(160 days)
The VIDAS Lyme IgG (LYG) assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgG 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 IgG positive specimens should be further tested with a Western Blot IgG assay to obtain supportive evidence of infection with B. burgdorferi.
The VIDAS Lyme IgG assay principle combines a two-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA). 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 sample is cycled in and out of the SPR. Antibodies to B. burgdorferi present in the specimen will bind to the B. burgdorferi antigen coating the interior of the SPR. Unbound sample components are washed away. Anti-human IgG 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. burgdorfen IgG antibodies present in the sample. At the end of the assay, results are automatically calculated by the instrument. A test value is generated and a report is printed for each test.
Here's a breakdown of the acceptance criteria and the study details for the VIDAS® Lyme IgG Assay, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria values for sensitivity, specificity, or agreement rates. Instead, the study reports the performance of the VIDAS Lyme IgG assay and compares it to a predicate device, aiming to demonstrate substantial equivalence rather than meeting specific numerical thresholds set forth as acceptance criteria. However, we can infer performance targets based on the documented results and competitive performance against the predicate.
For the purpose of this exercise, I will present the reported performance, and where applicable, indicate an implicit "acceptance" based on comparison to the predicate device or a recognized standard (like the CDC panel).
| Performance Metric | Acceptance Criteria (Inferred/Implicit) | Reported Device Performance (VIDAS Lyme IgG) | Supporting Study Section |
|---|---|---|---|
| Sensitivity (Clinical) | At least comparable to predicate device | Overall: 64.40% (95% CI [57.3% – 71.0%]) | H. Clinical Testing - Sensitivity testing |
| Stage I (1-30 days) | 49.60% | ||
| Stage II (1-30 days) | 83.60% | ||
| Stage III (late) | 90.90% | ||
| Positive % Agreement (PPA) | Not explicitly stated | 74.0 % (94/127) [95% CI; 65.5% - 81.4%] | H. Clinical Testing - Method Comparison |
| Negative % Agreement (NPA) | Not explicitly stated | 95.8 % (812/848) [95% CI; 94.2% - 97.0%] | H. Clinical Testing - Method Comparison |
| Analytical Specificity (Endemic) | Not explicitly stated | 3.0% Positivity, 97.0% Negativity | H. Clinical Testing - Analytical Specificity |
| Analytical Specificity (Non-Endemic) | Not explicitly stated | 0.0% Positivity, 100.0% Negativity | H. Clinical Testing - Analytical Specificity |
| CDC Reference Panel (Agreement with Clinical Status) | Demonstrated performance with characterized panel (no specific %) | Overall: 66.6% (26/39) | H. Clinical Testing - CDC Reference Panel |
| Normals | 100.0 % (5/5) | ||
| < 1 month | 40.0 % (2/5) | ||
| 1-2 months | 66.6 % (4/6) | ||
| 3-12 months | 50.0 % (8/16) | ||
| > 1 year | 100.0 % (7/7) | ||
| Precision | Acceptable within-run, within-day, between-days variability | See detailed table in section G. | G. Nonclinical Tests - Precision |
| Reproducibility | Acceptable within-run, within-day, between-days, and between-site variability | See detailed table in section G. | G. Nonclinical Tests - Reproducibility |
| Interfering Substances | No significant influence from specified substances | None identified for listed substances | G. Nonclinical Tests - Interfering Substances |
| Cross-Reactivity | Low cross-reactivity for listed conditions | Small numbers of positive results for some conditions (e.g., Anti Nuclear Antibodies 8.33%, Systemic Lupus Erythematosus 7.14%) | H. Clinical Testing - Cross-Reactivity |
2. Sample Size Used for the Test Set and Data Provenance
- Sensitivity Testing: 202 retrospective samples
- Data Provenance: Not explicitly stated (implied clinical samples from patients meeting case definition).
- Method Comparison (PPA/NPA): 975 fresh or frozen prospectively collected sera
- Data Provenance: Endemic area of the United States (prospectively collected).
- Analytical Specificity: 100 sera from an endemic population (New York) and 100 sera from a non-endemic population (Texas).
