VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II

K141133 · BIOMERIEUX · LYR · Jul 9, 2015 · Microbiology

Device Facts

• Record ID: K141133
• Device Name: VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II
• Applicant: BIOMERIEUX
• Product Code: LYR · Microbiology
• Decision Date: Jul 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Intended Use

VIDAS® D-Dimer Exclusion II™ is an automated quantitative test for use on the instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products (FbDP) in human plasma (sodium citrate, CTAD) using the ELFA technique (Enzyme Linked Fluorescent Assay). VIDAS D-Dimer Exclusion II is indicated for use in conjunction with a clinical pretest probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease in outpatients suspected of DVT or PE. This device is an in vitro diagnostic medical device for professional use only.

Device Story

VIDAS 3 is an automated, standalone, multiparametric immunodiagnostic analyzer for clinical laboratory use. It utilizes Enzyme Linked Fluorescent Assay (ELFA) technology to process human serum or plasma samples. The system performs primary tube sampling, automated dilution, and reagent handling using predispensed disposable reagent strips and Solid Phase Receptacles (SPRs). Operation involves an alkaline phosphatase-based enzymatic reaction where 4-MUP substrate is converted to 4-MU, which is measured via fluorescence at 450nm. The device includes a scanner head for optical reading and a computation engine for data reduction and result interpretation. It is operated by trained laboratory technicians and administrators. The system provides quantitative or qualitative results to healthcare providers to aid in the diagnosis and management of various conditions, including infectious diseases, pregnancy, thyroid disorders, and venous thromboembolism. The device improves laboratory workflow through automated sample handling and synchronization compared to manual methods.

Clinical Evidence

Bench testing only. Performance was verified using 9 previously cleared VIDAS assays. Studies included precision/reproducibility (CLSI EP5-A2), linearity (CLSI EP06-A), detection limits (CLSI EP17-A2), and method comparison (CLSI EP9/EP12-A2) against the predicate VIDAS instrument. Results showed high correlation (r > 0.97) and acceptable precision across all analytes. No clinical diagnostic sensitivity/specificity studies were required as the assays were previously cleared and the instrument change did not alter assay performance.

Technological Characteristics

Automated multiparametric immunoassay system using ELFA technology. Energy source: electrical. Sensing: optical scanner head measuring 4-MU fluorescence at 450nm. Reagents: predispensed disposable strips and coated SPRs. Connectivity: standalone, supports LIS integration. Software: proprietary computation engine for data reduction. Sterilization: N/A (reagents are pre-packaged).

Indications for Use

Indicated for professional in vitro diagnostic use by trained laboratory personnel. Specific populations: H. pylori (adult symptomatic), Lyme (patients with history/symptoms of B. burgdorferi), Rubella (immune status determination), Toxo IgM (acute/recent/reactivated infection aid), HCG (pregnancy detection), T4/TSH (thyroid/pituitary disorder aid), Testosterone (androgen excess/deficiency management), D-Dimer (DVT/PE exclusion in outpatients). Contraindications: Not for prenatal/newborn screening (Toxo/Rubella), not for blood donor screening (Toxo), not for Point-of-Care use.

Regulatory Classification

Identification

Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases. Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.

Predicate Devices

• VIDAS Instrument (k891385)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

BIOMERIEUX JOHN ALBRIGHT REGULATORY AFFAIRS MANAGER 595 ANGLUM ROAD HAZELWOOD MO 63042-2320

July 9, 2015

Re: K141133

Trade/Device Name: VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II

Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: I Product Code: LYR, JJE, LSR, LFX, LGD, DHA, KLI, CDZ, JLW, DAP Dated: June 15, 2015 Received: June 16, 2015

Dear Mr. Albright:

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 Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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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 regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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) K141133

#### Device Name

VIDAS H. pylori IgG, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO IgM, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II

# Indications for Use (Describe)

#### For VIDAS H. pylori IgG:

VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on the instruments of the VIDAS family, for the detection of anti-Helicobacter pylori IgG antibodies in human serum or plasma (EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS HPY assay is intended as an aid in diagnosis of H. pylori infection in an adult symptomatic population.

This device is an in vitro diagnostic medical device for professional use only.

