Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard ELISA assay and its components, with no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No.
This device is an in vitro diagnostic test for detecting antibodies, which aids in the diagnosis of Lyme disease but does not directly treat or prevent a disease.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section states that the test kit is intended as a qualitative test for the detection of IgG antibodies to B. burgdorferi, and that positive results by either methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi. It also specifies that "A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory findings," indicating it provides information used in making a diagnosis.

SaMD (Software as a Medical Device)

No

The device is a physical test kit containing reagents, controls, and strips for performing an ELISA assay, which is a laboratory-based diagnostic method involving chemical reactions and a microplate reader. It is not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states it's a "qualitative test for the detection of IgG antibodies to B. burgdorferi sensu stricto in human serum". This indicates the device is used to examine specimens derived from the human body (serum) to provide information for the diagnosis of a disease (Lyme disease).
Device Description: The description details a laboratory test procedure involving reagents (antigen-coated strips, conjugate, substrate, etc.) and a photometric reading, which are characteristic of in vitro diagnostic tests.
Performance Studies: The document includes extensive performance studies (nonclinical and clinical) evaluating the device's accuracy (sensitivity, specificity, agreement) in detecting antibodies in human samples, which is a requirement for IVD devices.
Predicate Device: The mention of a predicate device (K894224 Trinity Biotech MarDx Borrelia burgdorferi EIA IgG Test Kit) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit is intended as a qualitative test for the detection of IgG antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. When used as the first-tier screening test, positive and equivocal results must be supplemented through additional testing by one of the following methods:

· Standard two-tier test methodology (STTT) using an IgG blot test following current interpretation guidelines, OR

• Modified two-tier test methodology (MTT) using the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/ IgM ELISA Test.

The assay can also be used as a second-tier confirmation test using the MTTT methodology when used with the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test as the first-tier screening test.

Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory findings.

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

LSR

Device Description

The kit includes 12 x 8 well Antigen Coated strips. Conjugate. Substrate, Stop Solution, Wash Buffer, Diluent, Negative Control, Positive Control, and Cutoff Control. The controls are provided to determine if the assay is functioning properly and to determine the antibody level. The reagents are sufficient for 96 determinations.

During the test procedure, antibodies to B. burgdorferi (sensu stricto) if present in the human serum sample will bind to the antigens coated onto the wells forming antigen-antibody complexes. Excess antibodies are removed by washing. A conjugate of goat anti-human IgG antibodies conjugated with horseradish peroxidase is then added, which binds to the antigenantibody complexes. Excess conjugate is removed by washing. This is followed by the addition of a chromogenic substrate, tetramethylbenzidine (TMB). If specific antibodies to the antigen are present in the patients' serum, a blue color will develop. The enzymatic reaction is then stopped with a stopping solution causing the contents of the well to turn yellow. The wells are read photometrically with a microplate reader at 450nm.

The antigens used in the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test kit is a combination of B. burgdorferi sensu stricto strain B31 lysate, B. burgdorferi sensu stricto strain 2591 lysate, and a recombinant VlsE from B. burgdorferi sensu stricto strain B31. The lysates use spirochetes growing in BSK-H complete medium until mid-exponential phase. The recombinant VlsE protein is produced in E. coli SURE2 cells and purified by affinity chromatography. The purity of each antigen is assayed by SDS-PAGE followed by Coomassie staining and/or Western blotting.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical Studies:

Determination of the Assay Cutoff:
- 210 normal sera (105 from endemic, 105 from non-endemic Lyme disease regions) were used to determine the cutoff. The mean plus two standard deviations was used.
- An additional 194 samples (114 Lyme disease, 8 negative healthy, 72 negative Lyme disease with other diseases causing cross-reactivity) were tested.
- A ROC analysis was performed to confirm the chosen cutoff provided the best compromise between sensitivity and specificity.
Precision:
- A within-lab precision study was conducted using a masked and randomized panel (negative, high negative, low positive, moderate positive samples, and kit controls).
- Each panel member was tested in duplicate, twice per day, for 12 days.
Reproducibility:
- A reproducibility study was conducted at three different sites (one internal, two external) using a masked and randomized panel (negative, high negative, low positive, moderate positive samples, and kit controls).
- Each panel member was tested in triplicate, twice per day, for five days.
Analytical Specificity:
- 208 asymptomatic individuals' samples from endemic and non-endemic regions were tested.
- Endemic Region: 103 samples, 4 Positive/Equivocal, Analytical Specificity 96.1%.
- Non-endemic Region: 105 samples, 0 Positive/Equivocal, Analytical Specificity 100.0%.
Cross Reactivity:
- 377 samples from different disease conditions were tested to evaluate potential cross-reactivity.
- Rickettsiosis IgG: 25 samples, 6 positive (24%).
- Ehrlichiosis IgG: 10 samples, 2 positive (20%).
- Epstein-Barr Virus IgG: 34 samples, 1 positive (3%).
- Varicella Zoster Virus: 16 samples, 1 positive (6%).
- Other conditions tested showed 0% positivity (Tick-borne Relapsing Fever IgG, Treponemal Infections (TPPA), Babesiosis IgG, H. pylori IgG, Parvovirus B19 IgG, Influenza A&B IgG, Cytomegalovirus IgG, Herpes Simplex Virus IgG, Fibromyalgia, Rheumatoid Arthritis, Autoimmune Disease, Multiple Sclerosis, Severe Periodontitis).
Interfering Substances:
- Evaluated the effect of albumin, bilirubin, cholesterol, hemoglobin, and triglycerides on high negative, equivocal, and low positive samples.
- No effect on performance was detected for the tested substances at recommended concentrations.

