(439 days)
MRL Diagnostics' Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgG test is intended for the qualitative detection of IgG class antibodies, in human serum, to the genogroup 1 (Borrelia burgdorferi sensu stricto) of B. burgdorferi sensu lato. The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot IgG test is intended to provide supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease as an aid in the diagnosis of Lyme disease, using serum samples which have been found positive or equivocal by a B. burgdorferi screening method (e.g., IFA or ELISA). The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot IgG can be used at any time following onset of symptoms provided the IFA or ELISA is positive or equivocal. Also, it should be used for follow up when: 1) only IgM antibodies were originally detected, 2) IgG antibodies were detected, but were not considered significant by Western blot, or 3) previously seronegative patients subsequently test positive by IFA or ELISA.
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 IgG 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 IgG, (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.
Response to Request for Information on Device Acceptance Criteria and Study Details:
This document is a 510(k) Safety and Effectiveness Summary for the MRL Diagnostics Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgG device. It describes the device, its intended use, and performance data.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal "acceptance criteria" with numerical targets for sensitivity, specificity, and reproducibility. Instead, it presents the results of studies demonstrating the device's performance across various populations and conditions. The implied acceptance, given the 510(k) clearance, is that the demonstrated performance is considered substantially equivalent to a predicate device and adequate for its intended use as an aid in diagnosing Lyme disease.
Here's a table summarizing the reported device performance:
| Performance Metric | Reported Device Performance (MRL Diagnostics Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgG) |
|---|---|
| Sensitivity (Overall) | 46% (83/179) (95% CI: 39-54%) (Across three investigational sites) |
| Specificity (Normals) | 100% (0/82 for endemic normals; 0/244 for non-endemic normals) |
| Specificity (Cross-reactives) | Generally 0%, with some exceptions: Arthritis (7%), Arthralgia (9%), Misc. Neurologic (4%) |
| Reproducibility (Intra-lab) | 90% for interpretation, 90-100% for individual bands |
| Reproducibility (Inter-lot) | 90% for interpretation, 90-100% for individual bands |
| Reproducibility (Inter-reader) | 94% for interpretation, 90-98% for individual bands |
| Reproducibility (Inter-site) | 88% for interpretation, 73-97% for individual bands |
Note: The sensitivity values are provided for different timeframes post-infection as well, indicating varying performance throughout the course of the disease. The document highlights that "weakly reactive (borderline) specimens decrease the kit's reproducibility."
2. Sample Sizes Used for the Test Set and Data Provenance:
Sensitivity Study (Lyme Disease Population):
- Total Sample Size: 184 well-characterized Lyme disease positive patient sera from 158 patients.
- Data Provenance: Retrospective.
- Investigational Sites 1 and 2 used samples from their "own well-characterized serum banks."
- Investigational Site 3 used a "retrospective well characterized serum panel supplied by the CDC."
- Country of Origin: Not explicitly stated but implied to be United States given the CDC involvement.
Specificity Study (Normal and Cross-reactive Populations):
- Total Sample Size: 606 sera.
- Normal Population: 326 serum samples (from endemic and non-endemic areas).
- Cross-reactive Disease Samples: 286 disease state serum samples.
- Data Provenance: Retrospective.
- Normal samples from persons with "no known history of Lyme disease."
- Cross-reactive samples from patients with "potentially cross-reactive diseases."
- Country of Origin: Not explicitly stated but implied to be United States given the context of general public health data and CDC involvement.
Reproducibility Studies:
- Intra-laboratory and Inter-lot Reproducibility: 10 serum samples (of varying reactivity).
- Inter-reader and Inter-site Reproducibility: 18 patient sera.
- Data Provenance: Retrospective, as these were established serum samples used for testing.
- Country of Origin: Not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not explicitly state the number of individual experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the test sets.
However, it describes the ground truth for the Lyme Disease population as:
- Patients with EM (Erythema migrans), a late stage symptom per the CDC case definition.
- B. burgdorferi seropositive.
- B. burgdorferi culture positive.
For the CDC panel, it describes "well-characterized" and "masked, characterized serum panel." This implies that the CDC (Centers for Disease Control and Prevention), a leading public health institution in the US, established the characterization, which would involve expert consensus and established diagnostic criteria for Lyme disease.
For normal and cross-reactive populations, the ground truth was based on "persons with no known history of Lyme disease" and "patients with potentially cross-reactive conditions or infections," respectively. This suggests clinical diagnosis by healthcare professionals rather than a specially convened expert panel for the study.
4. Adjudication Method for the Test Set:
The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the test set. The ground truth appears to have been established prior to the study using existing clinical and laboratory diagnostics, often leveraging CDC definitions and characterized serum banks.
