Type |  | Neg. | Neg. | Cut.  |
|   |  Positives |  | 1 | 2 | 58  |
|   |  Negatives |  | 575 | 574 | 518  |
|   |  % Positive |  |  |  |   |
|  5 | Low Positive | 1.31 | 0.2% | 0.3% | 10.1%  |
|   |  Band Type |  | Pos. | Neg. | Pos.  |
|   |  Positives |  | 572 | 0 | 576  |
|   |  Negatives |  | 4 | 576 | 0  |
|   |  % Positive |  |  |  |   |
|  6 | Cutoff | 1.37 | 99.3% | 0.0% | 100.0%  |
|   |  Band Type |  | Cut. | Neg. | WPos.  |
|   |  Positives |  | 442 | 0 | 504  |
|   |  Negatives |  | 134 | 576 | 72  |
|   |  % Positive |  |  |  |   |
|  7 | Moderate Positive* | 3.36 | 76.7% | 0.0% | 87.5%  |
|   |  Band Type |  | Pos. | Neg. | Pos.  |
|   |  Positives |  | 573 | 0 | 572  |
|   |  Negatives |  | 1 | 574 | 2  |
|   |  % Positive |  |  |  |   |
|  8 | Moderate Positive | 2.92 | 99.8% | 0.0% | 99.7%  |
|   |  Band Type |  | Pos. | Pos. | Pos.  |
|   |  Positives |  | 576 | 572 | 576  |
|   |  Negatives |  | 0 | 4 | 0  |
|   |  % Positive |  | 100.0% | 99.3% | 100.0%  |

* Two replicates of this run are missing due to lack of sample.

b. Linearity/assay reportable range: Not applicable (N/A)

c. Traceability, Stability, Expected values (controls, calibrators, or methods): N/A

{6}

d. Detection limit: N/A
e. Analytical specificity:

Sera from 220 normal individuals, with no history of physician-diagnosed Lyme disease representing endemic and non-endemic geographic regions of the United States were tested with the Lyme B. burgdorferi (IgM) Marstripe Test. Analytical specificity was determined to be  $99.5\%$  (95% CI:  $97.1\% - 100\%$ ). See Tables 3 and 4 below.

Table 3. Analytical Specificity Results by Band

|  Specimen |   |  | Pos | p41 | p39 | p23  |
| --- | --- | --- | --- | --- | --- | --- |
|  Normal Individuals | n | 220 | 1 | 2 | 1 | 4  |
|   |  % |  | 0.5% | 0.9% | 0.5% | 1.8%  |

Table 4. Analytical Specificity Results

|   | Population  |   |
| --- | --- | --- |
|   |   |  Normal Individuals  |
|  Lyme IgM | Positive | 1  |
|  MarStripe | Negative | 219  |
|  Test | Total | 220  |

# Cross-Reactivity:

A total of 136 potentially cross-reactive specimens from individuals with other autoimmune disorders or infectious conditions, including Ehrlichia chafeensis (10), Babesia microti (10), Leptospira interrogans (10), Helicobacter pylori (10), Syphilis (10), Influenza (10), Rocky Mountain spotted fever (10), parvovirus B19 (9), CMV (10) systemic lupus erythematosus (15), rheumatoid arthritis (16), and celiac disease (16) were tested. Positive results and breakdown of antibody reactions by line are provided below in Table 5.

