(91 days)
Not Found
No
The device is an ELISA test kit, which is a traditional laboratory assay based on biochemical reactions and photometric reading, not AI/ML. The summary explicitly states "Not Applicable (ELISA test, not a machine learning model)" for sections related to training and test sets.
No
This device is an in vitro diagnostic test kit designed to detect antibodies to Borrelia burgdorferi in human serum, which is used for diagnosis, not for treatment or therapy.
Yes
The device is intended as a qualitative presumptive test for the detection of IgM antibodies to B. burgdorferi, which is used to help identify individuals suspected of infection. This falls under the definition of a diagnostic device as it is used to diagnose a disease or condition.
No
The device is an in vitro diagnostic test kit that includes physical reagents and controls, not solely software.
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 kit is intended for the detection of IgM antibodies to B. burgdorferi in human serum. This is a diagnostic test performed in vitro (outside the body) on a biological sample (serum).
- Device Description: The description details the components of a laboratory test kit designed to analyze a biological sample. It describes the process of detecting antibodies in serum using an ELISA method.
- Performance Studies: The document includes detailed information about nonclinical and clinical studies performed to evaluate the performance of the device in diagnosing Lyme disease. This is a standard requirement for IVD devices.
- Predicate Device: The mention of a "Predicate Device" (K894293; Trinity Biotech MarDx Borrelia burgdorferi EIA IgM Test Kit) indicates that this device is being compared to a previously cleared IVD device, which is a common regulatory pathway for new IVDs.
All of these points strongly indicate that the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test kit is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test kit is intended as a qualitative presumptive (first step) test for the detection of IgM 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.
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 IgM 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 450mm.
The antigens used in the Gold Standard Diagnostics Borrelia burgdorferi IgM 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 protein 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
The cutoff was determined by testing a total of 208 normal sera which consisted of 103 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.
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Studies:
- Determination of the Assay Cutoff: A total of 208 normal sera (103 from endemic region, 105 from non-endemic region) were tested to determine the cutoff. An additional 194 samples (114 from different phases of Lyme disease, 8 negative healthy, 72 negative Lyme disease with cross-reactivity potential) were tested. A ROC analysis was performed.
- Precision: Within-lab precision study conducted over 12 days. A panel of negative, high negative, low positive, and moderate positive samples, plus controls, was tested in duplicate, twice per day (N=48 for each type of sample/control).
- Moderate Positive: Mean Units 20.6, Total SD 1.222, Total CV 5.9%
- Low Positive: Mean Units 12.4, Total SD 0.834, Total CV 6.7%
- High Negative: Mean Units 5.7, Total SD 0.727, Total CV 12.8%
- Negative: Mean Units 2.5, Total SD 0.324, Total CV 13.1%
- Positive Control: Mean Units 25.2, Total SD 1.183, Total CV 4.7%
- Cutoff Control: Mean Units 9.9, Total SD 0.287, Total CV 2.9%
- Negative Control: Mean Units 0.7, Total SD 0.123, Total CV 17.9%
- Reproducibility: Multi-site reproducibility study conducted at three different sites. A panel of negative, high negative, low positive, and moderate positive samples, plus controls, was tested in triplicate, twice per day, for five days (N=90 for samples, N=N=30 for positive control, N=60 for cutoff control, N=30 for negative control).
- Moderate Positive: Mean Units 54.4, Total SD 3.73, Total CV 6.9%
- Low Positive: Mean Units 17.1, Total SD 1.29, Total CV 7.6%
- High Negative: Mean Units 6.5, Total SD 0.75, Total CV 11.4%
- Negative: Mean Units 1.8, Total SD 0.34, Total CV 18.6%
- Positive Control: Mean Units 24.2, Total SD 1.64, Total CV 6.8%
- Cutoff Control: Mean Units 9.9, Total SD 0.34, Total CV 3.4%
- Negative Control: Mean Units 0.7, Total SD 0.72, Total CV 13.1%
- Analytical Specificity: Tested 208 asymptomatic individuals' samples from endemic (103 samples, 4 positive/equivocal, 96.1% Analytical Specificity) and non-endemic (105 samples, 10 positive/equivocal, 90.5% Analytical Specificity) regions.
