The Inanovate Lyme-ID IgG Test is an in vitro qualitative microarray assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease. It is intended to detect antibodies to VlsE and multiple other B.burgdorferi antigens following a modified two-tier test methodology. Positive results from the Lyme-ID IgG Test are supportive evidence for the presence of antibodies and exposure to B. burgdorferi, the causative agent for Lyme disease. Negative results do not preclude infection with B. burgdorferi. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures as an aid in diagnosis of Lyme disease.

The Inanovate Lyme-ID IgG Test must be used with Inanovate's Bio-ID800 instrument and Lyme-ID Software.

Device Description

Designed as a modified solid-phase ELISA, the Lyme-ID IgG Test is a protein microarray assay. A whole cell lysate sample of B. burgdorferi, along with antigens Outer Surface Protein C (OspC) and Variable Lipoprotein Surface-Exposed (VlsE) are bound to the glass surface of the Lyme-ID IgG Test cartridge. The antigens are immobilized as individual spots onto the glass surface. Positions of the spots are exactly defined and can be assigned to each antigen reliably. A negative control spot, positive control spot, and six signal control spots are applied to each microarray to ensure that the assay performs properly and to verify the reliability of individual sample results.

The Bio-ID800 Instrument is a bench-top analyzer which contains an optics system for detecting and reading fluorescence produced during the assay, pressure system for flowing reagents through the microfluidics channels in the cartridge, and a manifold for clamping the cartridge and aligning the cartridge over the optics scan area. The optics system excites the fluorescent reagent for analyte detection using a 532nm wavelength laser projected through a series of mirrors and expanders to a scan lens located directly under the stage for the cartridge. This enables the assay area of the cartridge to be scanned for fluorescence through an aperture and read as it returns down an optics path to a photomultiplier tube (PMT). The PMT converts the collected fluorescent light into a corresponding output voltage that is read by a high-speed data acquisition card. Reagent and sample flow rates are pulsed using high-speed valves connected to externally sourced compressed air through a series of regulators and sensors. Assay reaction temperature is controlled using filtered fans and vents to maintain the chamber at room temp with a negative pressure at the cartridge loading door.

The cartridge contains up to six patient samples and two controls (positive and negative), detection reagent, and blocking buffer wells all connected by microfluidic channels to an assay array field. As reagents or samples flow through the field, they are collected in waste wells, so that no waste leaves the cartridge. Each cartridge consists of a glass plate (containing the protein and cell lysate antigens, along with positive and negative control spots), a PDMS polymer assay reservoir which contains the microfluidic flow paths molded into the bottom, and a protective frame that aids in the alignment.

The Lyme-ID Software controls the Bio-ID800 and communicates with the instrument to collect data into a database, enabling both storage of the assay data and analysis. The software enables self-tests of the instrument and communication through the user interface with the user and instrument for warnings, errors, and prompts. During assay performance, the control of the valves for pressurizing cartridges is controlled by the software. Signal generated through the PMT is interpreted using a statistical average function and stored by the software as an image file. The software then analyzes the image files to ensure the test was performed without error and analyzes the data collected from the analytes to compute the positive or negative status of the sample. Results are then printed from the computer with a standalone printer.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - Lyme-ID IgG Test

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

November 14, 2025

Inanovate Inc.
Aaron Harmon
Director of Regulatory and Quality
4800 N. Career Ave. STE 132
Sioux Falls, South Dakota 57107

Re: K252627
Trade/Device Name: Lyme-ID IgG Test; Bio-ID800
Regulation Number: 21 CFR 866.3830
Regulation Name: Treponema Pallidum Treponemal Test Reagents
Regulatory Class: Class II
Product Code: LSR, NSU
Dated: August 20, 2025
Received: August 20, 2025

Dear Aaron Harmon:

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 (the 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 available 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.

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K252627 - Aaron Harmon Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K252627 - Aaron Harmon Page 3

assistance/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,

Bryan M. Grabias -S
2025.11.14 12:18:00
-05'00'

Bryan Grabias, PhD
Acting Branch Chief
Bacterial Respiratory and Medical Countermeasures Branch
Division of Microbiology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K252627

Device Name: Lyme-ID IgG Test; Bio-ID800

Indications for Use (Describe):

The Inanovate Lyme-ID IgG Test must be used with Inanovate's Bio-ID800 instrument and Lyme-ID Software.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

