(126 days)
The Platelia" Lyme IgG assay is a qualitative test intended for use in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum or plasma (K3 EDTA, sodium heparin or sodium citrate). The EIA test system should be used to test serum or plasma from patients with a history and symptoms of infection with B. burgdorferi. All positive and equivocal specimens should be re-tested with a specific, second-tier test such as Western blot. Positive second-tier results are supportive evidence of infection with B. burgdorferi. The diagnosis of Lyme disease should be made based on history and symptoms (such as erytherna migrans), and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first or second-tier) should not be used to exclude Lyme disease.
The Platelia" Lyme IgG Assay is a qualitative assay for the detection of human IgG antibodies to Borrelia burgdorferi in human serum or plasma. The PlateliaTM Lyme IgG Assay uses an indirect ELISA immuno-enzymatic method. Inactivated antigens of Borrelia burgdorferi B31 are used for coating the microplate. A monoclonal antibody labeled with peroxidase which is specific for human gamma chains (anti-IgG) is used as the conjugate.
The Bio-Rad Platelia™ Lyme IgG assay is a qualitative test intended for the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum or plasma.
Here's an analysis of the acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the sensitivity and specificity values. Instead, it presents the performance of the device and a comparative analysis. Here's a summary of the reported performance:
| Performance Metric | Acceptance Criteria (Implicit from comparable device performance and general expectations for diagnostic tests) | Reported Device Performance (Platelia™ Lyme IgG) |
|---|---|---|
| Sensitivity | Demonstrated ability to detect Borrelia burgdorferi IgG antibodies in infected individuals. | - Retrospective Study (Culture-confirmed): All Stages: 62.7% (CI [54.5, 69.0]) Early Stage: 59.2% (CI [50.2, 67.6]) Disseminated Stage: 60.6% (CI [43.7, 75.3]) Late Stage: 100.0% (CI [77.2, 100]) |
| Specificity | Demonstrated ability to yield negative results in uninfected individuals and those with other conditions. | - Analytical Specificity (Blood Donors): Endemic Region: 1.2% positive/equivocal Non-Endemic Region: 0.0% positive/equivocal Overall: 0.5% positive/equivocal |
| Agreement with Clinical Diagnosis (CDC Panel) | Comparable agreement to a marketed device for various time points from onset and normal samples. | Total: 69.8% (for the Platelia™ Lyme IgG) vs. 63.6% (for Predicate Lyme IgG EIA Assay) |
| Cross-Reactivity | Minimal cross-reactivity with other disease conditions. | 1 out of 161 (0.62%) samples from 16 disease conditions showed cross-reactivity (1 Syphilis sample) |
| Precision | Acceptable intra-assay, inter-assay, and inter-site variability (CV%). | CV% values generally ranged from ~2% to ~18% across various samples and precision types. |
| Matrix Comparison | Results for plasma should be comparable to serum with minimal change in interpretation. | Small variation in positive/equivocal samples, no change in interpretation. Large variation in negative plasma vs. serum, but no change in interpretation. |
| Interfering Substances | Results should not be affected by common interfering substances. | No effect observed from albumin, unconjugated bilirubin, triolein, and hemoglobin within specified concentrations. |
2. Sample Sizes and Data Provenance
- Sensitivity (Retrospective Study):
- Test set size: 166 patient samples.
- Data provenance: Retrospective. The origin country is not explicitly stated, but it's implied to be within relevant geographical regions for Lyme disease based on the nature of the study.
- Sensitivity (CDC Panel):
- Test set size: 43 samples (Platelia™ Lyme IgG) / 44 samples (Predicate Lyme IgG EIA Assay).
- Data provenance: A serum panel obtained from the CDC. The document mentions this panel is "masked, characterized." Implied U.S. origin.
- Prospective Study:
- Test set size: 439 samples.
- Data provenance: Prospective, collected at two different sites in an endemic region in the United States.
- Analytical Specificity:
- Test set size: 183 blood donor samples.
