(251 days)
The VIDAS Lyme IgM (LYM) assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgM antibodies to Borrelia burgdorferi in human serum (plain or separation gel) or plasma (sodium heparin or lithium heparin). It should be used to test patients with a history and/or symptoms of infection with B. burgdorferi. All VIDAS Lyme IgM positive and equivocal specimens should be further tested with a Western Blot IgM assay to obtain supportive evidence of infection with B. burgdorferi.
The VIDAS Lyme IgM assay principle combines a 2-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA) (see User's Manual).
The Solid Phase Receptacle (SPR®) serves as the solid phase as well as the pipetting device for the assay. Reagents for the assay are ready-to-use and predispensed in the sealed reagent strips.
All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times.
After a preliminary wash step and a sample dilution step, the antibodies to B. burgdorferi present in the specimen will bind to the B. burgdorferi specific recombinant proteins coating the interior of the SPR.
Unbound sample components are washed away. Anti-human IgM antibodies conjugated with alkaline phosphatase, will attach to the immunocomplex bound to the SPR wall.
A final wash step removes unbound conjugate. During the final detection step, the substrate (4-Methyl-umbellifery) phosphate) is cycled in and of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the quantity of anti-B. burgdorferi IgM antibody present in the sample.
At the end of the VIDAS Lyme IgM assay, results are automatically calculated by the instrument. A test value is generated and a report is printed.
The provided text describes the 510(k) summary for the VIDAS® Lyme IgM Assay. Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for performance metrics. Instead, it presents the device's performance results, which are then compared to a predicate device and established Lyme disease testing methodologies. The "acceptance" can be inferred from the statement in Section I, "Conclusion," which states that the results "demonstrate that the VIDAS® Lyme IgM is substantially equivalent to the predicate device."
However, we can extract the key performance metrics reported in relation to the predicate and other ground truth methods:
| Performance Metric | Acceptance Criteria (Implied / Comparator) | Reported Device Performance (VIDAS Lyme IgM) | Study/Section |
|---|---|---|---|
| Sensitivity (Stage I Lyme Disease) | Compared to Predicate (Platelia™ Lyme IgM) | 52.1% (62/119) | Clinical Testing - Sensitivity |
| Sensitivity (Stage II Lyme Disease) | Compared to Predicate (Platelia™ Lyme IgM) | 91.9% (57/62) | Clinical Testing - Sensitivity |
| Sensitivity (Stage III Lyme Disease) | Compared to Predicate (Platelia™ Lyme IgM) | 76.2% (16/21) | Clinical Testing - Sensitivity |
| Overall Sensitivity (All Stages) | Compared to Predicate (Platelia™ Lyme IgM) | 66.8% (135/202) | Clinical Testing - Sensitivity |
| First Tier Positive % Agreement (PPA) | Compared to Predicate Lyme IgM | 51.0% (107/210) | Clinical Testing - Method Comparison |
| Negative % Agreement (NPA) | Compared to Predicate Lyme IgM | 88.6% (678/765) | Clinical Testing - Method Comparison |
| Second Tier Positive % Agreement (PPA) | Compared to Predicate Lyme IgM + Western Blot IgM | 80.8% (84/104) | Clinical Testing - Second-Tier Testing |
| Concordance with IgM Western Blot | Not explicitly stated as a target, but reported for comparison. | 49.0% (95/194) | Clinical Testing - Second-Tier Testing |
| Cross-Reactivity (Overall Range) | Not explicitly stated, but reported for various infections/diagnoses. | Ranges from 4.34% (Mumps) to 35.00% (HIV) | Clinical Testing - Cross-Reactivity |
| Precision (Total CV%) | Not explicitly stated, but clinical data provided | Sample 1: 5.2%; Sample 2: 9.1%; Sample 3: 4.7%; Sample 4: 6.9%; Positive Control: 10.1%; Negative Control: 0.0% | Nonclinical Tests - Precision |
| Reproducibility (Total CV%) | Not explicitly stated, but clinical data provided | Sample 1: 6.3%; Sample 2: 7.8%; Sample 3: 6.2%; Sample 4: 9.4%; Positive Control: 12.1%; Negative Control: 0.0% | Nonclinical Tests - Reproducibility |
2. Sample Size for the Test Set and Data Provenance
Sensitivity Testing (Retrospective):
- Sample Size: 202 retrospective samples.
- Data Provenance: Samples were from patients meeting a case definition of Lyme Disease (LD) and confirmed positive for B. burgdorferi infection. The country of origin is not specified but implied to be regions with LD prevalence due to the context of "clinical testing." These were clearly retrospective samples.