{7}

Table 5. Cross-Reactivity Results by Antibody Band

|   |   | Positive specimens/reactive antibody lines - n(%)  |   |   |   |
| --- | --- | --- | --- | --- | --- |
|  Population | n | Positive | p41 | p39 | p23  |
|  E. chafeensis | 10 | 3 (30)* | 3 (30) | 5 (50) | 4 (40)  |
|  B. microti | 10 | 2 (20)* | 2 (20) | 1 (10) | 1 (10)  |
|  L. interrogans | 10 | 1 (10)* | 1 (10) | 1 (10) | 1 (10)  |
|  H. pylori | 100 | 1 (1)* | 1 (1) | 1 (1) | 1 (1)  |
|  Syphilis | 10 | 0 (0) | 0 (0) | 0 (0) | 0 (0)  |
|  Influenza | 10 | 0 (0) | 0 (0) | 1 (10) | 0 (0)  |
|  Epstein-Barr Virus | 22 | 0 (0) | 1 (4.5) | 0 (0) | 0 (0)  |
|  Rocky Mountain Spotted fever | 10 | 0 (0) | 0 (0) | 0 (0) | 0 (0)  |
|  Parvovirus B19 | 9 | 0 (0) | 0 (0) | 2 (22.2) | 1 (11.1)  |
|  Systmatic lupus erythematosus | 15 | 0 (0) | 0 (0) | 0 (0) | 0 (0)  |
|  Cytomegalovirus | 10 | 0 (0) | 0 (0) | 0 (0) | 0 (0)  |
|  Rheumatoid arthritis | 15 | 0 (0) | 0 (0) | 0 (0) | 0 (0)  |
|  Celiac disease | 15 | 0 (0) | 0 (0) | 0 (0) | 0 (0)  |

* Positive results were also observed with an FDA cleared western blot

## Interferences:

Five (5) specimens (2 negative, 3 positive) were spiked with hemoglobin (2g/L), unconjugated bilirubin (342 μmol/L), rheumatoid factor (100 IU/ml), triglycerides (3.7 mmol/L) and total cholesterol (13 mmol/L), and then tested for Borrelia burgdorferi IgM following guidance of CLSI EP7-A2. Samples were tested with and without interfering agents. Qualitative agreement between results, spiked and unspiked was 100% for all interferents tested.

## f. Assay cut-off:

Cut-off was established by testing a panel of Lyme positive specimens along with healthy normal and controls. The Cut-Off Control Line was derived from these studies and provides a qualitative visual reference point for determination of bands as positive or negative.

## 2. Comparison studies:

a. Method comparison with predicate device:

### Prospective Study:

Specimens that were determined positive using an FDA cleared first-step EIA assay were tested prospectively at three geographically distinct study sites. The specimens testing positive (n=676) on a FDA cleared first-step EIA were tested with Lyme B. burgdorferi (IgM) MarStripe Test and an FDA cleared immunoblot. Interpretation of immunoblot results followed the recommended criteria described by the Centers for Disease Control (CDC) and the Second National Conference on Serological Diagnosis of Lyme Disease. The results are summarized below in Table 6.

{8}

Table 6. Results of Lyme B. burgdorferi (IgM) MarStripe Test and Predicate - Prospective Specimens

|   | FDA Cleared Immunoblot  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  Lyme IgM MarStripe Test | Positive | 302 | 23 | 325  |
|   |  Negative | 21 | 330 | 351  |
|   |  Total | 323 | 353 | 676  |

Positive Percent Agreement:  $93.5\%$  (95% CI: 90.1% - 95.8%)

Negative Percent Agreement:  $93.5\%$  (95% CI: 90.2% - 95.7%)

# b. Matrix comparison:

To establish equivalence of serum vs. plasma matrices, 20 pairs of sera/plasma (samples A-J below) were sourced from specimens tested on an FDA cleared Lyme EIA assay. These specimens included 3 Western Blot IgM positives and 17 negatives. These samples were assayed on the Lyme B. burgdorferi (IgM) MarStripe Test. AQL was  $100\%$  agreement between serum and plasma. See Table 7 below for results.

