(174 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 AI or ML in the device description, intended use, or performance studies. The interpretation is based on comparing visualized bands to controls, not algorithmic analysis.
No
This device is an in vitro diagnostic assay used to detect antibodies, providing supplemental information for the diagnosis of Lyme disease, not to treat or directly manage a condition in a living organism.
Yes
The "Intended Use / Indications for Use" section states that the kit provides "additional, specific evidence of infection with B. burgdorferi which may be useful in the diagnosis of Lyme disease." This directly indicates its role in diagnosis.
No
The device description clearly outlines a physical in vitro diagnostic assay involving chemical reactions, membrane strips, and visualization of colored bands, which are hardware components.
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 an "in vitro qualitative assay for the detection of human IgG antibodies reactive with Borrelia burgdorferi antigens present on a membrane strip." It also states its purpose is for "supplemental testing of human serum specimens" to provide "additional, specific evidence of infection with B. burgdorferi which may be useful in the diagnosis of Lyme disease." This clearly indicates the device is intended for use outside of the body to examine specimens for diagnostic purposes.
- Device Description: The "Device Description" details a laboratory procedure involving the analysis of human serum specimens using a Western Blot technique. This process is performed in vitro (in a test tube or laboratory setting).
- Specimen Type: The device uses "human serum specimens," which are biological samples taken from the body for analysis.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The QualiCode™ B. burgdorferi IgG Western Blot Kit is an in vitro qualitative assay for the detection of human IgG antibodies reactive with Borrelia burgdorferi antigens present on a membrane strip. The QualiCode™ B. burgdorferi IgG Western Blot Kit is intended for supplemental testing of human serum specimens which yield positive or equivocal results on B. burgdorferi ELISA or IFA screening assays: QualiCode test results can provide additional, specific evidence of infection with B. burgdorferi which may be useful in the diagnosis of Lyme disease. The OualiCode™ B, burgdorferi IgG Western Blot Kit can be used to test human sera at any time following onset of symptoms, and when (1) only IgM antibodies were originally detected: (2) IgG antibodies were detected previously, but were not considered significant by Western Blot; or (3) previously seronegative patients become positive by ELISA or IFA screening tests.
The Immunetics QualiCode™ B. burgdorferi IgG Western Blot Kit 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 Immunetics QualiCode™ B. burgdorferi IgG Western Blot Kit 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) IqG antibodies were detected but were not considered significant or (3) previously tested seroneqative individuals are shown to develop antibodies by EIA or IFA test procedures.
Product codes (comma separated list FDA assigned to the subject device)
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 dodecvl sulfate. 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 resolved Borrelia burgdorferi antigens are then reacted with diluted serum and controls (positive and negative sera of defined reactivity).
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 containing anti-human IgG antibodies conjugated with alkaline 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Specificity Study:
- Study Type: Specificity determination.
- Sample Size: 602 total samples (430 Normal population, 172 Cross Reactive Panel).
- Data Source: Normal population samples were from Lyme disease endemic (n=279) and non-endemic (n=151) regions. Cross Reactive Panel samples were from patients with diseases other than Lyme disease that may be cross-reactive.
- Key Results:
- Normal - endemic region: 97% Negative (95% CI: 95-99%)
- Normal - non-endemic region: 96% Negative (95% CI: 92-98%)
- Normal - overall: 97% Negative (95% CI: 95-98%)
- Cross-reactive Panel: 93% Negative (95% CI: 88-96%)
Sensitivity Study:
- Study Type: Sensitivity determination.
- Sample Size: 199 well-characterized sera from patients with Lyme disease, drawn at different times after onset of disease.
- Data Source: Lyme Disease Panel samples from patients with a clinical diagnosis of Lyme disease (based on presence of erythema migrans or one or more symptoms of late Lyme disease), and which tested positive or equivocal on ELISA or other screening assays for B. burgdorferi antibodies.
- Key Results:
- Draw Time (months) Unknown (n=54): 81% Positive (69-91 % CI)
- Draw Time (months) 12 (n=18): 39% Positive (17-63 % CI)
Reproducibility Studies:
- Inter-lot reproducibility:
- Study Type: Inter-lot reproducibility.
- Sample Size: Panel of 20 specimens (positive, weakly reactive, and negative sera).
