VIDAS LYME IGG

• K Number: K122986
• Device Name: VIDAS LYME IGG
• Manufacturer: BIOMERIEUX SA
• Date Cleared: 2013-03-05 ( 160 days)
• Product Code: LSR
• Regulation Number: 866.3830

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.

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.

Predicate Devices

K080012

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard automated enzyme immunoassay with fluorescent detection and automated calculation of results based on measured fluorescence intensity. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or decision-making beyond basic proportional calculations.

Therapeutic

No
This device is an in vitro diagnostic assay used for the presumptive detection of human IgG antibodies to Borrelia burgdorferi, which aids in the diagnosis of Lyme disease, rather than directly treating or preventing a disease.

Diagnostic

Yes.

The device is intended for the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum or plasma to test patients with a history and/or symptoms of infection with B. burgdorferi. This directly supports the diagnosis of Lyme disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical assay kit with reagents, a solid phase receptacle (SPR), and an automated instrument for performing the assay steps and measuring fluorescence. This involves significant hardware and chemical components, not just software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is intended for the "presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum (plain or separation gel) or plasma (sodium heparin or lithium heparin)." This indicates that the device is used to test samples taken from the human body in vitro (outside the body) to provide information about a person's health status (presence of antibodies related to Lyme disease).
• Device Description: The description details a laboratory-based assay using reagents and an instrument to analyze a biological sample (serum or plasma). This is characteristic of an in vitro diagnostic device.
• Performance Studies: The document includes detailed performance studies (precision, reproducibility, sensitivity, method comparison, analytical specificity, cross-reactivity) conducted on human samples, which are standard for evaluating the performance of IVD devices.

The core function of the device is to analyze a biological sample in vitro to aid in the diagnosis of a disease, which is the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes (comma separated list FDA assigned to the subject device)

LSR

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.

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

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Precision Study:

• Study Type: Precision
• Sample Size: 4 serum samples tested in duplicate in 40 different runs (2 runs per day over 20 days) with 2 reagent lots at 1 site (n = 80).
• Key Results: The total precision data reflects 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.
  • Negative Panel Member: Mean Index 0.11, Total SD 0.02, Total CV 18.5%
  • High Negative Panel Member: Mean Index 0.15, Total SD 0.03, Total CV 18.3%
  • Low Positive Panel Member: Mean Index 0.26, Total SD 0.02, Total CV 6.8%
  • High Positive Panel Member: Mean Index 2.34, Total SD 0.13, Total CV 5.7%
  • Positive Control: Mean Index 0.45, Total SD 0.03, Total CV 6.7%
  • Negative Control: Mean Index 0.00, Total SD 0.00, Total CV 0.0%

Reproducibility Study:

• Study Type: Reproducibility
• Sample Size: 4 serum samples tested in 40 different runs (2 runs per day over 20 days) with 2 reagent lots at 3 sites (n = 240).
• Key Results: The total reproducibility reflects 240 values generated per sample for all sites and considers replicate, run, day, calibration, lot, and site as potential sources of variation. Out of 240 total values, 2 high negatives gave a positive value and 2 low positives gave a negative value. The total reproducibility for controls includes within-day, between-days, between-calibration and between-site variability and is lot specific.
  • Negative Panel Member: Mean Index 0.11, Total SD 0.02, Total CV 15.5%
  • High Negative Panel Member: Mean Index 0.15, Total SD 0.02, Total CV 15.5%
  • Low Positive Panel Member: Mean Index 0.26, Total SD 0.02, Total CV 7.7%
  • High Positive Panel Member: Mean Index 2.31, Total SD 0.12, Total CV 5.3%
  • Positive Control: Mean Index 0.45, Total SD 0.03, Total CV 6.3%
  • Negative Control: Mean Index 0.00, Total SD 0.00, Total CV 0.0%

Sensitivity Testing:

• Study Type: Clinical Testing - Sensitivity
• Sample Size: 202 retrospective samples from patients meeting a case definition of LD and confirmed positive for B. Burgdorferi infection.
• Key Results:
  • Stage I (early localized, single lesion) 1 - 30 days (N=119): VIDAS Lyme IgG 49.60% Sensitivity (95% CI [40.3% – 58.9%]); Predicate Lyme IgG 42.90% Sensitivity (95% CI [33.8% – 52.3%]); Difference +6.7% (95% CI [(-6)% – (19)%])
  • Stage II (early disseminated, multiple lesions) 1 – 30 days (N=61): VIDAS Lyme IgG 83.60% Sensitivity (95% CI [71.9% – 91.8%]); Predicate Lyme IgG 54.10% Sensitivity (95% CI [40.8% – 66.9%]); Difference +29.5% (95% CI [(14)% – (45)%])
  • Stage III (late disseminated) (N=22): VIDAS Lyme IgG 90.90% Sensitivity (95% CI [70.8% – 98.9%]); Predicate Lyme IgG 72.70% Sensitivity (95% CI [49.8% – 89.3%]); Difference +18.2% (95% CI [(-4)% – (40)%])
  • All stages (N=202): VIDAS Lyme IgG 64.40% Sensitivity (95% CI [57.3% – 71.0%]); Predicate Lyme IgG 49.50% Sensitivity (95% CI [42.4% – 56.6%]); Difference +14.9% (95% CI [(5)% – (24)%])

Method Comparison:

• Study Type: Prospective Clinical Study
• Sample Size: 975 fresh or frozen prospectively collected sera.
• Key Results:
  • Positive % Agreement (PPA): 74.0 % (94/127) [95% CI; 65.5% - 81.4%]
  • Negative % Agreement (NPA): 95.8 % (812/848) [94.2% - 97.0%]
  • Second-Tier PPA with Western Blot: 98.4% (62/63) [95% Cl; 91.47 - 99.96]

Analytical Specificity:

• Study Type: Analytical Specificity (Healthy subjects)
• Sample Size: 100 sera from apparently healthy subjects from an endemic population (New York) and 100 sera from a non-endemic population (Texas).
• Key Results:
  • Endemic Population: VIDAS Positivity 3.0%, VIDAS Negativity 97.0%; Predicate Positivity 3.0%, Predicate Negativity 97.0%.
  • Non-Endemic Population: VIDAS Positivity 0.0%, VIDAS Negativity 100.0%; Predicate Positivity 1.0%, Predicate Negativity 99.0%.

CDC Reference Panel:

• Study Type: Performance with a masked, characterized serum panel from CDC.
• Sample Size: Not explicitly stated as a single number, but results are broken down by time from onset for a total of 39 samples.
• Key Results:
  • Normals (N=5): VIDAS Agreement with clinical status 100.0 % (5/5); Western Blot Agreement with clinical status 100.00 % (5/5)
  • 1 year (N=7): VIDAS Agreement with clinical status 100.0 % (7/7); Western Blot Agreement with clinical status 100.00 % (7/7)
  • Total (N=39): VIDAS Agreement with clinical status 66.6 % (26/39); Western Blot Agreement with clinical status 53.84% (21/39)

Cross-Reactivity:

• Study Type: Cross-reactivity
• Sample Size: Varied by disease (e.g., Anti Nuclear Antibodies N=60, Syphilis N=256).
• Key Results: Percentage of cross-reactivity for each studied infection or diagnosis. Range from 0.00% to 8.33%.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