510(k) Summary

I. BACKGROUND INFORMATION:

A. 510(k) Number

K252627

B. Applicant

Inanovate Inc.
4800 North Career Ave
Suite 132
Sioux Falls, SD 57107

C. Contact Person

Dr. Aaron Harmon
Director of Regulatory and Quality
aharmon@inanovate.com
1-712-301-4205

D. Date Prepared

August 19, 2025

E. Proprietary and Established Names

Lyme-ID IgG Test, Bio-ID800

F. Regulatory Information

Product Code(s): LSR, NSU
Reagent Classification: Class II
Regulation Section: 21 CFR 866.3830 - Treponema Pallidum Treponemal Test Reagents
Reagents Panel: MI - Microbiology

II. SUBMISSION/DEVICE OVERVIEW:

A. Purpose for Submission:

To obtain a substantial equivalence determination for a new device.

B. Measurand:

IgG antibodies to Borreliella burgdorferi (B. burgdorferi)

Page 6

C. Type of Test:

Enzyme Immunoassay

III. INTENDED USE/INDICATIONS FOR USE:

A. Intended Use(s):

See Indications for Use below.

B. Indication(s) for Use:

The Inanovate Lyme-ID IgG Test is an in vitro qualitative microarray assay for the detection of IgG antibodies to Borreliella burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease. It is intended to detect antibodies to VlsE and multiple other B. burgdorferi antigens following a modified two-tier test methodology. Positive results from the Lyme-ID IgG Test are supportive evidence for the presence of antibodies and exposure to B. burgdorferi, the causative agent for Lyme disease. Negative results do not preclude infection with B. burgdorferi. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures as an aid in diagnosis of Lyme disease.

The Inanovate Lyme-ID IgG Test must be used with Inanovate's Bio-ID800 instrument and Lyme-ID Software.

C. Special Conditions for Use Statement(s):

For prescription use only

D. Special Instrument Requirements:

Bio-ID800 Instrument and Lyme-ID Software

IV. DEVICE/SYSTEM CHARACTERISTICS:

A. Device Description:

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532nm wavelength laser projected through a series of mirrors and expanders to a scan lens located directly under the stage for the cartridge. This enables the assay area of the cartridge to be scanned for fluorescence through an aperture and read as it returns down an optics path to a photomultiplier tube (PMT). The PMT converts the collected fluorescent light into a corresponding output voltage that is read by a high-speed data acquisition card. Reagent and sample flow rates are pulsed using high-speed valves connected to externally sourced compressed air through a series of regulators and sensors. Assay reaction temperature is controlled using filtered fans and vents to maintain the chamber at room temp with a negative pressure at the cartridge loading door.

B. Principle of Operation:

During each test, the diluted test serum of each sample is added to one microarray. If B. burgdorferi specific antibodies are present in the test sample, they will bind to the antigens immobilized on the glass surface. During the next step, fluorescently labelled detection antibodies flow across the microarray, binding to B. burgdorferi specific antibodies bound to the antigens on the glass surface. Once bound, the fluorescently labelled detection antibodies emit a fluorescent signal detected and measured by the Bio-ID800 instrument. These steps (or cycles) are performed with fluorescent signal measurements collected over a number of timepoints, ultimately generating a curve reflective of the change in fluorescent signal over time. From this curve, an area under the curve (AUC) value is calculated providing an indirect measurement of B. burgdorferi specific antibodies present in the patient specimen (sample). After completion of each assay, the Lyme-ID software performs an analysis of each antigen spot of each sample (including the positive and negative control samples) to determine if the assay ran successfully. The results of each antigen spot from each sample are reviewed by the Lyme-ID software against the algorithm below in Table 1 to determine the Lyme Disease Evaluation – Report Result.

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Table 1. Lyme Disease Evaluation

Cell Lysate Result	OspC Result	VlsE Result	Reported Result
+	+	+	POSITIVE
+	+	-	POSITIVE
+	-	+	POSITIVE
+	-	-	NEGATIVE
-	+	+	NEGATIVE
-	+	-	NEGATIVE
-	-	+	NEGATIVE
-	-	-	NEGATIVE

The Lyme-ID IgG Test meets the CDC's Modified Two-Tiered Test (MTTT) methodology requirement The Lyme-ID IgG Test detects human serum IgG antibodies against B. burgdorferi cell lysate, OspC, and VlsE. The test system simplifies the MTTT method by combining the two tiers of testing into one test, giving results for all three targets simultaneously.