For reproducibility studies, two readers at each site performed the inter-reader and inter-site assessments, but no formal adjudication of discrepancies is described, only the percentage of identical interpretations and band readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
A formal MRMC comparative effectiveness study comparing human readers with and without AI assistance was not conducted. The device described is a diagnostic test (Western Blot IgG), not an AI-powered image analysis tool that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies conducted are standalone evaluations of the diagnostic device. The device itself is a laboratory assay (Western Blot) that produces a pattern of bands. Interpretation of these bands is inherent to the use of the device, but the performance metrics provided (sensitivity, specificity) reflect the output of the device and its interpretation rules, rather than the performance of an AI algorithm assisting a human. The reproducibility studies evaluate the consistency of interpretation by human readers, but this is part of the device's operational performance, not an AI assisting human performance.
7. The Type of Ground Truth Used:
The ground truth used for the test sets was a combination of:
- Clinical Definition/Case Definition: For Lyme Disease patients, the CDC case definition (presence of EM, late-stage symptoms) was used.
- Laboratory Confirmation: B. burgdorferi seropositivity or culture positivity was used for Lyme disease patients.
- Historical Data/Clinical Diagnosis: For normal individuals, a lack of known history or symptoms of Lyme disease. For cross-reactive conditions, the clinical diagnosis of those specific conditions.
- Well-Characterized Serum Panels: The CDC supplied a "masked, characterized serum panel" for one of the investigational sites. This typically implies a rigorous, expert-driven characterization process.
8. The Sample Size for the Training Set:
The document does not mention a "training set" in the context of an algorithm or AI. This is a traditional diagnostic assay (Western Blot), not a machine learning model that requires a distinct training phase. The populations described (Lyme disease, Normal, Cross-reactive) are test sets used to evaluate the assay's performance.
9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" for an algorithm in this context, this question is not applicable. The device relies on biochemical reactions and a predefined interpretive criteria for bands rather than a trained algorithm.
{0}------------------------------------------------
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 JUN
DIAGNOSTICS
510(k) Safety and Effectiveness Summary ______________________________________________________________________________________________________________________________________ (Page 1 of 6)
| Applicant: | MRL Diagnostics |
|---|---|
| 10703 Progress Way | |
| Cypress, California 90630 |
2023365 Establishment Registration No:
- Michael J. Wagner Contact Person:
(714) 220-1900 Phone:
(714) 220-1182 Telefax:
mwagner@mrlinfo.com E-mail:
May 20, 1998 Summary Date:
Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgG Device Name:
- Lyme Disease Borrelia burgdorferi Serological Reagents Classification: 21 CFR §866.3830 Class II
MRL Diagnostics Lyme Disease IFA IgG kit (K883487) Predicate Device:
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for MRL Diagnostics. The letters "MRL" are stacked on top of the word "DIAGNOSTICS". There is a thick black line between the two words. The text is in a bold, sans-serif font.
$971006
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 IgG 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 IgG, (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 B. burgdorferi Genogroup 1 Western Blot IgG test is Intended Use: intended for the qualitative detection of IgG class antibodies, in human serum, to the genogroup 1 (Borrelia burgdorferi sensu stricto) of B. burgdorferi sensu lato. The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot IgG test is intended to provide supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease as an aid in the diagnosis of Lyme disease, using serum samples which have been found positive or equivocal by a B. burgdorferi screening method (e.g., IFA or ELISA). The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot IgG can be used at any time following onset of symptoms provided the IFA or ELISA is positive or equivocal. Also, it should be used for follow up when: 1) only IgM antibodies were originally detected, 2) IgG antibodies were detected, but were not considered significant by Western blot, or 3) previously seronegative patients subsequently test positive by IFA or ELISA.
