BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET

K080008 · Bio-Rad Laboratories, Inc. · OMI · Feb 23, 2009 · Microbiology

Device Facts

• Record ID: K080008
• Device Name: BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: OMI · Microbiology
• Decision Date: Feb 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3510
• Device Class: Class 2

Intended Use

The BioPlex™ 2200 ToRC IgG kit is a multiplex flow immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella, and the qualitative detection of IgG antibodies to Cytomegalovirus (CMV) in human serum and EDTA or heparinized plasma. The ToRC IgG kit is intended for use with the Bio-Rad BioPlex 2200 System. This kit is intended as an aid in the determination of serological status to T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors. Performance characteristics for T. gondii and Rubella have not been evaluated in immunocompromised or immunosuppressed individuals. Performance characteristics for CMV have not been evaluated in immunosuppressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at a point of care.

Device Story

Multiplex flow immunoassay using fluoromagnetic beads coated with T. gondii, Rubella, and CMV antigens; includes internal standard, serum verification, and reagent blank beads. Operates on BioPlex 2200 System; patient sample mixed with diluent and beads; incubated at 37°C; bound IgG detected via PE-labeled anti-human IgG conjugate using flow cytometry. System calculates results in relative fluorescence intensity (RFI); T. gondii and Rubella reported in IU/mL (quantitative); CMV reported as antibody index (qualitative). Used in clinical laboratories by trained personnel. Output aids clinicians in determining patient serological status. Benefits include simultaneous multi-analyte testing from a single sample.

Clinical Evidence

Clinical performance evaluated via prospective and retrospective studies. Prospective study (N=700-1500) compared BioPlex 2200 against predicate immunoassays. T. gondii IgG agreement: 97.5% positive, 98.8% negative. Rubella IgG agreement: 97.2% positive, 100% negative (pregnant women). CMV IgG agreement: 99.0% positive, 98.7% negative. Retrospective study (N=226) for Rubella IgG showed 92.8% positive agreement. CDC reference panel testing (N=100 per analyte) confirmed performance. Studies included reproducibility (CLSI EP5-A2), linearity (CLSI EP6-A), and interference/cross-reactivity testing.

Technological Characteristics

Multiplex flow immunoassay using paramagnetic microbeads infused with red/infrared fluorescent dyes for classification. Antigen-coated beads (T. gondii, Rubella, CMV lysates). Detection via green fluorescence (phycoerythrin-conjugated anti-human IgG). System includes internal standard, serum verification, and reagent blank beads. Preservatives: ProClin 300, sodium benzoate, sodium azide. Automated system (BioPlex 2200) with integrated software.

Indications for Use

Indicated for the quantitative detection of IgG antibodies to T. gondii and Rubella, and qualitative detection of IgG antibodies to CMV in human serum and EDTA/heparinized plasma to aid in determining serological status. Not for blood/plasma donor screening, neonatal screening, or point-of-care use. Performance not established for immunocompromised/immunosuppressed individuals (T. gondii/Rubella) or organ transplant patients (CMV).

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

• bioMerieux, Inc. VIDAS® TOXO IgG II (K993319)
• bioMérieux, Inc. VIDAS® Rubella IgG (K902925)
• bioMérieux, Inc. VIDAS® CMV IgG (K920661)

Submission Summary (Full Text)

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## 510(k) Summary for Bio-Rad Laboratories, Inc. BioPlex™ 2200 ToRC IgG

#### 1. Applicant/Sponsor

Bio-Rad Laboratories, Inc. BioPlex Division 5500 East Second Street Benicia, CA 94510

Contact Person: Teresa Peterson Telephone: [phone] Date Prepared: February 18, 2009

#### 2. Device Name

Proprietary Name:

Common/Usual Name:

Classification Name:

BioPlex™ 2200 ToRC IgG Kit BioPlex™ 2200 ToRC IgG Calibrator Set BioPlex™ 2200 ToRC IgG Control Set · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

Multi-Analyte Detection System for Toxoplasma gondii IgG, Rubella IqG and Cytomegalovirus (CMV) IqG

Toxoplasma gondii serological reagents Rubella virus serological reagents Cytomegalovirus serological reagents Calibrator, multi-analyte mixture Multi-analyte controls, all kinds (assayed and unassayed)