V. SUBSTANTIAL EQUIVALENCE INFORMATION:

A. Predicate Device Name(s):

Viramed Borrelia All-In-One ViraChip Test Kit

B. Predicate 510(k) Number(s):

K220016

C. Comparison with Predicate(s):

Item	Device: Lyme-ID IgG Test	Predicate: Viramed Borrelia All-In-One ViraChip Test Kit (K220016)
Similarities

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| Intended Use / Indications for Use | The Inanovate Lyme-ID IgG Test is an in vitro qualitative microarray assay for the detection of IgG antibodies to Borreliella burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease. It is intended to detect antibodies to VlsE and multiple other B. burgdorferi antigens following a modified two-tier test methodology. Positive results from the Lyme-ID IgG Test are supportive evidence for the presence of antibodies and exposure to B. burgdorferi, the causative agent for Lyme disease. Negative results do not preclude infection with B. burgdorferi. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures as an aid in diagnosis of Lyme disease. The Inanovate Lyme-ID IgG Test must be used with Inanovate's Bio-ID800 instrument and Lyme-ID Software. | The Viramed Biotech AG Borrelia All-In-One ViraChip is an in vitro qualitative microarray assay for the detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease. It is intended to detect antibodies to VlsE and multiple other B. burgdorferi antigens following a modified two- tier test methodology. Positive results from the Viramed Biotech AG Borrelia All-In-One ViraChip are supportive evidence for the presence of antibodies and exposure to B. burgdorferi, the causative agent for Lyme disease. Negative results do not preclude infection with B. burgdorferi. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures as an aid in diagnosis of Lyme disease. The Viramed Biotech AG Borrelia All-In-One ViraChip Test must be used with a ViraChip Reader and the ViraChip Software. |
| Specimen Type | Serum | Serum |
| Antibodies Detected | IgG | IgM and IgG |
| Controls | Positive Control Serum Negative Control Serum | Positive Control Serum Negative Control Serum |
| Method | Qualitative | Qualitative |

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Differences

Item	Device	Predicate
Assay Technology	Antigen Spotted Glass (Microarrays)	Antigen Coated Wells (Microarrays)
Antigens	VlsE, OspC, and whole cell extract of B. burgdorferi	VlsE, 93 kD, 58 kD, 45 kD, 39 kD, 30 kD, 23 kD, 21 kD, 19 kD, 18 kD, and 17 kD antigens of B. burgdorferi
Sample Volume	Samples diluted 1:150 and 200 µL added per well	Samples diluted 1:76 and 100 µL added per well
Reagents	Assay Buffer, Blocking Buffer, Fluorescent Detection Reagent	10X Wash Buffer, Sample Buffer, Chromogen/Substrate Solution
Procedural Steps	Pressure driven flow of sample and detection reagent through microarray over multiple cycles	Wash after sample and conjugate step
Result Generation	Automated with Bio-ID800 Instrument and Lyme-ID Software	Automated with ViraChip Reader

VI. STANDARDS/GUIDANCE DOCUMENTS REFERENCED:

Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff - MARCH 2013

VII. PERFORMANCE CHARACTERISTICS (IF/WHEN APPLICABLE):

A. Analytical Performance:

1. Precision/Reproducibility:

a. Precision: A panel of six samples was tested by the Lyme-ID IgG Test in four replicates per day (two replicates per run, two runs per day) over 20 days for a total of 80 replicates for each specimen. Samples selected for the panel included two moderate positive, two low positive, one high negative and one negative specimen. Final positive and negative agreement was 100% for all specimens with the exception of a high negative sample which exhibited a positive result in 13/80 replicates. Results are shown below in Table 2.

Table 2. Precision Study Results Summary

Sample	Test results	Positive test results	Negative test results	% Agreement
Moderate Positive	80	80	0	100%
Moderate Positive	80	80	0	100%

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| Low Positive | 80 | 80 | 0 | 100% |
| Low Positive | 80 | 80 | 0 | 100% |
| High Negative | 80 | 13 | 67 | 84% |
| Negative | 80 | 0 | 80 | 100% |

b. Reproducibility: A panel of six samples was tested by the Lyme-ID IgG Test in four replicates per day (two operators each completing two runs per day, one replicate per run) over five days for a total of 20 replicates for each specimen. This was repeated at two external sites (separate from the manufacturer's site), each with two new operators, for a total of 59 valid replicates for each specimen (except for one of the moderate positive samples which had 60 valid replicates). Samples selected for the panel included two moderate positive, one low positive, one borderline (expected to test positive approximately 50% of the time), and two negative samples. Results are shown below in Table 3.

