K Number

Device Name

Lyme B. burgdorferi (IgM) MarStripe Test

Manufacturer

Trinity Biotech

Date Cleared

2017-10-23

(89 days)

Product Code

LSR

Regulation Number

866.3830

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 Description

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.

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Center

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Date Received

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Device Name

Decision

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Street 2

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Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K951709

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, and there are no mentions of AI, ML, or image processing.

Therapeutic

This device is a diagnostic test, specifically an immunoblot assay, used to detect antibodies for Lyme disease. It does not provide any form of therapy or treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an immunoblot assay for the in vitro qualitative detection of human IgM antibody to individual proteins of Borrelia burgdorferi... to provide supportive evidence of infection with B. burgdorferi." This directly aligns with the definition of a diagnostic device, as it aims to identify evidence of a disease (Lyme disease) in human samples.

SaMD (Software as a Medical Device)

The device is a laboratory test kit containing physical components like nitrocellulose strips, diluents, controls, conjugate, substrate, and wash buffer. The test involves manual steps and visual interpretation of results on the physical strips.

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 the "in vitro qualitative detection of human IgM 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 using biological samples (serum or plasma) and various reagents to detect specific antibodies. This is consistent with the nature of an IVD.
Regulatory Information: The "Intended User / Care Setting" specifies "Prescription Use (Part 21 CFR 801 Subpart D)", which is a regulatory classification for medical devices, including IVDs.
Performance Studies: The document describes various non-clinical and clinical tests performed to evaluate the device's performance using biological samples. This is standard practice for demonstrating the safety and effectiveness of an IVD.
Predicate Device: The mention of a "Predicate Device" (K951709; MarDx B. burqdorferi IgM MarBlot Strip Test System) which is also an IgM Western blot test for Lyme disease, further confirms that this device falls within the category of IVDs.

All of these factors indicate that the Lyme B. burgdorferi (IgM) MarStripe Test is designed to be used outside of the body to examine specimens from the human body for the purpose of providing information for diagnosis, which is the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

LSR

Device Description

The kit is an immunoblot method to detect IgM antibodies against B. burgdorferi 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

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

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.

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

Indications for Use

510(k) Number (if known) K172254

Device Name

Lyme B. burgdorferi (IgM) MarStripe Test

Indications for Use (Describe)

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
1. Substantially equivalent to: MarDx B. burqdorferi IgM MarBlot Strip Test System (K951709)
1. 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 60 Pineview Drive ● Buffalo, NY 14228-2120 ● USA Toll free (800) 537-8378 ● tel. (716) 691-0091 ● fax (716) 691-0466

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
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 (800) 537-8378  •  tel. (716) 691-0091  •  fax (716) 691-0466

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

60 Pineview Drive USA Toll free (800) 537-8378 ● tel. (716) 691-0091 ● fax (716) 691-0466

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

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
MarStripe Test	Positive	302	23	325
Lyme IgM
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 (800) 537-8378 ● tel. (716) 691-0091 ● fax (716) 691-0466

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
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

Kevin J. Lawson VP Regulatory Affairs

60 Pineview Drive ● USA Toll free (800) 537-8378 ● tel. (716) 691-0091