#### For VIDAS 3:

The VIDAS 3 system is a complete standalone immunodiagnostic system intended for trained and qualified laboratory technicians (daily routine use) and laboratory administrators (application configuration). This device is an in vitro diagnostic medical device for professional use only.

#### For VIDAS Lyme IgG II:

The VIDAS Lyme IgG II (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). It should be used to test patients with a history and/or symptoms of infection with B. burgdorferi. All VIDAS Lyme IgG II positive specimens should be further tested with a Western Blot IgG assay to obtain supportive evidence of infection with B. burgdorfei. This device is an in vitro diagnostic medical device for professional use only.

#### For VIDAS RUB IgG:

The VIDAS® RUB IgG (RBG) assay uses Enzyme Linked Fluorescent Assay (ELFA) technology on the instruments of the VIDAS family for the in vitro quantitative measurement of IgG antibodies to rubella virus in human serum. The VIDAS RUB IgG (RBG) assay is intended as an aid in the determination of immune status to rubella. The performance of this device has not been established for screening of cord blood, or for neonatal samples. Likewise, performance characteristics of the assay have not been established for immunocompromised or immunosuppressed individuals.

This device is an in vitro diagnostic medical device for professional use only.

#### For VIDAS TOXO IgM:

The VIDAS® TOXO IgM (TXM) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated enzyme-linked fluorescent immunoassay (ELF A) for the presumptive qualitative detection of anti-Toxoplasma gondii IgM antibodies in human serum, as an aid in the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection. This assay must be performed in conjunction with an anti-Toxoplasma gondii lgG antibody assay. VIDAS TOXO IgM (TXM) assay performance has not been established for prenatal screening or newborn testing. This assay has not been cleared by the FDA for blood/plasma donor screening. This device is an in vitro diagnostic medical device for professional use only.

#### For VIDAS Human Chorionic Gonadotropin:

The VIDAS® HCG (HCG) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyme linked fluorescent immunoassay (ELFA) for the determination of human Chorionic Gonadotropin (hCG) concentration in human serum or plasma. The VIDAS HCG (HCG) assay is intended to aid in the early detection of pregnancy.

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This device is an in vitro diagnostic medical device for professional use only.

# For VIDAS T4:

The VIDAS® T4 (T4) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyme-linked fluorescent immunoassay for the determination of human thyroxine (T4) concentration in serum or plasma (heparin). It is intended for use as an aid in the diagnosis and treatment of thyroid disorders. This device is an in vitro diagnostic medical device for professional use only.

# For VIDAS Testosterone:

The VIDAS Testosterone (TES) assay is an automated quantitative test for use on the instruments of the VIDAS family for the enzyme immunoassay measure of total testosterone in human serum or plasma (lithium heparin), using the ELF A technique (Enzyme Linked Fluorescent Assay). It is intended as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.

This device is an in vitro diagnostic medical device for professional use only.

# For VIDAS TSH:

The VIDAS® TSH (TSH) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyne-linked fluorescent immunoassay (ELFA) for the determination of human thyroid stimulating hormone- (TSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of thyroid or pituitary disorders.

This device is an in vitro diagnostic medical device for professional use only.

# For VIDAS D-Dimer Exclusion II:

VIDAS® D-Dimer Exclusion II™ is an automated quantitative test for use on the instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products (FbDP) in human plasma (sodium citrate, CTAD) using the ELFA technique (Enzyme Linked Fluorescent Assay).

VIDAS D-Dimer Exclusion II is indicated for use in conjunction with a clinical pretest probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease in outpatients suspected of DVT or PE. This device is an in vitro diagnostic medical device for professional use only.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a blue circle with a half-moon design on the left side. A green and yellow line runs vertically through the center of the circle. The word "BIOMÉ" is written in black, sans-serif font above the word "RIEUX".

# 510(k) SUMMARY

According to the 21 CFR 807.92, this 510(k) summary aims to provide an understanding of the basis for a determination of substantial equivalence.