{2}------------------------------------------------
510(k) Safety and Effectiveness Summary_______________________________________________________________________________________________________________________________________ (Page 3 of 6)
Expected
Values:
Three investigational sites (2 independent off-site investigators and 1 on-site investigator) studied the following 3 distinct populations:
-
- a Lyme Disease population (n=183) 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=326) 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=282) 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:
| Disease State | n | %Pos | Any Band | 21 | 23 | 28 | 30 | 39 | 41 | 45 | 58 | 66 | 93 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lyme Disease (By Disease Stage) (n=183) | |||||||||||||
| Lyme I | 72 | 21% | 96% | 17% | 39% | 7% | 14% | 54% | 93% | 7% | 24% | 22% | 11% |
| Lyme II | 41 | 37% | 95% | 32% | 27% | 24% | 49% | 73% | 95% | 39% | 41% | 24% | 34% |
| Lyme III | 70 | 71% | 97% | 59% | 54% | 54% | 64% | 86% | 94% | 33% | 73% | 59% | 61% |
| Lyme Disease (By Months Post Infection Onset) (n=183) | |||||||||||||
| < 1 month | 40 | 28% | 93% | 17% | 35% | 13% | 20% | 60% | 90% | 20% | 28% | 28% | 13% |
| 1 to 2 months | 25 | 28% | 100% | 28% | 48% | 20% | 32% | 64% | 96% | 12% | 24% | 24% | 32% |
| 3 to 12 months | 64 | 44% | 95% | 39% | 38% | 30% | 47% | 70% | 94% | 27% | 52% | 33% | 36% |
| > 12 months | 54 | 63% | 98% | 50% | 50% | 44% | 54% | 81% | 96% | 30% | 65% | 54% | 54% |
| Normal Population (n=326) | |||||||||||||
| Endemic | 82 | 0% | 49% | 0% | 0% | 0% | 1% | 7% | 32% | 0% | 9% | 2% | 0% |
| Non-Endemic | 244 | 0% | 61% | 0% | 1% | 0% | 2% | 8% | 48% | 3% | 4% | 6% | 1% |
| Possible Cross-reactives (n=281) | |||||||||||||
| Spirochetal | 104 | 0% | 85% | 0% | 4% | 3% | 5% | 16% | 66% | 11% | 5% | 10% | 3% |
| Auto-Immune | 22 | 0% | 77% | 0% | 0% | 0% | 5% | 0% | 55% | 0% | 5% | 9% | 5% |
| Tick Borne | 21 | 0% | 43% | 0% | 0% | 0% | 5% | 14% | 38% | 14% | 5% | 14% | 0% |
| Musc. Skeletal | 33 | 6% | 88% | 9% | 9% | 6% | 12% | 15% | 79% | 21% | 9% | 6% | 9% |
| Neurologic | 27 | 4% | 78% | 4% | 0% | 0% | 7% | 11% | 59% | 4% | 22% | 15% | 4% |
| Viral | 32 | 0% | 66% | 0% | 3% | 3% | 6% | 0% | 44% | 9% | 6% | 0% | 0% |
| Symptomology | 15 | 0% | 93% | 7% | 0% | 0% | 13% | 7% | 73% | 7% | 7% | 7% | 0% |
| Misc. Disease | 29 | 0% | 93% | 0% | 0% | 0% | 7% | 21% | 72% | 10% | 17% | 3% | 0% |
{3}------------------------------------------------
K971006
mwagner(@mr)into.com
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=184) from patients (n=158) 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 IgG Western Blot, and 2) the number of samples which were IgG negative but IgM positive by MRL Diagnostics' B. burgdorferi Western Blots ("IgG Negative & IgM Positive"):
| Months PostInfection Onset | IgGSensitivity | IgG95% CI | IgG Negative &IgM Positive |
|---|---|---|---|
| <1 | 25% (1/4) | 1 to 81% | 3 |
| 1 to 2 | 22% (2/9) | 3 to 60% | 6 |
| 3 to 6 | 31% (5/16) | 11 to 59% | 9 |
| >6 | 82% (9/11) | 48 to 98% | 1 |
| OverallSensitivity | 43% (17/40) | 27 to 59% | 19 |
For all three sites, sensitivity results are provided in the following table for 1) the IgG Western Blot and 2) the number of samples which were IgG negative but IgM positive by MRL Diagnostics' B. burgdorferi Western Blots ("IgG Negative & IgM Positive"):
| Months PostInfection Onset | IgGSensitivity | IgG95% CI | IgG Negative &IgM Positive |
|---|---|---|---|
| <1 | 28% (11/39) | 15 to 45% | 20 |
| 1 to 2 | 28% (7/25) | 12 to 49% | 15 |
| 3 to 6 | 41% (17/42) | 26 to 57% | 15 |
| >6 | 65% (47/72) | 53 to 76% | 5 |
| Unspecified | 100% (1/1) | ||
| OverallSensitivity | 46% (83/179) | 39 to 54% | 55 |
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:
| Initial Draw | Subsequent Draw Sensitivity | ||
|---|---|---|---|
| Sensitivity | <1 Mo. | 1-2 Mo. | 3-6 Mo. |
| 12% (2/17) | 0% (0/1) | 10% (1/10) | 0% (0/9) |
10703 PROGRESS WAY, CYPRESS CALIFORNIA 90630 800 445-0185 714 220-1900 FAX • 714 220-1182
{4}------------------------------------------------
K971006
510(k) Safety and Effectiveness Summary ________(Page 5 of 6)
To determine assay Specificity, Investigational Sites 1, 2, and 3 assayed 606 sera consisting Specificity of 326 serum samples from persons with no known history of Lyme disease (from endemic and non-endemic areas) (Investigational Sites 1, 2, and 3) and 286 disease state serum samples from potentially cross-reactive 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), and those with potentially cross-reactive diseases (Potential Cross-reactives),specificity results are provided in the following table for 1) the IgG Western Blot and 2) the number of samples which were IgG negative but IgM positive by MRL Diagnostics' B. burgdorferi Western Blots ("IgG Negative & IgM Positive"):
| Condition | IgG Positivity | IgG Negative &IgM Positive |
|---|---|---|
| Normal Population (n=326) | ||
