(326 days)
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No
The device description details a standard Western Blot assay based on biochemical reactions and visual interpretation of bands. There is no mention of AI or ML in the description, intended use, or performance studies.
No.
This device is an in vitro diagnostic test for detecting antibodies to Lyme disease, not a device used for treatment or therapy.
Yes
The device aids in diagnosing Borrelia burgdorferi infection by detecting IgM antibodies in human serum, providing supportive evidence of infection.
No
The device description clearly outlines a laboratory assay involving physical components (gels, membranes, antibodies, substrates) and chemical reactions, which are hardware and wetware components, not software.
Based on the provided information, the Cambridge Biotech Human Lyme B. burgdorferi IgM Western Blot is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that it is an "in vitro test system for the qualitative detection of human Immunoglobulin M (IgM) antibodies to Borrelia burgdorferi antigens in human serum." The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism.
- Device Description: The description details a laboratory-based assay involving the analysis of human serum samples with reagents and a chemical reaction to detect antibodies. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The performance studies involve testing human serum samples to determine the device's specificity and sensitivity in detecting antibodies related to Lyme disease. This is a standard evaluation for IVD devices.
Therefore, all the provided information aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cambridge Biotech Human Lyme B. burgdorferi IgM Western Blot is an in vitro test system for the qualitative detection of human Immunoglobulin M (IgM) antibodies to Borrelia burgdorferi antigens in human serum. The Cambridge Biotech Human Lyme B. burgdorferi IgM Western Blot is intended for use in testing human serum samples which have demonstrated positive or equivocal responses using EIA or IFA test procedures to provide supportive evidence of infection with Borrelia burgdorferi.
The Cambridge Biotech Human Lyme B. burgdorferi IgM Western Blot can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this period, infected patients are usually found to be Western Blot positive for IgG. 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
LSR
Device Description
The device is a Western Blot assay. Proteins and other antigenic components of the Borrelia spirochete are fractionated by Polyacrylamide Gel Electrophoresis in the presence of Sodium Dodecylsulfate. The separated proteins are electrophoretically transferred from the gel to nitrocellulose membranes, which are subsequently blocked to minimize non-specific binding and cut into strips. These nitrocellulose strips with Borrelia burgdorferi antigens are then reacted with diluted serum and controls (positive and neqative sera of defined reactivity) during an incubation period. During the incubation period, human antibodies specific to the B. burgdorferi antigens, if present in the sample or control, will bind to the antigen to which they have affinity. Unbound serum and non-specific antibodies are washed from the strip. Detection of bound IgM antibodies is accomplished by reacting and incubating the strips with a solution containing anti-human IgM antibodies conjugated with alkaline phosphatase. Unbound conjugate antibodies are removed by washing. The qualitative assessment of the detected IgM antibodies is then accomplished by the reaction of the alkaline phosphatase with a chemical substrate, which is cleaved into a colored, insoluble product that can be visualized. The determination of the reactivity of each unknown specimen is accomplished by comparison of the identified, visualized bands to the Band Identifying and Band Intensity Controls.
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
Specificity: 1062 total samples from normal donor (from endemic and non-endemic regions) and disease specimens.
Sensitivity: 296 total characterized Lyme disease specimens drawn at different times after onset of disease.
Precision: Six IgM Controls tested in duplicate on each of three days at three test sites, totaling 18 replicates per control for all sites.
Reproducibility: Ten positive and negative specimens from the CDC 47-member panel were tested at four sites.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Type: Clinical trial data.
Sensitivity: See table below.
Specificity: 97.5%, with 95% confidence intervals of 96.6% to 98.5%.
Precision: All three sites were in 100% agreement for the disposition of the six IgM Controls. Additionally, all three sites were in 100% agreement for the three diagnostic bands (p41, p39, and p23) for all six controls on every day of testing.
Reproducibility: 100% agreement for the IgM disposition scores with the 20 specimens at all four sites. 86.7% of the three diagnostic bands of all 20 specimens were scored identically at all four test sites. 94% overall agreement was shown between the scoring of positive IgM bands by the sites and the expected IgM band score results.
Sensitivity of the Cambridge Biotech Human Lyme B. burgdorferi lgM Western Blot
Relative to Lyme Disease Clinical Diagnosis and Treatment including Results by Draw Time
| Disease
Presentation | Draw
Time
(months) | Total
Number of
Specimens | Number
By Draw
Time | Number of
Specimens
Positive | Specimens
Positive
By Draw Time | Sensitivity | 95%
CL |
|-------------------------|--------------------------|---------------------------------|---------------------------|------------------------------------|---------------------------------------|-------------|----------------|
| Before
Treatment |
§ 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
Section 12 510(k) SUMMARY
Submitted By:
FEB 17 1998
Cambridge Biotech Corporation 1500 East Gude Drive Rockville, Maryland 20850-5307 (301) 251-0800, extension 145 (301) 762-1327 (fax)
Contact Person:
Rebecca Leaper, Vice President - Operations, Responsible Head (301) 251-0800, extension 105
Date of Preparation:
Revised on 4 February 1998 19 March 1997
Product Name and Information
- Name and Address of Owner/Operator, and Manufacturer 1.
