(126 days)
Not Found
No
The device description and performance studies focus on a standard ELISA immunoassay method, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is a qualitative test intended for the presumptive detection of human IgG antibodies to Borrelia burgdorferi, used for diagnostic purposes, not for treating any condition.
Yes
Explanation: The device is intended for the "presumptive detection of human IgG antibodies to Borrelia burgdorferi" and its results are used as "supportive evidence of infection." This aligns with the definition of a diagnostic device as it provides information for diagnosis, even if not definitive on its own.
No
The device description clearly states it is an "indirect ELISA immuno-enzymatic method" using "inactivated antigens" and a "monoclonal antibody labeled with peroxidase," which are physical components of a laboratory assay, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "qualitative test intended for use in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum or plasma". This describes a test performed in vitro (outside the body) on a biological sample (serum or plasma) to provide diagnostic information.
- Device Description: The description details an "indirect ELISA immuno-enzymatic method" using "inactivated antigens of Borrelia burgdorferi B31" and a "monoclonal antibody labeled with peroxidase". This is a standard laboratory technique performed in vitro to detect specific substances in a sample.
- Sample Type: The test is performed on "human serum or plasma", which are biological samples collected from a patient.
- Purpose: The purpose is to aid in the "presumptive detection" and provide "supportive evidence of infection" with B. burgdorferi, which is a diagnostic purpose.
All these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LSR
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sensitivity (Retrospective study)
- Study type: Retrospective study
- Sample size: 166 patient samples
- Data source: Patient samples confirmed positive for Borrelia burgdorferi infection by culture. Disease stage was available.
- Key Results:
- Overall Sensitivity: 62.7% (104/166), CI [54.5, 69.0] (Equivocal results considered as positive).
- Early Stage: 59.2% (71/120), CI [50.2, 67.6]
- Disseminated Stage: 60.6% (20/33), CI [43.7, 75.3]
- Late Stage: 100.0% (13/13), CI [77.2, 100]
CDC Panel Study
- Study type: Evaluation with a masked, characterized serum panel.
- Sample size: 44 samples (43 for Platelia Lyme IgG).
- Data source: Serum panel obtained from the CDC.
- Key Results: Platelia™ Lyme IgG showed 69.8% agreement with clinical diagnosis (25/43 positive/equivocal samples, equivocal samples considered positive). Predicate Lyme IgG EIA Assay showed 63.6% agreement (23/44 positive/equivocal samples).
Prospective Study
- Study type: Prospective study
- Sample size: 439 samples (339 from Site 1, 100 from Site 2).
- Data source: Samples collected at two different sites from endemic region in United States and routinely tested for Lyme disease.
- Key Results: 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). Out of 78 Platelia™ Lyme IgG positive or equivocal samples, 9 were Western Blot IgG Positive, resulting in a positive agreement of 11.5%.
Analytical Specificity
- Study type: Analytical specificity determination.
- Sample size: 183 samples (100 from non-endemic states, 83 from northeastern US endemic region).
- Data source: Samples obtained from blood donors.
- Key Results:
- Endemic: 1.2% (1/83) Positive or Equivocal
- Non-Endemic: 0.0% (0/100) Positive or Equivocal
- Total: 0.5% (1/183) Positive or Equivocal
Precision
- Intra-assay precision:
- Sample size: 7 samples (3 near cut-off, 4 spanning assay range).
- Study design: Near cut-off samples tested 20 times, other samples 30 times in the same run.
- Key Metrics: Mean Ratio, SD, CV% for Sample OD/CO.
- Inter-assay precision:
- Sample size: 6 samples (2 equivocal, 1 medium, 1 high positive, 2 negative).
- Study design: Tested twice a day in different runs for 20 days.
- Key Metrics: Mean Ratio, SD, CV% for Sample OD/CO.
- Inter-site precision:
- Sample size: 6 samples (2 weakly positive, 2 medium-to high positive, 2 negative).
- Study design: Tested at three different sites. Each sample measured in three runs per day during five days, each run by a different technician.
- Key Metrics: Mean Ratio, SD, CV% for Sample OD/CO.
Cross Reactivity
- Study type: Cross-reactivity
- Sample size: 161 individuals.
- Data source: Sera from individuals with disease conditions other than Lyme disease.
