(326 days)
Not Found
Not Found
No
The device description details a traditional Western Blot assay based on biochemical reactions and visual interpretation of bands. There is no mention of computational analysis, algorithms, or learning processes.
No
The device is an in vitro diagnostic test designed to provide supportive evidence of infection with Borrelia burgdorferi by detecting antibodies in human serum samples. It is not intended for treatment or prevention of disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in testing human serum samples... to provide supportive evidence of infection with Borrelia burgdorferi." This directly indicates its use in aiding in the diagnosis of Lyme disease.
No
The device description clearly outlines a laboratory assay involving physical components, chemical reactions, and visual interpretation of results on nitrocellulose strips. This is a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "testing human serum samples" to provide "supportive evidence of infection with Borrelia burgdorferi." This involves analyzing a biological sample (serum) outside of the body to diagnose or provide information about a disease state.
- Device Description: The description details a laboratory assay (Western Blot) that involves reacting human serum with antigens and detecting antibodies. This is a classic example of an in vitro diagnostic procedure.
- Performance Studies: The document describes clinical trials and performance metrics (specificity, sensitivity, precision, reproducibility) based on testing human serum samples. This is standard for demonstrating the performance of an IVD.
The definition of an IVD is a medical device that is used to perform tests on samples such as blood, urine, or tissues to detect diseases or other conditions. This device clearly fits that definition.
N/A
Intended Use / Indications for Use
The Cambridge Biotech Human Lyme B. burgdorferi IgG 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 IgG Western Blot can be used at any time following onset of symptoms. It should also be used for follow up when (1) only IgM antibodies were originally detected, (2) IgG antibodies were detected but were not considered significant, or (3) previously tested seronegative individuals are shown to develop antibodies by EIA or IFA test procedures.
The assay is not intended for use as a screening assay, nor should it be used for analysis of serum from patients who have not demonstrated symptoms of Lyme Disease.
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 negative 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 IgG antibodies is accomplished by reacting and incubating the strips with a solution anti-human IgG antibodies conjugated with alkaline containing phosphatase. Unbound conjugate antibodies are removed by washing. The qualitative assessment of the detected IgG 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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 (erythema 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Specificity Study: 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 100%, with 95% confidence intervals of 99.8% to 100.0%.
Sensitivity Study: Sensitivity of the device was determined from analysis of test results of characterized Lyme disease specimens (287 total samples) that were drawn at different times after onset of disease. The specimens were taken from 169 individual patients. Second draws were done on 92 of the 169 patients, third draws were done on 36 of those patients. The specimens from patients under antibiotic treatment may interfere with positive results. Ten specimens that were tested for IgM, were not tested for IgG due to insufficient sample.
Sensitivity results are tabulated by disease presentation (Before Treatment, After Treatment, Lyme Late) and draw time in months. For "Before Treatment" group, sensitivity was 21% (95% CL: 12.6-28.7%). For "After Treatment" group, sensitivity was 19% (95% CL: 12.2-25.9%). For "Lyme Late" group, sensitivity was 88% (95% CL: 78.8-96.2%).
Precision Study: Six IgG Controls were tested in duplicate on each of three days at three test sites, totaling 18 replicates per control for all sites. All three sites were in 100% agreement for the disposition of the six IgG Controls. Additionally, all three sites were in 92% agreement as to the presentation of the IgG diagnostic band.
Reproducibility Study: Ten positive and negative specimens from the CDC 47-member panel were tested at four sites. There was 100% agreement for the IgG disposition scores with the 20 specimens at all four sites. Eighty seven point five percent (87.5%) of the ten diagnostic bands of all 20 specimens were scored identically at all four test sites. In addition, a 94% overall agreement was shown between the scoring of positive lgG bands by the sites and the expected IgG band score results.
Site 1: Correct Bands 86/101 (85%), Correct Interpretations 20/20 (100%).
Site 2: Correct Bands 98/101 (97%), Correct Interpretations 20/20 (100%).
Site 3: Correct Bands 97/101 (96%), Correct Interpretations 20/20 (100%).
Site 4: Correct Bands 97/101 (96%), Correct Interpretations 20/20 (100%).
Total: Correct Bands 378/404 (94%), Correct Interpretations 80/80 (100%).
Determination of Threshold Intensity: The threshold determination was originally performed by analysis of IgG sensitivity and specificity panels. The intensity of weakly reactive Lyme antibody-positive samples (n = 5) were compared to the intensities of highly reactive Lyme antibody-negative samples (n = 5) in preclinical testing to demonstrate that the threshold appropriately differentiated positive and negative specimens. The negative specimens included normal donor samples only. Subsequent lots of the Control have been approved based on continued demonstration of this characteristic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Specificity: 100%, with 95% confidence intervals of 99.8% to 100.0%.
Sensitivity:
Before Treatment: 21% (95% CL: 12.6-28.7%)
After Treatment: 19% (95% CL: 12.2-25.9%)
Lyme Late: 88% (95% CL: 78.8-96.2%)
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.
Not Found
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
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
KP111169
Section 12 510(k) SUMMARY
Submitted By:
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 27 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
FEB | 7 |998
1
2. Product Name
| Trade Name: | Cambridge Biotech Human Lyme Borrelia
burgdorferi IgG Western Blot kit |
|----------------------|-----------------------------------------------------------------------------------------|
| Common Name: | Lyme IgG 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 (erythema 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 negative 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
2
antigen to which they have affinity. Unbound serum and non-specific antibodies are washed from the strip. Detection of bound IgG antibodies is accomplished by reacting and incubating the strips with a solution anti-human IgG antibodies conjugated with alkaline containing phosphatase. Unbound conjugate antibodies are removed by washing. The qualitative assessment of the detected IgG 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.
-
- Intended Use
The Cambridge Biotech Human Lyme B. burgdorferi IgG 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.
- Intended Use
The Cambridge Biotech Human Lyme B. burgdorferi IgG Western Blot can be used at any time following onset of symptoms. It should also be used for follow up when (1) only IgM antibodies were originally detected, (2) lgG antibodies were detected but were not considered significant, or (3) previously tested seronegative individuals are shown to develop antibodies by EIA or IFA test procedures.
-
- Performance Summary
The report of the complete clinical trial for the Cambridge Biotech Human Lyme IgG 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.
- Performance Summary
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 100%, with 95% confidence intervals of 99.8% to 100.0%.
3
Sensitivity
Sensitivity of the device was determined from analysis of test results of characterized Lyme disease specimens (287 total samples) that were drawn at different times after onset of disease:
Sensitivity of the Cambridge Biotech Human Lyme B. burgdorferi IgGWestern 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 IgG Western Blot
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 no^ affect any obligation you might have under sections 531 through 542 of the Act for under the Electronic Product Radiation Control provisions, or other Federal lav 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
K971169 510(k) Number (if known):
Device Name: Cambridge Biotech Human Lyme Borrelia burgdorferi IgG Western Blot
Indications For Use:
The Cambridge Biotech Human Lyme B. burgdorferi IgG 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 IgG Western Blot can be used at any time following onset of symptoms. It should also be used for follow up when (1) only IgM antibodies were originally detected, (2) IgG antibodies were detected but were not considered significant, or (3) previously tested seronegative individuals are shown to develop antibodies by EIA or IFA test procedures.
The assay is not intended for use as a screening assay, nor should it be used for analysis of serum from patients who have not demonstrated symptoms of Lyme Disease.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
J. Anmo
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K971169
Concurrence of CDRH, Office Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR 801.109) ✓
Over-The-Counter Use
(Optional Format 1-2-96)