Clinical Studies:

Comparison with Predicate Device (STTT):
- Study Type: Comparison study at three sites (one internal, two external reference laboratories).
- Sample Size: 523 serum samples.
- Method: Tested on both the subject device and the predicate B. burgdorferi IgG ELISA Test.
- Results:
  - Positive percent agreement = 90.2% (55/61) (95% CI: 79.8% - 96.3%)
  - Negative percent agreement = 99.6% (460/462) (95% CI: 98.5% - 99.9%)
Second-Tier Testing (STTT):
- Study Type: Evaluation of second-tier testing.
- Method: All positive and equivocal samples from the subject device and predicate IgG ELISA were tested by an FDA cleared IgG blot assay.
- Results: Percent Agreement with Predicate Device (2nd Tier PPA) = 100.0% (37/37) (95% CI: 92.2% - 100.0%).
Clinical Sensitivity (STTT):
- Study Type: Sensitivity study using clinically characterized samples.
- Sample Size: 114 samples.
- Method: Tested on both the subject device and the predicate B. burgdorferi IgG ELISA Test.
- Results:
  - Early (n=58): Subject Device 46.6% (27/58), Predicate 27.6% (16/58).
  - Disseminated (n=17): Subject Device 82.4% (14/17), Predicate 52.9% (9/17).
  - Late (n=39): Subject Device 97.4% (38/39), Predicate 97.4% (38/39).
CDC Panel (STTT):
- Study Type: Evaluation using a masked characterized serum panel.
- Sample Size: 280 positive and negative specimens from the CDC.
- Method: Tested on both the subject device and the predicate device.
- Results (% Agreement with Clinical Diagnosis):
  - Healthy (n=100): Subject Device 99.0%, Predicate 99.0%.
  - Early Lyme (n=60): Subject Device 68.3%, Predicate 35.0%.
  - Cardiac Lyme (n=3): Subject Device 66.7%, Predicate 100.0%.
  - Neurological Lyme (n=7): Subject Device 85.7%, Predicate 42.9%.
  - Late (n=20): Subject Device 100.0%, Predicate 100.0%.
  - Look-alike Disease (n=90): Subject Device 87.8%, Predicate 88.9%.

MTTT Comparison (Modified Two-tier Testing):

Prospective Study (MTTT vs. STTT):
- Study Type: Comparison studies at three sites (one internal, two external laboratories).
- Sample Size: 481 serum samples (38 positive/equivocal in first tier).
- Method: Subject device used in MTTT (2-ELISA) protocol with Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test. Compared to STTT using Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA followed by predicate Gold Standard Diagnostics Borrelia burgdorferi IgG blot test.
- Results (Second-tier test comparison, n=38):
  - Positive percent agreement (with Predicate IgG Immunoblot) = 100.0% (23/23) (95% CI: 85.2% - 100.0%).
  - Negative percent agreement = 0.0% (0/15) (95% CI: 0.0% - 21.8%).
- Results (MTTT vs. STTT, all samples n=481):
  - Positive percent agreement = 100.0% (23/23) (95% CI: 85.2% - 100.0%).
  - Negative percent agreement = 96.7% (443/458) (95% CI: 94.7% - 98.2%).
Sensitivity Study (MTTT vs. STTT):
- Sample Size: 125 clinically characterized samples.
- Method: Tested on Gold Standard Diagnostics MTTT-IgG and predicate STTT-IgG.
- Results (% Agreement with Clinical Diagnosis):
  - Early (n=62): MTTT-IgG 48.4%, STTT-IgG 8.1%.
  - Disseminated (n=22): MTTT-IgG 81.8%, STTT-IgG 22.7%.
  - Late (n=41): MTTT-IgG 97.6%, STTT-IgG 95.1%.
CDC Reference Panel (MTTT vs. STTT):
- Sample Size: 280 positive and negative specimens from the CDC.
- Method: Tested on Gold Standard Diagnostics MTTT-IgG and predicate STTT-IgG.
- Results (% Agreement with Clinical Diagnosis):
  - Healthy (n=100): MTTT-IgG 100.0%, STTT-IgG 100.0%.
  - Early Lyme (n=60): MTTT-IgG 60.0%, STTT-IgG 33.3%.
  - Cardiac Lyme (n=3): MTTT-IgG 66.7%, STTT-IgG 33.3%.
  - Neurological Lyme (n=7): MTTT-IgG 85.7%, STTT-IgG 14.3%.
  - Late (n=20): MTTT-IgG 100.0%, STTT-IgG 100.0%.
  - Look-alike Disease (n=90): MTTT-IgG 100.0%, STTT-IgG 100.0%.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