Assigned 510(k) number: K141133

#### A1. Owner information

| Submitter's Name: | bioMérieux, Inc. |
|----------------------|----------------------------------------|
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| Contact Person: | John Albright |
| Telephone number | 314-731-8546 |
| Fax number | 314-731-8689 |
| Date of Preparation: | July 6, 2015 |

#### B1. Device Name

| Trade Name: | VIDAS® H.pylori IgG |
|------------------------|------------------------------------------|
| Common Name: | H.pylori IgG |
| Classification name: | Campylobacter fetus serological reagents |
| Classification panel: | Microbiology |
| Governing Regulation: | 21 CFR 866.3110 |
| Device Classification: | Class I |
| Product code: | LYR |

#### C1. Predicate Device

VIDAS H.pylori IgG (K001460)

#### D1. Device Description

The assay principle combines a 2-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA). All of the assay steps as well as the assay temperature are controlled automatically by the instrument. 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. After preliminary wash and sample dilution steps, the sample is cycled in and out of the SPR for a specified length of time. IgG antibodies to H. pylori present in the specimen will bind to the H. pylori antigen coating the interior of the SPR. Unbound sample components are washed away.

Anti-human IgG antibodies conjugated with alkaline phosphatase are cycled in and out of the SPR and will attach to any human IgG bound to the SPR wall. A final wash step removes unbound anti-human antibody conjugate. During the final detection step, the substrate (4 Methylumbellifery) phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a

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fluorescent product (4-Methylumbelliferone), the fluorescence of which is measured at 450 nm. The intensity of fluorescence is measured by the optical scanner in the instrument. At the assay, results are automatically calculated by the instrument, a test value is generated and a report is printed for each sample.

### E1. Intended Use

VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on the instruments of the VIDAS family, for the detection of anti-Helicobacter pylori IgG antibodies in human serum or plasma (EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS HPY assay is intended as an aid in diagnosis of H. pylori infection in an adult symptomatic population.

This device is an in vitro diagnostic medical device for professional use only.

#### F1. Technological Performances Summary

A summary of the technological characteristics of the new device in comparison to those of the predicate device is presented in the table below.

| Item | New Device<br>VIDAS H. pylori | Predicate (K001460)<br>VIDAS H. pylori |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Intended Use | VIDAS® H. pylori IgG (HPY) is an automated<br>qualitative test for use on the instruments of the<br>VIDAS family, for the detection of anti-Helicobacter<br>pylori IgG antibodies in human serum or plasma<br>(EDTA) using the ELFA technique (Enzyme Linked<br>Fluorescent Assay). The VIDAS HPY assay is<br>intended as an aid in diagnosis of H. pylori infection<br>in an adult symptomatic population. | Same |
| Sample type | Serum or plasma | Same |
| Analyte | H.pylori IgG | Same |
| Assay Technique | Enzyme-linked fluorescent immunoassay (ELFA) | Same |
| Kit Composition | 30 Strips, 1x30 SPRs, 1 Standard (liquid), 1 Positive<br>Control (liquid), 1 Negative Control (liquid) | Same<br>(no change to assay). |
| Automated | Yes | Same |
| Instrumentation | VIDAS, miniVIDAS, VIDAS 3 | VIDAS, miniVIDAS |

#### G1. Performance Data

#### Method Comparison

A study was conducted to verify the correlation of the VIDAS H. pylori IgG assay on the VIDAS 3 to the VIDAS H. pylori lgG assay on the VIDAS. One reagent lot, one of each instrument and 250 serum samples including positive, equivocal and negative samples were used, and results were evaluated according to CLSI EP12-A2 quideline "User Protocol for Evaluation of Qualitative Test Performance; Approved guideline".

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Image /page/6/Picture/1 description: The image contains the logo for bioMérieux. The logo features the company name in a stylized, sans-serif font, with the "bio" portion in a smaller font size than "Mérieux". Above the name is a circular graphic that is half blue and half white with a green and yellow curved line running through the middle of the circle and extending above and below it.

### Contingency Table:

| | | VIDAS | | | |
|---------|-----------|----------|-----------|----------|-------|
| | | Positive | Equivocal | Negative | Total |
| VIDAS 3 | Positive | 122 | 3 | 0 | 125 |
| | Equivocal | 0 | 6 | 4 | 10 |
| | Negative | 0 | 2 | 113 | 115 |
| | Total | 122 | 11 | 117 | 250 |

Associated percent agreements and their 95% two-sided score confidence intervals (CI) are calculated in the table below :

| Category | Samples of<br>interest/Total | Percent Agreement<br>2-sided 95% CI |
|----------|------------------------------|-------------------------------------|
| Negative | 113/117 | 96.6%<br>[ 91.5 ; 98.7 ] % |
| Positive | 122/122 | 100%<br>[ 96.9 ; 100.0 ] % |

