Lyme B. burgdorferi (IgM) MarStripe Test

K172254 · Trinity Biotech · LSR · Oct 23, 2017 · Microbiology

Device Facts

• Record ID: K172254
• Device Name: Lyme B. burgdorferi (IgM) MarStripe Test
• Applicant: Trinity Biotech
• Product Code: LSR · Microbiology
• Decision Date: Oct 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3830
• Device Class: Class 2

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.

Indications for Use

Indicated for patients suspected of Lyme disease who have tested positive or equivocal on a first-tier EIA or IFA test. 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 IgM MarBlot Strip Test System (K951709)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by flowing lines that resemble a ribbon or a wave.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 23, 2017

TRINITY BIOTECH KEVIN LAWSON REGULATORY OFFICER 60 PINEVIEW DR. BUFFALO NY 14031

Re: K172254

Trade/Device Name: Lyme B. Burgdorferi (igm) Marstripe Test Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: II Product Code: LSR Dated: July 11, 2017 Received: July 26, 2017

Dear Mr. Lawson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kristian M. Roth -S

For:

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K172254

Device Name

Lyme B. burgdorferi (IgM) MarStripe Test

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

|X | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image is a logo for Immco Diagnostics, a Trinity Biotech Company. The logo features a cluster of blue and green dots on the left side, followed by the word "immco" in blue, sans-serif font. Below "immco" is the word "DIAGNOSTICS" in green, sans-serif font. Underneath that is the text "A Trinity Biotech Company" in a smaller, sans-serif font.

## 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.

| 1. | Submitter Name: | Immco Diagnostics, Inc. a Trinity Biotech Company |
|----|-------------------|---------------------------------------------------|
| | Address: | 60 Pineview Dr., Buffalo, NY 14228 |
| | Phone Number: | 716-691-0091 ext. 110 |
| | Contact Person: | Kevin Lawson |
| | Summary Prepared: | 7-24-2017 |

- Device Name: Lyme B. burgdorferi (IgM) MarStripe Test 2. Common Name: Lyme B. burgdorferi (IgM) Immunoblot Product Code: LSR
- 3. Substantially equivalent to: MarDx B. burqdorferi IgM MarBlot Strip Test System (K951709)
- 4. Description of device: The kit is an immunoblot method to detect IgM antibodies against B. burqdorferi antigens. The test kit contains:
- . Nitrocellulose Test Strips with purified B. burgdorferi antigens (3) and quality control lines (3) present in specific positions
- . Sample Diluent. Provided for specimen dilutions. Contains BSA and PBS
- Positive Control derived from human serum positive for Lyme disease. Contains <0.1% sodium azide
- Negative Control derived from human serum negative for Lyme disease. Contains <0.1% sodium azide
- Conjugate. Antihuman IgM-HRP Conjugate binds reactive antibodies to the Substrate
- TMB Substrate. Provides colorimetric reaction for visual read of bound antibodies
- PBS Wash Buffer concentrate. Removes reagents and unbound antibodies after incubation steps. Must be reconstituted to 1L with distilled or deionized water.

To perform the test, serum or plasma is individual B. burgdorferi Test Strips. In positive sera antibodies specifically bind to one or more of the test lines on the strips are washed according to the protocol, and then the pre-diluted, ready-to-use Conjugate is added to the 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 as positive or equivocal (comparable to Cut-Off line). Strips which have 2 (or more) of the 3 test lines are considered positive for specific IgM antibody to B. buradorferi.