Table7. Serum vs. Plasma - Matrix Comparisson Study

|  Sample ID | Type | p41* | p39* | p23* | Result | Band % Pos Agrmt** | Band % Neg** Agrmt  |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  A | Serum | 0 | 0 | 0 | NEG | 100 | 100  |
|  A | Plasma | 0 | 0 | 0 | NEG  |   |   |
|  B | Serum | 1 | 0 | 1 | POS | 100 | 100  |
|  B | Plasma | 1 | 0 | 1 | POS  |   |   |
|  C | Serum | 0 | 0 | 0 | NEG | 100 | 100  |
|  C | Plasma | 0 | 0 | 0 | NEG  |   |   |
|  D | Serum | 0 | 0 | 1 | NEG | 100 | 100  |
|  D | Plasma | 0 | 0 | 1 | NEG  |   |   |
|  E | Serum | 1 | 0 | 1 | POS | 100 | 100  |
|  E | Plasma | 1 | 0 | 1 | POS  |   |   |
|  F | Serum | 0 | 0 | 1 | NEG | 100 | 100  |
|  F | Plasma | 0 | 0 | 1 | NEG  |   |   |
|  G | Serum | 0 | 0 | 1 | NEG | 100 | 100  |
|  G | Plasma | 0 | 0 | 1 | NEG  |   |   |
|  H | Serum | 0 | 0 | 0 | NEG | 100 | 100  |
|  H | Plasma | 0 | 0 | 0 | NEG  |   |   |
|  I | Serum | 0 | 0 | 0 | NEG | 100 | 100  |
|  I | Plasma | 0 | 0 | 0 | NEG  |   |   |
|  J | Serum | 1 | 0 | 1 | POS | 100 | 100  |
|  J | Plasma | 1 | 0 | 1 | POS  |   |   |
|  K | Serum | 0 | 0 | 0 | NEG | 100 | 100  |
|  K | Plasma | 0 | 0 | 0 | NEG  |   |   |

{9}

|  Sample ID | Type | p41* | p39* | p23* | Result | Band % Pos Agrmt** | Band % Neg** Agrmt  |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  L | Serum | 0 | 0 | 0 | NEG | 100 | 100  |
|  L | Plasma | 0 | 0 | 0 | NEG  |   |   |
|  M | Serum | 0 | 0 | 0 | NEG | 100 | 100  |
|  M | Plasma | 0 | 0 | 0 | NEG  |   |   |
|  N | Serum | 0 | 0 | 0 | NEG | 100 | 100  |
|  N | Plasma | 0 | 0 | 0 | NEG  |   |   |
|  O | Serum | 0 | 0 | 0 | NEG | 100 | 100  |
|  O | Plasma | 0 | 0 | 0 | NEG  |   |   |
|  P | Serum | 0 | 0 | 1 | NEG | 100 | 100  |
|  P | Plasma | 0 | 0 | 1 | NEG  |   |   |
|  Q | Serum | 0 | 0 | 0 | NEG | 100 | 100  |
|  Q | Plasma | 0 | 0 | 0 | NEG  |   |   |
|  R | Serum | 0 | 0 | 0 | NEG | 100 | 100  |
|  R | Plasma | 0 | 0 | 0 | NEG  |   |   |
|  S | Serum | 0 | 0 | 1 | NEG | 100 | 100  |
|  S | Plasma | 0 | 0 | 1 | NEG  |   |   |
|  T | Serum | 0 | 0 | 0 | NEG | 100 | 100  |
|  T | Plasma | 0 | 0 | 0 | NEG  |   |   |

*0 = negative band result, 1 = positive band result
**Refers to agreement across all three bands

# 3. Clinical studies:

# a. Clinical Sensitivity:

87 well characterized Lyme disease clinical specimens were tested with the Lyme  $B$ . burgdorferi (IgM) MarStripe Test. Specimens included samples from early, early disseminated, and late phases of the disease. The performance of the Lyme  $B$ . burgdorferi (IgM) MarStripe Test was compared with that of an FDA cleared device.