- Data provenance: 83 samples from endemic regions (northeastern US) and 100 samples from non-endemic regions (Nevada, Oregon, and Louisiana) in the United States.
- Cross-Reactivity:
- Test set size: 161 samples.
- Data provenance: Serums from individuals in the United States with disease conditions other than Lyme disease.
- Matrix Comparison Study:
- Test set size: 25 samples (12 negative, 13 positive or equivocal).
- Data provenance: Not specified, but likely from a lab setting where different matrices were prepared or collected.
3. Number of Experts to Establish Ground Truth and Qualifications
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test sets.
- Retrospective Study: Ground truth was "confirmed positive for Borrelia burgdorferi infection by culture." This suggests a gold standard method, not expert-based consensus.
- CDC Panel: The panel is described as "masked, characterized," implying that the clinical diagnoses were established by recognized authorities (CDC) using a combination of clinical information and laboratory results, but the specific expert count or qualifications aren't detailed.
- Prospective Study: The comparative method used was the "two-tier protocol recommended by the CDC (samples found positive or equivocal on ELISA are retested by Western Blot)." This is a standardized diagnostic workflow, not expert consensus for each individual case.
- Analytical Specificity and Cross-Reactivity: Ground truth appears to be based on the established clinical status of the blood donors (healthy) or patients with specific non-Lyme diseases, likely confirmed through standard diagnostic methods for those conditions.
4. Adjudication Method
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned for the establishment of ground truth in the document for any of the studies. The ground truth was primarily based on objective laboratory findings (culture, Western blot) or established clinical diagnoses rather than subjective expert review requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study involving human readers with and without AI assistance was done. This device is an in vitro diagnostic (IVD) immunoassay, not an AI-powered image analysis or diagnostic decision support tool intended to be used by human readers in that capacity.
6. Standalone (Algorithm Only) Performance
The studies presented describe the standalone performance of the Platelia™ Lyme IgG assay. As an immunoassay, its performance is inherently "standalone" in the sense of being an algorithmic/mechanical process that yields a result without direct human interpretation in achieving that result (though human interpretation is needed for clinical application of the result). The sensitivity, specificity, and agreement data directly reflect this standalone performance.
7. Type of Ground Truth Used
- Retrospective Study: Borrelia burgdorferi infection confirmed by culture. This is a strong and direct form of ground truth.
- CDC Panel: "Clinical diagnosis" and a "characterized serum panel," implying a combination of clinical presentation and other diagnostic results (which often include Western blot for Lyme).
- Prospective Study: The CDC two-tier protocol (ELISA followed by Western Blot for positives/equivocals) was used as the reference method. This is the accepted diagnostic pathway for Lyme disease.
- Analytical Specificity: Healthy blood donors (implied absence of Lyme disease) and individuals from non-endemic regions.
- Cross-Reactivity: Individuals with specific other disease conditions (e.g., Syphilis, CMV, ANA).
8. Sample Size for the Training Set
The document does not provide information about a separate "training set" in the context of device development. Immunoassays like the Platelia™ Lyme IgG are typically developed and validated using a structured approach that includes characterization of reagents, optimization of the assay protocol, and then performance evaluation using clinical samples. Unlike machine learning algorithms, there isn't a distinct "training set" in the same sense. The reported data pertains to the final validated performance of the device.
9. How the Ground Truth for the Training Set Was Established
Since there is no explicit mention of a "training set" in the context of machine learning, ground truth establishment for such a set is not applicable to this immunoassay. The development and validation process would have involved internal studies and characterization using various types of samples, but these are not typically categorized as a "training set" with ground truth established in the same manner as for AI/ML models.
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Page 7 of 15
.