- Cross Reactivity: Studied 277 samples from different infections and disease conditions. Results summarized in a table, with several conditions showing cross-reactivity (*Also positive on the predicate device):
- Tick-borne Relapsing Fever IgM (21 tested): 0% Positive
- Treponemal Infections (TPPA) (29 tested): 0% Positive
- Rickettsia IgM (23 tested): 0% Positive
- Ehrlichiosis IgM (10 tested): 60% Positive*
- Babesiosis IgM (16 tested): 63% Positive*
- Leptospirosis IgM (10 tested): 80% Positive*
- H. pylori IgM (10 tested): 0% Positive
- Epstein-Barr Virus IgM (14 tested): 0% Positive
- Varicella Zoster Virus (16 tested): 38% Positive
- Fibromyalgia (25 tested): 0% Positive
- Rheumatoid Arthritis (12 tested): 0% Positive
- Autoimmune Disease (46 tested): 0% Positive
- Multiple Sclerosis (22 tested): 0% Positive
- Severe Periodontitis (23 tested): 0% Positive
- 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.
Clinical Studies:
- Comparison with Predicate Device: Conducted at three sites. 531 serum samples were tested on both the subject device and the predicate device.
- Overall Agreement (Equivocal counted as positive): Positive percent agreement = 90.3% (93/103) with 95% CI (82.9% - 95.5%). Negative percent agreement = 99.6% (460/462) with 95% CI (98.5% - 99.9%).
- Second Tier Testing: All positive and equivocal samples from the comparison study (103 samples from both devices combined identified as positive or equivocal by at least one device) were tested by an FDA cleared IgM Western blot assay.
- 2nd Tier PPA (95% CI): 98.3% (58/59) (90.9% - 99.9%) for combined predicate+subject device results yielding 93 positive samples.
- Clinical Sensitivity: A sensitivity study performed on 114 clinically characterized samples (early, disseminated, and late stages of Lyme disease).
- Early (n=58): Subject device 75.9% (44/58), Predicate 77.6% (45/58)
- Disseminated (n=17): Subject device 100.0% (17/17), Predicate 100.0% (17/17)
- Late (n=39): Subject device 89.7% (35/39), Predicate 84.6% (33/39)
- CDC Panel: Tested a panel of 280 positive and negative specimens from CDC.
- Healthy (n=100): Subject device 7 positive/equivocal (93.0% agreement), Predicate 14 positive/equivocal (86.0% agreement)
- Early Lyme (n=60): Subject device 46 positive/equivocal (76.7% agreement), Predicate 48 positive/equivocal (80.0% agreement)
- Cardiac Lyme (n=3): Subject device 2 positive/equivocal (66.7% agreement), Predicate 2 positive/equivocal (66.7% agreement)
- Neurological Lyme (n=7): Subject device 7 positive/equivocal (100% agreement), Predicate 7 positive/equivocal (100% agreement)
- Late (n=20): Subject device 17 positive/equivocal (85.0% agreement), Predicate 17 positive/equivocal (85.0% agreement)
- Look-alike Disease (n=90): Subject device 17 positive/equivocal (81.1% agreement), Predicate 25 positive/equivocal (72.2% agreement)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for detailed metrics including:
- Analytical Specificity: 96.1% (Endemic Region), 90.5% (Non-endemic Region)
- Positive percent agreement: 90.3%
- Negative percent agreement: 99.6%
- Clinical Sensitivity: Ranges from 75.9% to 100.0% depending on disease stage.
- Agreement with Clinical Diagnosis (CDC Panel - Specificity for Healthy): 93.0%
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.
Trinity Biotech MarDx Borrelia burgdorferi EIA IgM Test Kit (K894293)
K894293
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.
