Lyme B. burgdorferi (IgG) MarStripe Test
Device Facts
| Record ID | K163095 |
|---|---|
| Device Name | Lyme B. burgdorferi (IgG) MarStripe Test |
| Applicant | Trinity Biotech |
| Product Code | LSR · Microbiology |
| Decision Date | Feb 1, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3830 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K163095 · Feb 1, 2017 | Lyme B. burgdorferi (IgG) MarStripe Test | Trinity Biotech | Healthy blood donor serum samples; Clinical specimens from individuals with other infectious or medical conditions | Retrospective clinical samples were used to establish analytical specificity and cross-reactivity profiles for the device. | Analytical specificity; Cross-reactivity; Healthy blood donors; Clinical specimens |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Retrospective analysis of clinical samples | Healthy blood donors from endemic geographic regions of the United States; Sample Size: 219 | Not applicable for this study | Analytical specificity |
| Retrospective analysis of clinical samples | Individuals with other infectious or clinical conditions; Sample Size: 136 | Predicate IgG Western blot device | Cross-reactivity incidence |
Indications for Use
Lyme B. burgdorferi (IgG) MarStripe Test is an immunoblot assay for the in vitro qualitative detection of human IgG 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
Lyme B. burgdorferi (IgG) MarStripe Test is an immunoblot assay for detecting IgG antibodies against B. burgdorferi antigens. Input: human serum or plasma (K2-EDTA) previously screened as positive/equivocal by EIA or IFA. Operation: patient sample incubated with nitrocellulose test strips containing purified B. burgdorferi antigens and control lines; reactive antibodies bind to antigens; anti-human IgG-HRP conjugate and TMB substrate added to produce visible blue/purple lines. Output: visual qualitative assessment of band intensity compared to a Cut-Off control line. Interpretation: strips with 5 or more of 10 test lines are positive for specific IgG antibody. Used in clinical laboratory settings by trained personnel. Results provide supportive evidence of B. burgdorferi infection, aiding clinical diagnosis of Lyme disease.
Clinical Evidence
Clinical study of 753 prospectively collected specimens compared the subject device to the predicate. Positive agreement was 92.9% (95% CI: 88.6%-95.7%) and negative agreement was 97.7% (95% CI: 95.9%-98.7%). Discrepant analysis using two additional Western blot methods confirmed the subject device's performance. Sensitivity was evaluated using 94 well-characterized clinical specimens (19.5% overall) and CDC reference panels (16.7% overall), showing performance comparable to the predicate. Analytical specificity was 99.5% (n=219). Interference and matrix equivalence (serum vs. plasma) studies showed 100% qualitative agreement.
Technological Characteristics
Immunoblot assay using nitrocellulose test strips with purified B. burgdorferi antigens and control lines (SAC, CAC, Cut-Off). Reagents include sample diluent (BSA/PBS), anti-human IgG-HRP conjugate, and TMB substrate. Qualitative visual readout. Manual test procedure. No software or electronic components.
Indications for Use
Indicated for the qualitative detection of human IgG antibodies to B. burgdorferi in human serum or plasma (K₂-EDTA) for patients previously testing positive or equivocal by EIA or IFA, to provide supportive evidence of Lyme disease infection. For prescription use only.
Regulatory Classification
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 IgG MarBlot Strip Test System (K950829)
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION SUMMARY
A. 510(k) Number: K163095
B. Purpose for Submission: To obtain a substantial equivalence determination and FDA clearance for a new device
C. Measurand: Anti-Borrelia burgdorferi (IgG) antibodies
D. Type of Test: Enzyme Immunoassay
E. Applicant: Immco Diagnostics
F. Proprietary and Established Names: Lyme B. burgdorferi (IgG) 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
H. Intended Use:
1. Intended use(s): Lyme B. burgdorferi (IgG) MarStripe Test is an immunoblot assay for the in vitro qualitative detection of human IgG 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: N/A
I. Device Description: The kit is an immunoblot method to detect IgG antibodies against B. burgdorferi antigens. The nitrocellulose test strips are coated with purified recombinant B. burgdorferi antigens (10) and quality control lines (3) in specific positions. To perform the test, serum or plasma is incubated with individual B. burgdorferi Test Strips. In positive sera antibodies specifically bind to one or more of the test lines on the strip. The strips are washed according to the protocol, and then the pre-diluted, ready-to-use Conjugate is added to the
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test strips. After incubation and wash steps, the ready-to-use Substrate is added to the strips. During a 10 minute (±4 min) incubation, conjugate and substrate binding produces visible blue/purple lines for Serum Addition Control (SAC), Conjugate Addition Control (CAC) and Cut-Off Control lines. If the sample is positive for any of the antigen coated test lines, it will show a reaction more intense than the Cut-Off line. Reactions are read visually and reported.