STTT Comparison:

Positive percent agreement = 90.2% (55/61)
Negative percent agreement = 99.6% (460/462)
2nd Tier PPA = 100.0% (37/37)

MTTT Comparison:

Second-tier test of the STTT when compared to the second-tier test of the MTTT (first tier positive samples only):
- Positive percent agreement = 100.0%
- Negative percent agreement = 0.0%
MTTT when compared to the STTT (all samples):
- Positive percent agreement = 100.0%
- Negative percent agreement = 96.7%

Sensitivity Studies:

STTT Clinical Sensitivity:
- Early: 46.6% (27/58)
- Disseminated: 82.4% (14/17)
- Late: 97.4% (38/39)
MTTT Clinical Sensitivity:
- Early: 48.4%
- Disseminated: 81.8%
- Late: 97.6%

CDC Panel (% Agreement with Clinical Diagnosis):

STTT:
- Healthy: 99.0%
- Early Lyme: 68.3%
- Cardiac Lyme: 66.7%
- Neurological Lyme: 85.7%
- Late: 100.0%
- Look-alike Disease: 87.8%
MTTT:
- Healthy: 100.0%
- Early Lyme: 60.0%
- Cardiac Lyme: 66.7%
- Neurological Lyme: 85.7%
- Late: 100.0%
- Look-alike Disease: 100.0%

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K894224, K113847

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K200025

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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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March 22, 2021

Gold Standard Diagnostics Jennifer Roth Vice President, Product Development 2851 Spafford St. Davis, California 95618

Re: K203296

Trade/Device Name: Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema Pallidum Treponemal Test Reagents Regulatory Class: Class II Product Code: LSR Dated: November 4, 2020 Received: November 9, 2020

Dear Jennifer Roth:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Maria Ines Garcia, Ph.D. Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K203296

Device Name

Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit

Indications for Use (Describe)

The Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit is intended as a qualitative test for the detection of IgG antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. When used as the first-tier screening test, positive and equivocal results must be supplemented through additional testing by one of the following methods:

· Standard two-tier test methodology (STTT) using an IgG blot test following current interpretation guidelines, OR

• Modified two-tier test methodology (MTT) using the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/ IgM ELISA Test.

The assay can also be used as a second-tier confirmation test using the MTTT methodology when used with the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test as the first-tier screening test.

Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory findings.

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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510(k) Summary

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

Submitter's Name: Gold Standard Diagnostics Address: 620 Cantrill Drive Davis, CA. 95618 Phone Number: 530-759-8000 Contact Person: Jennifer Roth Date: November 3, 2020

1. Product and Trade Name: Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
  Common Name: Lyme ELISA Test

Regulation Section:

(21 CFR 866.3830) Treponema pallidum treponemal test reagents.

Classification: Class II

Product Code: LSR; Reagent, Borrelia Serological Reagent

Note: This clearance is for a modified use (Modified Two-tier Testing or MTTT use) for the previously cleared IVD test, the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (K200025). The information and study data for the modified use is presented under the heading of "MTTT Comparison" below. With the exception of the intended use, all other information and data remain the same.

3) Legally Marketed Device to Which the Submitter Claims Equivalence:

a. STTT Trinity Biotech MarDx Borrelia burgdorferi EIA IgG Test Kit (K894224).
b. MTTT Gold Standard Diagnostics Borrelia burgdorferi IgG Blot Test Kit (K113847)

4) Description of the Device:

The kit includes 12 x 8 well Antigen Coated strips. Conjugate. Substrate, Stop Solution, Wash Buffer, Diluent, Negative Control, Positive Control, and Cutoff Control. The controls are provided to determine if the assay is functioning properly and to determine the antibody level. The reagents are sufficient for 96 determinations.