MAY - 8 2008
510(k) SUMMARY
.
| Date of Summary | April 10, 2008 |
|---|---|
| Product Name | Platelia™ Lyme IgG |
| Sponsor | Bio-Rad3 Boulevard Raymond Poincaré92430 Marnes-la-CoquetteFrance |
| Correspondent | MDC Associates, LLCFran White, Regulatory Consultant163 Cabot StreetBeverly, MA 01915 |
| Substantially Equivalent Device | The Platelia™ Lyme IgG is substantially equivalent tothe Mardx B. burgdorferi IgG Assay |
Manufacturer: Mardx Diagnostics, Inc. Product: Mardx Lyme Disease EIA (IgG) Test - K894224
| Product Attribute | Bio-Rad PlateliaTM Lyme IgG | Mardx Lyme Disease Tests | SubstantialEquivalent |
|---|---|---|---|
| Intended use | The PlateliaTM Lyme IgG assay is a qualitative test intended for use in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum or plasma. The EIA system should be used to test serum or plasma from patients with a history and symptoms of infection with B. burgdorferi . All positive and equivocal specimens should be re-tested with a highly specific, second-tier test such as Western blot. Positive second-tier results are supportive evidence of infection with B. burgdorferi . | The MarDx B. burgdorferi Disease Enzyme Immunoassay (EIA) IgG Test is a qualitative test intended for use in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum. This EIA system should be used to test serum from patients with a history and symptoms of infection with B. burgdorferi . All positive and equivocal specimens should be re-tested with a highly specific, second-tier test such as Western blot. Positive second-tier results | √ |
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| The diagnosis of Lymedisease should be made basedon history and symptoms(such as erythema migrans),and other laboratory data, inaddition to the presence ofantibodies to B. burgdorferi.Negative results (either first orsecond-tier) should not beused to exclude Lyme disease. | are supportive evidence ofinfection with B.burgdorferi. The diagnosisof Lyme disease should bemade based on history andsymptoms (such aserythema migrans), andother laboratory data, inaddition to the presence ofantibodies to B.burgdorferi. Negativeresults (either first orsecond-tier) should not beused to exclude Lymedisease. | ||
|---|---|---|---|
| Sample | Plasma or serum | Serum | √ |
| Testmethodology | ELISA | ELISA | √ |
PRODUCT DESCRIPTION
The Platelia" Lyme IgG Assay is a qualitative assay for the detection of human IgG antibodies to Borrelia burgdorferi in human serum or plasma.
INTENDED USE
The Platelia™ Lyme IgG Test is a qualitative test intended for use in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum or plasma (K3 EDTA, sodium heparin or sodium citrate). The EIA system should be used to test serum or plasma from patients with a history and symptoms of infection with B. burgdorferi. All positive and equivocal specimens should be retested with a specific, second-tier test such as Western blot. Positive second-tier results are supportive evidence of infection with B. burgdorferi. The diagnosis of Lyme disease should be made based on history and symptoms (such as erythema migrans), and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first or second-tier) should not be used to exclude Lyme disease.
SUMMARY OF TECHNOLOGY
The PlateliaTM Lyme IgG Assay uses an indirect ELISA immuno-enzymatic method. Inactivated antigens of Borrelia burgdorferi B31 are used for coating the microplate. A monoclonal antibody labeled with peroxidase which is specific for human gamma chains (anti-IgG) is used as the conjugate.
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Page 9 of 15
PERFORMANCE DATA
Bio-Rad confirms that any/all data provided in this submission may be released upon request.
Sensitivity
a. Retrospective study
One hundred sixty-six patient samples confirmed positive for Borrelia burgdorferi infection by culture were run on the Platelia™ Lyme IgG assay. Disease stage was available for each sample tested. Data below summarizes the overall sensitivity of the assay, and the sensitivity considering the different stages of Lyme disease.
Performance of the Platelia™ Lyme IgG Assay on retrospective samples
| Positive | Equivocal | Negative | Total | % Sensitivity (1) | ||
|---|---|---|---|---|---|---|
| Platelia™Lyme IgG | Early Stage | 55 | 16 | 49 | 120 | 59.2%(71/120)CI(2) [50.2, 67.6] |
| Disseminated Stage | 18 | 2 | 13 | 33 | 60.6%(20/33)CI [43.7, 75.3] | |
| Late Stage | 13 | 0 | 0 | 13 | 100.0%(13/13)CI [77.2, 100] | |
| All Stages | 86 | 18 | 62 | 166 | 62.7%(104/166)CI [54.5, 69.0] |
(1) Equivocal results were considered as positive for calculation of sensitivity.