- Intended Use: Lyme B. burqdorferi (JgM) MarStripe Test is an immunoblot assay for the in vitro qualitative detection of human 5. lgM antibody to individual proteins of Borrelia burgdorferi in human serum or plasma (K.- EDTA) in samples which have been found positive or equivocal using an ElA or IFA test procedure to provide supportive evidence of infection with B. burgdorferi.
- 6. Similarities and Differences: The Lyme B. burgdorferi (IgM) MarStripe Test was compared to a commercially marketed kit by Trinity Biotech the B. burgdorferi (JgM) MarBlot Strip Test System (K951709). Both kits have the same intended use and use the same methodology except that the MarStripe Test has been validated in plasma (K- EDTA) as well as serum. Both immunoblot kits detect antibodies to B. burgdorferi antigens using the standard immunoblot IgM algorithm. The MarStripe uses a Horseradish Peroxidase Conjugate and Tetramethylbenzidine (TMB) Substrate/Chromogen in comparison to The MarBlot Alkaline Phosphatase Conjugate and BCIP/NBT Substrate/Chromogen. The MarStripe uses a Cutoff Control line incorporated in the strip in comparison to the 41kD band of Weakly Reactive Control.
- Non-clinical Tests: 7. Precision

60 Pineview Drive Buffalo, NY 14228-2120 Toll free [phone] tel. [phone]

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Image /page/4/Picture/0 description: The image shows the logo for Immco Diagnostics. The logo features a series of blue and green dots on the left side, followed by the word "immco" in blue, with the word "DIAGNOSTICS" in green underneath. Below that, it says "A Trinity Biotech Company" in a smaller font.

Eight specimens were tested by Lyme B. burqdorferi (JgM) 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. burqdorferi ELISA results, including 2 low negative samples, 2 high negative samples, 1 cutoff sample and 2 moderate positive samples. Qualitative agreement was 100% for the low negative and moderate positive samples. The low positive specimen produced 99.0% positive agreement. The cutoff specimen produced 81.3% positive agreement.

| Sample | n=96 | p41 | p39 | p23 |
|--------|-------------------|--------|--------|--------|
| 1 | Low Negative | | | |
| | Band Type | Neg. | Neg. | Neg. |
| | Positives | 0 | 0 | 0 |
| | Negatives | 96 | 96 | 96 |
| | % Positive | 0.0% | 0.0% | 0.0% |
| 2 | Low Negative | | | |
| | Band Type | Neg. | Neg. | Neg. |
| | Positives | 0 | 0 | 3 |
| | Negatives | 96 | 96 | 93 |
| | % Positive | 0.0% | 0.0% | 3.1% |
| 3 | High Negative | | | |
| | Band Type | Neg. | Neg. | Neg. |
| | Positives | 0 | 0 | 0 |
| | Negatives | 96 | 96 | 96 |
| | % Positive | 0.0% | 0.0% | 0.0% |
| 4 | High Negative | | | |
| | Band Type | Neg. | Neg. | Cut. |
| | Positives | 0 | 0 | 3 |
| | Negatives | 96 | 96 | 93 |
| | % Positive | 0.0% | 0.0% | 3.1% |
| 5 | Cutoff | | | |
| | Band Type | Cut. | Neg. | Wpos. |
| | Positives | 88 | 0 | 79 |
| | Negatives | 8 | 96 | 17 |
| | % Positive | 91.7% | 0.0% | 82.3% |
| 6 | Low Positive | | | |
| | Band Type | Pos. | Neg. | Pos. |
| | Positives | 96 | 0 | 96 |
| | Negatives | 0 | 96 | 0 |
| | % Positive | 100.0% | 0.0% | 100.0% |
| 7 | Moderate Positive | | | |
| | Band Type | Pos. | Neg. | Pos. |
| | Positives | 96 | 0 | 96 |
| | Negatives | 0 | 96 | 0 |
| | % Positive | 100.0% | 0.0% | 100.0% |
| 8 | Moderate Positive | | | |
| | 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

Eight specimens were tested by Lyme B. burgdorferi (JgM) MarStripe Test in 4 replicates, two runs per day over 12 days for a total of 192 tests for each specimen at each of three laboratory sites. 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, including 2 low negative samples, 2 high negative samples, 1 cutoff sample and 2 moderate positive samples. Final positive or negative agreement was 100% for both low negative and one moderate positive sample. One high negative sample produced 99.7% negative arreement, one low positive sample produced 99.3% positive agreement. The cutoff sample produced 68.4% positive agreement.