- Data Provenance: New York (endemic), Texas (non-endemic).
- CDC Reference Panel: 39 serum samples
- Data Provenance: Obtained from the CDC.
- Cross-Reactivity: Varies for each infection/diagnosis, ranging from 19 to 256 samples.
- Data Provenance: Not explicitly stated for each group.
- Nonclinical Tests (Precision & Reproducibility): 4 serum samples tested multiple times (80 for precision, 240 for reproducibility) and controls.
- Data Provenance: Not specified, likely internally prepared or sourced.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish ground truth for the clinical samples.
- For the Sensitivity Testing, samples were from "patients meeting a case definition of LD and confirmed positive for B. burgdorferi infection." This implies clinical diagnosis and/or confirmatory testing (which often involves expert interpretation), but direct expert counting or qualifications are not provided.
- For the Method Comparison, samples were "submitted for routine Lyme disease testing." Ground truth was established by comparison with a predicate device and then confirmed with a commercially available Lyme IgG Western Blot method, following CDC recommendations for two-tier testing. This indicates a multi-methodological approach to ground truth, but not direct expert consensus on each case.
- For the CDC Reference Panel, the samples are described as a "masked, characterized serum panel." This implies the CDC (as an expert body) established the clinical status, but the specific process (e.g., number of experts, qualifications) is not detailed.
- For Cross-Reactivity, samples were "negative with the test being evaluated and positive for the potentially interfering disease." This indicates known positivity for other infections, likely established by standard diagnostic methods.
4. Adjudication Method for the Test Set
- Clinical Sensitivity/Method Comparison: The primary adjudication method for positive cases appears to be second-tier testing with a Western Blot IgG assay, in accordance with CDC recommendations. The document states: "All VIDAS Lyme IgG positive specimens should be further tested with a Western Blot IgG assay to obtain supportive evidence of infection with B. burgdorferi" and "the VIDAS Lyme IgG positive results and the predicate Lyme IgG positive and equivocal results were confirmed using a commercially available Lyme IgG Western Blot method." This suggests a hierarchical adjudication process where initial positives are subjected to a confirmatory test.
- For the initial comparison between VIDAS and the predicate (prior to Western Blot), "equivocal results [from the predicate] were considered as positive for the evaluation."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted. This device is an automated in vitro diagnostic assay, not an AI-assisted diagnostic tool that interprets images or signals requiring human reader input or comparison.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, the studies presented are standalone performance evaluations of the VIDAS Lyme IgG assay. As an automated enzyme immunoassay, its performance is assessed independently, without human interaction in the analytical process itself, beyond sample loading and results interpretation. The assay generates a quantitative result which is then interpreted qualitatively (positive/negative) by the instrument.
7. The Type of Ground Truth Used
The ground truth used in the studies varies by context:
- Clinical Sensitivity: "Patients meeting a case definition of LD and confirmed positive for B. burgdorferi infection" - implies a combination of clinical diagnosis and potentially laboratory confirmation (though specific methods for confirmation aren't exhaustively detailed for this set).
- Method Comparison: Western Blot IgG results served as the confirmatory ground truth for positive and equivocal first-tier results, following CDC recommendations. The initial comparison was against a predicate EIA (Platelia™ Lyme IgG).
- Analytical Specificity: Clinical categorization as "apparently healthy subjects from an endemic population" or "non-endemic population with no known history of Lyme disease" for negative cases, and diagnosed "infection or diagnosis" for cross-reactivity panels.
- CDC Reference Panel: The CDC provided a "masked, characterized serum panel," indicating ground truth established by the CDC, likely based on clinical status and expert characterization.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of device development or algorithm training. This is expected for an in vitro diagnostic assay of this type, where performance is derived from biochemical reactions rather than machine learning algorithms trained on data. The studies described are validation and verification studies for the manufactured product.
9. How the Ground Truth for the Training Set was Established
Since no explicit training set is mentioned as part of the assay's development or a machine learning approach, the concept of establishing ground truth for a training set is not applicable here. The assay's "training" in a broad sense would be in its initial design, optimization, and calibration based on known positive and negative samples, but these are not described in the same way as a machine learning training dataset.