Not Found
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
§ 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).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 6, 2020
Gold Standard Diagnostics Napoleon Monce Director, Product Development 2851 Spafford St. Davis, California 95618
Re: K200023
Trade/Device Name: Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema Pallidum Treponemal Test Reagents Regulatory Class: Class II Product Code: LSR Dated: December 27, 2019 Received: January 6, 2020
Dear Napoleon Monce:
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 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
1
- 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 (OS) 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.
Steven Gitterman, M.D., Ph.D. Deputy Director 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
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Image /page/2/Picture/0 description: The image is a logo for Gold Standard Diagnostics. The logo features the words "GOLD STANDARD" in large, bold, black letters. To the left of the words is a gold circle with the letters "GSD" inside. Below the words "GOLD STANDARD" are the words "DIAGNOSTICS" in smaller, black letters.
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: 2851 Spafford St. Davis. CA. 95618 Phone Number: 530-759-8000 Contact Person: Napoleon Monce Date: December 27, 2019
-
- Product and Trade Name: Gold Standard Diagnostics Borrelia burgdorferi IgM 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
-
- Legally Marketed Device to Which the Submitter Claims Equivalence: Trinity Biotech MarDx Borrelia burgdorferi EIA IgM Test Kit (K894293).
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 IgM 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 450mm.
3
The antigens used in the Gold Standard Diagnostics Borrelia burgdorferi IgM 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 protein 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.
5) Intended Use of the Device:
The Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test kit is intended as a qualitative presumptive (first step) test for the detection of IgM 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.
6) Comparison with the Predicate Device:
The tables below provide a comparison of the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test kit with the Trinity Biotech MarDx Borrelia burgdorferi EIA IgM Test kit (predicate device: K894293).
| Similarities | ||
|---|---|---|
| Item | Subject Device: Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Predicate Device: Trinity Biotech MarDx Borrelia burgdorferi EIA IgM Test Kit |
| Intended Use | The Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test kit is intended as a qualitative presumptive (first step) test for the detection of IgM 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. | Trinity Biotech MarDx Borrelia burgdorferi EIA IgM Test System is a qualitative test intended for use in the presumptive detection of human IgM 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. burgdorferi. 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. burgdorferi. 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. burgdorferi. Negative results (either first or second-tier) should not be used to exclude Lyme disease. |
| Assay Format | Antigen coated microtiter plate – 96 wells. | Same |
| Technology | ELISA | Same |
4
| 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, | ||
| Absorption Solution | Same | |
| Reported Results | Positive, Equivocal, Negative | Same |
| Assay Output | Optical density readings from | |
| Spectrophotometer | Same |
| Differences | ||
|---|---|---|
| Item | Subject Device: Gold Standard | |
| Diagnostics Borrelia burgdorferi | ||
| IgM ELISA Test Kit | Predicate Device: Trinity Biotech | |
| MarDx Borrelia burgdorferi EIA | ||
| IgM 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 | Convert to units. | |
| Negative H. pylori IgM | 10 | 0 / (0%) |
| Epstein-Barr Virus IgM | 14 | 0 / (0%) |
| Varicella Zoster Virus | 16 | 6 / (38%) |
| Fibromyalgia | 25 | 0 / (0%) |
| Rheumatoid Arthritis | 12 | 0 / (0%) |
| Autoimmune Disease | 46 | 0 / (0%) |
| Multiple Sclerosis | 22 | 0 / (0%) |
| Severe Periodontitis | 23 | 0 / (0%) |
*Also positive on the predicate device
Interfering Substances