> 60 Pineview Drive ● Buffalo, NY 14228-2120 ● USA Toll free [phone] ● tel. [phone] ● fax [phone]

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Image /page/5/Picture/0 description: The image shows the logo for Immco Diagnostics. The logo features a series of blue and green dots arranged in a circular pattern on the left side. To the right of the dots is the company name "immco" in blue, with "DIAGNOSTICS" in green below it. Underneath the company name is the text "A Trinity Biotech Company" in a smaller font size.

| Sample | n=576 | p41 | p39 | p23 |
|--------|-------------------|--------|-------|--------|
| 1 | Low Negative | | | |
| | Band Type | Neg. | Neg. | Neg. |
| | Positives | 0 | 0 | 1 |
| | Negatives | 576 | 576 | 575 |
| | % Positive | 0.0% | 0.0% | 0.2% |
| 2 | Low Negative | | | |
| | Band Type | Neg. | Neg. | Neg. |
| | Positives | 0 | 0 | 26 |
| | Negatives | 576 | 576 | 550 |
| | % Positive | 0.0% | 0.0% | 4.5% |
| 3 | High Negative | | | |
| | Band Type | Neg. | Neg. | Neg. |
| | Positives | 0 | 0 | 0 |
| | Negatives | 576 | 576 | 576 |
| | % Positive | 0.0% | 0.0% | 0.0% |
| 4 | High Negative | | | |
| | Band Type | Neg. | Neg. | Cut. |
| | Positives | 1 | 2 | 58 |
| | Negatives | 575 | 574 | 518 |
| | % Positive | 0.2% | 0.3% | 10.1% |
| 5 | Cutoff | | | |
| | Band Type | Cut. | Neg. | WPos. |
| | Positives | 442 | 0 | 504 |
| | Negatives | 134 | 576 | 72 |
| | % Positive | 76.7% | 0.0% | 87.5% |
| 6 | Low Positive | | | |
| | Band Type | Pos. | Neg. | Pos. |
| | Positives | 572 | 0 | 576 |
| | Negatives | 4 | 576 | 0 |
| | % Positive | 99.3% | 0.0% | 100.0% |
| 7 | Moderate Positive | | | |
| | Band Type | Pos. | Neg. | Pos. |
| | Positives | 573 | 0 | 572 |
| | Negatives | 1 | 574 | 2 |
| | % Positive | 99.8% | 0.0% | 99.7% |
| 8 | Moderate Positive | | | |
| | Band Type | Pos. | Pos. | Pos. |
| | Positives | 576 | 572 | 576 |
| | Negatives | 0 | 4 | 0 |
| | % Positive | 100.0% | 99.3% | 100.0% |

Pos = positive band. Neg = negative band. Cut = equivocal band. Note: two replicates of one run are missing due to lack of sample 7.

Analytical Specificity: 220 sera from normal individuals (blood bank donors) representing endemic geographic regions of the United States were tested with Lyme B. burgdorferi (JgM) MarStripe Test. Analytical specificity was determined to be 99.5% (95% CI: 97.1% - 100%).

| | | Normal Individuals |
|----------------------------|----------|--------------------|
| Lyme IgM MarStripe<br>Test | Positive | 1 |
| | Negative | 219 |
| | Total | 220 |

Cross-reactivity: A total of 246 potentially cross-reactive specimens from individuals with other or infectious conditions were tested on Lyme B. burgdorferi (lgM) MarStripe Test. All positive specimens by the Lyme B. burgdorferi (IgM) MarStripe Test were confirmed positive when tested by the predicate IgM Western blot device.

> 60 Pineview Drive ● Buffalo, NY 14228-2120 ● USA Toll free [phone]  •  tel. [phone]  •  fax [phone]

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Image /page/6/Picture/0 description: The image shows the logo for Immco Diagnostics. The logo features a cluster of blue and green dots on the left, followed by the word "immco" in blue, and "DIAGNOSTICS" in green. Below the word "DIAGNOSTICS" is the text "A Trinity Biotech Company".

| | | 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. interogans | 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 | 15 | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Total | 246 | 7 (2.8) | 8 (3.2) | 11 (4.4) | 8 (3.2) |

Interference: Two Lyme IgM negative and three IgM positive sera were spiked with hemoglobin (2g/L), unconjugated bilirubin (342 µmo//L), RF (100 IU/ml), triglycerides (3.7 mmol/L) and total cholesterol (13 mmol/L) and tested using this assay. Samples were tested with and without interfering agents. Qualitative agreement was 100% for all specimens.

