Lyme B. burgdorferi (IgG) MarStripe Test

• K Number: K163095
• Device Name: Lyme B. burgdorferi (IgG) MarStripe Test
• Manufacturer: Trinity Biotech
• Date Cleared: 2017-02-01 ( 89 days)
• Product Code: LSR
• Regulation Number: 866.3830

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.

Device Description

The kit is an immunoblot method to detect IgG antibodies against B. burqdorferi antigens. The test kit contains: Nitrocellulose Test Strips with purified B. burgdorferi antigens (10) and quality control lines (3) present in specific positions, Sample Diluent, Positive Control, Negative Control, Conjugate (Antihuman IgG-HRP Conjugate), TMB Substrate, and PBS Wash Buffer concentrate. To perform the test, serum or plasma is added to 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-diuted, 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 5 (or more) of the 10 test lines are considered positive for specific IgG antibody to B. burgdorferi.

Predicate Devices

K950829

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a traditional immunoblot assay with visual interpretation of results, with no mention of AI or ML.

Therapeutic

No.

This device is an in vitro diagnostic (IVD) test designed to detect antibodies to B. burgdorferi, providing supportive evidence for infection with Lyme disease. It does not provide any therapy or treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "for the in vitro qualitative detection of human IgG antibody to individual proteins of Borrelia burgdorferi in human serum or plasma... to provide supportive evidence of infection with B. burgdorferi," which is a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device is an in vitro diagnostic kit that includes physical components like nitrocellulose test strips, diluents, controls, conjugate, substrate, and wash buffer. The results are read visually by human operators.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for "in vitro qualitative detection of human IgG antibody to individual proteins of Borrelia burgdorferi in human serum or plasma". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
• Device Description: The description details a laboratory test performed on biological samples (serum or plasma) using reagents and test strips. This is consistent with the nature of an IVD.
• Sample Type: The device uses human serum or plasma, which are biological specimens collected from a patient for diagnostic testing.
• Purpose: The purpose is to provide "supportive evidence of infection with B. burgdorferi," which is a diagnostic purpose.

Therefore, based on the provided information, the Lyme B. burgdorferi (IgG) MarStripe Test is an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 .

Product codes

LSR

Device Description

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

• . Nitrocellulose Test Strips with purified B. burgdorferi antigens (10) 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

Regulation Number and Section

§ 866.3830

Treponema pallidum treponemal test reagents.(a)
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), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).

Summary

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February 1, 2017

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

Immco Diagnostics, Inc. Kevin Lawson Regulatory Officer 60 Pineview Dr. Buffalo, New York 14031

Re: K163095

Trade/Device Name: Lyme B. Burgdorferi (IgG) MarStripe Test Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LSR Dated: September 10, 2016 Received: November 4, 2016

Dear Kevin 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 Part 801 and Part 809); medical device reporting (reporting of

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 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/ResourcesforYou/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.

Steven R. Gitterman -S

Uwe Scherf, 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | K163095 |
| Device Name | Lyme B. burgdorferi (IgG) MarStripe Test |
| Indications for Use (Describe) | 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 . |

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

☑ 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 shows the logo for Immco Diagnostics, a Trinity Biotech Company. The logo features a cluster of blue and green dots on the left, followed by the company name "immco" in blue, and "DIAGNOSTICS" in green below it. Underneath the company name, it says "A Trinity Biotech Company" in a smaller 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:	1-4-2017

• Lyme B. burgdorferi (IgG) MarStripe Test 2. Device Name: Common Name: Lyme B. burgdorferi (IgG) Immunoblot Product Code: LSR
• 3. Substantially equivalent to: MarDx B. burgdorferi IgG MarBlot Strip Test System (K950829)
• 4. Description of device: The kit is an immunoblot method to detect IgG antibodies against B. burqdorferi antigens. The test kit contains:
  • . Nitrocellulose Test Strips with purified B. burgdorferi antigens (10) 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 60 Pineview Drive ● Buffalo, NY 14228-2120 ● 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 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.

The 29 discrepant specimens 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

Sensitivity: 94 well characterized Lyme disease clinical specimens from the above study were B. burgdorferi (IgG) MarStripe Test. Specimens included samples from early, early disseminated, and late phase. The sensitivity obtained was compared with that of the predicate device.

| 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: Predicate device: Difference in proportion:

22.3% (21/94) (95% Cl: 14.7%-32.3%) 20.2% (19/94) (95% Cl: 12.9%-30.0%) 2.1%

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 (lgG) 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 |
| Overall | 42 | 7 | 16.7 | 7 | 16.7 |

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.

• 9. Conclusion: From the performance data and kit comparison above, it is our conclusion that the Lyme B. burgdorferi (IgG) MarStripe Test is substantially equivalent to the B. burgdorferi (IgG) MarBlot Strip Test System (K950829) commercially marketed by Trinity Biotech
     Klaus

Kevin J. Lawson VP Regulatory Affairs

60 Pineview Drive Buffalo, NY 14228-2120 537-8378 · fax [phone]