Table 8. Lyme B.burgdorferi (IgM) MarStripe Test and Predicate Results for Well-Characterized Samples

|  Interval | n | Lyme IgM MarStripe |   | FDA cleared IgM WB  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  Positive | % | Positive | %  |
|  Early Lyme (stage 1) | 19 | 8 | 42.1 | 9 | 47.4  |
|  Early disseminated (stage 2) | 43 | 5 | 11.6 | 6 | 14  |
|  Late Lyme (stage 3) | 25 | 3 | 12 | 2 | 8  |
|  Overall | 87 | 16 | 18.4 | 17 | 19.5  |

# Sensitivity Comparison:

Lyme B. burgdorferi (IgM) MarStripe Test:  $18.4\%$  (16/87) (95% CI: 11.2% - 28.4%) Predicate device:  $19.5\%$  (17/87) (95% CI: 12.1% - 29.7%)

{10}

CDC Panel Testing: A reference panel from the Center for Disease Control and Prevention (Lyme Disease Validation Panel n=10, Lyme Disease Basic Research Panel n=32) was tested with the Lyme B. burgdorferi (IgM) MarStripe Test and the predicate device.

Table 9. Lyme B.burgdorferi (IgM) MarStripe Test and Predicate Results for CDC Panel

|  Interval | n | Lyme IgM MarStripe Test |   | Predicate IgM WB  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  positive | % | positive | %  |
|  Controls | 25 | 0 | 0 | 2 | 8  |
|  Early Lyme (stage 1) | 10 | 6 | 60 | 6 | 60  |
|  Early disseminated (stage 2) | 3 | 3 | 100 | 3 | 100  |
|  Late Lyme (stage 3) | 4 | 1 | 25 | 2 | 50  |
|  Overall | 42 | 10 | 23.8 | 13 | 31.0  |

Note: 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.

b. Clinical specificity: N/A
c. Other clinical supportive data (when a. and b. are not applicable): N/A

4. Clinical cut-off: N/A
5. Expected Values/Reference range:

The performance of the Lyme B. burgdorferi (IgM) MarStripe Test was evaluated in clinical studies using sera obtained from the following: 1) patients meeting a case definition for Lyme disease based on physician diagnosis, B. burgdorferi culture, and other laboratory tests; 2) patients for whom requests were made for routine B. burgdorferi serology tests; and 3) apparently healthy individuals from endemic and non-endemic regions for Lyme disease.

The first table summarizes the presence of  $B$  burgdorferi specific bands in specimens from documented cases of Lyme disease. Specimens have been grouped by the time after onset of symptoms.

Table 10. Lyme B. burgdorferi (IgM) MarStripe Test results in defined Lyme disease populations

|  Disease Stage |  | MarStripe Results  |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   |   |  n | Pos | p41 | p39 | p23  |
|  Early Lyme, Stage 1 | n | 19 | 8 | 9 | 7 | 9  |
|   |  % |  | 42.1% | 47.4% | 36.8% | 47.4%  |
|  Early disseminated, Stage 2 | n | 43 | 5 | 8 | 6 | 10  |
|   |  % |  | 11.6% | 18.6% | 14.0% | 23.3%  |
|  Late Lyme, Stage 3 | n | 25 | 3 | 2 | 2 | 5  |
|   |  % |  | 12.0% | 8.0% | 8.0% | 20.0%  |

{11}

12

Table 11. Lyme B. burgdorferi (IgM) MarStripe Test results in the prospective study

|  Specimen |  | MarStripe Results  |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   |   |  n | Pos | p41 | p39 | p23  |
|  Lyme EIA positive / equivocal specimens | n | 676 | 325 | 362 | 218 | 365  |
|   |  % |  | 48.1% | 53.6% | 32.2% | 54.0%  |

Table 12. Lyme B. burgdorferi (IgM) MarStripe Test results in healthy normal individuals

|  Specimen |  | MarStripe Results  |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   |   |  n | Pos | p41 | p39 | p23  |
|  Normal individuals | n | 220 | 1 | 2 | 1 | 4  |
|   |  % |  | 0.5% | 0.9% | 0.5% | 1.8%  |

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.

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K172254](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K172254)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com