{0}------------------------------------------------
510(k) SUMMARY
K122986
VIDAS® Lyme IgG Assay
510(k) SUMMARY
MAR 5 2013
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 IgG
A. Submitter Information
| Submitter's Name: | bioMérieux SA |
|---|---|
| Address: | Chemin de l'Orme |
| 69280 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: | September 2012 |
B. Device Name
| Trade Name: | VIDAS® Lyme IgG |
|---|---|
| Common Name: | Lyme IgG Assay |
| Classification Name: | 21 CFR 866.3830 - Treponema pallidum treponemal test reagents |
C. Predicate Device Name
Trade Name: Platelia™ Lyme IgG
D. Device Description
The VIDAS Lyme IgG assay principle combines a two-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA). 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 sample is cycled in and out of the SPR. Antibodies to B. burgdorferi present in the specimen will bind to the B. burgdorferi antigen coating the interior of the SPR. Unbound sample components are washed away. Anti-human IgG 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. burgdorfen IgG antibodies present in the sample. At the end of the assay, results are automatically calculated by the instrument. A test value is generated and a report is printed for each test.
1
{1}------------------------------------------------
E. Intended Use
The VIDAS Lyme IgG (LYG) assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgG 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 IgG positive specimens should be further tested with a Western Blot IgG 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 IgG (LYG) Assay | Platelia™ Lyme IgG (K080012) |
|---|---|---|
| Intended Use | The VIDAS Lyme IgG (LYG) assay isan automated qualitative enzymeimmunoassay intended for use on theinstruments of the VIDAS family inthe presumptive detection of humanIgG antibodies to Borrelia burgdorferiin human serum (plain or separationgel) or plasma (sodium heparin orlithium heparin). It should be used totest patients with a history and/orsymptoms of infection with B.burgdorferi. All VIDAS Lyme IgGpositive specimens should be furthertested with a Western Blot IgG assayto obtain supportive evidence ofinfection with B. burgdorferi. | The Platelia™ Lyme IgG Test is aqualitative test intended for use inthe presumptive detection ofhuman IgG antibodies to Borreliaburgdorferi in human serum orplasma (K3 EDTA, sodium heparinor sodium citrate). The EIA systemshould be used to test serum orplasma from patients with a historyand symptoms of infection with B.burgdorferi. All positive andequivocal specimens should bere- tested with a specific, second-tier test such as Western-Blot.Positive second- tier results aresupportive evidence of infectionwith B. burgdorferi. The diagnosisof Lyme disease should be madebased on history and symptoms(such as erythema migrans), andother laboratory data, in additionto the presence of antibodies toB. burgdorferi. Negative results(either first or second-tier) shouldnot be used to exclude Lymedisease. |
| Specimen | Serum or plasma | Serum or plasma |
| Analyte | IgG antibodies to Borreliaburgdorferi | IgG antibodies to Borreliaburgdorferi |
| Automated | Yes | No |
| AssayTechnique | Enzyme-linked fluorescent assay(ELFA) | Enzyme immunoassay (EIA) |
{2}------------------------------------------------
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 CLSI® document EP5-A2. The total precision da 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 | Mean Index | Within-run | Within-day | Between-days | Total | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| Negative | 80 | 0.11 | 0.01 | 9.7 | 0.00 | 3.8 | 0.01 | 5.4 | 0.02 | 18.5 |
| High Negative | 80 | 0.15 | 0.02 | 11.2 | 0.01 | 5.3 | 0.00 | 0.0 | 0.03 | 18.3 |