(2) CI = 95% Confidence Interval
CDC Panel b.
The following information is from a serum panel obtained from the CDC and tested by the Platelia™ Lyme IgG Kit. The 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 following data summarizes results obtained on Platelia™ Lyme IgG and a marketed device.
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| Platelia™ Lyme IgG | Predicate Lyme IgG EIA Assay | |||||||
|---|---|---|---|---|---|---|---|---|
| Timefromonset | Positiveorequivocal | Negative | Total | %agreementwithclinicaldiagnosis(1) | Positiveorequivocal | Negative | Total | %agreementwithclinicaldiagnosis(1) |
| Normals | 0 | 5 | 5 | 100.0%(5/5) | 0 | 5 | 5 | 100.0%(5/5) |
| 0-1Month | 2 | 3 | 5 | 40.0%(2/5) | 3 | 2 | 5 | 60.0%(3/5) |
| 1-2Months | 5 | 3 | 8 | 62.5%(5/8) | 3 | 5 | 8 | 37.5%(3/8) |
| 3-12Months | 10 | 7 | 17 (2) | 58.8%(10/17) | 10 | 8 | 18 | 55.6%(10/18) |
| > 1 Year | 8 | 0 | 8 | 100.0%(8/8) | 7 | 1 | 8 | 87.5%(7/8) |
| Total | 25 | 18 | 43 (2) | 69.8%(30/43) | 23 | 21 | 44 | 63.6%(28/44) |
Performance of the Platelia™ Lyme IgG Assay on Lyme CDC panel
(1) Equivocal samples considered as positive
(2) One sample not tested due to insufficient sample volume
Prospective study
A prospective study was conducted on 439 samples collected at two different sites from endemic region in United States and routinely tested for Lyme disease. The Platelia™ Lyme IgG assay was evaluated in comparison with the two-tier protocol recommended by the CDC (samples found positive or equivocal on ELISA are retested by Western Blot). Data are summarized below.
Performance of the Platelia™ Lyme IgG Assay on prospective samples
| Platelia™ Lyme IgG | |||
|---|---|---|---|
| Positive | Equivocal | Negative | |
| Site 1(n=339) | 45 | 18 | 276 |
| Site 2(n=100) | 10 | 7 | 83 |
| Total(n=439) | 55 | 25 | 359 |
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Page 11 of 15
| Lyme IgG | |||
|---|---|---|---|
| Platelia™Lyme IgGPositive orEquivocal | Western BlotIgG Positive | PositiveAgreementsamples(%) | |
| Site 1(n=339) | 61 (1) | 6 (1) | 9.8% |
| Site 2(n=100) | 17 | 3 | 17.6% |
| Total(n=439) | 78 | 9 | 11.5% |
Results of Western-Blot on prospective samples found positive or equivocal with the Platelia™ Lyme IgG Assay
(1) Two samples were not interpretable on Western Blot IgG and were not considered for calculation.
Analytical Specificity
Analytical specificity of the assay was determined by testing a panel of 183 samples obtained from blood donors. 100 samples were collected in states considentic for Lyme disease (Nevada, Oregon and Louisiana). 83 samples were collected in northeastern US considered as endemic region for Lyme disease. Data provided summarizes the percent of positive/equivocal results obtained in each category.
Analytical specificity of Platelia™ Lyme IgG Assay in blood donors
| Endemic | Non-Endemic | Total | |
|---|---|---|---|
| Number of samples tested | 83 | 100 | 183 |
| Positive or Equivocal | 1.2%(1/83) | 0.0%(0/100) | 0.5%(1/183) |
Precision
a. Intra-assay precision
In order to evaluate intra-assay precision, three samples close to equivocal zone and four samples spaming the assay range were respectively tested 20 and 30 times during the same run. The ratio (Sample OD/CO) was determined for each sample. The data were then analyzed for intra-assay and inter-assay precision according to the Clinical and Laboratory Standards Institute guidance (formerly NCCLS) EP-5A2 revised November 2004. Mean Ratio, Standard Deviation (SD) and Coefficient of Variation (%CV) for each of the seven specimens are provided.