Method Comparison (Prospective):
- Sample Size: 975 fresh or frozen prospectively collected sera.
- Data Provenance: Samples were submitted for routine Lyme disease testing from an endemic area of the United States. These were prospective samples.
Analytical Specificity:
- Sample Size: 100 sera from apparently healthy subjects from an endemic population (New York) and 100 sera from a non-endemic population (Texas).
- Data Provenance: Healthy subjects from New York (endemic) and Texas (non-endemic). These are likely retrospective collections of healthy individuals.
CDC Reference Panel:
- Sample Size: 39 samples (5 Normals, 5 < 1 month, 6 1-2 months, 16 3-12 months, 7 > 1 year).
- Data Provenance: A serum panel obtained from the CDC. The origin of the individual samples within the panel is not detailed but is typically well-characterized retrospective samples.
Cross-Reactivity Testing:
- Sample Size: Varied per infection/diagnosis, ranging from 20 (HIV) to 270 (Syphilis). Total samples across all categories would be the sum (e.g., 60 ANA, 61 CRP, etc.).
- Data Provenance: Samples from patients negative for Lyme but positive for various other conditions. The country of origin is not specified but implies diverse patient populations to cover various diseases. These are likely retrospective collections.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the test set.
However, the ground truth for the Sensitivity Testing refers to "patients meeting a case definition of LD and confirmed positive for B. Burgdorferi infection." This implies a clinical diagnosis, potentially relying on multiple factors and clinical judgment.
For the Second-Tier Testing, the ground truth for confirmation was a "commercially available Lyme IgM Western Blot method." While Western Blot itself is a laboratory test, its interpretation often involves expertise. The document doesn't specify if expert consensus was used for Western Blot interpretation in this study.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for establishing the ground truth or resolving discrepancies between readers/tests.
For the sensitivity and method comparison studies, the performance of the VIDAS assay was compared to either a "case definition" (for sensitivity) or a "predicate Lyme IgM EIA method" and subsequently "Western Blot IgM assay" for confirmation. The document implies that the results of these comparator methods, particularly Western Blot for the second tier, served as the reference standard without detailing a multi-expert adjudication process.
For both the VIDAS Lyme IgM and the predicate test in the sensitivity study, "equivocal results were considered as positive for the evaluation." This is a defined rule for handling equivocal results rather than an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on evaluating the performance of an automated laboratory assay (VIDAS Lyme IgM) against a predicate device and established diagnostic algorithms (e.g., 2-tier testing with Western Blot), not on the comparative effectiveness of human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The VIDAS® Lyme IgM assay is an automated qualitative enzyme immunoassay. The studies (precision, reproducibility, sensitivity, method comparison, analytical specificity, cross-reactivity, CDC reference panel) evaluate the performance of this assay as a device in itself, producing results automatically by the instrument, without a human-in-the-loop component for result generation or primary interpretation in the context of these evaluations. The output is a numerical index and a qualitative result (positive, equivocal, negative).
7. The Type of Ground Truth Used
The types of ground truth used include:
- Clinical Case Definition/Confirmed Infection: For the sensitivity study, samples were from "patients meeting a case definition of LD and confirmed positive for B. Burgdorferi infection." This implies a combination of clinical symptoms and other diagnostic evidence.
- Predicate Device/Western Blot IgM Assay: For the method comparison and second-tier testing, the predicate Platelia™ Lyme IgM assay and a "commercially available Lyme IgM Western Blot method" were used as reference standards for comparison and confirmation, respectively.
- Known Health Status/Other Infection: For analytical specificity and cross-reactivity, subjects were either "apparently healthy" or known to be infected with other specific pathogens/conditions while being negative for Lyme disease.
- CDC Characterized Serum Panel: A masked serum panel from the CDC, which is typically characterized through extensive clinical and laboratory data, served as another reference.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set size. This is typical for a 510(k) summary for an immunoassay, which does not employ machine learning or AI models that require specific training sets in the same way. The device's underlying "algorithm" (ELFA technique) is based on biochemical reactions, not data-driven machine learning.
9. How the Ground Truth for the Training Set was Established
Since no training set is mentioned (as the device is not an AI/ML system), the establishment of ground truth for a training set is not applicable to this device.
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510(k) SUMMARY
VIDAS® Lyme IgM Assay
510(k) SUMMARY
JUN 0 4 2013
1
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.
