VIDAS RUB IGG

K080766 · bioMerieux, Inc. · LFX · Dec 23, 2008 · Microbiology

Device Facts

• Record ID: K080766
• Device Name: VIDAS RUB IGG
• Applicant: bioMerieux, Inc.
• Product Code: LFX · Microbiology
• Decision Date: Dec 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3510
• Device Class: Class 2

Intended Use

The VIDAS® RUB IgG (RBG) assay uses Enzyme Linked Fluorescent Assay (ELFA) technology on the VIDAS® automated instruments for the in vitro quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum. The VIDAS® RUB IgG 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.

Device Story

VIDAS® RUB IgG is an automated enzyme-linked fluorescent immunoassay (ELFA) for detecting rubella-specific IgG in human serum. The system uses a Solid Phase Receptacle (SPR®) as both a pipette tip and solid phase, and a reagent strip containing assay reagents. The process involves: sample dilution; incubation in the SPR where anti-rubella IgG binds to rubella antigen; washing; incubation with alkaline phosphatase-conjugated anti-human IgG; and final fluorescent detection using 4-methyl-umbelliferyl phosphate substrate. The VIDAS instrument measures fluorescence intensity, which is proportional to antibody concentration. Results are calculated against a stored calibration curve traceable to the WHO 1st International Standard (RUBI-1-94). The device is used in clinical laboratories by professional staff. Output is a quantitative value (IU/mL) used alongside clinical history to assess rubella immune status. The automated workflow reduces manual handling and provides standardized, objective results for clinical decision-making regarding vaccination or infection risk.

Clinical Evidence

Clinical performance was evaluated using 1,130 specimens (prospective and retrospective) compared against a consensus of three FDA-cleared assays. The study included pregnant women and general populations. Results showed high positive agreement (92.0%–97.1%) and negative agreement (66.7%–100%) across cohorts. CDC panel testing (100 samples) demonstrated 97.6% positive and 100% negative agreement. Analytical studies confirmed linearity (0–274 IU/mL), precision (total CV 10.2%–13.8%), and lack of cross-reactivity with common disease states. No clinical data for immunocompromised or neonatal populations.

Technological Characteristics

ELFA technology; automated instrument-based. Solid Phase Receptacle (SPR) coated with rubella antigen. Detection: 450 nm fluorescence. Reagents: alkaline phosphatase-labeled mouse monoclonal anti-human IgG. Standardization: traceable to WHO 1st International Rubella Reference Standard. Measurement range: 0-400 IU/mL. Sample volume: 100 μL.

Indications for Use

Indicated for the quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum to aid in the determination of immune status to rubella. Not for use in cord blood, neonatal samples, or immunocompromised/immunosuppressed individuals.

Regulatory Classification

Identification

Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).

Special Controls

*Classification.* Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards': (i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,” (ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,” (iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,” (iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and (v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,” (2) Centers for Disease Control's: (i) Low Titer Rubella Standard, (ii) Reference Panel of Well Characterized Rubella Sera, and (3) World Health Organization's International Rubella Standard.

Predicate Devices

• AxSYM Rubella IgG Antibody Assay (K954045)

Submission Summary (Full Text)

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#### K080766 510(k) SUMMARY

### VIDAS® RUB IgG Assay

# DEC 2 3 2008

#### A. Submitter Information

| Submitter's Name: | bioMérieux, Inc. |
|-------------------------------|--------------------------------------------------------------------|
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| Contact Person: | Sandra Perreand<br>Sr. Director, North American Regulatory Affairs |
| Phone Number: | 314-731-8594 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | December 2008 |
| B. Device Name<br>Trade Name: | VIDAS® RUB IgG Assay |

| | 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Rubella IqG Antibody |
| Classification Name: | Enzyme Linked Immunoabsorbent Assay, Rubella |

#### C. Predicate Device Name Trade Name:

AxSYM Rubella IgG Antibody Assay

#### D. Device Description

The assay principle combines a 2-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. It is coated with Rubella antigen. The other reagents for the assay are ready-to-use and pre-dispensed in the sealed reagent strips. The individual kit components are described in detail on the following pages.

All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times. This operation enables the Rubella antigen fixed onto the interior wall of the SPR to capture the Rubella antibodies present in the sample. After dilution, the sample is incubated with the SPR. Rubella IgG antibodies present in the specimen bind to the Rubella antigen coating the interior of the SPR. Unbound components are eliminated during the preliminary wash step.

A second incubation step is then performed using alkaline phosphatase labeled monoclonal anti-human IgG antibodies (mouse), followed by a second wash step.

