(63 days)
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No
The summary describes a standard ELISA kit and an automated processor for performing the assay. There is no mention of AI, ML, or any computational analysis beyond basic data processing for calculating results and precision metrics.
No
The device is an in vitro diagnostic (IVD) test used to detect IgM antibodies to Borrelia burgdorferi in human serum to assist in the diagnosis of Lyme disease. It does not directly treat or prevent a condition.
Yes
The device detects IgM antibodies to Borrelia burgdorferi in human serum to support a clinical diagnosis of Lyme disease in patients with signs and symptoms consistent with the disease.
No
The device is an ELISA kit, which is a laboratory assay involving physical reagents and processes, not solely software. While it can be used with an automated processor (MAGO TM PLUS), the core device described is a physical test kit.
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 IgM antibodies to Borrelia burgdorferi in human serum." This indicates the device is used to examine a sample taken from the human body (serum) to provide information about a medical condition (presence of antibodies to Borrelia burgdorferi).
- Device Description: The device is described as an "enzyme-linked immunosorbent assay (ELISA) for the detection of IgM to Borrelia burgdorferi antigen in human serum." This confirms it's a laboratory test performed on a biological sample.
- Performance Studies: The document includes detailed performance studies (Clinical Sensitivity and Specificity, Prospective Sample Study, Precision, Specificity with Potentially Cross-Reactive Sera, Correlation of Manual and MAGO Plus Results, MAGO Plus Precision) which are typical for IVD devices to demonstrate their analytical and clinical performance.
- Predicate Device: The mention of a "Predicate Device(s)" (Zeus Lyme Elisa) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the qualitative presumptive detection of 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 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.
The Is-anti-Borrelia burgdorferi IgM Test Kit can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this early period, infected patients are usually found to develop IgG antibodies. A positive IgM test alone is not recommended for use in determining active disease in persons with illness of longer than one month.
Product codes (comma separated list FDA assigned to the subject device)
LSR
Device Description
The & Borrelia burgdorferi IgM ELISA Kit is an enzyme-finked immunosorbent assay (ELISA) for the detection of 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
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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: Two panels of characterized sera were used.
- CDC panel: 5 normal sera and 42 sera with clinical diagnosis of Lyme disease. Equivocal samples were considered positive. Results stratified by time from onset. Total % Agreement was 40.4%.
- Wisconsin clinical lab panel: 72 sera with clinical diagnosis of Lyme disease. Equivocal samples were considered positive. Total % Agreement was 81.9%.
- Prospective Sample Study: 173 prospective sera from an endemic area.
- Comparison with another commercially available EIA kit.
- Positive and equivocal results from both EIAs were supplemented by Western Blot.
- Is-IgM EIA: 2.89% (5/173) EIA Pos. or Equiv.; 0.58% (1/173) EIA Pos. or Equiv. and Western Blot Pos.; 20% (1/5) % Western Blot Pos. among EIA Pos. or Equiv.
- Precision: Is-anti-B burgdorferi IgM Test Kit precision determined using four positive and two negative sera, assayed ten times each in three different runs at three different sites. Intra- and inter-assay precision were reported for each site.
- Specificity with Potentially Cross-Reactive Sera: Tested a group of sera with laboratory results that may cross-react or interfere with the assay.
- RPR+: 20 samples (1 equivocal, 0 positive)
- ds-DNA+: 15 samples (0 equivocal, 0 positive)
- RF+: 5 samples (0 equivocal, 0 positive)
- Lipemic+: 5 samples (0 equivocal, 0 positive)
- Bilirubin+: 5 samples (0 equivocal, 0 positive)
- Elevated ESR: 4 samples (0 equivocal, 0 positive)
- Elevated CRP: 5 samples (0 equivocal, 0 positive)
- EBV+: 7 samples (1 equivocal, 1 positive)
- CMV+: 6 samples (0 equivocal, 0 positive)
- Rocky MT Spotted Fever: 4 samples (0 equivocal, 0 positive)
- Correlation of Manual and MAGO Plus Results: 294 sera tested by both methods. Pearson Correlation Coefficient of 0.973, indicating good correlation.