- Key Results: Only 1 out of 34 Syphilis samples showed Positive/Equivocal result. All other conditions (H. pylori (5), CMV IgG (10), EBV IgG (5), HSV IgG (10), Toxoplasmosis IgG (10), Rubella IgG (10), Measles IgG (10), Mumps IgG (10), VZV IgG (10), HIV (10), Antinuclear Antibodies (ANA) (10), Human anti-mouse antibodies (HAMA) (10), CRP (5), SLE (2), Rheumatoid Factor (9)) showed 0 positive/equivocal results.
Matrix Comparison Study
- Study type: Plasma versus serum comparisons.
- Sample size: 25 samples (12 negative, 13 positive or equivocal).
- Key Results: Large variation observed on negative plasma compared to negative sera, but without a change in results interpretation. Small variation within positive or equivocal samples, did not change results interpretation.
Interfering Substances
- Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity (Retrospective study - Equivocal results considered as positive): 62.7% (104/166), 95% Confidence Interval [54.5, 69.0]
Analytical Specificity (Positive or Equivocal):
- Endemic: 1.2% (1/83)
- Non-Endemic: 0.0% (0/100)
- Total: 0.5% (1/183)
Precision: Presented as Mean Ratio, Standard Deviation (SD), and Coefficient of Variation (%CV) for intra-assay, inter-assay, and inter-site precision.
Cross-reactivity: Number of Positive/Equivocal results for various disease conditions.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Mardx Lyme Disease EIA (IgG) Test - K894224
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).
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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-Rad |
| 3 Boulevard Raymond Poincaré | |
| 92430 Marnes-la-Coquette | |
| France | |
| Correspondent | MDC Associates, LLC |
| Fran White, Regulatory Consultant | |
| 163 Cabot Street | |
| Beverly, MA 01915 | |
| Substantially Equivalent Device | The Platelia™ Lyme IgG is substantially equivalent to |
| the 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 | Substantial
Equivalent |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| 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 | √ |
1
Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is in a rounded rectangle shape with the words "BIO-RAD" in white letters on a black background. The letters are bold and sans-serif.
| | 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. | 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. | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|
| Sample | Plasma or serum | Serum | √ |
| Test
methodology | 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 | |||||||
|---|---|---|---|---|---|---|---|---|
| Time | ||||||||
| from | ||||||||
| onset | Positive | |||||||
| or | ||||||||
| equivocal | Negative | Total | % | |||||
| agreement | ||||||||
| with | ||||||||
| clinical | ||||||||
| diagnosis | ||||||||
| (1) | Positive | |||||||
| or | ||||||||
| equivocal | Negative | Total | % | |||||
| agreement | ||||||||
| with | ||||||||
| clinical | ||||||||
| diagnosis | ||||||||
| (1) | ||||||||
| Normals | 0 | 5 | 5 | 100.0% | ||||
| (5/5) | 0 | 5 | 5 | 100.0% | ||||
| (5/5) | ||||||||
| 0-1 | ||||||||
| Month | 2 | 3 | 5 | 40.0% | ||||
| (2/5) | 3 | 2 | 5 | 60.0% | ||||
| (3/5) | ||||||||
| 1-2 | ||||||||
| Months | 5 | 3 | 8 | 62.5% | ||||
| (5/8) | 3 | 5 | 8 | 37.5% | ||||
| (3/8) | ||||||||
| 3-12 | ||||||||
| Months | 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 IgG | |||
| Positive or | |||
| Equivocal | Western Blot | ||
| IgG Positive | Positive | ||
| Agreement | |||
| samples | |||
| (%) | |||
| 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% | |
| Samples | |||||
| spanning the | |||||
| Platelia™ Lyme | |||||
| IgG 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 % | ||
| Negative | |||||||
| 1 | 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% | ||||
| Negative | |||||||
| 2 | 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% | ||||
| Low | |||||||
| Positive | |||||||
| 1 | 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% | ||||
| Low | |||||||
| Positive | |||||||
| 2 | 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% | ||||
| High | |||||||
| Positive | |||||||
| 1 | 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% | ||||
| High | |||||||
| Positive | |||||||
| 2 | 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
| | | 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 or
Positive 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.
8
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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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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
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