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| N | Mean Ratio | SD | CV % | ||
|---|---|---|---|---|---|
| Near the Cut-Off samples | Sample 1 | 20 | 0.85 | 0.045 | 5.3% |
| Sample 2 | 20 | 1.00 | 0.050 | 5.4% | |
| Sample 3 | 20 | 1.19 | 0.111 | 9.4% | |
| Samplesspanning thePlatelia™ LymeIgG assay range | Sample 4 | 30 | 0.20 | 0.010 | 6.4% |
| Sample 5 | 30 | 0.95 | 0.082 | 8.6% | |
| Sample 6 | 30 | 1.38 | 0.116 | 8.4% | |
| Sample 7 | 30 | 6.31 | 0.134 | 2.1% |
Intra-assay precision of Platelia™ Lyme IgG
Inter-assay precision
In order to evaluate inter-assay precision, two equivocal, one medium and one high positive samples were tested twice a day in different runs for 20 days. The ratio (Sample OD/CO) was determined for each sample. Mean Ratio, Standard Deviation (SD) and Coefficient of Variation (%CV) for each of the seven specimens are provided.
| N | Mean Ratio | SD | CV % | |
|---|---|---|---|---|
| Negative 1 | 40 | 0.19 | 0.032 | 16.7% |
| Negative 2 | 40 | 0.23 | 0.025 | 10.9% |
| Low equivocal | 40 | 0.85 | 0.115 | 13.5% |
| High equivocal | 40 | 1.16 | 0.208 | 18.0% |
| Medium Positive | 40 | 3.92 | 0.335 | 8.5% |
| High Positive | 40 | 6.67 | 0.650 | 9.7% |
Inter-assay precision of Platelia™ Lyme IgG
Inter-site precision
In order to evaluate total assay precision, six samples (two weakly positive and two medium-to high positive samples) were tested at three different sites. Each sample was measured in three runs per day during five days, each run being performed by a different technician. The ratio (Sample OD/CO) was determined for each sample. Mean Ratio, Standard Deviation (SD) and Coefficient of Variation (%CV) for each of the six specimens are provided. Total assay precision of Platelia™ Lyme IgG
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| Between-Day Precision | Total Precision | ||||||
|---|---|---|---|---|---|---|---|
| Mean | SD | CV % | Mean | SD | CV % | ||
| Negative1 | Site 1 | 0.32 | 0.033 | 10.4% | |||
| Site 2 | 0.44 | 0.045 | 9.5% | 0.40 | 0.075 | 18.6% | |
| Site 3 | 0.45 | 0.050 | 11.0% | ||||
| Negative2 | Site 1 | 0.31 | 0.031 | 9.8% | |||
| Site 2 | 0.43 | 0.028 | 6.6% | 0.38 | 0.068 | 17.6% | |
| Site 3 | 0.41 | 0.060 | 14.6% | ||||
| LowPositive1 | Site 1 | 1.53 | 0.122 | 8.0% | |||
| Site 2 | 1.62 | 0.224 | 13.8% | 1.59 | 0.202 | 12.7% | |
| Site 3 | 1.62 | 0.243 | 15.0% | ||||
| LowPositive2 | Site 1 | 1.41 | 0.115 | 8.1% | |||
| Site 2 | 1.45 | 0.155 | 10.7% | 1.45 | 0.128 | 8.9% | |
| Site 3 | 1.48 | 0.108 | 7.3% | ||||
| HighPositive1 | Site 1 | 3.06 | 0.256 | 8.4% | |||
| Site 2 | 3.19 | 0.357 | 11.2% | 3.11 | 0.296 | 9.5% | |
| Site 3 | 3.08 | 0.267 | 8.7% | ||||
| HighPositive2 | Site 1 | 3.37 | 0.498 | 14.8% | |||
| Site 2 | 3.40 | 0.335 | 9.9% | 3.37 | 0.391 | 11.6% | |
| Site 3 | 3.36 | 0.344 | 10.2% |
Cross Reactivity
Sera from 161 individuals from United States with disease conditions other than Lyme disease were tested for potential cross-reactivity with the Platelia™ Lyme IgG assay. Results for sixteen conditions are presented.