# J. Substantial Equivalence Information:
1. Predicate device name(s): MarDx B. burgdorferi IgG MarBlot Strip Test System
2. Predicate 510(k) number(s): K950829
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Lyme B. burgdorferi (IgG) MarStripe Test | MarDx B. burgdorferi IgG MarBlot Strip Test System (K950829) |
| Intended Use | Lyme B. burgdorferi (IgG) MarStripe Test is an immunoblot assay for the in vitro qualitative detection of human IgG 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. | A Western blot assay for the qualitative in vitro detection of human IgG antibody to individual proteins of Borrelia burgdorferi in human serum. The MarDx B. burgdorferi (IgG) MarBlot Strip Test System is intended for use in testing human serum 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 | 10 antibodies directed against Borrelia burgdorferi IgG antigens associated with Lyme disease | 10 antibodies directed against Borrelia burgdorferi IgG antigens associated with Lyme disease |
| Quantitation | Qualitative | Qualitative |
| Component set | Includes B. burgdorferi MarStripe test strips, B. burgdorferi IgG Positive Control, B. burgdorferi B. burgdorferi Negative Control, Conjugate (Anti-Human IgG), Substrate, Diluent and Wash Buffer | Includes B. burgdorferi Marblot strips, B. burgdorferi WB IgG Serum Band Locator, B. burgdorferi WB Weakly Reactive IgG Control, B. burgdorferi Negative Control, Alkaline Phosphatase Conjugate (Anti-Human IgG), Alkaline Phosphatase Developing Solution, 10x Sample Diluent Wash Solution |
| Positive | Anti-B. burgdorferi IgG antibodies | Anti-B. burgdorferi IgG antibodies |
| Screening dilution | 1:101 | 1:101 |
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| Differences | | |
| --- | --- | --- |
| Item | Lyme B. burgdorferi (IgG) MarStripe Test | MarDx B. burgdorferi IgG MarBlot Strip Test System (K950829) |
| 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 |
# K. Standard/Guidance Document Referenced (if applicable): N/A
# L. Test Principle: Enzyme Immunoassay
# M. Performance Characteristics (if/when applicable):
# 1. Analytical performance:
# a. Precision/Reproducibility:
Precision: Eight specimens were tested by the Lyme B. burgdorferi (IgG) MarStripe Test in 4 replicates, 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, 2 low positive samples and 2 moderate positive samples. Final positive or negative agreement was $100\%$ for all specimens.
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| Sample | n=96 | P03 | P06 | P08 | P45 | P47 | P99 | P30 | P39 | P23 | P18 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | Low Neg | | | | | | | | | | |
| | Band Type | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. |
| | Positives | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| | Negatives | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 96 |
| | % Positive | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 0% |
| 2 | Low Neg | | | | | | | | | | |
| | Band Type | Neg. | Neg. | Neg. | Neg. | Pos. | Neg. | Neg. | Neg. | Neg. | Neg. |
| | Positives | 0 | 0 | 0 | 0 | 96 | 0 | 0 | 0 | 0 | 0 |
| | Negatives | 96 | 96 | 96 | 96 | 0 | 96 | 96 | 96 | 96 | 96 |
| | % Positive | 0% | 0% | 0% | 0% | 100% | 0% | 0% | 0% | 0% | 0% |
| 3 | High Neg | | | | | | | | | | |
| | Band Type | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. |
| | Positives | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| | Negatives | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 96 | 96 |