| Low Positive | 80 | 0.26 | 0.01 | 4.3 | 0.01 | 3.8 | 0.01 | 2.4 | 0.02 | 6.8 |
| High Positive | 80 | 2.34 | 0.09 | 3.7 | 0.05 | 2.3 | 0.07 | 3.0 | 0.13 | 5.7 |
| Positive Control | 40 | 0.45 | NA | NA | 0.03 | 5.9 | 0.01 | 1.4 | 0.03 | 6.7 |
| 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 reproducib 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 high negatives gave a positive value and 2 low positives gave a negative value. The total reproducibility for controls include within-day, between-days, betweencalibration 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 (%) | |||
| Negative | 240 | 0.11 | 0.01 | 7.6 | 0.00 | 4.3 | 0.00 | 3.8 | 0.00 | 0.0 | 0.02 | 15.5 |
| HighNegative | 240 | 0.15 | 0.01 | 8.6 | 0.00 | 3.3 | 0.00 | 0.0 | 0.00 | 0.0 | 0.02 | 15.5 |
{3}------------------------------------------------
| PanelMember | N | MeanIndex | Within-run | Within-day | Between-days | Between-site | Total | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV (%) | |||
| LowPositive | 240 | 0.26 | 0.01 | 5.4 | 0.01 | 3.9 | 0.00 | 1.6 | 0.00 | 0.0 | 0.02 | 7.7 |
| HighPositive | 240 | 2.31 | 0.10 | 4.1 | 0.04 | 1.8 | 0.03 | 1.2 | 0.02 | 0.8 | 0.12 | 5.3 |
| PositiveControl | 120 | 0.45 | NA | NA | 0.02 | 5.2 | 0.00 | 0.0 | 0.00 | 0.0 | 0.03 | 6.3 |
| 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 CLSI® document EP7-A2. None of the following factors have been found to significantly influence this assay:
-
hemolysis (hemoglobin: 5 g/L (monomer)),
-
lipemia (lipids: 30 g/L equivalent in triglycerides),
-
bilirubinemia (bilirubin: 0.3 g/L),
-
human albumin (albumin up to 60 g/L).
It is recommended not to use samples that are hemolyzed, lipemic or icteric and, if possible, to collect a new sample.
Exogenous Interferents: 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 |
{4}------------------------------------------------
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 IgG assay and the predicate Lyme IgG assay.
For the predicate test, equivocal results were considered as positive for the evaluation. The following results were obtained:
| Stage | N | VIDAS Lyme IgG% Sensitivity | Predicate Lyme IgG% Sensitivity | Difference inproportions |
|---|---|---|---|---|
| Stage I(early localized,single lesion)1 - 30 days | 119 | 49.6095% CI [40.3% –58.9%] | 42.9095% CI [33.8% –52.3%] | +6.7%95% CI [(-6)% –(19)%] |
| Stage II(early disseminated,multiple lesions)1 – 30 days | 61 | 83.6095% CI [71.9% –91.8%] | 54.1095% CI [40.8% –66.9%] | +29.5%95% CI [(14)% –(45)%] |
| Stage III(late disseminated) | 22 | 90.9095% CI [70.8% –98.9%] | 72.7095% CI [49.8% –89.3%] | +18.2%95% CI [(-4)% –(40)%] |
| All stages | 202 | 64.4095% CI [57.3% –71.0%] | 49.5095% CI [42.4% –56.6%] | +14.9%95% CI [(5)% –(24)%] |
(1) 95% Confidence Interval.
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 IgG EIA method (predicate) and the VIDAS Lyme IgG 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 IgG | ||
|---|---|---|---|
| VIDAS Lyme IgG | Positive | Equivocal | Negative |
| Positive | 77 | 17 | 36 |
| Negative | 18 | 15 | 812 |
| Total | 95 | 32 | 848 |
| Positive % Agreement95% CI | 74.0 % (94/127)[65.5% - 81.4%] | ||
| Negative % Agreement95% CI | 95.8 % (812/848)[94.2% - 97.0%] |
{5}------------------------------------------------
Second-Tier Testing: In accordance with the CDC recommendations for use of a 2-tier Lyme disease testing scheme, the VIDAS Lyme IgG positive results and the predicate Lyme IgG positive and equivocal results were confirmed using a commercially available Lyme IgG Western Blot method. The percent agreement between VIDAS and predicate Lyme IgG positives and the percent agreement between VIDAS-predicate-Western Blot IgG positives and Predicate-Western Blot IgG positives is shown below.