#### 3. Predicate Devices

| • bioMerieux VIDAS® TOXO IgG II | K993319 |
|---------------------------------|---------|
| • bioMerieux VIDAS® Rubella IgG | K902925 |
| • bioMerieux VIDAS® CMV IgG | K920661 |

FEB 2 3 2009

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#### 4. DEVICE DESCRIPTION

The BioPlex™ 2200 ToRC IgG kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional EIA, but permits simultaneous detection and identification of many antibodies in a single tube. "ToRC" is an acronym for individual tests to detect antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV). Three (3) different populations of dyed beads are coated with cell lysates bearing T. gondii, Rubella, or CMV antigens. and the state of the first the

The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel; the mixture is incubated at 37°C. After a wash cycle, anti-human IgG antibody, conjugated to phycoerythrin (PE), is added to the dyed beads, and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data are calculated in relative fluorescence intensity (RFI).

Three additional dyed beads, Internal Standard Bead (ISB), Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum or plasma to the reaction vessel and the absence of significant non-specific binding in serum or plasma.

The instrument is calibrated using a set of six (6) distinct calibrator vials, the BioPlex 2200 ToRC IgG Calibrator Set. For T. gondii and Rubella, six (6) vials, representing six (6) different levels of antibody concentrations, are used for quantitative calibration, and results for patient samples are expressed in IU/mL. For T. gondii, results of ≤ 9 IU/mL are negative, 10 and 11 IU/mL are equivocal, and results of ≥ 12 IU/mL are reported as positive. For Rubella, results of ≤ 7 : U/mL are reported as negative, 8 and 9 /U/mL are equivocal, and ≥ 10 IU/mL are reported as positive. For CMV, four (4) vials, representing four (4) different antibody concentrations, are used for qualitative calibration. CMV results are expressed as an antibody index (Al) and results of ≤ 0.8 Al are negative, 0.9 and 1.0 Al are equivocal, and results of ≥ 1.1 Al are reported as positive.

The BioPlex 2200 ToRC IgG Control Set includes a negative control as well as two (2) multi-analyte positive controls. The BioPlex ToRC IgG Low Positive Control contains antibodies for T. gondii, Rubella and CMV and the BioPlex ToRC IgG High Positive Control contains antibodies for T. gondii and Rubella. The BioPlex ToRC IqG Positive Controls are manufactured to give positive results, with values above the cut-off for each specific analyte. The BioPlex ToRC IgG Negative Control is manufactured to give negative results, with values below the cut-off for each specific analyte. The recommended frequency for performing quality control is once every 24-hour testing

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period. Performing quality control is also necessary after each new assay calibration and certain service procedures.

#### BioPlex™ 2200 ToRC IgG Kit Components

The BioPlex 2200 ToRC IgG kit (665-1650) contains supplies sufficient for 100 tests.

| Vial | Description |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bead Set | One (1) 10 mL vial containing three (3) different populations<br>of dyed beads coated with lysates (tachyzoites, Vero cell and<br>nuclear) of T. gondii, Rubella and CMV; plus an Internal<br>Standard Bead (ISB), a Serum Verification Bead (SVB) and a<br>Reagent Blank Bead (RBB); with protein stabilizers (bovine)<br>in a saline buffer. ProClin® 300 (0.3%), sodium benzoate<br>(0.1%) and sodium azide (<0.1%) as preservatives. |
| Conjugate | One (1) 5 mL vial, containing murine monoclonal anti-human<br>IgG/phycoerythrin conjugate, in a phosphate buffer. ProClin®<br>300 (0.3%), sodium benzoate (0.1%) and sodium azide<br>(<0.1%) as preservatives. |
| Sample Diluent | One (1) 10 mL vial, containing protein stabilizers (bovine and<br>murine) in a saline buffer. ProClin® 300 (0.3%), sodium<br>benzoate (0.1%) and sodium azide (<0.1%) as preservatives. |