Table 3. Reproducibility Study Results Summary

Sample	Test results	Positive test results	Negative test results	% Agreement
Moderate Positive	60	60	0	100%
Moderate Positive	59	58	1	98%
Low Positive	59	58	1	98%
Borderline	59	30	29	51%
Negative	59	0	59	100%
Negative	59	0	59	100%

2. Linearity:

Not applicable.

3. Cross-Reactivity/Interference:

a. Cross-Reactivity Study: A total of 175 sera determined to contain antibodies to other infectious disease agents were evaluated on the Lyme-ID IgG Test. Results are shown below in Table 4.

Table 4. Cross-Reactivity Study Results Summary

Disease Condition	Total Number Tested	Number of Positive Results	% Cross Reactive
Anaplasmosis	9	2ᵃ	22.2%
Babesiosis	11	5ᵇ	45.4%
Ehrlichiosis	10	2	20%
CMV (IgG)	10	2	20%

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| CMV (IgM) | 10 | 1 | 10% |
| EBV | 10 | 1ᶜ | 10% |
| Fibromyalgia | 10 | 0 | 0% |
| Helicobacter Pylori | 9 | 1 | 11.1% |
| Herpes Simplex | 7 | 1 | 14.3% |
| Influenza A | 10 | 0 | 0% |
| Leptospira | 9 | 0 | 0% |
| Multiple Sclerosis | 10 | 0 | 0% |
| Parvovirus | 10 | 0 | 0% |
| Rheumatoid Arthritis | 10 | 0 | 0% |
| Rubella | 10 | 0 | 0% |
| Syphilis | 10 | 2 | 20% |
| Toxoplasmosis | 10 | 0 | 0% |
| VZV | 10 | 0 | 0% |

ᵃTwo positive samples also tested Lyme Positive through STTT, possible co-infection with Lyme antibodies.
ᵇOne of five positive samples also tested Lyme Positive through STTT, possible co-infection with Lyme antibodies.
ᶜOne positive sample also tested Lyme Positive through STTT, possible co-infection with Lyme antibodies.

b. Interference from Endogenous Analytes: The potential interfering effect of endogenous substances in patient samples using the Lyme-ID IgG Test was evaluated using one moderate positive, one low positive, and one negative Lyme sample. Samples were spiked with the endogenous substances at the concentrations listed in Table 5 below. All samples were tested in a minimum of five replicates. No interference was observed in the tested samples, even at the highest concentration of each analyte.

Table 5 – Effect of Interfering Substances on Lyme-ID IgG Test

Interfering Substance	Concentrations Tested	Effect on Lyme-ID IgG Test
Albumin	1.25g/dL, 2.5g/dL, 3.75g/dL, 5.0g/dL	No effect
Bilirubin	3.75mg/dL, 7.5mg/dL, 11.25mg/dL, 15.0mg/dL	No effect
Cholesterol	100mg/dL, 200mg/dL, 300mg/dL, 400mg/dL	No effect
Hemoglobin	5g/dL, 10g/dL, 15g/dL, 20g/dL	No effect
Intralipid	200mg/dL, 400mg/dL, 600mg/dL, 800mg/dL	No effect
Triglycerides	125mg/dL, 250mg/dL, 375mg/dL, 500mg/dL	No effect

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4. Assay Reportable Range:

Not applicable.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

Not applicable.

6. Detection Limit:

Not applicable.

7. Assay Cut-Off:

The cut-off of the Lyme-ID IgG Test is defined for each antigen individually by multiplying the mean intensity of the Lyme Positive Control with an antigen specific factor (Normalization Factor). Specific antigen factors are established for each kit lot according to the performance of the Lyme Positive Control sample when compared to established absolute cutoff values for the test. Absolute cutoff values were validated with pre-characterized blood serum and were optimized for both maximum sensitivity and specificity for each antigen.

B. Clinical Studies:

1. Method Comparison with comparator (STTT):

The performance of the Lyme-ID IgG Test for detection of Borrelial-specific antibodies was compared to FDA-cleared EIA and immunoblot as part of the standard two-tier test methodology (STTT). A total of 150 serum samples were collected from two clinical sites and distributed between three separate testing sites. Table 6 below summarizes the distribution of samples per collection site.

Table 6: Sample distribution by clinical site and cohort.