VIDAS® Lyme IgM
A. Submitter Information
| Submitter's Name: | bioMérieux SA |
|---|---|
| Address: | Chemin de l'Orme69280 Marcy-l'Etoile - France |
| Contact Person: | Catherine FRITSCH |
| Phone Number: | +33 4 78 87 23 98 |
| Fax Number: | +33 4 78 87 20 75 |
| Date of Preparation: | August 2012 |
B. Device Name
| Trade Name: | VIDAS® Lyme IgM |
|---|---|
| Common Name: | Lyme IgM Assay |
| Classification Name: | 21 CFR 866.3830 - Treponema pallidum treponemal test reagents |
C. Predicate Device Name
Trade Name: Platelia™ Lyme IgM
D. Device Description
The VIDAS Lyme IgM assay principle combines a 2-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA) (see User's Manual).
The Solid Phase Receptacle (SPR®) serves as the solid phase as well as the pipetting device for the assay. Reagents for the assay are ready-to-use and predispensed in the sealed reagent strips.
All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times.
After a preliminary wash step and a sample dilution step, the antibodies to B. burgdorferi present in the specimen will bind to the B. burgdorferi specific recombinant proteins coating the interior of the SPR.
Unbound sample components are washed away. Anti-human IgM antibodies conjugated with alkaline phosphatase, will attach to the immunocomplex bound to the SPR wall.
A final wash step removes unbound conjugate. During the final detection step, the substrate (4-Methyl-umbellifery) phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the quantity of anti-B. burgdorferi IgM antibody present in the sample.
At the end of the VIDAS Lyme IgM assay, results are automatically calculated by the instrument. A test value is generated and a report is printed.
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E. Intended Use
The VIDAS Lyme IgM (LYM) assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgM antibodies to Borrelia burgdorferi in human serum (plain or separation gel) or plasma (sodium heparin or lithium heparin). It should be used to test patients with a history and/or symptoms of infection with B. burgdorferi. All VIDAS Lyme IgM positive and equivocal specimens should be further tested with a Western Blot IgM assay to obtain supportive evidence of infection with B. burgdorferi.
F. Technological Characteristics Summary
A general comparison of the similarities and differences of the assays is presented in the table below.
| Item | VIDAS® Lyme IgM (LYM) Assay | Platelia™ Lyme IgM (K081362) |
|---|---|---|
| Intended Use | The VIDAS Lyme IgM (LYM) assayis an automated qualitative enzymeimmunoassay intended for use onthe instruments of the VIDAS familyin the presumptive detection ofhuman IgM antibodies to Borreliaburgdorferi in human serum (plain orseparation gel) or plasma (sodiumheparin or lithium heparin). It shouldbe used to test patients with ahistory and/or symptoms of infectionwith B. burgdorferi. All VIDAS LymeIgM positive and equivocalspecimens should be further testedwith a Western Blot IgM assay toobtain supportive evidence ofinfection with B. burgdorferi. | The Platelia™ Lyme IgM Test is aqualitative test intended for use inthe presumptive detection ofhuman IgM antibodies to Borreliaburgdorferi in human serum orplasma (K3 EDTA, sodiumheparin or sodium citrate). TheEIA system should be used to testserum or plasma from patientswith a history and symptoms ofinfection with Borrelia burgdorferi.All positive and equivocalspecimens should be re-testedwith a specific, second-tier testsuch as Western-Blot. Positivesecond-tier results are supportiveevidence of infection with Borreliaburgdorferi. The diagnosis ofLyme disease should be madebased on history and symptoms(such as erythema migrans), andother laboratory data, in additionto the presence of antibodies toBorreliaburgdorferi. Negative results(either first- or second-tier) shouldnot be used to exclude Lymedisease. |
| Specimen | Serum or plasma | Serum or plasma |
| Analyte | IgM antibodies to Borrelia burgdorferi | IgM antibodies to Borreliaburgdorferi |
| Automated | Yes | No |
| AssayTechnique | Enzyme-linked fluorescent assay(ELFA) | Enzyme immunoassay (EIA) |
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G. Nonclinical Tests
A summary of the non-clinical results is presented below.