#### Additional Required Items, Available from Bio-Rad:

| Catalog # | Description |
|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 663-1600 | BioPlex 2200 ToRC IgG Calibrator Set: Six (6) 0.5 mL vials<br>containing antibodies to T. gondii, Rubella and CMV derived<br>from human disease state plasma, in a human serum matrix<br>made from defibrinated plasma. ProClin® 300 (0.3%),<br>sodium benzoate (0.1%) and sodium azide (<0.1%) as<br>preservatives. |
| 663-1630 | BioPlex 2200 ToRC IgG Control Set: Two (2) 1.5 mL vials of<br>Low Positive Control containing antibodies to T. gondii,<br>Rubella and CMV; two (2) 1.5 mL vials of High Positive<br>Control containing antibodies to T. gondii and Rubella; and<br>two (2) 1.5 mL vials of Negative Control Serum. All controls<br>in a human serum matrix made from defibrinated plasma,<br>with ProClin® 300 (0.3%), sodium benzoate (0.1%) and<br>sodium azide (<0.1%) as preservatives. All antibodies are<br>derived from human disease state plasma. |
| 660-0817 | BioPlex 2200 Sheath Fluid: Two (2) 4 L bottles containing<br>Phosphate Buffered Saline (PBS). ProClin® 300 (0.03%) and<br>sodium azide (<0.1%) as preservatives. |
| 660-0818 | BioPlex 2200 Wash Solution: One (1) 10 L bottle containing<br>Phosphate Buffered Saline (PBS) and Tween 20. ProClin®<br>300 (0.03%) and sodium azide (<0.1%) as preservatives. |
| 660-0000 | BioPlex 2200 Instrument and Software System. |

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#### 5. Intended Use

#### BioPlex™ 2200 ToRC IgG Kit

The BioPlex™ 2200 ToRC IgG kit is a multiplex flow immunoassay intended for the quantitative detection of IqG antibodies to Toxoplasma gondii (T. gondii) and Rubella, and the qualitative detection of IgG antibodies to Cytomegalovirus (CMV) in human serum and EDTA or heparinized plasma.

The ToRC IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.

This kit is intended as an aid in the determination of serological status to T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors.

Performance characteristics for T. gondii and Rubella have not been evaluated in immunocompromised or immunosuppressed individuals. Performance characteristics for CMV have not been evaluated in immunosuppressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at a point of care.

#### BioPlex™ 2200 ToRC IgG Calibrator Set

The BioPlex 2200 ToRC IgG Calibrator Set is intended for the calibration of the BioPlex 2200 ToRC IgG Reagent Pack.

#### BioPlex™ 2200 ToRC IgG Control Set

The BioPlex 2200 ToRC IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex ToRC IgG Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 ToRC IgG Control Set has not been established with any other Toxoplasma gondii, Rubella or Cytomegalovirus (CMV) IgG antibody assays.

#### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The following tables summarize the similarities and differences between the BioPlex 2200 ToRC IgG kit and the predicate devices used in comparative studies with the BioPlex 2200 ToRC IgG kit.

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BioPlex™ 2200 ToRC IgG Kit vs. Predicate Devices - Similarities