	Number of Samples	Sample Type and Cohort	Clinical Sites Providing Samples
Site 1	131	Clinical serum samples – Cohort 1	Sanford Health
Site 2	19	Clinical serum samples – Cohort 2	Northwell Health

Samples were randomized, blinded, and distributed to each of three testing sites and tested per the instructions for use for the Lyme-ID IgG Test. Performance by cohort is summarized below in Tables 7 and 8.

Table 7: Performance summary of prospectively collected samples from Sanford Health (n=131)

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with results of Lyme-ID IgG Test compared to results of STTT method.

Table 7 – Sanford Health cohort performance table

	STTT Results (IgG)
	Positive	Negative	Total
Lyme-ID IgG Test Positive	27	5	32
Lyme-ID IgG Test Negative	1	98	99
Total	28	103	131

PPA (95% CI) 96.4% (82.3%, 99.4%)
NPA (95% CI) 95.1% (89.1%, 97.9%)

Table 8: Performance summary of prospectively collected samples from Northwell Health (n=16) with results of Lyme-ID IgG Test compared to results of STTT method.

Table 8: Lyme-ID IgG Test performance in known positive samples

	Positive*
Lyme-ID IgG Test Positive	16
Lyme-ID IgG Test Negative	0
Total	16

PPA (95% CI) 100% (80.6%, 100%)

*Three samples positive with Lyme-ID IgG Test were positive for anti-B. burgdorferi IgM antibodies and negative for anti-B. burgdorferi IgG antibodies when tested by STTT method

2. Clinical Sensitivity/Specificity:

CDC Serum Panel: A panel of 280 serum samples provided by the CDC was tested with the Lyme-ID IgG Test. Samples within this panel were from patients diagnosed with Lyme Disease at different stages (Stages 1, 2, and 3), Lyme disease look-like infections (infectious mononucleosis, multiple sclerosis, rheumatoid arthritis, fibromyalgia and severe periodontitis), and from healthy controls living in endemic and non-endemic regions of Lyme disease. Results were analyzed and compared to results from both a STTT and MTTT method.

The sensitivity of the Lyme-ID IgG Test when testing the CDC Reference Panel was 81.7% in stage I Lyme disease samples, 100% in stage II samples, and 100% in stage III samples. Results are shown below in Table 9.

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Table 9. Sensitivity of Inanovate's Lyme-ID IgG Test (CDC Reference Panel)

	Lyme Stage I (60)		Lyme Stage II (10)		Lyme Stage III (20)
	Lyme-ID	STTT	Lyme-ID	STTT	Lyme-ID	STTT
Positive	49	19	10	6	20	20
Negative	11	41	0	4	0	0
Sensitivity	81.7%	31.7%	100.0%	60.0%	100.0%	100.0%

The specificity of the Lyme-ID IgG Test when testing the CDC Reference Panel was 100% in endemic healthy control samples, 92% in non-endemic healthy control samples and 91.1% in disease control samples. Results are shown below in Table 10.

Table 10. Specificity of Inanovate's Lyme-ID IgG Test (CDC Reference Panel)

	Healthy Controls (Endemic, 50)		Healthy Controls (Non-Endemic, 50)		Disease Controls (90)
	Lyme-ID	STTT	Lyme-ID	STTT	Lyme-ID	STTT
Positive	0	0	4	0	8	0
Negative	50	50	46	50	82	90
Specificity	100.0%	100.0%	92.0%	100.0%	91.1%	100.0%

3. Other Clinical Supportive Data:

Sample stability study: 60 decoded remnant patient serum samples were tested fresh (no freeze-thaw cycles) and again after one, two, and three freeze-thaw cycles. Lyme Diagnosis as determined by the Lyme-ID IgG Test was measured at each timepoint and any changes in diagnosis between timepoints was examined further. No effects of one, two, or three freeze-thaw cycles on any of the samples was observed. Clinical performance of the Lyme-ID IgG Test for fresh and frozen samples was comparable, confirming that the Lyme-ID IgG Test can be used with both fresh and frozen samples.

C. Clinical Cut-Off:

Not applicable.

D. Expected Values/Reference Range:

The incidence of IgG antibodies to B. burgdorferi antigens in patients tested by the Lyme-ID test is summarized in table 11 below.

Table 11: Observed Reactivity of Lyme ID test

Cohort	Samples tested	Lyme-ID positive	Prevalence
Prospective cohort	131	32	24.43%

VIII. PROPOSED LABELING:

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The labeling is sufficient and satisfies the requirements of 21 CFR Part 809.10

IX. CONCLUSION:

The information submitted in this premarket notification is complete and supports a substantial equivalence decision.

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).