- Key Results: 90% agreement between interpretations from three kit lots. Reproducibility of scoring individual bands varied from 60% to 95%, averaging 77%.
- Inter-run reproducibility:
- Study Type: Inter-run reproducibility.
- Sample Size: 20 specimen panel.
- Key Results: 92% agreement overall between interpretations from two runs averaged over all three sites. Reproducibility of individual band scoring varied between 77% and 95%, averaging 88% over all ten bands.
- Inter-reader reproducibility:
- Study Type: Inter-reader reproducibility.
- Sample Size: 20 specimen panel.
- Key Results: 97% agreement overall between interpretations from two readers averaged over three sites. Band scoring reproducibility varied between 83% and 100%, averaging 91.5% over all ten bands.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Specificity:
- Normal - endemic region: 97% Negative
- Normal - non-endemic region: 96% Negative
- Normal - overall: 97% Negative
- Cross-reactive Panel: 93% Negative
Sensitivity:
- Draw Time (months) Unknown: 81% Positive
- Draw Time (months) 12: 39% Positive
Reproducibility:
- Inter-lot: 90% Interpretation agreement
- Inter-run: 92% Interpretation agreement
- Inter-reader: 97% Interpretation agreement
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 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
and the comments of the comments of the comments of
510(k) Safety and Effectiveness Summary
Submitted by:
Immunetics. Inc. 63 Rogers Street Cambridge, MA 02142
Contact Person:
Andrew E. Levin, Ph.D. Scientific Director
(617) 492 - 5416
Date of Preparation:
September 9, 1999
1. Name and Address of Owner/Operator and Manufacturer:
Immunetics, Inc. 63 Rogers Street Cambridge, MA 02142
2. Product Name:
Trade Name: QualiCode™ B. burgdorferi IgG Western Blot Kit
Common Name: B. burgdorferi IgG Western Blot Kit
3. Claim of Substantial Equivalence
The characterized samples used for the establishment of Substantial Equivalence were obtained from patients with a clinical diagnosis of Lyme Disease in accordance with the CDC case definition, i.e. based on the presence of EM (erythema migrans) or the presentation of late Lyme clinical manifestations (e.g., arthritic, cardiac, or neurological symptoms). Infection was confirmed by culture of Borrelia from biopsies in many examples.
Each of the clinical trial sites provided specimens that were well characterized by the site using Lyme-specific serological analyses, including EIA and/or Western Blot testing. In particular, specimens selected for the trial were required to have tested positive or indeterminate on a B. burgdorferi screening assay, typically an ELISA, in accordance with the two-tier testing protocol recommended by CDC/ASTPHLD (CDC (1995) "Recommendations for test performance and interpretation from the Second National
1
Conference on Serologic Diagnosis of Lyme Disease", Morbid. Mort. Weekly Rep. 44:590-591.).
Substantial equivalence of this device is based on the assessment of performance of the device in these clinical trials in which the well-characterized, 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 dodecvl sulfate. 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 resolved Borrelia burgdorferi antigens are then reacted with diluted serum and controls (positive and negative sera of defined reactivity).
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 containing anti-human IgG antibodies conjugated with alkaline 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.
റ് Intended Use
The QualiCode™ B. burgdorferi IgG Western Blot Kit is an in vitro qualitative assay for the detection of human IgG antibodies reactive with Borrelia burgdorferi antigens present on a membrane strip. The QualiCode™ B. burgdorferi IgG Western Blot Kit is intended for supplemental testing of human serum specimens which yield positive or equivocal results on B. burgdorferi ELISA or IFA screening assays: QualiCode test results can provide additional, specific evidence of infection with B. burgdorferi which may be useful in the diagnosis of Lyme disease. The OualiCode™ B, burgdorferi IgG Western Blot Kit can be used to test human sera at any time following onset of symptoms, and when (1) only IgM antibodies were originally detected: (2) IgG antibodies were detected previously, but were not considered significant by Western Blot; or (3) previously seronegative patients become positive by ELISA or IFA screening tests.
2
6. Summary of Performance
From a summary of the clinical trial data, the following performance characteristics are described:
Expected values
Three investigational sites, including Immunetics and two independent off-site investigators assaved samples from the following patient populations:
-
- Normal population (n=430) comprised of samples from Lyme disease endemic (n=279) and non-endemic (n=151) regions.