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 concentration of antibodies present in the sample. At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory, and then printed out.

#### E. Intended Use

The VIDAS® RUB IgG (RBG) assay uses Enzyme Linked Fluorescent Assay (ELFA) technology on the VIDAS® automated instruments for the in vitro quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum. The VIDAS® RUB IgG 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.

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#### F. Technological Characteristics Summary

A general comparison of the similarities and differences of the VIDAS RUB IgG assay to the predicate
device is presented in the table below.

| Item | VIDAS® RUB IgG Assay | Abbott's<br>AxSYM Rubella IgG Antibody Assay<br>(K954045) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Comparison | | |
| Intended Use | The VIDAS® RUB IgG (RBG) assay uses<br>Enzyme Linked Fluorescent Assay<br>(ELFA) technology on the VIDAS®<br>automated instruments for the <i>in vitro</i><br>quantitative and qualitative measurement<br>of IgG antibodies to rubella virus in<br>human serum. The VIDAS® RUB IgG<br>assay is intended as an aid in the<br>determination of immune status to rubella.<br>The performance of this device has not<br>been established for screening of cord<br>blood, or for neonatal samples. Likewise,<br>performance characteristics of the assay<br>have not been established for<br>immunocompromised or<br>immunosuppressed individuals. | The AxSYM Rubella IgG assay is a<br>Microparticle Enzyme Immunoassay<br>(MEIA) for the quantitative and<br>qualitative measurement of IgG<br>antibodies to rubella virus in human<br>serum or plasma (EDTA, heparin or<br>sodium citrate) to aid in the<br>determination of immune status to<br>rubella. |
| Specimen | Serum | Serum or plasma (EDTA, heparin or<br>sodium citrate) |
| Analyte | Rubella IgG | Rubella IgG |
| Antibody | Mouse monoclonal anti-human IgG | Goat anti-human IgG |
| Assay Principle | Two step antibody binding of Rubella<br>antibodies. An antigen is bound to a solid<br>phase and anti-human IgG is in liquid<br>form and is labeled with fluorescent<br>compound | Twostep antibody binding of Rubella<br>antibodies. An antigen is bound to a<br>solid phase and anti-human IgG is in<br>liquid form and is labeled with<br>fluorescent compound |
| Automated | Yes | Yes |
| Assay Technique | Enzyme-linked fluorescent assay (ELFA) | Microparticle enzyme immunoassay<br>(MEIA) |
| Sample Volume | 100 μL | 180 μL |
| Traceability/<br>Standardization | Master curve for each kit lot and each<br>calibrator lot are traceable to the 2nd<br>preparation of the World Health<br>Organization (WHO) 1st International<br>Rubella Reference Standard | Each calibrator lot is traceable to the<br>World Health Organization (W.H.O.)<br>2nd International Standard for Anti-<br>Rubella Immunoglobulin |
| Measurement range | 0 - 400 IU/mL | 0 - 500.0 IU/mL |

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# G. Performance Data

# Precision

Four serum samples were tested in duplicate twice a day (2 runs per day over 10 days) on each of the 2 reagent lots using a single instrument at each of three sites (N = 240). The repeatability (intra-run precision, between-site precision and total precision were calculated according to the CLS10 EP5-A2 document.

| | | Repeatability | | Inter-run<br>precision | | Between site<br>precision | | Total precision | |
|----------|-----------------------------------|-----------------------|-----------|------------------------|-----------|---------------------------|-----------|-----------------------|-----------|
| Sample | Mean<br>concentration<br>on IU/mL | Standard<br>deviation | CV<br>(%) | Standard<br>deviation | CV<br>(%) | Standard<br>deviation | CV<br>(%) | Standard<br>deviation | CV<br>(%) |
| Sample 1 | 7.8 | 0.58 | 7.4 | 0.58 | 7.4 | 0.20 | 2.5 | 0.84 | 10.8 |
| Sample 2 | 8.8 | 0.57 | 6.4 | 0.66 | 7.4 | 0.22 | 2.5 | 0.89 | 10.2 |
| Sample 3 | 29.8 | 1.46 | 4.9 | 2.62 | 8.8 | 0.95 | 3.2 | 3.14 | 10.6 |
| Sample 4 | 154.6 | 10.58 | 6.8 | 18.49 | 12.0 | 0.00 | 0.0 | 21.30 | 13.8 |

# Clinical Performance

The following tables compare the results of the V!DAS® RUB !gG assay to the consensus comparator