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| | BioPlex™ 2200<br>ToRC IgG Kit | bioMerieux, Inc. VIDAS®<br>TOXO IgG II (K993319) | bioMerieux, Inc. VIDAS®<br>Rubella IgG (K902925) | bioMerieux, Inc. VIDAS®<br>CMV IgG (K920661) |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | - The BioPlex™ 2200 ToRC<br>IgG kit is a multiplex flow<br>immunoassay intended for the<br>quantitative detection of IgG<br>antibodies to Toxoplasma<br>gondii ( <i>T. gondii</i> ) and Rubella,<br>and the qualitative detection of<br>IgG antibodies to<br>Cytomegalovirus (CMV) in<br>human serum and EDTA or<br>heparinized plasma.<br>- The ToRC IgG kit is intended<br>for use with the Bio-Rad<br>BioPlex 2200 System.<br>- This kit is intended as an aid<br>in the determination of<br>serological status to <i>T. gondii</i> ,<br>Rubella and CMV. This kit is<br>not intended for use in the<br>screening of blood or plasma<br>donors. | VIDAS® Toxo IgG II (TXG) is<br>an automated quantitative test<br>for use on the VIDAS analyzer<br>for the measurement of anti-<br>Toxoplasma IgG in human<br>serum using the ELFA<br>technique. It is intended for<br>use as an aid in determination<br>of immune status. | VIDAS® Rubella IgG (RBG)<br>assay is intended for use with<br>a VIDAS (Vitek<br>ImmunoDiagnostic Assay<br>System) instrument as an<br>automated qualitative<br>enzyme-linked fluorescent<br>immunoassay (ELFA) for the<br>detection of IgG antibodies to<br>rubella virus in human serum. | VIDAS® Cytomegalovirus IgG<br>(CMVG) is intended for use<br>with the VIDAS (Vitek<br>ImmunoDiagnostic Assay<br>System) instrument as a semi-<br>quantitative automated<br>enzyme-linked fluorescent<br>immunoassay (ELFA)for the<br>detection of IgG antibodies to<br>Cytomegalovirus in human<br>serum. |
| Antigen | Partially purified cell lysates of<br><i>T. gondii</i> , Rubella, and CMV | Membrane and cytotoxic<br>Toxoplasma antigen<br>(RH Sabin Strain) | Inactivated Rubella virus<br>(HPV-77) | Purified and inactivated CMV<br>antigen (Strain AD 169) |
| Assay Type | Quantitative detection for<br><i>T. gondii</i> , Rubella, and<br>qualitative for CMV | | Same | Same |
| Analyte Detected | Human IgG antibodies<br>to <i>T. gondii</i> , Rubella, and<br>CMV | | Same | Same |
| Signal Detection | Fluorescence | | Same | Same |
| Item | BioPlex™ 2200<br>TORC IgG Kit | bioMerieux, Inc. VIDAS®<br>TOXO IgG II (K993319) | bioMerieux, Inc. VIDAS®<br>Rubella IgG (K902925) | bioMerieux, Inc. VIDAS®<br>CMV IgG (K920661) |
| Number of Analytes<br>Simultaneously<br>Detected | Multiple (3) | Single | Single | Single |
| Enzyme Conjugate | Phycoerythrin conjugated | | Horseradish peroxidase conjugated | |
| Matrices | Serum and plasma (EDTA<br>and heparin) | Serum and plasma (EDTA<br>and heparin) | Serum | |
| Assay Technology | Multiplex flow immunoassay | | Two-step enzyme immunoassay sandwich method with fluorescent detection (ELFA) | |
| Solid Phase | Antigen-coated paramagnetic<br>microbead reagent.<br>Microbeads are infused with<br>red and infrared fluorescent<br>dyes for bead classification.<br>Green fluorescence from the<br>immunoassay label is used for<br>analyte measurement. | | Antigen-coated solid phase receptacles | |
| Calibrator(s) | Multiple Calibrators | | Single Calibrator | |
| Controls | Negative Control and multi-<br>analyte Positive Controls | Negative Control and Positive<br>Control specific for <i>T. gondii</i> | Negative Control and Positive<br>Control specific for rubella<br>virus | Negative Control and Positive<br>Control specific for CMV virus |

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Bio-Rad Laboratories, Inc. 510(K)
Additional Information - K080008

510(k) Summary

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February 18, 2009

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BioPlex 2200 ToRC IgG Kit vs. Predicate Devices - Differences

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510(k) Summary

February 18, 2009

Bio-Rad Laboratories, Inc. 510(k

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#### 7. Performance Testing

A series of studies was conducted to evaluate the performance of the BioPlex™ 2200 ToRC IgG kit. The studies included reproducibility, linearity, interfering substances, cross-reactivity, correlation with CDC evaluation panels, expected values and performance characteristics. The results of all studies demonstrated that the BioPlex 2200 ToRC IgG kit performed according to its specifications.

#### A. Reproducibility

Separate internal and external reproducibility studies were conducted to evaluate the reproducibility of the BioPlex 2200 ToRC IgG kit on the BioPlex 2200 instrument. Reproducibility studies were based on the principles described in Clinical and Laboratory Standards Institute (CLSI) EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods.

For the internal reproducibility study, three (3) panels made from serum and plasma (EDTA and heparinized) were assayed two (2) times in two (2) separate daily runs over 20 days (n=80). The data were analyzed for withinrun, between-run, between-day, and total precision and the standard deviation (SD) and percent coefficient of variation (% CV) were calculated. The within-run precision for positive samples, greater than their respective cut-offs. in all sample matrices ranged from 3.9% to 9.5% for T. gondii IgG, 3.0% to 5.0% for Rubella IgG, and 1.8% to 5.6% for CMV IgG. The total precision for positive samples, greater than their respective cut-offs, in all sample matrices ranged from 6.6% to 12.3% for T. gondii IgG, 5.2% to 9.9% for Rubella IgG, and 3.8% to 8.7% for CMV IgG.