• Sensitivity:
  • Stage I: 49.60% (VIDAS), 42.90% (Predicate)
  • Stage II: 83.60% (VIDAS), 54.10% (Predicate)
  • Stage III: 90.90% (VIDAS), 72.70% (Predicate)
  • All stages: 64.40% (VIDAS), 49.50% (Predicate)
• Positive % Agreement (PPA): 74.0 % (94/127) [95% CI; 65.5% - 81.4%]
• Negative % Agreement (NPA): 95.8 % (812/848) [94.2% - 97.0%]
• Second-Tier PPA: 98.4% (62/63) [95% Cl; 91.47 - 99.96]
• Positivity (Analytical Specificity): Endemic Population (VIDAS 3.0%, Predicate 3.0%); Non-Endemic Population (VIDAS 0.0%, Predicate 1.0%)
• Negativity (Analytical Specificity): Endemic Population (VIDAS 97.0%, Predicate 97.0%); Non-Endemic Population (VIDAS 100.0%, Predicate 99.0%)
• Cross-reactivity: Ranges from 0.00% (Cytomegalovirus, Epstein Barr Virus, Measles, Mumps, Rheumatoid Factor, Varicella Zoster Virus) to 8.33% (Anti Nuclear Antibodies).

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.

K080012

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

Regulation Number and Section

§ 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).

Summary

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:	[phone]
Fax Number:	[phone]
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 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 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
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 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.
Specimen	Serum or plasma	Serum or plasma
Analyte	IgG antibodies to Borrelia
burgdorferi	IgG antibodies to Borrelia
burgdorferi
Automated	Yes	No
Assay
Technique	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 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.

| Panel
Member | N | Mean
Index | 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 |
| High
Negative | 240 | 0.15 | 0.01 | 8.6 | 0.00 | 3.3 | 0.00 | 0.0 | 0.00 | 0.0 | 0.02 | 15.5 |

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| Panel
Member | N | Mean
Index | Within-run | | Within-day | | Between-
days | | Between-
site | | Total | |
|---------------------|-----|---------------|------------|-----------|------------|-----------|------------------|-----------|------------------|-----------|-------|--------|
| | | | SD | CV
(%) | SD | CV
(%) | SD | CV
(%) | SD | CV
(%) | SD | CV (%) |
| Low
Positive | 240 | 0.26 | 0.01 | 5.4 | 0.01 | 3.9 | 0.00 | 1.6 | 0.00 | 0.0 | 0.02 | 7.7 |
| High
Positive | 240 | 2.31 | 0.10 | 4.1 | 0.04 | 1.8 | 0.03 | 1.2 | 0.02 | 0.8 | 0.12 | 5.3 |
| Positive
Control | 120 | 0.45 | NA | NA | 0.02 | 5.2 | 0.00 | 0.0 | 0.00 | 0.0 | 0.03 | 6.3 |
| Negative
Control | 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

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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 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 in
proportions |
|----------------------------------------------------------------------|-----|------------------------------------|-------------------------------------|-------------------------------------|
| Stage I
(early localized,
single lesion)
1 - 30 days | 119 | 49.60
95% CI [40.3% –
58.9%] | 42.90
95% CI [33.8% –
52.3%] | +6.7%
95% CI [(-6)% –
(19)%] |
| Stage II
(early disseminated,
multiple lesions)
1 – 30 days | 61 | 83.60
95% CI [71.9% –
91.8%] | 54.10
95% CI [40.8% –
66.9%] | +29.5%
95% CI [(14)% –
(45)%] |
| Stage III
(late disseminated) | 22 | 90.90
95% CI [70.8% –
98.9%] | 72.70
95% CI [49.8% –
89.3%] | +18.2%
95% CI [(-4)% –
(40)%] |
| All stages | 202 | 64.40
95% CI [57.3% –
71.0%] | 49.50
95% 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 % Agreement
95% CI	74.0 % (94/127)
[65.5% - 81.4%]
Negative % Agreement
95% CI	95.8 % (812/848)
[94.2% - 97.0%]

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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 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 from

onset	VIDAS Lyme IgG			Western Blot IgG
	Positive	Negative	Agreement
with clinical
status	Positive	Negative	Agreement
with clinical
status
Normals	0	5	100.0 %
(5/5)	0	5	100.00 %
(5/5)
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 Lyme
IgG
positive
results | % 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 |
| Human
Immunodeficiency Virus | 20 | 1 | 5.00 |
| Human Anti-mouse
Antibodies | 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 Lupus
Erythematosus | 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 [phone]. 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 [phone] or [phone] 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)

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