Serum vs. Plasma Matrix Comparison Studies: To establish equivalence of serum vs. plasma matrix, 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. Qualitative agreement for all pairs was 100%.

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

60 Pineview Drive USA Toll free [phone] ● tel. [phone] ● fax [phone]

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Image /page/7/Picture/0 description: The image shows the logo for Immco Diagnostics. The logo features a cluster of blue and green dots on the left, followed by the word "immco" in blue, with a small dot above the "o". Below "immco" is the word "DIAGNOSTICS" in green. Underneath that is the text "A Trinity Biotech Company" in a smaller font.

| N | Plasma | 0 | 0 | 0 | NEG | |
|---|--------|---|---|---|-----|-----|
| O | Serum | 0 | 0 | 0 | NEG | 100 |
| O | Plasma | 0 | 0 | 0 | NEG | |
| P | Serum | 0 | 0 | 1 | NEG | 100 |
| P | Plasma | 0 | 0 | 1 | NEG | |
| Q | Serum | 0 | 0 | 0 | NEG | 100 |
| Q | Plasma | 0 | 0 | 0 | NEG | |
| R | Serum | 0 | 0 | 0 | NEG | 100 |
| R | Plasma | 0 | 0 | 0 | NEG | |
| S | Serum | 0 | 0 | 1 | NEG | 100 |
| S | Plasma | 0 | 0 | 1 | NEG | |
| T | Serum | 0 | 0 | 0 | NEG | 100 |
| T | Plasma | 0 | 0 | 0 | NEG | |

1. 0 = negative band result. 1 = positive band result.

#### 8. Clinical Tests:

Method Comparison: A prospective study of FDA cleared first-step ElA specimens was performed at three geographically distinct study sites. The specimens testing positive (n=676) on a FDA cleared first-step ElA were tested with Lyme B. burgdorferi (lgM) MarStripe Test and an FDA cleared 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 22. The results are summarized below.

| | | Predicate IgM WB | | |
|----------------------------|----------|------------------|----------|-------|
| | | Positive | Negative | Total |
| Lyme IgM<br>MarStripe Test | Positive | 302 | 23 | 325 |
| Lyme IgM<br>MarStripe Test | Negative | 21 | 330 | 351 |
| | Total | 323 | 553 | 676 |

Positive % Agreement: Negative % Agreement:

93.5% (95% CI: 90.1% - 95.8%) 93.5% (95% Cl: 90.2% - 95.7%)

Sensitivity: 87 well characterized Lyme disease clinical specimens were tested with the Lyme B. burgdorferi (bgM) MarStripe Test. Specimens included samples from early, early diseminated, and late phases of the sensitivity obtained was compared with that of the predicate device.

| Interval | n | Lyme IgM MarStripe Test | | Predicate 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%) Difference in proportion: 1.1%

CDC Panels: Reference panels 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 (JgM) MarStripe Test and the predicate device.

> 60 Pineview Drive ● Buffalo, NY 14228-2120 ● USA Toll free [phone] ● tel. [phone] ● fax [phone]

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Image /page/8/Picture/0 description: The image is a logo for Immco Diagnostics, a Trinity Biotech Company. The logo features a cluster of blue and green dots on the left side, followed by the word "immco" in blue, sans-serif font. Below "immco" is the word "DIAGNOSTICS" in green, sans-serif font. Underneath that is the text "A Trinity Biotech Company" in a smaller, sans-serif font.

| Interval | n | Lyme IgM<br>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.

- Conclusion: From the performance data and kit comparison above, it is our conclusion that the Lyme B. burgdorferi (IgM) 9. MarStripe Test is substantially equivalent to the B. burgdorferi (JgM) MarBlot Strip Test System (K951709) commercially marketed by Trinity Biotech
Kus lausa

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