-
- Cross Reactive Panel (n=172) comprised of samples from patients with diseases other than Lyme disease that may be cross - reactive.
-
- Lyme Disease Panel (n=199) comprised of samples from patients with a clinical diagnosis of Lyme disease, based on presence of erythema migrans or one or more symptoms of late Lyme disease, and which tested positive or equivocal on ELISA or other screening assays for B. burgdorferi antibodies.
Specificity
Specificity of the device was determined from analysis of testing normal donor specimens from endemic and non-endemic regions and potentially cross reactive disease specimens (602 total samples). The specificity values derived from testing each population are shown in the table below in the "% Negative" column:
| Sample Type | n | % Positive | % Negative | 95% CI |
|---|---|---|---|---|
| Normal - endemic region | 279 | 3 | 97 | 95-99 % |
| Normal - non-endemic region | 151 | 4 | 96 | 92-98% |
| Normal - overall | 430 | 3 | 97 | 95-98 % |
| Cross-reactive Panel | 172 | 7 | 93 | 88-96 % |
Sensitivity
Sensitivity of the device was determined by testing a total of 199 well-characterized sera from patients with Lyme disease, which had been drawn at different times after onset of disease. Sensitivity for each time after onset category is shown in the table below in the "% Positive" column:
3
Sensitivity of the Immunetics, Inc. QualiCode™ B. burgdorferi IgG Western Blot Kit vs. Time after Onset
| Draw Time (months) | n | % Positive | % Negative | 95% CI |
|---|---|---|---|---|
| Unknown | 54 | 81% | 19% | 69-91 % |
| 12 | 18 | 39% | 61% | 17-63 % |
Reproducibility
Inter-lot reproducibility was determined by assaying a panel of 20 specimens, including positive, weakly reactive and negative sera, on three lots of the Immunetics QualiCode™ kit. There was 90% agreement between interpretations from the three kit lots. The reproducibility of scoring of individual bands between the three lots varied from 60% to 95%, averaging 77%.
Inter-run reproducibility was determined by assaying the 20 specimen panel twice, on separate days, at each of three sites. There was 92% agreement overall between interpretations from the two runs averaged over all three sites. The reproducibility of individual band scoring between the two runs averaged over all three sites varied between 77% and 95%, with an average of 88% over all ten bands.
Inter-reader reproducibility was determined by assaying the 20 specimen panel twice, on separate days, at each of three sites, with each strip interpreted by two independent readers. There was 97% agreement overall between interpretations from the two readers averaged over the three sites. Band scoring reproducibility varied between 83% and 100% averaged over the three sites, with an average of 91.5% over all ten bands.
| Study | n | % Interpretation agreement |
|---|---|---|
| Inter-lot | 20 | 90 |
| Inter-run | 20 | 92 |
| Inter-reader | 20 | 97 |
7. Conclusions
Based on performance in the clinical trial, this device has been shown to be safe and effective for the intended use in the qualitative detection of human immunoglobulin G (IgG) antibodies in serum or plasma to Borrelia burgdorferi antigens, and as a supplemental, more specific, test to aid in the diagnosis of infection by or exposure to Borrelia burgdorferi, the causative agent of Lyme disease.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles forming a wing-like shape.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 1 1999
Andrew E. Levin, Ph.D. Scientific Director Immunetics, Inc. 63 Rogers Street Cambridge, Massachusetts 02142
Re: K991063
Trade Name: QualiCode™ B. burgdorferi IgG Western Blot Kit Regulatory Class: II Product Code: LSR Dated: July 8, 1999 Received: July 9, 1999
Dear Dr. Levin:
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.
5
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 Butman
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
6
510(k) Number (if known):
Device Name: QualiCode B. burgdorferi IgG Western Blot Kit
Indications For Use:
The Immunetics QualiCode™ B. burgdorferi IgG Western Blot Kit 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 Immunetics QualiCode™ B. burgdorferi IgG Western Blot Kit 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) IqG antibodies were detected but were not considered significant or (3) previously tested seroneqative individuals are shown to develop antibodies by EIA or IFA test procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubres
(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number K 991063
Prescription Use 7 (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional format 1-2-96)