Precision
For the precision study, 4 serum samples were tested in duplicate in 40 different runs (2 runs per day over 20 days) with 2 reagent lots at 1 site (n = 80). The precision was calculated following the recommendations of the CLS10 document EP5-A2. The total precision data in the table reflect the 80 values generated per sample for Site 1 and takes into account replicate, run, day, calibration, and lot as potential sources of variation. The total precision for controls include within-day, between-days and between-calibration variability and is lot specific.
| Panel Member | N | MeanIndex | Within-run | Within-day | Between-days | Total | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | |||
| Sample 1 | 80 | 0.19 | 0.01 | 3.9 | 0.01 | 2.7 | 0.00 | 0.0 | 0.01 | 5.2 |
| Sample 2 | 80 | 0.27 | 0.01 | 4.7 | 0.01 | 2.8 | 0.00 | 1.4 | 0.02 | 9.1 |
| Sample 3 | 80 | 0.38 | 0.01 | 2.6 | 0.01 | 3.0 | 0.00 | 0.3 | 0.02 | 4.7 |
| Sample 4 | 80 | 1.31 | 0.03 | 2.1 | 0.02 | 1.6 | 0.01 | 0.9 | 0.09 | 6.9 |
| Positive Control | 40 | 0.74 | NA | NA | 0.04 | 5.3 | 0.00 | 0.0 | 0.07 | 10.1 |
| Negative Control | 40 | 0.00 | NA | NA | 0.00 | 0.0 | 0.00 | 0.0 | 0.00 | 0.0 |
Reproducibility
For reproducibility, 4 serum samples were tested in 40 different runs (2 runs per day over 20 days) with 2 reagent lots at 3 sites (n =240). The reproducibility was calculated following the recommendations of the CLSI® document EP5-A2. The total reproducibility data in the table reflects the 240 values generated per sample for all sites and takes into account replicate, run, day, calibration, lot, and site as potential sources of variation. Out of the 240 total values, 2 Low Positives (Sample 3) gave an equivocal value (< 0.32). The total reproducibility for controls include within-day, between-days, between-calibration and between-site variability and is lot specific.
| PanelMember | N | MeanIndex | Within-run | Within-day | Between-days | Between-site | Total | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | |||
| Sample1 | 240 | 0.19 | 0.01 | 3.5 | 0.00 | 2.1 | 0.00 | 1.0 | 0.00 | 0.0 | 0.01 | 6.3 |
| Sample2 | 240 | 0.26 | 0.01 | 4.3 | 0.01 | 2.7 | 0.00 | 0.7 | 0.01 | 2.1 | 0.02 | 7.8 |
3
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510(k) SUMMARY
VIDAS® Lyme IgM Assay
| PanelMember | N | MeanIndex | Within-run | Within-day | Between-days | Between-site | Total | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | |||
| Sample3 | 240 | 0.37 | 0.01 | 3.1 | 0.01 | 2.1 | 0.00 | 0.0 | 0.00 | 0.0 | 0.02 | 6.2 |
| Sample4 | 240 | 1.26 | 0.03 | 2.5 | 0.02 | 1.9 | 0.01 | 0.4 | 0.00 | 0.0 | 0.12 | 9.4 |
| PositiveControl | 120 | 0.72 | NA | NA | 0.03 | 4.6 | 0.00 | 0.0 | 0.00 | 0.0 | 0.09 | 12.1 |
| NegativeControl | 120 | 0.00 | NA | NA | 0.00 | 0.0 | 0.00 | 0.0 | 0.00 | 0.0 | 0.00 | 0.0 |
Interfering Substances
Specimen-related interference
Interferences were studied according to the recommendations of CLS1® document EP7-A2. None of the following factors have been found to significantly influence this assay:
- hemolysis (after spiking samples with hemoglobin: 5 g/L (monomer)), ।
- t lipemia (after spiking samples with lipids: 30 g/L equivalent in triglycerides),
- bilirubinemia (after spiking samples with bilirubin: 0.3 g/L), ।
- human albumin (after spiking samples with albumin up to 60 g/L).
It is recommended not to use samples that are clearly hemolyzed, lipemic or icteric and, if possible, to collect a new sample.
Exogenous Interferents: Following the recommendations of CLSI® document EP7-A2, the potential interferences with 15 commonly used drugs were studied. No interference was observed at the concentration tested.
| Drug | Concentration tested | Drug | Concentration tested |
|---|---|---|---|
| Acetylsalicylic acid | 3.62 mmol/L | Ibuprofen | 2425 µmol/L |
| Amoxicillin | 206 µmol/L | Minocycline | 4.1 µmol/L |
| Azithromycin | 34 µmol/L | Penicillin G | 240 000 U/L |
| Betamethasone | 8.31 µmol/L | Penicillin Phenoxymethyl | 30 000 U/L |
| Ceftriaxone | 1460 µmol/L | Prednisolone | 8.31 µmol/L |
| Cefuroxime axetil | 1416 µmol/L | Roxithromycin | 15.3 µmol/L |
| Doxycycline hyclate | 16.1 µmol/L | Tetracyclines | 67.5 µmol/L |
| Erythromycin | 22.2 µmol/L |
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H. Clinical Testing
Sensitivity testing
202 retrospective samples from patients meeting a case definition of LD and confirmed positive for B. Burgdorferi infection were run on the VIDAS Lyme IgM assay and the predicate Lyme IgM assay.