## Precision

Three serum samples with samples close to the assay cut-off and moderate positive samples were tested in triplicate (3 replicates) twice a day (2 runs per day) over 6 days on 1 reagent lot using 3 instruments at 1 site (N = 108). The repeatability (within-run precision), between-day, between calibration, between instrument, total between calibration, and total between instrument precision were calculated according to CLSI EP5-A2 "Evaluation of Precision Performance of Quantitative Measurement Methods" and CLSI EP12-A2 "User Protocol for Evaluation of Qualitative Test Performance; Approved guideline - Second Edition". The results were as follows:

| | Sample 1<br>N = 108<br>Mean Test Value (TV)<br>0.76 | | Sample 2<br>N = 108<br>Mean Test Value (TV)<br>1.26 | | Sample 3<br>N = 108<br>Mean Test Value (TV)<br>2.23 | |
|-------------------------------|-----------------------------------------------------|--------|-----------------------------------------------------|--------|-----------------------------------------------------|--------|
| | SD | CV (%) | SD | CV (%) | SD | CV (%) |
| Within-RUN<br>(Repeatability) | 0.06 | 7.7 | 0.08 | 6.2 | 0.12 | 5.2 |
| Between-RUN | 0.04 | 5.7 | 0.04 | 3.0 | 0.04 | 1.7 |
| Between-DAY | 0.00 | 0.0 | 0.00 | 0.0 | 0.05 | 2.4 |
| Between-<br>CALIBRATION | 0.01 | 2.0 | 0.03 | 2.0 | 0.05 | 2.1 |
| Between-<br>INSTRUMENT | 0.02 | 2.4 | 0.00 | 0.0 | 0.05 | 2.3 |

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Image /page/7/Picture/1 description: The image shows the logo for bioMérieux. The logo features the company name in a sans-serif font, with the letters spaced apart. Above the name is a blue sphere with curved lines on the left side, and a green line extending upwards from the sphere.

| Sample 1 | | Sample 2 | | Sample 3 | | |
|-------------------------------|--------|------------------------------|--------|------------------------------|--------|-----|
| N = 108 | | N = 108 | | N = 108 | | |
| Mean Test Value (TV)<br>0.76 | | Mean Test Value (TV)<br>1.26 | | Mean Test Value (TV)<br>2.23 | | |
| SD | CV (%) | SD | CV (%) | SD | CV (%) | |
| Total Between-<br>CALIBRATION | 0.07 | 9.8 | 0.09 | 7.2 | 0.14 | 6.4 |
| Total Between-<br>INSTRUMENT | 0.08 | 10.1 | 0.09 | 7.2 | 0.15 | 6.8 |

#### H1. Conclusion

The results for the performance testing submitted in this premarket notification are complete and demonstrate that the VIDAS H.pylori Assay is substantially equivalent to the predicate device identified in Item C1 of this summary. The addition of the VIDAS 3 instrument to the VIDAS Family does not affect the safety and effectiveness of the Reagent kit.

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Image /page/8/Picture/13 description: The image shows the logo for bioMérieux. The logo consists of the company name in a sans-serif font, with a stylized globe above it. A green line bisects the globe and the company name, adding a touch of visual interest to the logo.

### A2. Owner information

| Submitter's Name: | bioMérieux, Inc. |
|----------------------|----------------------------------------|
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| Contact Person: | John Albright |
| Telephone number | 314-731-8546 |
| Fax number | 314-731-8689 |
| Date of Preparation: | July 6, 2015 |

#### B2. Device Name

| Trade Name: | VIDAS® 3 |
|------------------------|---------------------------------------------------------------|
| Common Name: | VIDAS 3 |
| Classification name: | Analyzer, chemistry (photometric, discrete), for clinical use |
| Classification panel: | Clinical Chemistry |
| Governing Regulation: | 21 CFR 862.2160 |
| Device Classification: | Class I |
| Product code: | JJE |

#### C2. Predicate Device Name

Trade Name:

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)

#### D2. Device Description

The VIDAS® 3 instrument is an automated multiparametric immunoassay system, which uses ELFA (Enzyme Linked Fluorescent Assay) technology. The VIDAS 3 system offers primary tube sampling, automated sample dilution, reagent/sample detection and reagent traceability.

