(439 days)
Not Found
No
The device description outlines a traditional laboratory assay based on protein separation and antibody binding, with interpretation based on visual band reactivity. There is no mention of automated analysis, image processing, or any computational methods that would suggest the use of AI/ML.
No
This device is an in vitro diagnostic (IVD) test intended to provide supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease, by detecting antibodies in human serum. It is not used for treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the test "allows the qualitative detection of IgM class antibody in human serum... intended to provide supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease." This directly indicates its use for diagnosing a medical condition.
No
The device description clearly outlines a laboratory-based assay involving physical components like nitrocellulose membranes, gels, and chemical reagents, which are used to detect antibodies in serum samples. 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 / Indications for Use" section explicitly states that the test "allows the qualitative detection of IgM class antibody in human serum" and is "intended to provide supportive evidence of infection with B. burgdorferi". This clearly indicates that the device is used to examine specimens derived from the human body (serum) to provide information for diagnostic purposes (evidence of infection).
- Device Description: The description details a laboratory procedure involving the analysis of patient serum samples to detect specific antibodies. This is a hallmark of in vitro diagnostic testing.
- Performance Studies: The document includes detailed performance studies (Sensitivity, Specificity, Reproducibility) conducted on human serum samples from different populations (Lyme Disease, Normal, Cross-reactivity). This type of testing and data is required for IVD devices to demonstrate their analytical and clinical performance.
- Predicate Device: The mention of a "Predicate Device(s)" (K883767; MRL Diagnostics Lyme Disease IFA IgM kit) 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 of these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MRL Diagnostics' Lyme Disease Borrelia burgdorferi Genogroup 1 Western Blot IgM test allows the qualitative detection of IgM class antibody in human serum to individual proteins of the genogroup 1 (B. burgdorferi sensu stricto) of B. burgdorferi sensu lato. The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot assay is intended to provide supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease, using serum samples which have been found positive or equivocal by another B. burgdorferi detection methodology (e.g. IFA or ELISA).
The MRL Diagnostics Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgM can be used alone during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After the acute phase, infected patients are usually found to be Western Blot positive for IgG. For persons beyond the acute phase, a positive IgM test alone is not recommended for determining active disease in patients. Therefore, both IgG and IgM Western Blots should be used after the acute phase.
Product codes (comma separated list FDA assigned to the subject device)
LSR
Device Description
MRL Diagnostics separates B. burgdorferi proteins by polyacrylamide gel electrophoresis and electrophoretically transfers the fractionated proteins from the gel to a nitrocellulose membrane. The nitrocellulose membrane is dried and cut into strips. The antigen strips are numbered and packaged.
The MRL Diagnostics Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgM test is a two stage procedure. In the first stage, the patient sera is diluted and incubated with individual antigen strips. If antibodies to B. burgdorferi are present in the sera, they will bind to the Borrelia antigens immobilized on the nitrocellulose membranes. In the second stage, visualization of the bound antibodies is accomplished by incubating the blots with alkaline phosphatase-conjugated goat anti-human IgM, (Fc fragment specific) followed by the addition of substrate (BCIP/NBT) which forms a colored precipitate at each site (antigen band) where the anti-human conjugate has bound. The resulting pattern of band reactivity is then interpreted.
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
To determine assay Sensitivity, two independent off-site investigations (Investigational Sites 1 and 2) and one on-site investigational Site 3), assayed well characterized Lyme disease positive patient sera (n=176) from patients (n=155) with EM, a late stage symptom per the CDC case definition and B. burgdorferi seropositive, or B. burgdorferi culture positive. Investigational Sites 1 and 2 used retrospective serum samples from their own well-characterized serum banks, and Investigational Site 3 used a retrospective well characterized serum panel supplied by the CDC.
To determine assay Specificity, Investigational Sites 1, 2, and 3 assayed 606 sera consisting of 325 serum samples from persons with no known history of Lyme disease (from endemic and non-endemic areas) (Investigational Sites 1, 2, and 3) and 284 disease state serum samples from potentially cross-reactive diseases (including diseases likely to produce similar clinical presentation) (Investigational Sites 1 and 3).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sensitivity Study:
Study Type: Sensitivity
Sample Size: 176 patient sera (155 patients)
Key Results:
- CDC panel results for IgM Western Blot: Overall Sensitivity 66% (27/40)
- All three sites, IgM Western Blot: Overall Sensitivity 55% (97/176)
- Initial Draw Sensitivity: 76% (13/17)
- Subsequent Draw Sensitivity:
§ 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
JUN । 1998
MRL DIAGNOSTICS
K971007
510(k) Safety and Effectiveness Summary_______________________________________________________________________________________________________________________________________ (Page 1 of 6)
MRL Diagnostics Applicant: 10703 Progress Way Cypress, California 90630 2023365 Establishment Registration No: Michael J. Wagner Contact Person: Phone: (714) 220-1900 Telefax: (714) 220-1182
mwagner@mrlinfo.com E-mail:
Summary Date: May 20, 1998
Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgM Device Name:
Lyme Disease Borrelia burgdorferi Serological Reagents Classification: 21 CFR §866.3830 Class II
- MRL Diagnostics Lyme Disease IFA IgM kit (K883767) Predicate Device:
1
IAGNOSTICS
971007
510(k) Safety and Effectiveness Summary ______________________________________________________________________________________________________________________________________
(Page 2 of 6)
MRL Diagnostics separates B. burgdorferi proteins by polyacrylamide gel electrophoresis Device and electrophoretically transfers the fractionated proteins from the gel to a nitrocellulose Description: membrane. The nitrocellulose membrane is dried and cut into strips. The antigen strips are numbered and packaged.