During the test procedure, antibodies to B. burgdorferi (sensu stricto) if present in the human serum sample will bind to the antigens coated onto the wells forming antigen-antibody complexes. Excess antibodies are removed by washing. A conjugate of goat anti-human IgG

4

antibodies conjugated with horseradish peroxidase is then added, which binds to the antigenantibody complexes. Excess conjugate is removed by washing. This is followed by the addition of a chromogenic substrate, tetramethylbenzidine (TMB). If specific antibodies to the antigen are present in the patients' serum, a blue color will develop. The enzymatic reaction is then stopped with a stopping solution causing the contents of the well to turn yellow. The wells are read photometrically with a microplate reader at 450nm.

The antigens used in the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test kit is a combination of B. burgdorferi sensu stricto strain B31 lysate, B. burgdorferi sensu stricto strain 2591 lysate, and a recombinant VlsE from B. burgdorferi sensu stricto strain B31. The lysates use spirochetes growing in BSK-H complete medium until mid-exponential phase. The recombinant VlsE protein is produced in E. coli SURE2 cells and purified by affinity chromatography. The purity of each antigen is assayed by SDS-PAGE followed by Coomassie staining and/or Western blotting.

5) Intended Use of the Device:

The Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit is intended as a qualitative test for the detection of IgG antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. When used as the first-tier screening test, positive and equivocal results must be supplemented through additional testing bv one of the following methods:

Standard two-tier test methodology (STTT) using an IgG blot test following current ● interpretation guidelines, OR
. Modified two-tier test methodology (MTTT) using the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test.

The assay can also be used as a second-tier confirmation test using the MTTT methodology when used with the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test as the first-tier screening test.

Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory findings.

6) Comparison with the Predicate Device:

The tables below provide a comparison of the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test kit with the Trinity Biotech MarDx Borrelia burgdorferi EIA IgG Test kit (predicate device: K894224).

Similarities
Item	Subject Device: Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit	Predicate Device: Trinity Biotech MarDx Borrelia burgdorferi EIA IgG Test Kit
Intended Use	The Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA	Trinity Biotech MarDx Borrelia burgdorferi EIA IgG Test System is a

5

| | Test kit is intended as a qualitative
presumptive (first step) test for the
detection of IgG antibodies to B.
burgdorferi sensu stricto in human
serum from symptomatic patients
or people suspected of infection.
Positive and equivocal results
must be supplemented by testing
with a second-step Western blot
assay. | qualitative test intended for use in the
presumptive detection of human IgG
antibodies to Borrelia burgdorferi in
human serum. This EIA system should
be used to test serum from patients with
a history and symptoms of infection with
B. burdorferi. All positive and equivocal
specimens should be retested with a
highly specific, second-tier test such as
Western blot. Positive second-tier
results are supportive evidence of
infection with B. burdorferi. The
diagnosis of Lyme disease should be
made based on history and symptoms
(such as erythema migrans), and other
laboratory data, in addition to the
presence of antibodies to B. burdorferi.
Negative results (either first or second-
tier) should not be used to exclude Lyme | | |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Assay Format | Antigen coated microtiter plate -
96 wells. | Same | | |
| Technology | ELISA | Same | | |
| Sample Matrix | Human serum | Same | | |
| Sample Processing | Dilute Samples 1:100 in Diluent | Same | | |
| Controls Provided | Positive, Cutoff, Negative | Same | | |
| Reagents Provided | Diluent, Wash, Conjugate,
Substrate, Stop Solution | Same | | |
| Reported Results | Positive, Equivocal, Negative | Same | | |
| Interpretation | Optical density readings from
Spectrophotometer | Same | | |

Differences
Item	Subject Device: Gold Standard
Diagnostics Borrelia burgdorferi
IgG ELISA Test Kit	Predicate Device: Trinity Biotech
MarDx Borrelia burgdorferi EIA
IgG Test Kit
Volumes	100ul sample, 50ul substrate, 50ul
stop solution	100ul sample, 100ul substrate,
100ul stop solution
Incubation	15/15/15 minutes at room
temperature	30/30/10 minutes at room
temperature
Antigens	B. burgdorferi B31 strain,
B. burgdorferi 2591 strain,
B. burgdorferi recombinant VlsE
B31 strain	B. burgdorferi B31 strain
Results Interpretation	Convert to units.
Negative 11.0	Positive >1.2
--	----------------	---------------
--	----------------	---------------

6(b1): Nonclinical Studies:

Determination of the Assav Cutoff

The cutoff was determined by testing a total of 210 normal sera which consisted of 105 sera from an endemic region of Lyme disease and 105 sera from a non-endemic region of Lyme disease. The mean plus two standard deviations was used to determine the assay cutoff. A known positive sample was then diluted to produce a ready to use cutoff control. An additional 194 samples consisting of 114 samples from different phases of Lyme disease, 8 negative healthy samples, 72 negative Lyme disease samples but do have other diseases that may cause serologic cross-reactivity, were tested. A receiver operating characteristics (ROC) analysis was performed to evaluate the performance of the assay and confirm that the chosen cutoff provided the best compromise between sensitivity and specificity.