Cross-reactivity conditions with Platelia™ Lyme IgG
| Disease Condition | N | Positive / Equivocal |
|---|---|---|
| Syphilis | 34 | 1 |
| H. pylori | 5 | 0 |
| CMV IgG | 10 | 0 |
| EBV IgG | 5 | 0 |
| HSV IgG | 10 | 0 |
| Toxoplasmosis IgG | 10 | 0 |
| Rubella IgG | 10 | 0 |
| Measles IgG | 10 | 0 |
| Mumps IgG | 10 | 0 |
| VZV IgG | 10 | 0 |
| HIV | 10 | 0 |
| Antinuclear Antibodies (ANA) | 10 | 0 |
| Human anti-mouse antibodies(HAMA) | 10 | 0 |
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Page 14 of 15
PLATELIATM LYME IgG 510(k) Submission: K080012 Request for Additional Information
| CRP | 5 | 0 |
|---|---|---|
| SLE | 2 | 0 |
| Rheumatoid Factor | 9 | 0 |
MATRIX COMPARISON STUDY
Plasma versus serum comparisons were performed with a panel of 25 samples (12 negative and 13 positive or equivocal samples). See table 10 below.
istribution of percent difference versus serum
| <10% | ≥10% to ≤20% | >20% | Mean of differences | ||
|---|---|---|---|---|---|
| Negative samples(n=12) | K3 EDTA | 16.7% | 8.3% | 75.0% | -16.7% |
| Na Heparin | 33.3% | 0.0% | 66.7% | -12.4% | |
| Na Citrate | 8.3% | 8.3% | 83.4% | -20.9% | |
| Equivocal orPositive samples(n = 13) | K3 EDTA | 46.1% | 15.4% | 38.5% | 2.9% |
| Na Heparin | 61.5% | 15.4% | 23.1% | 0.6% | |
| Na Citrate | 38.5% | 46.1% | 15.4% | 0.0% |
A large variation has been observed on negative plasma compared to negative sera but without a change in results interretation. However, the variation within the positive or equivocal samples is small and did not change the results interpretation.
INTERFERING SUBSTANCES
Samples containing 90 gL of albumin or 100 mg/L of unconjugated bilirubin, lipenic samples containing the equivalent of 36 g/L of triolein (triglyceride), and hemolyzed samples containing up to 10 g/L of hemoglobin do not affect the results.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MDC Associates, LLC c/o Ms. Fran White Regulatory Consultant 163 Cabot Street Beverly, MA 01915
MAY - 8 2008
Re: K080012 Trade/Device Name: Platelia™ Lyme IgG Assay Regulation Number: 21 CFR§ 866.3830 Regulation Name: Treponema pallidum treponemal test reagents. Regulatory Class: Class II Product Code: LSR Dated: April 10, 2008 Received: April 14, 2008
Dear Ms. White:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 --
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sales, a Hog
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K080012
Device Name:
Platelia™ Lyme IgG
Indications for Use:
The Platelia" Lyme IgG assay is a qualitative test intended for use in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum or plasma (K3 EDTA, sodium heparin or sodium citrate). The EIA test system should be used to test serum or plasma from patients with a history and symptoms of infection with B. burgdorferi. All positive and equivocal specimens should be re-tested with a specific, second-tier test such as Western blot. Positive second-tier results are supportive evidence of infection with B. burgdorferi. The diagnosis of Lyme disease should be made based on history and symptoms (such as erytherna migrans), and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first or second-tier) should not be used to exclude Lyme disease.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Ludie M. Poole
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K030012
Page 1 of 1
§ 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).