VIDAS LYME IGM

K122979 · Biomerieux S.A. · LSR · Jun 4, 2013 · Microbiology

Device Facts

• Record ID: K122979
• Device Name: VIDAS LYME IGM
• Applicant: Biomerieux S.A.
• Product Code: LSR · Microbiology
• Decision Date: Jun 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3830
• Device Class: Class 2

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.

Device Story

Automated qualitative enzyme-linked fluorescent assay (ELFA) for detection of IgM antibodies to B. burgdorferi. Input: human serum or plasma. Process: 2-step sandwich immunoassay using recombinant B. burgdorferi proteins coated on Solid Phase Receptacle (SPR); alkaline phosphatase-conjugated anti-human IgM; substrate (4-Methyl-umbelliferyl phosphate) hydrolysis produces fluorescent signal measured at 450 nm. Output: automated test value/index. Used in clinical laboratories on VIDAS/miniVIDAS instruments. Results assist clinicians in identifying potential Lyme disease, requiring follow-up with Western Blot for confirmation.

Clinical Evidence

Prospective study (n=975) compared VIDAS Lyme IgM to predicate EIA. 1st-tier PPA 51.0% (95% CI 44.0-57.9%). 2nd-tier PPA (vs Western Blot) 80.8% (95% CI 72.2-87.2%). Retrospective sensitivity study (n=202) showed 66.8% overall sensitivity. Analytical specificity evaluated in 200 healthy subjects (13% positive/equivocal). Cross-reactivity tested against 19 conditions; highest cross-reactivity observed with HIV (35.0%), CMV (17.6%), and HSV (15.3%).

Technological Characteristics

Automated ELFA using Solid Phase Receptacle (SPR) technology. Reagents: recombinant B. burgdorferi proteins, alkaline phosphatase conjugate, 4-Methyl-umbelliferyl phosphate substrate. Detection: fluorescence at 450 nm. Sample types: serum (plain/gel), plasma (sodium/lithium heparin). Instrument: VIDAS/miniVIDAS family. Software: automated calculation of test index.

Indications for Use

Indicated for presumptive detection of human IgM antibodies to Borrelia burgdorferi in human serum or plasma. Target population: patients with history or symptoms of B. burgdorferi infection. Positive/equivocal results require follow-up with Western Blot IgM assay.

Regulatory Classification

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), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.

Predicate Devices

• Platelia™ Lyme IgM (K081362)

Submission Summary (Full Text)

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K122979

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'Orme<br>69280 Marcy-l'Etoile - France |
| Contact Person: | Catherine FRITSCH |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| 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) assay<br>is an automated qualitative enzyme<br>immunoassay intended for use on<br>the instruments of the VIDAS family<br>in the presumptive detection of<br>human IgM antibodies to Borrelia<br>burgdorferi in human serum (plain or<br>separation gel) or plasma (sodium<br>heparin or lithium heparin). It should<br>be used to test patients with a<br>history and/or symptoms of infection<br>with B. burgdorferi. All VIDAS Lyme<br>IgM positive and equivocal<br>specimens should be further tested<br>with a Western Blot IgM assay to<br>obtain supportive evidence of<br>infection with B. burgdorferi. | The Platelia™ Lyme IgM Test is a<br>qualitative test intended for use in<br>the presumptive detection of<br>human IgM antibodies to Borrelia<br>burgdorferi in human serum or<br>plasma (K3 EDTA, sodium<br>heparin or sodium citrate). The<br>EIA system should be used to test<br>serum or plasma from patients<br>with a history and symptoms of<br>infection with Borrelia burgdorferi.<br>All positive and equivocal<br>specimens should be re-tested<br>with a specific, second-tier test<br>such as Western-Blot. Positive<br>second-tier results are supportive<br>evidence of infection with Borrelia<br>burgdorferi. The diagnosis of<br>Lyme disease should be made<br>based on history and symptoms<br>(such as erythema migrans), and<br>other laboratory data, in addition<br>to the presence of antibodies to<br>Borrelia<br>burgdorferi. Negative results<br>(either first- or second-tier) should<br>not be used to exclude Lyme<br>disease. |
| Specimen | Serum or plasma | Serum or plasma |
| Analyte | IgM antibodies to Borrelia burgdorferi | IgM antibodies to Borrelia<br>burgdorferi |
| Automated | Yes | No |
| Assay<br>Technique | Enzyme-linked fluorescent assay<br>(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 | Mean<br>Index | 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.