Owner/Operator:
Cambridge Biotech Corporation A Wholly Owned Subsidiary of bioMérieux Vitek, Inc. 1500 East Gude Drive Rockville, MD 20850-5307
Manufacturer:
Cambridge Biotech Corporation A Wholly Owned Subsidiary of bioMérieux Vitek, Inc. 1500 East Gude Drive Rockville, MD 20850-5307
1
2. Product Name
| Trade Name: | Cambridge Biotech Borrelia burgdorferi
Human Lyme IgM Western Blot kit |
|----------------------|---------------------------------------------------------------------------|
| Common Name: | Lyme IgM Western Blot kit |
| Classification Name: | Reagent, Borrelia Serological Reagent |
3. Claim of Substantial Equivalence
The characterized samples used for the establishment of Substantial Equivalence have a clinical diagnosis of Lyme Disease based on the probability of exposure/infection (tick bite and/or patient presence in potential tick habitats in an endemic region within 30 days prior to the onset of EM (ervthema migrans)), Borrelia isolation by culture (where possible), or, for non-EM patients, the presentation of Late Lyme clinical manifestations (e.g., cardiac, joint-involvement, or neurological symptoms).
Each of the clinical trial sites provided specimens that were wellcharacterized by the site using Lyme-specific serological analyses, including EIA and Western Blot testing.
Substantial equivalence of this device is based on the assessment of performance of the device in these clinical trials in which the wellcharacterized, archived Lyme Disease specimens, the Centers for Disease Control Lyme Disease Serum Panel, normal donor specimens (from endemic and non-endemic regions), and samples from diverse disease conditions were analyzed.
4. Description
The device is a Western Blot assay. Proteins and other antigenic components of the Borrelia spirochete are fractionated by Polyacrylamide Gel Electrophoresis in the presence of Sodium Dodecylsulfate. The separated proteins are electrophoretically transferred from the gel to nitrocellulose membranes, which are subsequently blocked to minimize non-specific binding and cut into strips. These nitrocellulose strips with Borrelia burgdorferi antigens are then reacted with diluted serum and controls (positive and neqative sera of defined reactivity) during an incubation period.
2
During the incubation period, human antibodies specific to the B. burgdorferi antigens, if present in the sample or control, will bind to the antigen to which they have affinity. Unbound serum and non-specific antibodies are washed from the strip. Detection of bound IgM antibodies is accomplished by reacting and incubating the strips with a solution containing anti-human IgM antibodies conjugated with alkaline phosphatase. Unbound conjugate antibodies are removed by washing. The qualitative assessment of the detected IgM antibodies is then accomplished by the reaction of the alkaline phosphatase with a chemical substrate, which is cleaved into a colored, insoluble product that can be visualized. The determination of the reactivity of each unknown specimen is accomplished by comparison of the identified, visualized bands to the Band Identifying and Band Intensity Controls.
5. Intended Use
The Cambridge Biotech Human Lyme B. burgdorferi IgM Western Blot is. an in vitro test system for the qualitative detection of human Immunoglobulin M (IgM) antibodies to Borrelia burgdorferi antigens in human serum. The Cambridge Biotech Human Lyme B. burgdorfen IgM Western Blot is intended for use in testing human serum samples which have demonstrated positive or equivocal responses using EIA or IFA test procedures to provide supportive evidence of infection with Borrelia burgdorferi.
The Cambridge Biotech Human Lyme B. burgdorferi IgM Western Blot can be used during the acute phase (0-4 weeks of symptoms onset) of B.
burgdorferi infection. After this period, infected patients are usually found
to be Western Blot posit recommended for use in determining active disease in persons with illness of longer than one month.
Performance Summary റ.
The report of the complete clinical trial for the Cambridge Biotech Human Lyme IgM kit is contained in this section. Data for IgG and IgM have not been interpreted together, but separately, as will be required in clinical settings.
3
From a summary of the clinical trial data, the following performance characteristics are described:
Specificity
Specificity of the device was determined from analysis of testing results of normal donor (from endemic and non-endemic regions) and disease specimens (1062 total samples) and was shown to be 97.5%, with 95% confidence intervals of 96.6% to 98.5%.
Sensitivity
Sensitivity of the device was determined from analysis of test results of characterized Lyme disease specimens (296 total samples) that were drawn at different times after onset of disease:
Sensitivity of the Cambridge Biotech Human Lyme B. burgdorferi lgM Western Blot
Relative to Lyme Disease Clinical Diagnosis and Treatment including Results by Draw Time
| Disease
Presentation | Draw
Time
(months) | Total
Number of
Specimens | Number
By Draw
Time | Number of
Specimens
Positive | Specimens
Positive
By Draw Time | Sensitivity | 95%
CL |
|-------------------------|--------------------------|---------------------------------|---------------------------|------------------------------------|---------------------------------------|-------------|----------------|
| Before
Treatment | Trade Name: Cambridge Biotech Human Lyme Borrelia burgdorferi IgM Western Blot Kit Regulatory Class: II Product Code: LSR Dated: December 3, 1997 Received: December 3, 1997
Dear Mr. Edwin:
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 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.
6
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
7
Section 8 Statement of Indications for Use
510(k) Number (if known):
Cambridge Biotech Human Lyme Borrelia burdorferi IgM Device Name: Western Blot Kit
Indications For Use:
The Cambridge Biotech Human Lyme B. burgdorferi IgM Western Blot is an in vitro test system for the qualitative detection of human Immunoglobulin M (IgM) antibodies to Borrelia burgdorferi antigens in human serum. The Cambridge Biotech Human Lyme B. burgdorferi IgM Western Blot is intended for use in testing human serum samples which have demonstrated positive or equivocal responses using EIA or IFA test procedures to provide supportive evidence of infection with Borrelia burgdorferi.
The Cambridge Biotech Human Lyme B. burgdorferi IgM Western Blot can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this period, infected patients are usually found to be Western Blot positive for IgG. 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 Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
Over-The-Counter Use
Ue How 2/17
Division Sign-Off
OR
Division of Clin oratory Devices (Optional Format 1-2-96)
510(k) Number