The MRL Diagnostics Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgM test is a two stage procedure. In the first stage, the patient sera is diluted and incubated with individual antigen strips. If antibodies to B. burgdorferi are present in the sera, they will bind to the Borrelia antigens immobilized on the nitrocellulose membranes. In the second stage, visualization of the bound antibodies is accomplished by incubating the blots with alkaline phosphatase-conjugated goat anti-human IgM, (Fc fragment specific) followed by the addition of substrate (BCIP/NBT) which forms a colored precipitate at each site (antigen band) where the anti-human conjugate has bound. The resulting pattern of band reactivity is then interpreted.
MRL Diagnostics' Lyme Disease Borrelia burgdorferi Genogroup 1 Western Blot IgM test Intended Use: allows the qualitative detection of IgM class antibody in human serum to individual proteins of the genogroup 1 (B. burgdorferi sensu stricto) of B. burgdorferi sensu lato. The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot assay is intended to provide supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease, using serum samples which have been found positive or equivocal by another B. burgdorferi detection methodology (e.g. IFA or ELISA).
The MRL Diagnostics Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgM can be used alone during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After the acute phase, infected patients are usually found to be Western Blot positive for IgG. For persons beyond the acute phase, a positive IgM test alone is not recommended for determining active disease in patients. Therefore, both IgG and IgM Western Blots should be used after the acute phase.
2
MIRI DIAGNOSTICS
971007
510(k) Safety and Effectiveness Summary ______________________________________________________________________________________________________________________________________ (Page 3 of 6)
Three investigational sites (2 independent off-site investigators and 1 on-site investigator) Expected studied the following 3 distinct populations: Values:
-
- a Lyme Disease population (n=181) consisting of serum samples from patients with EM, a late stage symptom per the CDC case definition and B. burgdorferi seropositive, or B. burgdorferi culture positive;
-
- a Normal population (n=325) consisting of serum samples from donors with no known history or symptoms of Lyme Disease (including persons from Lyme disease endemic and non-endemic areas), and;
-
- a Cross-reactivity population (n=281) consisting of serum samples from patients with potentially cross-reactive conditions or infections.
The frequency of criteria bands observed in the three populations are described in the following table:
| Criteria Bands (kDa) | ||||||
|---|---|---|---|---|---|---|
| Disease State | n | %Pos | Any Band | 23 | 39 | 41 |
| Lyme Disease (By Disease Stage) | (n=181) | |||||
| Lyme Stage I | 72 | 69% | 86% | 71% | 49% | 55% |
| Lyme Stage II | 42 | 66% | 83% | 59% | 56% | 76% |
| Lyme Stage III | 67 | 30% | 70% | 27% | 31% | 42% |
| Lyme Disease (By Months Post Infection Onset) (n=181) | ||||||
| 12 months | 53 | 34% | 81% | 34% | 36% | 49% |
| Normal Population | (n=325) | |||||
| Endemic | 81 | 0% | 7% | 1% | 0% | 2% |
| Non-Endemic | 244 | 2% | 23% | 11% | 2% | 9% |
| Potential Cross-reactives (n=281) | ||||||
| Spirochetal | 104 | 3% | 40% | 19% | 5% | 12% |
| Auto-Immune | 22 | 18% | 55% | 41% | 0% | 23% |
| Tick Borne | 21 | 24% | 38% | 29% | 5% | 29% |
| Muscular Skeletal | 33 | 3% | 24% | 9% | 0% | 6% |
| Neurologic | 27 | 4% | 41% | 7% | 0% | 22% |
| Viral | 32 | 0% | 13% | 3% | 0% | 9% |
| Symptomology | 15 | 0% | 27% | 13% | 0% | 13% |
| Misc. Disease | 27 | 4% | 15% | 4% | 4% | 11% |
714 220-1900
3
DIAGNOSTICS
971007
510(k) Safety and Effectiveness Summary_______________________________________________________________________________________________________________________________________ (Page 4 of 6)
To determine assay Sensitivity, two independent off-site investigations (Investigational Sites Sensitivity: 1 and 2) and one on-site investigational Site 3), assayed well characterized Lyme disease positive patient sera (n=176) from patients (n=155) with EM, a late stage symptom per the CDC case definition and B. burgdorferi seropositive, or B. burgdorferi culture positive. Investigational Sites 1 and 2 used retrospective serum samples from their own well-characterized serum banks, and Investigational Site 3 used a retrospective well characterized serum panel supplied by the CDC. The CDC panel results are presented as a means to convey further information on the performance of this assay with a masked, characterized serum panel. This does not imply an endorsement of the assay by the CDC. For the CDC panel, sensitivity results are provided in the following table for 1) the IgM Western Blot, and 2) the number of samples which were IgM negative but IgG positive by