- MAGO Plus Precision: Precision on MAGO Plus Automated EIA Processor determined by assaying 6 sera 10 times each in three different runs. Intra- and inter-assay precision were reported.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Sensitivity and Specificity (% Agreement):
CDC Serum Panel: Total % Agreement = 40.4%
Wisconsin Lyme Sera Panel: Total % Agreement = 81.9%
Prospective Study Results:
Is-IgM EIA:
EIA Pos. or Equiv. = 2.89% (5/173) (95% CI: 0.34-5.44%)
EIA Pos. or Equiv. and Western Blot Pos. = 0.58% (1/173) (95% CI: 0-1.73%)
% Western Blot Pos. among EIA Pos. or Equiv. = 20% (1/5) (95% CI: 0-55.8%)
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.
Zeus 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.
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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).
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§ 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
DEC 1 6 1998
KC983606
510k Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements 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 IgM ELISA Kit |
|---|---|
| Common Name. | Borrelia burgdorferi EIA Test |
| Classification Name; | Borrelia Serological Reagent |
Equivalent Device: Zeus Lyme Elisa
Device Description: The & Borrelia burgdorferi IgM ELISA Kit is an enzyme-finked immunosorbent assay (ELISA) for the detection of IgM to Borrelia burgdorferi antigen in human serum.
Intended Use: For the qualitative presumptive detection of 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 Equivocal or positive results must be supplemented by testing with a standardized Western blot disease. 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.
The Is-anti-Borrelia burgdorferi IgM Test Kit can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this early period, infected patients are usually found to develop IgG antibodies. A positive IgM test alone is not recommended for use in determining active disease in persons with illness of longer than one month.
Principle of Procedure:
The & Borrelia burgdorferi IgM ELISA Kit is an enzymelinked immunosorbent assay to detect IgM to Borrelia burgdorferi in human serum. Partially purified Borrelia burgdorferi antigen is attached to a solid phase (microtiter well). Prediluted test sera an added to each well. If antibodies which recognize the, Borrelia
1
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 unbound antibody. An enzyme labeled anti-human immunoglobulin (conjugate) is added to each test well. If antibody is present the enzyme-linked antibody will bind to it. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is then added to each well. If enzyme 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.
Performance Characteristics
1.Clinical Sensitivity and Specificity :
The following information is from a panel of characterized sera obtained from the CDC (Centers for Disease Control and Prevention) and assayed by Diamedix Corp. using the Is-anti B.burgdorferi IgM Test Kit. The panel consists of 5 normal sera and 42 sera with a clinical diagnosis of Lyme disease and obtained at different times from onset of disease. The results as a 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 1 illustrates the performance of the assay with this serum panel.
| Elapsed Time
| From Onset | Positive | Equiv. | Negative | Total | % Agreement |
|---|---|---|---|---|---|
| > 1 Yr | 1 | 0 | 7 | 8 | 12.5% |
| 3 - 12 Months | 8 | 1 | 11 | 20 | 45.0% |
| 1 - 2 Months | 3 | 0 | 6 | 9 | 33.3% |
| 1 Yr | 0 | 2 | 1 | 3 | 66.7% |
| 3 - 12 Months | 9 | 2 | 2 | 13 | 84.6% |
| 1 - 2 Months | 9 | 0 | 4 | 13 | 69.2% |
| Trade Name: Is-Borrelia burgdorferi 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 OS 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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Page 2
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
8
510(k) Number: K983606
Device Name: Borrelia burgdorferi IgM ELISA Test
Indications For Use: For the qualitative presumptive detection of 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 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.
The Is-anti-Borrelia burgdorferi IgM Test Kit can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this early period, infected patients are usually found to develop IgG antibodies. A positive IgM test alone is not recommended for use in determining active disease in persons with illness of longer than one month.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use > (Per 21 CFR 801. 109)
OR
Over-The Counter Use (Optional Format 1-2-96)
Woody Dubois
510(k) Number