| | % Positive | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 0% |
| 4 | High Neg | | | | | | | | | | |
| | Band Type | Neg. | Neg. | Neg. | Neg. | Pos. | Neg. | Neg. | Neg. | Neg. | Neg. |
| | Positives | 0 | 0 | 0 | 0 | 96 | 0 | 0 | 0 | 0 | 0 |
| | Negatives | 96 | 96 | 96 | 96 | 0 | 96 | 96 | 96 | 96 | 96 |
| | % Positive | 0% | 0% | 0% | 0% | 100% | 0% | 0% | 0% | 0% | 0% |
| 5 | Low Pos | | | | | | | | | | |
| | Band Type | Neg. | Neg. | Neg. | Neg. | Pos. | Neg. | Neg. | Neg. | Pos. | Neg. |
| | Positives | 0 | 0 | 0 | 0 | 96 | 0 | 0 | 0 | 96 | 0 |
| | Negatives | 96 | 96 | 96 | 96 | 0 | 96 | 96 | 96 | 0 | 96 |
| | % Positive | 0% | 0% | 0% | 0% | 100% | 0% | 0% | 0% | 100% | 0% |
| 6 | Low Pos | | | | | | | | | | |
| | Band Type | Neg. | Neg. | Neg. | Neg. | Pos. | Neg. | Neg. | Neg. | Pos. | Neg. |
| | Positives | 0 | 0 | 0 | 0 | 96 | 0 | 0 | 0 | 96 | 0 |
| | Negatives | 96 | 96 | 96 | 96 | 0 | 96 | 96 | 96 | 0 | 96 |
| | % Positive | 0% | 0% | 0% | 0% | 100% | 0% | 0% | 0% | 100% | 0% |
| 7 | Moderate Pos | | | | | | | | | | |
| | Band Type | Wpos. | Pos. | Pos. | Neg. | Pos. | Pos. | Cut. | Pos. | Pos. | Pos. |
| | Positives | 88 | 96 | 96 | 0 | 96 | 96 | 88 | 96 | 96 | 96 |
| | Negatives | 8 | 0 | 0 | 96 | 0 | 0 | 8 | 0 | 0 | 0 |
| | % Positive | 92% | 100% | 100% | 0% | 100% | 100% | 92% | 100% | 100% | 100% |
| 8 | Moderate Pos | | | | | | | | | | |
| | Band Type | Pos. | Neg. | Pos. | Neg. | Pos. | Pos. | Neg. | Neg. | Pos. | Neg. |
| | Positives | 96 | 0 | 96 | 0 | 96 | 96 | 0 | 0 | 96 | 0 |
| | Negatives | 0 | 96 | 0 | 96 | 0 | 0 | 96 | 96 | 0 | 96 |
| | % Positive | 100% | 0% | 100% | 0% | 100% | 100% | 0% | 0% | 100% | 0% |
Pos = positive band. Neg = negative band. Wpos = weak positive band. Cut = equivocal band.
Reproducibility: Eight specimens were tested by Lyme B. burgdorferi (IgG) MarStripe Test in 4 replicates, two runs per day over 9 days for a total of 72 tests for each specimen at three laboratory sites. Results were read by 2 human operators at each site, equaling a total of 432 read-outs. Samples were selected based on FDA cleared B. burgdorferi ELISA results, including 2 low negative samples, 2 high negative samples, 2 low positive samples and 2 moderate positive samples. Final positive or negative agreement was $100\%$ for all specimens.
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| Sample | n=432 | P0 | P6 | P8 | P16 | P17 | P9 | P10 | P28 | P33 | P34 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | Low Neg | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. |
| | Band Type | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| | Positives | 432 | 432 | 432 | 432 | 432 | 432 | 432 | 432 | 432 | 432 |
| | Negatives | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 0% |
| 2 | % Positive | | | | | | | | | | |
| | Low Neg | Neg. | Neg. | Neg. | Neg. | Pos. | Neg. | Neg. | Neg. | Neg. | Neg. |
| | Band Type | 0 | 0 | 0 | 0 | 432 | 0 | 0 | 0 | 0 | 0 |
| | Positives | 432 | 432 | 432 | 432 | 0 | 432 | 432 | 432 | 432 | 432 |
| 3 | % Positive | | | | | | | | | | |
| | High Neg | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. | Neg. |
| | Band Type | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| | Positives | 432 | 432 | 432 | 432 | 432 | 432 | 432 | 432 | 432 | 432 |
| 4 | % Positive | | | | | | | | | | |
| | Low Pos | Neg. | Neg. | Neg. | Neg. | Pos. | Neg. | Neg. | Neg. | Neg. | Neg. |
| | Band Type | 0 | 0 | 0 | 0 | 432 | 0 | 0 | 0 | 0 | 0 |