The technology used, which is adaptable to a wide range of assays, combines the EIA method with a final fluorescence reading: this technology is known as ELFA (Enzyme Linked Fluorescent Assay). The enzyme used in the VIDAS product range is alkaline phosphatase, which catalyzes the hydrolysis of the substrate 4-methyl umbelliferyl phosphate (4-MUP) into a fluorescent product 4-methyl umbelliferone (4-MU) the fluorescence of which is measured at 450nm. The immunological methods are either indirect ElA, immunocapture, sandwich or competition, all involving a conjugate using the alkaline phosphatase.

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Image /page/9/Picture/1 description: The image contains the logo for bioMérieux. The logo features a blue globe-like design with curved lines on the right side, and a green blade of grass extending from the top of the globe. Below the globe, the word "BIOMÉRIEUX" is written in a sans-serif font.

# E2. Intended Use

The VIDAS 3 system is a complete standalone immunodiagnostic system intended for trained and qualified laboratory technicians (daily routine use) and laboratory administrators (application configuration).

This device is an in vitro diagnostic medical device for professional use only.

# F2. Technological Performances Summary

| Component | New Device<br>VIDAS 3 | Predicate (K891385)<br>VIDAS Instrument |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | VIDAS 3 | VIDAS |
| Indications for<br>Use | The VIDAS 3 system is a complete standalone<br>immunodiagnostic system intended for trained<br>and qualified laboratory technicians (daily<br>routine use) and laboratory administrators<br>(application configuration).<br>This device is an in vitro diagnostic medical<br>device for professional use only. | The VIDAS® is a compact automated<br>multiparametric immunoanalyzer that<br>using predispensed disposable reagent<br>strips and specially coated Solid Phase<br>Receptacles (SPRs), can pipette, mix,<br>incubate, control and analyze samples<br>for in vitro diagnostic purposes.<br>The VIDAS is only dedicated to be used<br>in combination with VIDAS reagents<br>range, designed and produced by<br>bioMérieux.<br>The technology used, which is<br>adaptable to a wide range of assays,<br>combines the EIA method with a final<br>fluorescence reading: this technology is<br>known as ELFA (Enzyme Linked<br>Fluorescent Assay). The enzyme used<br>in the VIDAS product range is alkaline<br>phosphatase, which catalyzes the<br>hydrolysis of the substrate 4-methyl<br>umbelliferyl phosphate (4-MUP) into a<br>fluorescent product 4-methyl<br>umbelliferone (4-MU) the fluorescence<br>of which is measured at 450nm.<br>The immunological methods are either<br>indirect EIA, immunocapture, sandwich<br>or competition, all involving a conjugate<br>using the alkaline phosphatase.<br>This device is an in vitro diagnostic<br>medical device for professional use<br>only. |
| Technology | Automated multiparametric immunoassay<br>system which uses ELFA (Enzyme Linked<br>Fluorescent Assay) technology. | Same |
| # Sections | 4 | 5 |
| Reagent slots<br>per section | 3 | 6 |
| Component | New Device<br>VIDAS 3 | Predicate (K891385)<br>VIDAS Instrument |
| Total # samples<br>that can be run<br>simultaneously | 12 | 30 |
| Monitor | Peripheral (Attached) | Peripheral |
| Computer | Peripheral | Peripheral |
| Keyboard | Peripheral | Peripheral |
| Printer | Peripheral | Peripheral |
| Instrument<br>Components | All unique or updated components are verified<br>to not affect reagent performance. | All unique or updated components are<br>verified to not affect reagent<br>performance. |
| Components<br>(Scanner head) | The scanner head is an instrument sub-system<br>that's primary function is to perform the optical<br>reading of the fluorescence as generated by the<br>immunoassay reaction. | Same |
| Components<br>(Software) | The user Software functions include: entry of<br>patient data; run execution; data reduction and<br>interpretation through a computation engine;<br>edition of results; system supervision;<br>management of calibrations and controls;<br>validation of results; management of patient<br>records. | While the VIDAS 3 software is unique<br>to the VIDAS 3, it offers the same basic<br>functions as the VIDAS software and<br>uses the same computation engine. |
| Components<br>(Reagents) | VIDAS reagents are comprised of predispensed<br>disposable reagent strips and specially coated<br>Solid Phase Receptacles (SPRs). | Same |
| Reagent<br>(Principle of<br>Operation) | Each VIDAS assay has been designed to be<br>run on any of the three VIDAS family<br>instruments. Each assay has a unique protocol<br>(volumes, sequence of steps, incubation times,<br>etc) that is independent of the instrument. | Same |
| Reagent | The assay intended use, clinical utility, principle<br>of operation, kit composition, kit stability, kit<br>storage conditions, calibration type, calibration<br>frequency, sample type, sample volume,<br>calculation of results, and interpretation of<br>results are all independent of the instrument. | Same |
| Reagent Loading | Manual | Same |
| SPR/Strip<br>synchronization | Automated confirmation | Manual |
| Sample Pipetting | Manual or automated | Manual |
| Sample dilutions | Manual or automated | Manual |
| Execution of the<br>assay protocol | Each assay has its own pre-defined protocol<br>that defines the sequence of assay steps (e.g.<br>volumes, incubation times, order of steps). | Same |
| Enzymatic<br>Reading | The reading made by the scanner head is<br>based on the 4-methylumbelliferone (4-MU)<br>fluorescent product located in the optical<br>cuvette of the reagent strip after the enzymatic<br>reaction has occurred. | Same |
| Component | New Device<br>VIDAS 3 | Predicate (K891385)<br>VIDAS Instrument |
| Calculation and<br>Interpretation of<br>results | Data reduction of the fluorescence<br>measurement is based upon computation<br>engine and a knowledge base including assay<br>and lot specific information. | Same |
| Unload Strips /<br>SPRs | After completion of the run, the user manually<br>removes the reagent Strips and SPRs. | Same |
| Unload other<br>reagents and<br>waste | Manual | Not applicable |

