(63 days)
Jus Lyme Elisa
Not Found
No
The summary describes a standard ELISA kit and an automated processor, neither of which are described as using AI or ML. The performance studies focus on traditional metrics like sensitivity, specificity, and precision.
No
The device is an in vitro diagnostic (IVD) test used for the qualitative presumptive detection of antibodies to Borrelia burgdorferi, which supports the diagnosis of Lyme disease. It does not directly treat or alleviate a condition.
Yes.
This device is designed for the "qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum" and its results "can be used to support a clinical diagnosis of Lyme disease," indicating its role in identifying a potential medical condition.
No
The device description explicitly states it is an "enzyme-linked immunosorbent assay (ELISA) kit," which is a laboratory test kit containing reagents and physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum." This indicates the device is used to test a sample taken from the human body (serum) in vitro (outside the body) to provide diagnostic information about a disease (Lyme disease).
- Device Description: The description confirms it is an "enzyme-linked immunosorbent assay (ELISA) for the detection of IgG/IgM to Borrelia burgdorferi antigen in human serum." This further supports its use for in vitro testing of human samples.
- Intended User / Care Setting: The intended user is a "Clinical laboratory," which is a typical setting for performing in vitro diagnostic tests.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia bargdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The test can be performed either manually or in conjunction with the MAGO TM PLUS Automated EIA Processor.
Product codes (comma separated list FDA assigned to the subject device)
LSR
Device Description
The & Borrelia burgdorferi IgG/IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG/IgM to Borrelia burgdorferi antigen in human serum.
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Clinical Sensitivity and Specificity:
- CDC Serum Panel: A panel of 47 characterized sera from the CDC (Centers for Disease Control and Prevention), with 5 normal sera and the remainder having clinical diagnosis of Lyme disease. Equivocal samples were considered positive. The overall % Agreement was 70.2%.
- Clinical Lab Serum Panel: A panel of 72 characterized sera from a clinical lab in Wisconsin, all with a clinical diagnosis of Lyme disease. Equivocal samples were considered positive. The overall % Agreement was 80.6%.
- Prospective Sample Study:
- Study Type: Comparison of the subject device (Is-EIA) with another commercially available EIA kit, with positive/equivocal results supplemented by Western Blot.
- Sample Size: 173 prospective sera from patients of various ages and gender from an endemic area.
- Key Results:
- Prevalence of EIA Pos. or Equiv.: Is-EIA = 8.09% (95% CI: 3.95-12.20%); Other EIA = 20.8% (95% CI: 14.6-27.0%).
- Pos. or Equiv. Western Blot Pos.: Is-EIA = 6.36% (95% CI: 2.65-10.07%); Other EIA = 8.09% (95% CI: 3.95-12.24%).
- % Western Blot Pos. among EIA Pos. or Equiv.: Is-EIA = 78.6% (95% CI: 56.6%-100%); Other EIA = 38.9% (95% CI: 22.64-55.14%).
- Precision:
- Study Type: Intra- and inter-assay precision determination.
- Sample Size: Four positive and two negative sera, assayed ten times each in three different runs at three different sites.
- Key Results: CV values were reported for intra- and inter-assay precision for 6 serum samples at 3 different sites. For Site 1, inter-assay CV ranged from 9.62% to 20.68%. For Site 2, inter-assay CV ranged from 8.26% to 13.51%. For Site 3, inter-assay CV ranged from 5.21% to 15.45%.
- Specificity with Potentially Cross-Reactive Sera:
- Study Type: Evaluation of performance with potentially cross-reactive sera.
- Sample Size: Group of sera with various laboratory results (e.g., RPR+, ds-DNA+, RF+, Lipemic+, Bilirubin+, Elevated ESR, Elevated CRP, EBV+, CMV+, Rocky MT Spotted Fever).
- Key Results: Demonstrated varying numbers of equivocal and positive results with cross-reactive sera. For example, 7 equivocal and 1 positive result in RPR+ sera, and 2 equivocal and 1 positive result in CMV+ sera.
- Correlation of Manual and MAGO Plus Results:
- Study Type: Correlation study between manual and automated (MAGO Plus) methods.
- Sample Size: 296 sera.
- Key Results: Pearson Correlation Coefficient of 0.991, indicating good correlation.