The effect of potential interfering substances on samples using the Gold Standard Diagnostics Borrelia burgdorferi IgM 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
7
Standards Institute were used (see table below). The tested substances did not affect the performance of the Gold Standard Diagnostics Borrelia burgdorferi IgM 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 thirty one (531) serum samples were tested on both the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test and on the predicate B. burgdorferi IgM ELISA Test. The results are summarized in the following table:
| Predicate IgM ELISA | |||||
|---|---|---|---|---|---|
| Positive | Equivocal* | Negative | Total | ||
| Gold Standard Diagnostics | |||||
| Borrelia burgdorferi IgM | |||||
| ELISA Test Kit | Positive | 72 | 9 | 5 | 86 |
| Equivocal* | 4 | 8 | 5 | 17 | |
| Negative | 1 | 9 | 418 | 428 | |
| Total | 77 | 26 | 428 | 531 |
*Equivocal samples counted as positive
| Positive percent agreement = 90.3% (93/103) |
|---|
| Negative percent agreement = 99.6% (460/462) |
95% CI (82.9% - 95.5%) 95% CI (98.5% - 99.9%)
Second Tier Testing
All positive and equivocal samples by the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test and by the Predicate IgM ELISA were tested by an FDA cleared IgM Western blot assay. The results are summarized in the following table:
| | Tier 1 Positive
or Equivocal | IgM Blot
Positive | IgM Blot
Negative |
|----------------------------------------------------------------------------|---------------------------------|----------------------|----------------------|
| Predicate IgM ELISA | 103 | 59 | 44 |
| Gold Standard
Diagnostics Borrelia
burgdorferi IgM
ELISA Test Kit | 103 | 61 | 42 |
| Predicate IgM ELISA
-
| 93 | 58 | 35 |
8
| Gold Standard
| Diagnostics Borrelia | ||
|---|---|---|
| burgdorferi IgM | ||
| ELISA Test Kit |
| 2nd Tier Percent Agreement | ||
|---|---|---|
| 2nd Tier PPA | ||
| (95% CI) | 98.3% | |
| (90.9% - 99.9%) | 58/59 |
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 IgM ELISA Test and on the predicate B. burgdorferi IgM ELISA Test. The results are summarized in the following table:
| Disease
Stage | n | Gold Standard
Diagnostics Borrelia
burgdorferi IgM
ELISA Test Kit | Predicate
IgM ELISA |
|------------------|----|----------------------------------------------------------------------------|------------------------|
| Early | 58 | 75.9% (44/58) | 77.6% (45/58) |
| Disseminated | 17 | 100.0% (17/17) | 100.0% (17/17) |
| Late | 39 | 89.7% (35/39) | 84.6% (33/39) |
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 IgM 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 IgM 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:
| Disease Stage | n | Gold Standard Diagnostics
Borrelia burgdorferi IgM
ELISA Test Kit | | Predicate
IgM ELISA | |
|---------------|-----|--------------------------------------------------------------------------------|-------------------------------------------|-----------------------------|-------------------------------------------|
| | | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis |
| Healthy | 100 | 7 | 93.0% | 14 | 86.0% |
| Early Lyme | 60 | 46 | 76.7% | 48 | 80.0% |
| Cardiac Lyme | 3 | 2 | 66.7% | 2 | 66.7% |
9
| Neurological Lyme | 7 | 7 | 100% | 7 | 100% |
|---|---|---|---|---|---|
| Late | 20 | 17 | 85.0% | 17 | 85.0% |
| Look-alike | |||||
| Disease | 90 | 17 | 81.1% | 25 | 72.2% |
Expected Values
The range of values and positivity rate among different studies and population for the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test are as follows:
| Unit Results | Qualitative Results | |||||
|---|---|---|---|---|---|---|
| Population | # Samples | Mean | Range | Std. | ||
| Dev. | # | |||||
| Positive/ | ||||||
| Equivocal | % | |||||
| Positive/ | ||||||
| Equivocal | ||||||
| Normal | ||||||
| Endemic | 103 | 3.5 | 0.4 - 10.7 | 2.341 | 4 | 3.9% |
| Normal | ||||||
| Non-Endemic | 105 | 4.2 | 0.0 - 15.5 | 3.136 | 10 | 9.5% |
| Prospective | ||||||
| Study | 531 | 7.7 | 0.0 - 76.6 | 11.742 | 103 | 19.4% |
| Sensitivity | ||||||
| Study | 114 | 32.6 | 0.0 - 81.0 | 21.138 | 96 | 84.2% |
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 IgM ELISA Test is substantially equivalent to the Trinity Biotech MarDx Borrelia burgdorferi EIA IgM Test kit (predicate device: K894293).