| 1st Tier+ or ± | IgG Western | ||
|---|---|---|---|
| Pos. | Neg. | ||
| Predicate IgG | 127 | 63 | 64 |
| VIDAS IgG | 130 | 65 | 65 |
| VIDAS IgG and Predicate IgG | 94 | 62 | 32 |
156 tier PPA = 74.0 % (94/127) [95% Cl; 65.5% - 81.4%] 2nd tier PPA = 98.4% (62/63) [95% Cl; 91.47 - 99.96]
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 IgG assay and the predicate Lyme IgG assay. The following results were obtained:
| VIDAS | Predicate | |||
|---|---|---|---|---|
| Positivity | Negativity | Positivity(1) | Negativity | |
| Endemic | 3.0% | 97.0% | 3.0% | 97.0% |
| Non-Endemic | 0.0% | 100.0% | 1.0% | 99.0% |
(1) 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 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 assay by the CDC.
| Time fromonset | VIDAS Lyme IgG | Western Blot IgG | ||||
|---|---|---|---|---|---|---|
| Positive | Negative | Agreementwith clinicalstatus | Positive | Negative | Agreementwith clinicalstatus | |
| Normals | 0 | 5 | 100.0 %(5/5) | 0 | 5 | 100.00 %(5/5) |
| < 1 month | 2 | 3 | 40.0 %(2/5) | 2 | 3 | 40.00 %(2/5) |
| 1 - 2months | 4 | 2 | 66.6 %(4/6) | 0 | 6 | 0.00 %(0/6) |
| 3 - 12months | 8 | 8 | 50.0 % .(8/16) | 7 | 9 | 43.75%(7/16) |
| > 1 year | 7 | 0 | 100.0 %(7/7) | 7 | 0 | 100.00 %(7/7) |
| Total | 21 | 18 | 66.6 %(26/39) | 16 | 23 | 53.84%(21/39) |
ર્ભ
{6}------------------------------------------------
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 LymeIgGpositiveresults | % Cross-reactivity |
|---|---|---|---|
| Anti Nuclear Antibodies | 60 | 5 | 8.33 |
| C Reactive Protein | 61 | 2 | 3.28 |
| Cytomegalovirus | 40 | 0 | 0.00 |
| Epstein Barr Virus | 34 | 0 | 0.00 |
| Helicobacter Pylori | 143 | 2 | 1.40 |
| Hepatitis A Virus | 150 | 3 | 2.00 |
| Herpes Simplex Virus | 125 | 1 | 0.80 |
| HumanImmunodeficiency Virus | 20 | 1 | 5.00 |
| Human Anti-mouseAntibodies | 43 | 0 | 0.00 |
| Leptospirosis | 206 | 6 | 2.91 |
| Measles | 38 | 0 | 0.00 |
| Mumps | 46 | 0 | 0.00 |
| Rheumatoid Factor | 28 | 0 | 0.00 |
| Rickettsiosis | 133 | 3 | 2.25 |
| Rubella | 19 | 0 | 0.00 |
| Syphilis | 256 | 1 | 0.39 |
| Systemic LupusErythematosus | 28 | 2 | 7.14 |
| Toxoplasmosis | 26 | 1 | 3.85 |
| Varicella Zoster Virus | 58 | 0 | 0.00 |
The effect of Babesiosis, Erhlichiosis and Rocky Mountain spotted fever pathologies on the VIDAS Lyme IgG 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 IgG is substantially equivalent to the predicate device identified in Item C of this summary.
{7}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem that resembles an eagle or bird-like figure, composed of curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
bioMerieux SA c/o Catherine FRITSCH Regulatory Affairs Director 5 rue des Aqueducs 69290 Craponne, France
March 5, 2013
Re: K122986
Trade/Device Name: VIDAS® Lyme IgG Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LSR Dated: January 25, 2013 Received: January 28, 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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{8}------------------------------------------------
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 Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely yours,
Sally A. Hojvat
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
{9}------------------------------------------------
Indications for Use
510(k) Number (if known): ূK122986
Device Name: VIDAS® Lyme IgG
Indications For Use:
The VIDAS Lyme IgG (LYG) assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in himne 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 IgG positive specimens should be further tested with a Western Blot IgG 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)
John Hobson -S 2013.03.05 09:06:08 -05'00'
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
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).