Precision

To determine the precision of the Borrelia burgdorferi IgG ELISA Test, a within-lab precision study was conducted. A precision panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested in-house. The sample panel was masked and randomized. Each of the panel members was tested in duplicate. twice per day, for 12 days. The results are summarized in the following table:

| Sample | N | Mean
Units | | Within-Run | Between-Run | Between-Day | Total |
|----------------------|----|---------------|----|------------|-------------|-------------|-------|
| Moderate
Positive | 48 | 20.3 | SD | 1.488 | 1.312 | 1.257 | 1.439 |
| | | | CV | 7.3% | 6.5% | 6.2% | 7.1% |
| Low
Positive | 48 | 11.5 | SD | 0.845 | 0.718 | 0.718 | 0.816 |
| | | | CV | 7.4% | 6.2% | 6.2% | 7.1% |
| High
Negative | 48 | 8.3 | SD | 0.880 | 0.646 | 0.615 | 0.857 |
| | | | CV | 10.6% | 7.8% | 7.4% | 10.4% |
| Negative | 48 | 0.8 | SD | 0.116 | 0.049 | 0.076 | 0.113 |
| | | | CV | 14.2% | 6.5% | 10.0% | 14.8% |
| Positive
Control | 48 | 17.2 | SD | 0.947 | 0.649 | 0.739 | .932 |
| | | | CV | 5.5% | 3.8% | 4.3% | 5.4% |
| Cutoff
Control | 48 | 10.1 | SD | 0.241 | 0.115 | 0.285 | 0.264 |
| | | | CV | 2.7% | 1.1% | 2.8% | 2.6% |
| Negative
Control | 48 | 0.4 | SD | 0.052 | 0.424 | 0.144 | 0.051 |
| | | | CV | 12.9% | 10.6% | 11.0% | 12.7% |

Reproducibility

7

A reproducibility panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested at three different sites. The sample panel was masked and randomized. Each of the panel members was tested in triplicate, twice per day, for five days. The Within-Run, Between-Run, Between-Days, and Between-Sites Standard Deviation and Coefficients of Variation (CV) were calculated. The sample panel was masked and randomized. The results are summarized in the following table:

| Sample | N | Mean
Units | | Within-
Run | Between-
Run | Between-
Day | Between-
Site | Total |
|----------------------|----|---------------|----|----------------|-----------------|-----------------|------------------|-------|
| Moderate
Positive | 90 | 21.0 | SD | 1.54 | 0.40 | 1.07 | 0.91 | 1.29 |
| | | | CV | 7.3% | 1.9% | 5.1% | 4.3% | 6.1% |
| Low
Positive | 90 | 13.7 | SD | 0.72 | 0.34 | 1.09 | 1.24 | 1.28 |
| | | | CV | 5.5% | 2.6% | 8.0% | 9.1% | 9.3% |
| High
Negative | 90 | 6.6 | SD | 0.76 | 0.27 | 0.46 | 0.68 | 0.67 |
| | | | CV | 11.7% | 4.1% | 7.0% | 10.3% | 10.2% |
| Negative | 90 | 3.0 | SD | 0.33 | 0.56 | 0.49 | 0.56 | 0.55 |
| | | | CV | 21.1% | 18.7% | 16.4% | 18.8% | 18.3% |
| Positive
Control | 30 | 19.1 | SD | 0.65 | 0.67 | 0.67 | 0.63 | 0.62 |
| | | | CV | 3.5% | 3.5% | 3.5% | 3.3% | 3.2% |
| Cutoff
Control | 60 | 10.0 | SD | 0.25 | 0.22 | 0.23 | 0.22 | 0.22 |
| | | | CV | 2.4% | 2.2% | 2.3% | 2.2% | 2.2% |
| Negative
Control | 30 | 0.5 | SD | 0.08 | 0.06 | 0.06 | 0.50 | 0.50 |
| | | | CV | 11.0% | 11.0% | 11.0% | 9.5% | 9.6% |

Analytical Specificity

The analytical specificity was determined by testing 208 asymptomatic individuals' samples from endemic and non-endemic regions. The Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test results are summarized in the following table:

| | Number of Samples | Number
Positive/Equivocal | Analytical Specificity |
|--------------------|-------------------|------------------------------|------------------------|
| Endemic Region | 103 | 4 | 96.1% |
| Non-endemic Region | 105 | 0 | 100.0% |