- Mago Plus Precision:
- Study Type: Intra- and inter-assay precision determination using the MAGO Plus automated system.
- Sample Size: 6 sera assayed 10 times each in three different runs.
- Key Results: Inter-assay CV ranged from 7.05% to 35.59%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- % Agreement (Clinical Sensitivity and Specificity)
- % Western Blot Pos. among EIA Pos. or Equiv.
- Coefficient of Variation (CV) for precision studies
- Pearson Correlation Coefficient
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.
Jus Lyme Elisa
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
K98365
510k Summary of Safety and Effectiveness
s summary of 510(k) safety and effectiveness information is being submitted in accordance with the . Juirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
Applicant Information:
| Date Prepared: | Oct 11, 1998 |
|---|---|
| Name: | Columbia Bioscience, Inc. |
| Address: | 8775 M Centre Park Drive, #559 |
| Columbia, MD 21045 |
| Contact Person: | Norman Jenkins |
|---|---|
| PhoneNumber. | 410-995-0450 |
| Fax Number. | 410-995-0448 |
Device Information:
| Trade Name: | Borrelia burgdorferi IgG/IgM ELISA Kit |
|---|---|
| Common Name. | Borrelia burgdorferi EIA Test |
| Classification Name; | Borrelia Serological Reagent |
livalent Device: Jus Lyme Elisa
Device Description: The & Borrelia burgdorferi IgG/IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG/IgM to Borrelia burgdorferi antigen in human serum.
Intended Use: For the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia bargdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The test can be performed either manually or in conjunction with the MAGO TM PLUS Automated EIA Processor.
Principle of Procedure:
The & Borrelia burgdorferi IgG/IgM ELISA Kit is an enzymelinked immunosorbent assay to detect IgG/IgM to Borrelia burgdorferi in human serum. Partially purified Borrelia burgdorferi antigen is attached to a solid phase (microtiter well). Diluted test sera an added to each well. If antibodies which recognize the, Borrelia burgdorferi antigen are present in the patient sample they will bind to the antigen in the well. After incubation, the wells are washed to remove unbody. An enzyme labeled anti-human immunoglobulin (conjugate)
the to each test well. If antibody is present the enzyme-linked antibody will bind to it. After incubation, wells are washed to remove unbound conjugate. A substrate solution is then added to each well. If enzyme
1
is present from prior step, the reaction is stopped and the, color intensity is measured photometrically producing an indirect detection of the specific antibody present in the patient sample.
rformance Characteristics
1. Clinical Sensitivity and Specificity :
The lollowing information is from a panel of characterized sera obtained from the CDC (Centers for Disease Control and Prevention) r no toned by Diamedix Corp. using the Is-anti B.burgdorferi IgG/IgM Test Kit. The panel consists of 5 normal sera with . clinical diagnosis of Lyme disease and obtained at different times from onset of disease. The results are means to convey further information on the performance of the assay with a masked, characterized serum panel. This does not imply an endorsement of the assay by the CDC. Table I illustrates the performance of the assay with this serum panel.
| Elapsed Time
| From Onset | Positive | Equiv. | Negative | Total | % Agreement |
|---|---|---|---|---|---|
| > 1 Yr | 8 | 0 | 0 | 8 | 100.0% |
| 3 - 12 Months | 9 | 3 | 8 | 20 | 60.0% |
| 1 - 2 Months | 4 | 1 | 4 | 9 | 55.6% |
| 1 Yr | 3 | 0 | 0 | 3 | 100% |
| 3 - 12 Months | 11 | 2 | 0 | 13 | 100% |
| 1 - 2 Months | 8 | 2 | 3 | 13 | 76.9% |
| Trade Name: Is-Borrelia burgdorferi IgG/IgM ELISA Test Regulatory Class: II Product Code: LSR Dated: October 11, 1998 Received: October 14, 1998 |
Dear Mr. Jenkins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number: not known
Device Name: Borrelia burgdorferi IgG/IgM ELISA Test
Indications For Use: For the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot Positive supplemental results are supportive evidence of exposure to B. procedure. burgdorfer i and can be used to support a clinical diagnosis of Lyme disease. The test can be performed either manually or in conjunction with the MAGO TM PLUS Automated EIA Processor.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Y (Per 21 CFR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)
Woody Dubois
on of Clinical Laboratory Devices 510(k) Number