| Endemic Normals | 0% (0/82) | 0 |
| Non-Endemic Normals | 0% (0/244) | 5 |
| Condition | IgGCrossreactivity | IgG Negative &IgM Positive |
| Spirochetal Disease Population (n=103) | ||
| Syphilis | 0% (0/73) | 1 |
| Periodontal | 0% (0/20) | 2 |
| Leptospirosis | 0% (0/10) | 0 |
| Auto Immune Disease Population (n=22) | ||
| RF | 0% (0/10) | 2 |
| ANA | 0% (0/11) | 2 |
| SLE (Lupus) | 0% (0/1) | 0 |
| Tickborne Disease Population (n=21) | ||
| Rickettsia | 0% (0/9) | 0 |
| E. chaffeensis | 0% (0/8) | 5 |
| HGE | 0% (0/3) | 0 |
| Tickborn Relapsing | 0% (0/1) | 0 |
| Muscular Skeletal Disease (n=33) | ||
| Arthritis | 7% (1/15) | 0 |
| 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=44) | ||
| Fatigue | 0% (0/15) | 0 |
| Misc. | 0% (0/29) | 1 |
- 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
{5}------------------------------------------------
971006
510(k) Safety and Effectiveness Summary_______________________________________________________________________________________________________________________________________
(Page 6 of 6)
Intra-laboratory Reproducibility was assessed by assaying 10 serum samples (of varying Reproducibility reactivity) once per day on 3 days using a single Antigen Strip lot. All 3 runs yielded identical screening interpretations for 9 of 10 selected sera. The remaining discrepant sample (a weakly reactive sample) produced identical interpretations on 8 of the 10 criteria bands. Overall, the 10 criteria bands yielded identical interpretations on 288 of 300 (96%) criteria band readings.
Inter-lot Reproducibility was assessed using 10 serum samples (of varying reactivity) on 3 lots of Antigen Strips. All 3 lots produced identical screening interpretations for 9 of the 10 selected sera. The discrepant sample (a weakly reactive sample) produced identical interpretations on 7 of the 10 criteria bands. Overall, the 10 criteria bands yielded identical interpretations on 284 of 300 (95%) criteria band readings.
Inter-reader Reproducibility was assessed by assaying 18 patient sera with a single lot of strips. The sera were assayed at up to three Investigational Sites (two sera were tested at two sites only), and read by two readers at each site. Overall, interpretation was identical 94% (49/52), and criteria band readings were identical 94% (491/520).
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 88% (91/104), and criteria band readings were identical 87% (900/1040).
The results indicate that for strongly reactive and negative specimens the assay Weakly reactive (borderline) specimens decrease the kit's reproducibility is high. reproducibility.
summarizes reproducibility by interpretation The following table and band reproducibility.
| Study | n | Interp | 21 | 23 | 28 | 30 | 39 | 41 | 45 | 58 | 66 | 93 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intra-lab | 10 | 90% | 90% | 90% | 90% | 90% | 100% | 90% | 90% | 100% | 90% | 100% |
| Inter-lot | 10 | 90% | 90% | 90% | 90% | 90% | 100% | 90% | 90% | 90% | 90% | 100% |
| Inter-reader | 18 | 94% | 90% | 92% | 94% | 98% | 98% | 98% | 92% | 96% | 90% | 90% |
| Inter-site | 18 | 88% | 88% | 83% | 84% | 80% | 91% | 84% | 73% | 94% | 92% | 97% |
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Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
1 1998 וחא
Michael J. Wagner Regulatory Affairs Specialist MRL Diagnostics 10703 Progress Way Cypress. CA 90630
Re: K971006
Trade Name: Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgG 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 (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.
{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): K971006
Device Name: Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgG
Indications for Use:
MRL Diagnostics' Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgG test is intended for the qualitative detection of IgG class antibodies, in human serum, to the genogroup 1 (Borrelia burgdorferi sensu stricto) of B. burgdorferi sensu lato. The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot IgG test is intended to provide supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease as an aid in the diagnosis of Lyme disease, using serum samples which have been found positive or equivocal by a B. burgdorferi screening method (e.g., IFA or ELISA). The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot IgG can be used at any time following onset of symptoms provided the IFA or ELISA is positive or equivocal. Also, it should be used for follow up when: 1) only IgM antibodies were originally detected, 2) IgG antibodies were detected, but were not considered significant by Western blot, or 3) previously seronegative patients subsequently test positive by IFA or ELISA.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
(Division Sigr ical Laboratory Dev K97100 510(k) Number _
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109 |
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).