For both the VIDAS Lyme IgM and the predicate test, equivocal results were considered as positive for the evaluation. The following results were obtained:
| Stage | N | VIDAS Lyme IgM% Sensitivity * | Predicate LymeIgM% Sensitivity * | Difference inproportions |
|---|---|---|---|---|
| Stage I(earlylocalized,single lesion)1 – 30 days | 119 | 52.1 (62/119)95% CI [42.8 –61.3]% | 54.6 (65/119)95% CI [45.2 –63.8]% | -2.5%95% CI [(-15.2)% –(10.2)%] |
| Stage II(earlydisseminated,multiplelesions)1 – 30 days | 62 | 91.9 (57/62)95% CI [82.2 –97.3]% | 91.9 (57/62)95% CI [82.2 –97.3]% | 0.0%95% CI [(-9.6)% –(9.6)%] |
| Stage III(latedisseminated) | 21 | 76.2 (16/21)95% CI [52.8 –91.8]% | 61.9 (13/21)95% CI [38.4 –81.9]% | 14.3%95% CI [(-13.3)% –(41.9)%] |
| All stages | 202 | 66.8 (135/202)95% CI [59.9 –73.3]% | 66.8 (135/202)95% CI [59.9 –73.3]% | 0.0%95% CI [(-9.2)% –(9.2)%] |
- includes positive and equivocal results.
Method Comparison
A prospective study was performed on 975 fresh or frozen prospectively collected sera submitted for routine Lyme disease testing from an endemic area of the United States. Testing was performed in three laboratories.
At each laboratory, the samples were tested in parallel using a commercially available Lyme IgM EIA method (predicate) and the VIDAS Lyme IgM assay. Positive % Agreement (PPA) is calculated for the positives and equivocals together since the 2-tier testing does not make a distinction and calls for both of them to be tested by Western Blot. Combined results from the three sites are shown below:
| N = 975 | Predicate Lyme IgM | ||
|---|---|---|---|
| VIDAS Lyme IgM | Positive | Equivocal | Negative |
| Positive | 71 | 10 | 32 |
| Equivocal | 15 | 11 | 55 |
| Negative | 50 | 53 | 678 |
| Total | 136 | 74 | 765 |
| Positive % Agreement95% CI | 51.0% (107/210)[44.0 - 57.9]% | ||
| Negative % Agreement95% CI | 88.6% (678/765)[86.2 - 90.8]% |
5
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Second-Tier Testing: In accordance with the CDC recommendations for use of a 2-tier Lyme disease testing scheme, the VIDAS Lyme IgM positive and equivocal results and the predicate Lyme IgM positive and equivocal results were confirmed using a commercially available Lyme IgM Western Blot method.
The percent agreement between VIDAS and predicate Lyme IgM positives (1ª tier PPA) and the percent agreement between VIDAS-predicate-Western Blot IgM positives and Predicate-Western Blot IgM positives (2nd tier PPA) are shown below.
| 1st Tier+ or ± | IgM WesternPos. | Neg. | |
|---|---|---|---|
| Predicate IgM | 210 | 104 | 106 |
| VIDAS IgM | 194 | 95 | 93* |
| VIDAS IgM and PredicateIgM | 107 | 84 | 23 |
*, Western Blot results were not available for 6 of the positive or equivocal samples by VIDAS Lyme IgM assay.
Agreement results:
18 Tier PPA = 51.0% (107/210), 95% Cl=[44.0% - 57.9%] 20d Tier PPA= 80.8% (84/104), 95% Cl=[72.2% - 87.2%]
Concordance with IgM Western Blot:
Predicate device: 49.5% (104/210) VIDAS Lyme IgM: 49.0% (95/194)
Analytical Specificity
100 sera from apparently healthy subjects from an endemic population (New York) and 100 sera from a non-endemic population (Texas) with no known history of Lyme disease were run on the VIDAS Lyme IgM assay and the predicate Lyme IgM assay. The following results were obtained:
| VIDAS | Predicate | |||
|---|---|---|---|---|
| Positivity* | Negativity | Positivity* | Negativity | |
| Endemic | 12.0% | 88.0% | 19.0% | 81.0% |
| Non-Endemic | 14.0% | 86.0% | 3.0% | 97.0% |
- Includes positives and equivocals.
