(439 days)
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.
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.
The provided text describes the MRL Diagnostics Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgM device and the studies conducted to establish its safety and effectiveness.
Here's an analysis of the acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve a sensitivity of X%"). Instead, it presents the observed performance metrics (sensitivity, specificity, reproducibility) from the studies.
| Performance Metric | Reported Device Performance (Summary) |
|---|---|
| Sensitivity | Overall IgM Sensitivity: 55% (97/176) for Lyme disease positive patient sera.Sensitivity by Months Post Infection Onset:- <1 month: 77% (30/39)- 1 to 2 months: 72% (18/25)- 3 to 6 months: 63% (25/40)- >6 months: 32% (23/71) |
| Specificity | Overall Normal Population Positivity (IgM): 2% (5/325)Cross-reactivity (IgM): Varied by condition, e.g., Syphilis 1% (1/74), Periodontal 10% (2/20), E. chaffeensis 63% (5/8). |
| Reproducibility | Intra-laboratory: 100% interpretation, 90-100% criteria band readings.Inter-lot: 100% interpretation, 90-100% criteria band readings.Inter-reader: 96% interpretation, 94-96% criteria band readings.Inter-site: 95% interpretation, 94-98% criteria band readings. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
-
Sensitivity Test Set:
- Total: 176 well-characterized Lyme disease positive patient sera.
- Provenance: Retrospective serum samples.
- Investigational Sites 1 and 2 used samples from their own well-characterized serum banks.
- Investigational Site 3 used a retrospective, masked, characterized serum panel supplied by the CDC.
- Country of Origin: Not explicitly stated, but the involvement of the CDC in the US suggests data largely from the US.
-
Specificity Test Set:
- Total: 606 sera.
- 325 serum samples from persons with no known history of Lyme disease (Normals, from endemic and non-endemic areas).
- 284 disease state serum samples from potentially cross-reactive diseases.
- Provenance: Retrospective.
- Country of Origin: Not explicitly stated, but implies similar geographical sources as the sensitivity study.
- Total: 606 sera.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document mentions "well-characterized Lyme disease positive patient sera... from patients with EM, a late stage symptom per the CDC case definition and B. burgdorferi seropositive, or B. burgdorferi culture positive." For specificity, it uses "persons with no known history of Lyme disease" and "disease state serum samples from potentially cross-reactive diseases."
No direct mention is made of a specific number of experts or their qualifications establishing the ground truth for the test set in a consensus-based reading scenario. The ground truth appears to be based on:
- Clinical diagnosis (EM, late stage symptom per CDC case definition).
- Laboratory confirmation (B. burgdorferi seropositive or B. burgdorferi culture positive).
- Known patient history for normal and cross-reactive cohorts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe an adjudication method for establishing the ground truth of the test set samples. The ground truth seems to be established based on clinical and laboratory criteria as described above, rather than expert interpretation of the western blot results themselves for the purpose of ground truth.
For the inter-reader reproducibility study, it mentions "read by two readers at each site," but this is to assess reader variability, not to establish a adjudicated ground truth for individual cases.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a diagnostic test (Western Blot IgM) interpreted by human readers, but the study focuses on the standalone performance and reproducibility of the device, not on comparing human reader performance with and without AI assistance. AI assistance is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The reported sensitivity and specificity values are for the device (MRL Diagnostics' Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgM test) as interpreted by trained personnel (implied by "read by two readers at each site" in reproducibility studies, but the main sensitivity/specificity data appears to be for the device's output). The "algorithm" in this context is the Western Blot interpretation criteria used by the trained readers. There is no mention of an automated algorithm separate from human interpretation for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the test set was established using:
- Clinical diagnosis: Patients with Erythema Migrans (EM), a late-stage symptom per the CDC case definition.
- Laboratory confirmation: B. burgdorferi seropositive or B. burgdorferi culture positive.
- Known patient history: For normal populations (no known history or symptoms of Lyme Disease) and cross-reactivity populations (patients with potentially cross-reactive conditions or infections).
This is a combination of clinical diagnosis and laboratory results.
8. The sample size for the training set
The document does not explicitly describe a separate "training set" in the context of machine learning or algorithm development. The "well-characterized" samples described in the studies are for evaluating the performance of the device. Medical devices like this Western Blot typically have their "criteria bands" for positivity established through extensive biological research and clinical correlation, not through a machine learning training process with a distinct training set. The criteria bands (e.g., 23, 39, 41 kDa) are pre-defined biological markers.
9. How the ground truth for the training set was established
As there is no distinct "training set" described for an algorithm, this question is not directly applicable. The "ground truth" for defining the diagnostic criteria of the Western Blot (i.e., which bands are indicative of infection) would have been established through prior fundamental research into B. burgdorferi immunology and clinical presentations of Lyme disease, correlating specific antibody band patterns with confirmed cases.