Cross Reactivity

A study using 377 samples was conducted to evaluate potential cross reactivity from different disease conditions. The samples were obtained from serum vendors who confirmed their positivity for each respective marker. The samples were tested on the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test. The results are summarized in the following table:

| Infection / Diagnosis | Number of
Sera Tested | # Positive /
(%) |
|--------------------------------|--------------------------|---------------------|
| Tick-borne Relapsing Fever IgG | 21 | 0 / (0%) |
| Treponemal Infections (TPPA) | 23 | 0 / (0%) |

8

Rickettsiosis IgG	25	6 / (24%)
Ehrlichiosis IgG	10	2 / (20%)
Babesiosis IgG	12	0 / (0%)
H. pylori IgG	11	0 / (0%)
Parvovirus B19 IgG	12	0 / (0%)
Influenza A&B IgG	12	0 / (0%)
Epstein-Barr Virus IgG	34	1 / (3%)
Cytomegalovirus IgG	31	0 / (0%)
Herpes Simplex Virus IgG	21	0 / (0%)
Varicella Zoster Virus	16	1 / (6%)
Fibromyalgia	32	0 / (0%)
Rheumatoid Arthritis	12	0 / (0%)
Autoimmune Disease	59	0 / (0%)
Multiple Sclerosis	23	0 / (0%)
Severe Periodontitis	23	0 / (0%)

Interfering Substances

The effect of potential interfering substances on samples using the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test was evaluated. Three samples, a high negative, an equivocal and a low positive were spiked with high levels of interferants and were tested along with serum without spiked interferants. The recommended concentrations from the guideline "Interference Testing in Clinical Chemistry" EP07-A3 from the Clinical and Laboratory Standards Institute were used (see table below). The tested substances did not affect the performance of the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test.

Substance	Concentration	Interference
Albumin	60 mg/ml	None detected
Bilirubin	0.4 mg/ml	None detected
Cholesterol	4.0 mg/ml	None detected
Hemoglobin	10 mg/ml	None detected
Triglycerides	15 mg/ml	None detected

6(b2): Clinical Studies:

Comparison with Predicate Device

Comparison studies were conducted at three sites (one internal and two external reference laboratories) using prospective samples submitted for Lyme serology testing. Five hundred twenty three (523) serum samples were tested on both the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test and on the predicate B. burgdorferi IgG ELISA Test. The results are summarized in the following table:

9

		Predicate IgG ELISA
		Positive	Equivocal*	Negative	Total
Gold Standard Diagnostics
Borrelia burgdorferi IgG
ELISA Test Kit	Positive	40	5	2	47
	Equivocal*	3	7	0	10
	Negative	2	4	460	466
	Total	45	16	462	523

*Equivocal samples counted as positive

Positive percent agreement = 90.2% (55/61)	95% CI (79.8% - 96.3%)
Negative percent agreement = 99.6% (460/462)	95% CI (98.5% - 99.9%)

Second-Tier Testing

All positive and equivocal samples by the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test and by the Predicate IgG ELISA were tested by a FDA cleared IgG blot assay. The results are summarized in the following table:

| | Tier 1 Positive
or Equivocal | IgG Blot
Positive | IgG Blot
Negative |
|--------------------------------------------------------------------------------------------------------|---------------------------------|----------------------|----------------------|
| Predicate IgG ELISA | 61 | 37 | 24 |
| Gold Standard
Diagnostics Borrelia
burgdorferi IgG
ELISA Test Kit | 57 | 37 | 20 |
| Predicate IgG ELISA
+
Gold Standard
Diagnostics Borrelia
burgdorferi IgG
ELISA Test Kit | 55 | 37 | 18 |

Percent Agreement with Predicate Device
2nd Tier PPA
(95% CI)	100.0%
(92.2% - 100.0%)	37/37

Clinical Sensitivity

Sensitivity Study

A sensitivity study was performed on 114 clinically characterized samples. The samples encompass early, disseminated, and late stages of Lyme disease. The samples were tested on both the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test and on the predicate B. burgdorferi IgG ELISA Test. The results are summarized in the following table:

10

| Disease
Stage | n | Gold Standard
Diagnostics Borrelia
burgdorferi IgG ELISA
Test Kit | Predicate
IgG ELISA |
|------------------|----|----------------------------------------------------------------------------|------------------------|
| Early | 58 | 46.6% (27/58) | 27.6% (16/58) |
| Disseminated | 17 | 82.4% (14/17) | 52.9% (9/17) |
| Late | 39 | 97.4% (38/39) | 97.4% (38/39) |