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#### G2. Performance Data

The VIDAS 3 performance testing was demonstrated through assay performance testing, using VIDAS D-Dimer Exclusion II, VIDAS H. pylori, VIDAS Human Chorionic Gonadotropin, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS T4, VIDAS Testosterone, VIDAS TOXO M, and VIDAS TSH assays as the representative assays. This assay performance testing, which included method comparison, precision, detection limits, and linearity, demonstrated equivalency of the VIDAS 3 to the VIDAS and that running a VIDAS assay on either the VIDAS instrument or the VIDAS 3 instrument has no significant impact on the assay results.

#### H2. Conclusion

The results for the performance testing submitted in this premarket notification are complete and demonstrate that the VIDAS 3 is substantially equivalent to the predicate device identified in Item C2 of this summary.

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### A3. Owner information

| Submitter's Name: | bioMérieux, Inc. |
|----------------------|----------------------------------------|
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| Contact Person: | John Albright |
| Telephone number | 314-731-8546 |
| Fax number | 314-731-8689 |
| Date of Preparation: | July 6, 2015 |

#### B3. Device Name

| Trade Name: | VIDAS® Lyme IgG II |
|------------------------|--------------------------------------------|
| Common Name: | Lyme IgG |
| Classification name: | Treponema pallidum treponemal test reagent |
| Classification panel: | Microbiology |
| Governing Regulation: | 21 CFR 866.3830 |
| Device Classification: | Class II |
| Product code: | LSR |

# C3. Predicate Device

VIDAS® Lyme IgG (K122986)

#### D3. Device Description

The VIDAS Lyme IgG II 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. Antihuman 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-Methylumbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methylumbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the quantity of anti-B. burgdorferi IgG antibody present in the sample.

At the end of the VIDAS Lyme IgG II assay, results are automatically calculated by the instrument. A test value is generated and a report is printed.

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### E3. Intended Use

The VIDAS Lyme IgG II (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 II positive specimens should be further tested with a Western Blot IgG assay to obtain supportive evidence of infection with B. burgdorferi.

This device is an in vitro diagnostic medical device for professional use only.

### F3. Technological Performances Summary

A summary of the technological characteristics of the new device in comparison to those of the predicate device is presented in the table below.

| Item | New Device<br>VIDAS Lyme IgG II | Predicate (K122986)<br>VIDAS Lyme IgG |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Intended Use | The VIDAS Lyme IgG II (LYG) assay is an<br>automated qualitative enzyme immunoassay<br>intended for use on the instruments of…