CDC Reference Panel
The following information is from a serum panel obtained from the CDC and tested using the VIDAS Lyme IgM 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 assay by the CDC.
б
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VIDAS® Lyme IgM Assay
.
510(k) SUMMARY
| Timefromonset | VIDAS Lyme IgM | Western blot IgM | ||||
|---|---|---|---|---|---|---|
| Positiveorequivocal | Negative | Agreementwith clinicalstatus | Positive | Negative | Agreementwith clinicalstatus | |
| Normals | 1 | 4 | 80.0 %(4/5) | 0 | 5 | 100.0 %(5/5) |
| < 1 month | 3 | 2 | 60.0 %(3/5) | 3 | 2 | 60.0 %(3/5) |
| 1 - 2months | 5 | 1 | 83.3 %(5/6) | 5 | 1 | 83.3 %(5/6) |
| 3- 12months | 12 | 4 | 75.0 %(12/16) | 7 | 9 | 43.8 %(7/16) |
| > 1 year | 3 | 4 | 42.9 %(3/7) | 3 | 4 | 42.9 %(3/7) |
| Total | 24 | 15 | 69.2%(27/39) | 18 | 21 | 59.0 %(23/39) |
Cross-Reactivity
Cross-reactivity is based on the study of samples that are negative with the test being evaluated and positive for the potentially interfering disease. The results of the samples tested according to the disease are shown in the table below:
| Infection or Diagnosis | N | VIDAS LymeIgMEquivocal orpositiveresults | % Cross-reactivity |
|---|---|---|---|
| Anti Nuclear Antibodies | 60 | 3 | 5.00 |
| C Reactive Protein | 61 | 4 | 6.55 |
| Cytomegalovirus | 34 | 6 | 17.64 |
| Epstein Barr Virus | 65 | 7 | 10.76 |
| Helicobacter pylori | 143 | 10 | 6.99 |
| Hepatitis A Virus | 153 | 22 | 14.37 |
| Herpes Simplex Virus | 98 | 15 | 15.30 |
| Human Immunodeficiency Virus | 20 | 7 | 35.00 |
| Human Anti-mouse Antibodies | 31 | 2 | 6.45 |
| Leptospirosis | 216 | 22 | 10.18 |
| Measles | 38 | 5 | 13.15 |
| Mumps | 46 | 2 | 4.34 |
| Rheumatoid Factor | 61 | 5 | 8.19 |
| Rickettsiosis | 112 | 6 | 5.35 |
| Rubella | 19 | 2 | 10.52 |
| Syphilis | 270 | 25 | 9.25 |
| Systemic Lupus Erythematosus | 28 | 2 | 7.14 |
| Toxoplasmosis | 26 | 5 | 19.23 |
| Varicella Zoster Virus | 58 | 4 | 6.89 |
7
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510(k) SUMMARY
8
The effect of Babesiosis, Erhlichiosis and Rocky Mountain spotted fever pathologies on the VIDAS Lyme IgM performance is not known.
l. Conclusion
The results from the nonclinical and clinical studies submitted in this premarket notification are complete and demonstrate that the VIDAS® Lyme IgM is substantially equivalent to the predicate device identified in Item C of this summary.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
bioMerieux SA c/o Catherine FRITSCH Regulatory Affairs Director 5 rue des Aqueducs 69290 Craponne, France
June 4, 2013
Re: K122979
Trade/Device Name: VIDAS® Lyme IgM Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LSR Dated: May 6, 2013 Received: May 7, 2013
Dear Ms. FRITSCH:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Catherine FRITSCH
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Uwe-Scherf -S for
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K122979
Device Name: VIDAS® Lyme IgM
Indications For Use:
The VIDAS Lyme IgM (LYM) assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgM antibodies to Borrelia burgdorferi in human serum (plain or separation gel) or plasma (sodium heparin or lithium heparin). It should be used to test patients with a history and/or symptoms of infection with B. burgdorferi. All VIDAS Lyme IgM positive and equivocal specimens should be further tested with a Western Blot IgM assay to obtain supportive evidence of infection with B. burgdorferi.
Prescription Use X · (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
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§ 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).