CDC Panel

A panel of 280 positive and negative specimens from the Center of Disease Control (CDC) for Lyme disease detection was tested on both the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test and on the predicate device. The results are presented as a means to convey further information on the performance of the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test with a masked characterized serum panel. This does not imply an endorsement of the assay by the CDC. The results are summarized in the following table:

| | | Gold Standard Diagnostics
Borrelia burgdorferi IgG
ELISA Test Kit | | Predicate
IgG ELISA | |
|-----------------------|-----|-------------------------------------------------------------------------|-------------------------------------------|-----------------------------|-------------------------------------------|
| Disease Stage | n | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis |
| Healthy | 100 | 1 | 99.0% | 1 | 99.0% |
| Early Lyme | 60 | 41 | 68.3% | 21 | 35.0% |
| Cardiac Lyme | 3 | 2 | 66.7% | 3 | 100.0% |
| Neurological Lyme | 7 | 6 | 85.7% | 3 | 42.9% |
| Late | 20 | 20 | 100.0% | 20 | 100.0% |
| Look-alike
Disease | 90 | 11 | 87.8% | 10 | 88.9% |

Expected Values

The range of values and positivity rate among different studies and population for the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test are as follows:

Population	# Samples	Unit Results			Qualitative Results
		Mean	Range	Std. Dev.	# Positive/ Equivocal	% Positive/ Equivocal
Normal
Endemic	103	3.7	0.5 - 14.3	2.452	4	3.9%
Normal
Non-Endemic	105	3.9	0.6 - 9.0	2.002	0	0.0%

11

| Prospective

Study	523	4.3	0.1 - 22.2	4.409	57	10.9%
Sensitivity
Study	114	13.6	0.9 – 40.4	7.994	81	71.1 %

Note: It is recommended that each laboratory determine its own normal range based on the population.

7) Conclusion:

From the comparison data, we conclude that the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test is substantially equivalent to the Trinity Biotech MarDx Borrelia burgdorferi EIA IgG Test kit (predicate device: K894224).

MTTT Comparison:

Comparison with the Predicate Device - MTTT:

The Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit, when used as the firststep or second-step test in combination with the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit in the Modified Two-tier Testing (MTTT) method, was compared to the Standard Two-tier testing (STTT) method using the predicates Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA (K200025) Test Kit as the first-step test followed by testing all the positive and equivocal results on the Gold Standard Diagnostics Borrelia burgdorferi IgG Blot Test (K113847). Below are tables comparing the two devices.

Similarities
Item	Subject Device: Gold Standard
Diagnostics Borrelia burgdorferi IgG
ELISA Test Kit	Predicate Device: Gold Standard
Diagnostics Borrelia burgdorferi
IgG Blot (K113847)
Intended Use	The Gold Standard Diagnostics Borrelia
burgdorferi IgG ELISA Test Kit is
intended as a qualitative test for the
detection of IgG antibodies to B.
burgdorferi sensu stricto in human serum
from symptomatic patients or people
suspected of infection. When used as the
first-tier screening test, positive and
equivocal results must be supplemented
through additional testing by one of the
following methods:
•Standard two-tier test methodology
(STTT) using an IgG blot test following
current interpretation guidelines, OR
•Modified two-tier test methodology
(MTTT) using the Gold Standard
Diagnostics Borrelia burgdorferi VlsE-
OspC IgG/IgM ELISA Test.
The assay can also be used as a second-
tier confirmation test using the MTTT	The Gold Standard Diagnostics
Borrelia burgdorferi B31 IgG Line
Blot Test Kit is intended for the
qualitative detection of IgG antibodies
to B. burgdorferi sensu stricto (B31)
in human serum. This test is intended
for use in testing human serum
samples which have been found
positive or equivocal using an ELISA
or IFA test procedure to provide
supportive evidence of infection with
B. burgdorferi.

12

| | methodology when used with the Gold
Standard Diagnostics Borrelia
burgdorferi VlsE-OspC IgG/IgM ELISA | |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| | Test as the first-tier screening test. | |
| | Positive test results by either the STTT
or MTTT methodology are supportive
evidence for the presence of antibodies
and exposure to Borrelia burgdorferi, the
cause of Lyme disease. A diagnosis of
Lyme disease should be made based on
the presence of Borrelia burgdorferi
antibodies, history, symptoms, and other
laboratory findings. | |
| Antigens | B. burgdorferi B31 strain, | Same |
| Sample Matrix | Human serum | Same |
| Controls Provided | Positive, Cutoff, Negative | Same |
| Sample Processing | Dilute Samples 1:100 | Same |
| Assay Type | Qualitative | Same |

Differences
Item	Subject Device: Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit	Predicate Device: Gold Standard Diagnostics Borrelia burgdorferi IgG Blot (K113847)
Assay Format	Antigen coated microtiter plate – 96 wells.	Nitrocellulose Strips
Reagents Provided	Diluent, Wash, Conjugate, Substrate, Stop Solution	Diluent/Wash, Conjugate, Substrate
Volumes	100ul sample, 50ul substrate, 50ul stop solution	1500ul sample, 1500ul substrate,
Incubation	15/15/15 minutes at room temperature	30/30/10-13 minutes at room temperature
Interpretation	Optical density readings from Spectrophotometer	Visual
Results Interpretation	Convert to units.
Negative 11.0	Compare to cutoff band
Reported Results	Positive, Equivocal, Negative	Positive, Negative

Method Comparison MTTT – IgG

The following studies were conducted to determine the performance of the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test as a first-tier or second-tier assay in the modified two-tier testing (MTTT) methodology.