| | Positives | 432 | 432 | 432 | 432 | 0 | 432 | 432 | 432 | 432 | 432 |
| 5 | % Positive | | | | | | | | | | |
| | Low Pos | Neg. | Neg. | Neg. | Neg. | Pos. | Neg. | Neg. | Neg. | Pos. | Neg. |
| | Band Type | 0 | 0 | 0 | 0 | 432 | 0 | 0 | 0 | 432 | 0 |
| | Positives | 432 | 432 | 432 | 432 | 0 | 432 | 432 | 432 | 0 | 432 |
| 6 | % Positive | | | | | | | | | | |
| | Low Pos | Neg. | Neg. | Neg. | Neg. | Pos. | Neg. | Neg. | Neg. | Pos. | Neg. |
| | Band Type | 0 | 0 | 0 | 0 | 432 | 0 | 0 | 0 | 432 | 0 |
| | Positives | 432 | 432 | 432 | 432 | 0 | 432 | 432 | 432 | 0 | 432 |
| 7 | % Positive | | | | | | | | | | |
| | Moderate Pos | Wpos. | Pos. | Pos. | Neg. | Pos. | Pos. | Cut. | Pos. | Pos. | Pos. |
| | Band Type | 412 | 432 | 432 | 0 | 432 | 432 | 412 | 432 | 432 | 432 |
| | Positives | 20 | 0 | 0 | 432 | 0 | 0 | 20 | 0 | 0 | 0 |
| 8 | % Positive | | | | | | | | | | |
| | Moderate Pos | Pos. | Neg. | Pos. | Neg. | Pos. | Pos. | Neg. | Neg. | Pos. | Neg. |
| | Band Type | 432 | 0 | 432 | 0 | 432 | 432 | 0 | 0 | 432 | 0 |
| | Positives | 0 | 432 | 0 | 432 | 0 | 0 | 432 | 432 | 0 | 432 |
Pos = positive band. Neg = negative band. Wpos = weak positive band. Cut = equivocal band.
b. Linearity/assay reportable range: N/A
c. Traceability, Stability, Expected values (controls, calibrators, or methods): N/A
d. Detection limit: N/A
e. Analytical specificity: 219 sera from normal individuals (blood bank donors) representing endemic and non-endemic geographic regions of the United States were tested with Lyme B. burgdorferi (IgG) MarStripe Test. Analytical specificity was determined to be $99.5\%$ (95% CI: $97.1\% - 100\%$ ).
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| | | Normal Individuals |
| --- | --- | --- |
| Lyme IgG
MarStripe
Test | Positive | 1 |
| | Negative | 218 |
| | Total | 219 |
Cross Reactivity: A total of 136 potentially cross-reactive specimens from individuals with other autoimmune disorders or infectious conditions were tested on Lyme B. burgdorferi (IgG) MarStripe Test. All positive specimens by the Lyme B. burgdorferi (IgG) MarStripe Test were confirmed positive when tested by the predicate IgG Western blot device.
| Population | n | n Positive | % Positive |
| --- | --- | --- | --- |
| Ehrlichia chafeensis | 10 | 0 | 0 |
| Babesia microti | 10 | 4 | 40 |
| Leptospira interrogans | 10 | 0 | 0 |
| Helicobacter pylori | 10 | 2 | 20 |
| Syphilis | 10 | 0 | 0 |
| Influenza | 10 | 0 | 0 |
| Rocky Mountain Spotted Fever | 10 | 0 | 0 |
| Parvovirus B19 | 9 | 0 | 0 |
| Systemic lupus erythematosus | 15 | 0 | 0 |
| Cytomegalovirus | 10 | 0 | 0 |
| Rheumatoid arthritis | 16 | 0 | 0 |
| Celiac | 16 | 0 | 0 |
| Total | 136 | 6 | 4.4 |
Interferences: Two Lyme IgG negative and three Lyme IgG positive sera were spiked with hemoglobin (2g/L), unconjugated bilirubin (342 μmol/L), RF (100 IU/ml), triglycerides (3.7 mmol/L) and total cholesterol (13 mmol/L) and tested using Lyme B. burgdorferi (IgG) MarStripe Test. Samples were tested with and without interfering agents. Qualitative agreement between results of spiked and unspiked specimens was 100% for all interferents tested.
f. Assay cut-off:
Band Cutoff Determination: Cutoff was established testing a panel of Lyme positive specimens along with healthy normals 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: A prospective study of FDA cleared first-step EIA specimens was performed at three geographically distinct study sites. The specimens testing positive (n=753) on a FDA cleared first-step EIA were tested with Lyme B.