| MRL Diagnostics' B. burgdorferi Western blots (“IgM Negative & IgG Positive”): | |||
|---|---|---|---|
| Months Post | |||
| Infection Onset | IgG Sensitivity | IgG | |
| 95% CI | IgG Negative & | ||
| IgM Positive | |||
| 6 | 36% (4/11) | 11 to 69% | 6 |
| Overall | |||
| Sensitivity | 66% (27/40) | 51 to 84% | 9 |
For all three sites, sensitivity results are provided in the following table for 1) the IgM Western Blot and 2) the number of samples which were IgM negative but IgG positive by MRL Diagnostics' B. burgdorferi Western blots ("IgM Negative & IgG Positive"):
| Months Post
Infection Onset | IgM
Sensitivity | IgM
95% CI | IgG Positive &
IgM Negative |
|--------------------------------|--------------------|---------------|--------------------------------|
| 6 | 32% (23/71) | 22 to 45% | 29 |
| Unspecified | 0% (0/1) | | 1 |
| Overall Sensitivity | 55% (97/176) | 47 to 63% | 42 |
Eighteen patients were drawn more than once, i.e., three patients were drawn three times and the other patients twice. One of those patients was drawn at 99 and 105 months post onset, and both draws were found IgG positive IgM negative. The other seventeen patients were initially drawn less than one month post onset, and the results for those multiple draws are summarized in the following table:
714 220-1900
| Initial Draw | Subsequent Draw Sensitivity | ||
|---|---|---|---|
| Sensitivity | Inter-lot Reproducibility was assessed using 10 serum samples on 3 lots of MRL Diagnostics Western Blot Genogroup 1 Strips. All 3 lots produced identical screening interpretations for all 10 selected sera. Overall, the 3 criteria bands vielded identical interpretations on 89 of 90 (99%) criteria band readings. |
Inter-reader Reproducibility was assessed by assaying 18 patient sera with a single lot of strips. The sera were assayed at the three Investigational Sites, and read by two readers at each site. Overall, interpretation was identical 94% (51/54), and criteria band readings were identical 96% (155/162).
Inter-site Reproducibility was assessed by assaying 18 patient sera with a single lot of strips. The sera were assayed at the three Investigational Sites, and read by two readers at each site. Overall, interpretation was identical 95% (97/108), and criteria band readings were identical 96% (311/324).
The following table summarizes the reproducibility studies by interpretation and band reproducibility.
| Study | 11 | Interp | 23 | 39 | 41 |
|---|---|---|---|---|---|
| Intra-lab | 10 | 100% | 100% | 90% | 100% |
| Inter-lot | 10 | 100% | 100% | 100% | 90% |
| Inter-reader | 18 | 96% | 96% | 94% | 96% |
| Inter-site | 18 | વેરી જેવી જેવી છે રીજે જિલ્લામાં આવેલું એક ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલત | 98% | 94% | 96% |
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1
Michael J. Wagner Regulatory Affairs Specialist MRL Diagnostics 10703 Progress Way Cypress, CA 90630
Re: K971007
Trade Name: Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgM Regulatory Class: II Product Code: LSR Dated: March 23, 1998 Received: March 25, 1998
Dear Mr. Wagner:
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 (OS) 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.
7
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
8
510(k) Number (if known): K971007
Device Name: Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgM
Indications for Use:
MRL Diagnostics' Lyme Disease Borrelia burgdorferi Genogroup 1 Western Blot IgM test allows the qualitative detection of IgM class antibody in human serum to individual proteins of the genogroup 1 (B. burgdorferi sensu stricto) of B. burgdorferi sensu lato. The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot assay is intended to provide supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease, using serum samples which have been found positive or equivocal by another B. burgdorferi detection methodology (e.g. IFA or ELISA).
The MRL Diagnostics Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgM can be used alone during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After the acute phase, infected patients are usually found to be Western Blot positive for IgG. For persons beyond the acute phase, a positive IgM test alone is not recommended for determining active disease in patients. Therefore, both IgG and IgM Western Blots should be used after the acute phase.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubios
Division Sign-off
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K971007
Prescription Use X
(Per 21 CFR 801.109
. P
OR
Over-The-Counter Use
(Optional Format 1-2-96)