13

Gold Standard Diagnostics MTTT-IgG ELISA Method Comparison: The Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test was utilized in a MTTT (2-ELISA) protocol with the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test. The MTTT (2-ELISA) results were compared to the standard two-tier testing (STTT) using the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA followed by testing all positive and equivocal results on the predicate Gold Standard Diagnostics Borrelia burgdorferi IgG blot test.

Prospective Study

Comparison studies were conducted at three sites (one internal and two external reference laboratories) using prospective samples submitted for Lyme serology testing. Four hundred eighty-one (481) serum samples were tested on the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test. A total of 38 positive and equivocal samples were obtained.

In the STTT protocol the samples that were positive or equivocal (n=38) were tested with the predicate B. burgdorferi IgG blot test. In the MTTT protocol the samples (n=38) were tested on a second ELISA, the Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC IgG/IgM ELISA Test. In the second-tier ELISA test, positive and equivocal results were considered positive.

The results of the second-tier test of the STTT when compared to the second-tier test of the MTTT, including only the samples that were positive in the first tier, are summarized in the following table:

		Predicate IgG Immunoblot
		Positive	Negative	Total
Gold Standard Diagnostics	Positive	23	ો ર	38
Borrelia burgdorferi IgG	Negative	0	0	0
ELISA	Total	23	15	38
Positive percent agreement = 100.0%
AT - - - Linne - un - - use - - use
1 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -		95% CI (85.2% - 100.0%)
000/ CT /0 00/ 01 00/ \

Negative percent agreement = 0.0%

95% Cl (0.0% - 21.8%)

The results of the MTTT when compared to the STTT, including all samples that were part of the prospective study (n=481), are summarized in the following table:

		Predicate STTT- IgG
		Positive	Negative	Total
Gold Standard Diagnostics
MTTT- IgG	Positive	23	15	38
	Negative	0	443	443
	Total	23	458	481

Positive percent agreement = 100.0% Negative percent agreement = 96.7%

95% CI (85.2% - 100.0%) 95% CI (94.7% - 98.2%)

14

Sensitivity Study

A sensitivity study was performed on 125 clinically characterized samples. The samples encompass early, disseminated, and late stages of Lyme disease. The samples were tested on both the Gold Standard Diagnostics MTTT-IgG and on the predicate STTT-IgG. The results are summarized in the following table:

| Disease
Stage | n | Gold Standard Diagnostics
MTTT - IgG | | Predicate
STTT - IgG | |
|------------------|----|-----------------------------------------|-------------------------------------------|-----------------------------|-------------------------------------------|
| | | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis |
| Early | 62 | 30 | 48.4% | 5 | 8.1% |
| Disseminated | 22 | 18 | 81.8% | 5 | 22.7% |
| Late | 41 | 40 | 97.6% | 39 | 95.1% |

CDC Reference Panel

A panel of 280 positive and negative specimens from the Centers of Disease Control (CDC) for Lyme disease detection was tested on both the Gold Standard Diagnostics MTTT-IgG and on the predicate STTT-IgG. The results are summarized in the following table:

| | n | Gold Standard Diagnostics
MTTT-IgG | | Predicate STTT- IgG | |
|---------------------|-----|---------------------------------------|-------------------------------------------|-----------------------------|-------------------------------------------|
| Disease Stage | | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis |
| Healthy | 100 | 0 | 100.0% | 0 | 100.0% |
| Early Lyme | 60 | 36 | 60.0% | 12 | 33.3% |
| Cardiac Lyme | 3 | 2 | 66.7% | 1 | 33.3% |
| Neurological Lyme | 7 | 6 | 85.7% | 1 | 14.3% |
| Late | 20 | 20 | 100.0% | 20 | 100.0% |
| Look-alike Disease* | 90 | 0 | 100.0% | 0 | 100.0% |

*infectious mononucleosis, fibromyalgia, multiple sclerosis, rheumatoid arthritis, syphilis and severe periodontitis

8) Conclusion:

From the comparison data, we conclude that the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test is substantially equivalent to the Gold Standard Diagnostics Borrelia burgdorferi IgG Blot Test Kit (K113847) when used for the Modified Two-tier Testing (MTTT) Lyme testing.