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burgdorferi (IgG) 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.
| | Predicate IgG WB | | | |
| --- | --- | --- | --- | --- |
| | | Positive | Negative | Total |
| Lyme IgG
MarStripe
Test | Positive | 221 | 12 | 233 |
| | Negative | 17 | 503 | 520 |
| | Total | 238 | 515 | 753 |
Positive Agreement: 92.9% (221/238) (95% CI: 88.6% - 95.7%)
Negative Agreement: 97.7% (503/515) (95% CI: 95.9% - 98.7%)
The 29 discrepant specimens from the above study were tested on two additional commercially available B. burgdorferi IgG Western blot methods. Results of the Lyme B. burgdorferi (IgG) MarStripe Test were compared to the consensus (2/3 comparator) results. The 12 positives by MarStripe remained positive by consensus testing and the 17 negatives by MarStripe were found to be positives.
| | Consensus Result | | |
| --- | --- | --- | --- |
| | | Positive | Negative |
| Lyme IgG
MarStripe Test | Positive | 12 | 0 |
| | Negative | 17 | 0 |
b. Matrix comparison: To establish equivalence of serum vs. plasma (K₂-EDTA) matrix, 10 pairs of sera/plasma (samples A-J below) were sourced from specimens tested with an FDA cleared Lyme EIA assay. Two of these were Western blot IgG positive, 8 were negative. These specimens were selectively pooled to create another set of 10 samples (samples 1-10 below), including 3 Western blot IgG positives and 7 negatives. These samples were assayed on the Lyme B. burgdorferi (IgG) MarStripe Test. Qualitative agreement for all pairs was 100%.
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| Sample ID1 | Type2 | p93 | p66 | p58 | p45 | p41 | p39 | p30 | p28 | p23 | p18 | Result | Band % Pos Agrmt | Band % Neg Agrmt |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| A | Serum | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | NEG | 100 | 100 |
| A | Plasma | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | NEG | | |
| B | Serum | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | 100 | 100 |
| B | Plasma | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | | |
| C | Serum | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 1 | POS | 100 | 100 |
| C | Plasma | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 1 | POS | | |
| D | Serum | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 1 | POS | 100 | 100 |
| D | Plasma | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 1 | POS | | |
| E | Serum | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | NEG | 100 | 100 |
| E | Plasma | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | NEG | | |
| F | Serum | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | 100 | 100 |
| F | Plasma | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | | |
| G | Serum | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | 100 | 100 |
| G | Plasma | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | | |
| H | Serum | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | 100 | 100 |
| H | Plasma | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | | |
| I | Serum | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | 100 | 100 |
| I | Plasma | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | | |
| J | Serum | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | 100 | 100 |
| J | Plasma | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | | |
| Pool 1 (A+B) | Serum | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | NEG | 100 | 100 |
| Pool 1 (A+B) | Plasma | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | NEG | | |
| Pool 2 (B+C) | Serum | 1 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | POS | 100 | 100 |
| Pool 2 (B+C) | Plasma | 1 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | POS | | |
| Pool 3 (C+D) | Serum | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 1 | POS | 100 | 100 |
| Pool 3 (C+D) | Plasma | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 1 | POS | | |
| Pool 4 (D+E) | Serum | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | POS | 100 | 100 |
| Pool 4 (D+E) | Plasma | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | POS | | |
| Pool 5 (A+E) | Serum | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | NEG | 100 | 100 |
| Pool 5 (A+E) | Plasma | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | NEG | | |
| Pool 6 (F+G) | Serum | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | 100 | 100 |
| Pool 6 (F+G) | Plasma | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | | |
| Pool 7 (G+H) | Serum | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | 100 | 100 |
| Pool 7 (G+H) | Plasma | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | | |
| Pool 8 (H+I) | Serum | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | 100 | 100 |
| Pool 8 (H+I) | Plasma | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | | |
| Pool 9 (I+J) | Serum | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | 100 | 100 |
| Pool 9 (I+J) | Plasma | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | | |
| Pool 10 (F+J) | Serum | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | 100 | 100 |
| Pool 10 (F+J) | Plasma | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | NEG | | |
1 Pool 1 to 10 contain a 1:1 mixture of the native samples as indicated.
${}^{2}0 =$ negative band result. $1 =$ positive band result.