{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) | ||||||
| < 1 month | 40 | 78% | 80% | 73% | 53% | 80% |
| 1 to 2 months | 25 | 72% | 92% | 72% | 60% | 76% |
| 3 to 12 months | 63 | 48% | 71% | 45% | 39% | 58% |
| > 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 PostInfection Onset | IgG Sensitivity | IgG95% CI | IgG Negative &IgM Positive |
| <1 | 100% (4/4) | 40 to 100% | 0 |
| 1 to 2 | 79% (7/9) | 40 to 97% | 1 |
| 3 to 6 | 75% (12/16) | 48 to 97% | 2 |
| >6 | 36% (4/11) | 11 to 69% | 6 |
| OverallSensitivity | 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 PostInfection Onset | IgMSensitivity | IgM95% CI | IgG Positive &IgM Negative |
|---|---|---|---|
| <1 | 77% (30/39) | 61 to 89% | 1 |
| 1 to 2 | 72% (18/25) | 51 to 88% | 4 |
| 3 to 6 | 63% (25/40) | 46 to 77% | 7 |
| >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 | <1 Mo. | 1-2 Mo. | 3-6 Mo. |
| 76% (13/17) | 100% (1/1) | 90% (9/10) | 67% (6/9) |
10703 PROGRESS WAY, CYPRESS CALIFORNIA 90630
800 445-0185
{4}------------------------------------------------
DIAGNOSTICS
1971007
(Page 5 of 6) 510(k) Safety and Effectiveness Summary
To determine assay Specificity, Investigational Sites 1, 2, and 3 assayed 606 sera consisting Specificity 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). Where specimen quantities were sufficient, the investigators assayed each specimen on both the IgG and the IgM Western Blots. For persons with no known history of Lyme disease (Normals), specificity 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"):
| Condition | IgMPositivity | IgG Positive &IgM Negative |
|---|---|---|
| Normal Population (n=325) | ||
| Endemic | 0% (0/81) | 0 |
| Non-endemic | 2%(5/244) | 0 |
| Overall Normal Positivity | 2%(5/325) | 0 |
| Condition | IgMCross-reactivity | IgG Positive &IgM Negative |
| Spirochetal Disease Population (n=104) | ||
| Syphilis | 1%(1/74) | 0 |
| Periodontal | 10%(2/20) | 0 |
| Leptospirosis | 0%(0/10) | 0 |
| Auto Immune Disease Population (n=22) | ||
| RF | 20%(2/10) | 0 |
| ANA | 18%(2/11) | 0 |
| SLE (Lupus) | 0% (0/1) | 0 |
| Tickborne Disease Population (n=21) | ||
| Rickettsia | 0% (0/9) | 0 |
| E. chaffeensis | 63% (5/8) | 0 |
| HGE | 0% (0/3) | 0 |
| Tickborne Relapsing | 0% (0/1) | 0 |
| Muscular Skeletal Disease (n=33) | ||
| Arthritis | 0%(0/15) | 1 |
| Arthralgia | 9%(1/11) | 1 |
| JRA | 0% (0/4) | 0 |
| Misc. Muscular | 0% (0/3) | 0 |
| Misc. Neurologic Disease (n=27) | 4%(1/27) | 1 |
| Viral Disease Population (n=36*) | ||
| EBV* | 0%(0/13) | 0 |
| CMV* | 0%(0/11) | 0 |
| HSV-1/2* | 0% (0/2) | 0 |
| HIV | 0%(0/10) | 0 |
| Misc. Disease/Similar Symptoms (n=42) | ||
| Fatigue | 0%(0/15) | 0 |
| Misc. | 4%(1/27) | 0 |
- includes 2 sera with antibody response to EBV, CMV, and HSV-1/2 10703 PROGRESS WAY, CYPRESS CALIFORNIA 90630 800 445-0185 714 220-1900
FAX • 714 220-1182
mwagner(@mrlinfo.com
{5}------------------------------------------------
DIAGNOSTICS
971007
510(k) Safety and Effectiveness Summary ______________________________________________________________________________________________________________________________________ (Page 6 of 6)
Intra-laboratory Reproducibility was assessed by assaying 10 serum samples once per day Reproducibility on 3 days using a single MRL Diagnostics Western Blot Genogroup 1 Strip lot. All 3 runs vielded identical screening interpretations for all 10 selected sera. Overall, the 3 criteria bands yielded identical interpretations on 89 of 90 (99%) criteria band readings.
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% |
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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)
§ 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).