| Panel<br>Member | N | Mean<br>Index | Within-run | | Within-day | | Between-days | | Between-site | | Total | |
|-----------------|-----|---------------|------------|-----------|------------|-----------|--------------|-----------|--------------|-----------|-------|-----------|
| | | | SD | CV<br>(%) | SD | CV<br>(%) | SD | CV<br>(%) | SD | CV<br>(%) | SD | CV<br>(%) |
| Sample<br>1 | 240 | 0.19 | 0.01 | 3.5 | 0.00 | 2.1 | 0.00 | 1.0 | 0.00 | 0.0 | 0.01 | 6.3 |
| Sample<br>2 | 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

| Panel<br>Member | N | Mean<br>Index | Within-run | | Within-day | | Between-<br>days | | Between-<br>site | | Total | |
|---------------------|-----|---------------|------------|-----------|------------|-----------|------------------|-----------|------------------|-----------|-------|-----------|
| | | | SD | CV<br>(%) | SD | CV<br>(%) | SD | CV<br>(%) | SD | CV<br>(%) | SD | CV<br>(%) |
| Sample<br>3 | 240 | 0.37 | 0.01 | 3.1 | 0.01 | 2.1 | 0.00 | 0.0 | 0.00 | 0.0 | 0.02 | 6.2 |
| Sample<br>4 | 240 | 1.26 | 0.03 | 2.5 | 0.02 | 1.9 | 0.01 | 0.4 | 0.00 | 0.0 | 0.12 | 9.4 |
| Positive<br>Control | 120 | 0.72 | NA | NA | 0.03 | 4.6 | 0.00 | 0.0 | 0.00 | 0.0 | 0.09 | 12.1 |
| Negative<br>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 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<br>% Sensitivity * | Predicate Lyme<br>IgM<br>% Sensitivity * | Difference in<br>proportions |
|----------------------------------------------------------------------------|-----|--------------------------------------------|--------------------------------------------|-----------------------------------------|
| Stage I<br>(early<br>localized,<br>single lesion)<br>1 – 30 days | 119 | 52.1 (62/119)<br>95% CI [42.8 –<br>61.3]% | 54.6 (65/119)<br>95% CI [45.2 –<br>63.8]% | -2.5%<br>95% CI [(-15.2)% –<br>(10.2)%] |
| Stage II<br>(early<br>disseminated,<br>multiple<br>lesions)<br>1 – 30 days | 62 | 91.9 (57/62)<br>95% CI [82.2 –<br>97.3]% | 91.9 (57/62)<br>95% CI [82.2 –<br>97.3]% | 0.0%<br>95% CI [(-9.6)% –<br>(9.6)%] |
| Stage III<br>(late<br>disseminated) | 21 | 76.2 (16/21)<br>95% CI [52.8 –<br>91.8]% | 61.9 (13/21)<br>95% CI [38.4 –<br>81.9]% | 14.3%<br>95% CI [(-13.3)% –<br>(41.9)%] |
| All stages | 202 | 66.8 (135/202)<br>95% CI [59.9 –<br>73.3]% | 66.8 (135/202)<br>95% CI [59.9 –<br>73.3]% | 0.0%<br>95% CI [(-9.2)% –<br>(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 % Agreement<br>95% CI | 51.0% (107/210)<br>[44.0 - 57.9]% | | |
| Negative % Agreement<br>95% CI | 88.6% (678/765)<br>[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<br>+ or ± | IgM Western<br>Pos. | Neg. |
|--------------------------------|--------------------|---------------------|------|
| Predicate IgM | 210 | 104 | 106 |
| VIDAS IgM | 194 | 95 | 93* |
| VIDAS IgM and Predicate<br>IgM | 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-<br>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

| Time<br>from<br>onset | VIDAS Lyme IgM | | | Western blot IgM | | |
|-----------------------|-----------------------------|----------|--------------------------------------|------------------|----------|--------------------------------------|
| | Positive<br>or<br>equivocal | Negative | Agreement<br>with clinical<br>status | Positive | Negative | Agreement<br>with clinical<br>status |
| Normals | 1 | 4 | 80.0 %<br>(4/5) | 0 | 5 | 100.0 %<br>(5/5) |
| < 1 month | 3 | 2 | 60.0 %<br>(3/5) | 3 | 2 | 60.0 %<br>(3/5) |
| 1 - 2<br>months | 5 | 1 | 83.3 %<br>(5/6) | 5 | 1 | 83.3 %<br>(5/6) |
| 3- 12<br>months | 12 | 4 | 75.0 %<br>(12/16) | 7 | 9 | 43.8 %<br>(7/16) |
| > 1 year | 3 | 4 | 42.9 %<br>(3/7) | 3 | 4 | 42.9 %<br>(3/7) |
| Total | 24 | 15 | 69.2%<br>(27/39) | 18 | 21 | 59.0 %<br>(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 Lyme<br>IgM<br>Equivocal or<br>positive<br>results | % Cross-<br>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 [phone] or [phone] 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 [phone] or [phone] 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)

| John Hobson-S |
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| | Division Sign-Off |
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| 2013.06.03 13:35:34 |
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| Office of In Vitro Diagnostics and Radiological Health |
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| 510(k) | K122979 |
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Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

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