# 3. Clinical studies:
a. Clinical Sensitivity: 94 well characterized Lyme disease clinical specimens were tested with the Lyme B. burgdorferi (IgG) MarStripe Test. Specimens included samples from early, early disseminated, and late phases of the disease. The sensitivity obtained was compared with that of the predicate device.
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| Interval | n | Lyme IgG MarStripe Test | | Predicate IgG WB | |
| --- | --- | --- | --- | --- | --- |
| | | positive | % | positive | % |
| Early Lyme (stage 1) | 22 | 4 | 18.2 | 3 | 13.6 |
| Early disseminated (stage 2) | 44 | 12 | 27.3 | 11 | 25.0 |
| Late Lyme (stage 3) | 28 | 5 | 17.9 | 5 | 17.9 |
| Overall | 94 | 21 | 19.5 | 19 | 20.2 |
Sensitivity Comparison:
Lyme B. burgdorferi (IgG) MarStripe Test: 22.3% (21/94) (95% CI: 14.7%-32.3%)
Predicate device: 20.2% (19/94) (95% CI: 12.9%-30.0%)
Difference in proportion: 2.1%
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) were tested on the Lyme B. burgdorferi (IgG) MarStripe Test and the predicate device.
| Interval | n | Lyme IgG MarStripe Test | | Predicate IgG WB | |
| --- | --- | --- | --- | --- | --- |
| | | positive | % | positive | % |
| Controls | 25 | 0 | 0 | 0 | 0 |
| Early Lyme (stage 1) | 10 | 1 | 10 | 1 | 10 |
| Early disseminated (stage 2) | 3 | 3 | 100 | 3 | 100 |
| Late Lyme (stage 3) | 4 | 4 | 100 | 4 | 100 |
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 (IgG) 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
{9}
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 presence of B. burgdorferi specific bands observed by testing with Lyme B. burgdorferi (IgG) MarStripe Test in different specimens is presented below.
## Defined Lyme Disease Population:
| | | Lyme IgG MarStripe Test | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Disease Stage | | | Pos | p93 | p66 | p58 | p45 | p41 | p39 | p30 | p28 | p23 | p18 |
| Early Lyme (0-4 weeks), Stage 1 | n | 22 | 4 | 2 | 4 | 7 | 3 | 17 | 4 | 2 | 3 | 11 | 5 |
| | % | 100% | 18.2% | 9.1% | 18.2% | 31.8% | 13.6% | 77.3% | 18.2% | 9.1% | 13.6% | 50.0% | 22.7% |
| Early disseminated, Stage 2 | n | 44 | 12 | 10 | 10 | 16 | 1 | 27 | 12 | 5 | 8 | 11 | 15 |
| | % | 100% | 27.3% | 22.7% | 22.7% | 36.4% | 2.3% | 61.4% | 27.3% | 11.4% | 18.2% | 25.0% | 34.1% |
| Late Lyme, Stage 3 | n | 28 | 12 | 5 | 6 | 8 | 0 | 16 | 5 | 2 | 3 | 6 | 7 |
| | % | 100% | 42.9% | 17.9% | 21.4% | 28.6% | 0.0% | 57.1% | 17.9% | 7.1% | 10.7% | 21.4% | 25.0% |
## Prospective Study Population:
| | | Lyme IgG MarStripe Test | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Specimen | | | Pos | p93 | p66 | p58 | p45 | p41 | p39 | p30 | p28 | p23 | p18 |
| Lyme EIA positive/ equivocal specimens | n | 753 | 238 | 125 | 188 | 254 | 48 | 574 | 270 | 123 | 134 | 345 | 360 |
| | % | 100% | 31.6% | 16.6% | 25.0% | 33.7% | 6.4% | 76.2% | 35.9% | 16.3% | 17.8% | 45.8% | 47.8% |
## Healthy Normal Individuals:
| | | Lyme IgG MarStripe Test | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Specimen | | | Pos | p93 | p66 | p58 | p45 | p41 | p39 | p30 | p28 | p23 | p18 |
| Normal individuals | n | 219 | 1 | 4 | 9 | 2 | 0 | 12 | 40 | 1 | 2 | 7 | 3 |
| | % | 100% | 0.5% | 1.8% | 4.1% | 0.9% | 0.0% | 5.5% | 18.3% | 0.5% | 0.9% | 3.2% | 1.4% |
## N. Software: N/A
## O. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
## P. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