# Prospective populations

| | Prospective Pregnant Women<br>2/3 Consensus | | | | Prospective General<br>2/3 Consensus | | | |
|--------|---------------------------------------------|-------|-----|-------|--------------------------------------|-------|-----|-------|
| VIDAS® | Pos | Equiv | Neg | Total | Pos | Equiv | Neg | Total |
| Pos | 309 | 1 | 0 | 310 | 170 | 1 | 0 | 171 |
| Equiv | 10 | 3 | 0 | 13 | 3 | 1 | 0 | 4 |
| Neg | 0 | 0 | 2 | 2 | 0 | 2 | 2 | 4 |
| Total | 319 | 4 | 2 | 325 | 173 | 4 | 2 | 179* |

| | % Agreement | 95% CI | % Agreement | 95% CI |
|----------|-----------------|-------------|-----------------|-------------|
| Positive | 96.9% (309/319) | 94.3 – 98.5 | 97.1% (170/175) | 93.5 – 99.1 |
| Negative | 66.7% (2/3) | 9.4 – 99.2 | 66.7% (2/3) | 9.4 – 99.2 |

*One sample was defined as QNS (quantity not sufficient) and excluded from the analysis.

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### Retrospective populations

| | Retrospective Pregnant Women<br>2/3 Consensus | | | | | Retrospective General<br>2/3 Consensus | | | |
|--------|-----------------------------------------------|-------|-----|-------|-----|----------------------------------------|-----|-------|--|
| VIDAS® | Pos | Equiv | Neg | Total | Pos | Equiv | Neg | Total | |
| Pos | 179 | 0 | 0 | 179 | 169 | 0 | 0 | 169 | |
| Equiv | 9 | 4 | 0 | 13 | 7 | 4 | 0 | 11 | |
| Neg | 0 | 5 | 3 | 8 | 1 | 6 | 104 | 111 | |
| Total | 188 | 9 | 3 | 200 | 177 | 10 | 104 | 291* | |

| | % Agreement | 95% CI | % Agreement | 95% CI |
|----------|-----------------|-----------------|-----------------|-----------------|
| Positive | 92.7% (179/193) | 88.1 –<br>96.0 | 92.3% (169/183) | 87.5 – 95.8 |
| Negative | 100% (3/3) | 29.2 –<br>100.0 | 100% (104/104) | 96.5 –<br>100.0 |

*Five samples were defined as QNS (quantity not sufficient) and excluded from the analysis

### Pre-selected Pregnant Women Population

| Pre-selected Pregnant Women<br>2/3 Consensus Method | | | | |
|-----------------------------------------------------|-----|-------|-----|-------|
| VIDAS® | Pos | Equiv | Neg | Total |
| Pos | 23 | 0 | 0 | 23 |
| Equiv | 0 | 0 | 0 | 0 |
| Neg | 0 | 2 | 102 | 104 |
| Total | 23 | 2 | 102 | 127* |

| | % Agreement | 95% CI |
|----------|----------------|--------------|
| Positive | 92.0% (23/25) | 74.0 - 99.0 |
| Negative | 100% (102/102) | 96.4 - 100.0 |

*Two samples were defined as QNS (quantity not sufficient) and excluded from the analysis.

### H. Conclusion

#### The VIDAS® RUB IgG Assay is substantially equivalent to Abbott Laboratories AxSYM Rubella lgG Antibody Assay.

The 510(k) summary includes only information that is also covered in the body of the 510(k). The summary does not contain any puffery or unsubstantiated labeling claims. The summary does not contain any raw data, i.e., contains only summary data. The summary does not contain any trade secret or confidential commercial information. The summary does not contain any patient identification information.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Sandra Perreand Sr. Director, N.A. Regulatory Affairs bioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042

DEC 2 3 2008

Re: K080766

> Regulation Number: 21CFR §866.3510 Regulation Name: Regulatory Class: Product Code: Dated: Received:

Trade/Device Name: VIDAS® RUB IgG Assay Rubella virus serological reagents Class II LFX December 19, 2008 December 22, 2008

Dear Ms. Perreand:

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, morket the device, subject to the general controls provisions of the Act. The general controls, ontrols. 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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the ruality our uns (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 attayma

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K080766

Device Name: VIDAS® RUB IgG

Indications For Use:

The VIDAS® RUB IgG (RBG) assay uses Enzyme Linked Fluorescent Assay (ELFA) technology on the VIDAS® automated instruments for the in vitro quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum. The VIDAS® RUB IgG 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.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Une Schaf

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k080766