An external reproducibility study was performed at each of three (3) U.S. testing facilities. Three (3) panels made from serum and plasma (EDTA and heparinized) were assayed two (2) times on two (2) separate daily runs over five (5) days at the three (3) sites (N=60). The data were analyzed for withinrun, between-run, between-day, between-site, and total precision and the standard deviation (SD) and percent coefficient of variation (% CV) were calculated. The within-run precision for positive samples, greater than their respective cut-offs, in all sample matrices ranged from 3.7% to 7.7% for T. gondii IgG, 4.6% to 6.6% for Rubella IgG, and 2.5% to 5.8% for CMV IgG. The total precision for positive samples, greater than their respective cut-offs, in all sample matrices ranged from 4.8% to 17.6% for T. gondii IgG, 7.2% to 10.3% for Rubella IgG and 4.4% to 12.1% for CMV IgG.

An additional external Rubella reproducibility study was performed at each of three (3) U.S. testing facilities. A panel of three (3) Rubella IgG samples measuring near cut-off was assayed in replicates of 40 in one run at each

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The data were analyzed for within-run precision and the standard site. deviation (SD) and percent coefficient of variation (% CV) were calculated. The within-run precision ranged from 5.2% to 9.7%.

#### B. Linearity

Linearity of the BioPlex 2200 ToRC IgG kit was determined based on the principles described in Clinical and Laboratory Standards Institute (CLSI) EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: Statistical Approach. The assay ranges are T. gondii (3 - 900 IU/mL), Rubella (1 - 250 IU/mL) and CMV (0.2 - 8.0 Al), and were established by examining the clinical relevance of reporting high value results and the ability of the calibration curve to discriminate sample dilutions. Five (5) high positive serum samples were obtained for each analyte in the kit. The samples were selected at the high end of the assay range and serial dilutions prepared using negative serum. Linear and polynomial regression analysis of IU/mL or Al vs. sample dilution was performed to determine if the dilution curves exhibit statistically significant non-linear regression. The results demonstrated acceptable dilution linearity, as all recoveries were within ±20% of the predicted value . . . . . . . . . . . . . . . . . . . . . . . .

Linearity of BioPlex ToRC IgG T. gondii and Rubella assays was evaluated using World Health Organization (WHO) IgG standards. Dilutions of anti-Toxoplasma serum, 3rd International Standard (TOXM), and anti-Rubella, immunoglobulin, 1st International Standard (RUBI-1-94), were prepared and tested in the respective assay. Results obtained demonstrated acceptable dilution linearity through the cut-off, as all recoveries were within ±20% of the predicted value.

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#### C. Interfering Substances

An interfering substances study was conducted to evaluate the potential interference of specific endogenous and exogenous substances with the BioPlex 2200 ToRC IgG assays. The study was conducted based on the principles described in Clinical and Laboratory Standards Institute (CLSI) EP7-A2, Interference Testing in Clinical Chemistry. No significant interference was observed with any of the substances tested. The substances and the maximum levels tested are shown in the table below.

| Substance | Concentration |
|-------------------------|---------------|
| Hemoglobin | 500 mg/dL |
| Bilirubin, Unconjugated | 30 mg/dL |
| Bilirubin, Conjugated | 30 mg/dL |
| Cholesterol | 500 mg/dL |
| Red Blood Cells | 0.4% (v/v) |
| Gamma Globulin | 6 g/dL |
| Triglyceride | 3500 mg/dL |
| Total Protein (albumin) | 12 g/dL |
| Ascorbic Acid | 3 mg/dL |
| Heparin Lithium | 8000 units/dL |
| Heparin Sodium | 8000 units/dL |
| EDTA | 800 mg/dL |

#### Interfering Substances

#### D. Cross-Reactivity miller in come the most in with and in

A cross-reactivity study was performed to determine if samples from various disease states and other potentially interfering factors interfere with test results when tested with the BioPlex 2200 ToRC IgG kit. A panel of ten (10) specimens positive for each cross reactant were evaluated for possible crossreactivity with each of the three (3) BioPlex ToRC IgG assays. Samples were also tested with reference ToRC IgG assays. The results demonstrated that the various disease state samples evaluated do not cross-react with the three (3) assays in the BioPlex ToRC IgG kit. Most of the samples evaluated were high positives for each disease state. If a specific disease state did cross react to the various assays of the BioPlex ToRC IgG kit, all samples for that particular disease would elicit a positive response. The majority of the samples that elicited a positive result were also confirmed positive by the corresponding reference ToRC IgG assay. Results are shown in the table below.

Bio-Rad Laboratories, Inc. 510(k) Additional Information - K080008 February 18, 2009

510(k) Summary 9 of 17

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#### Cross-Reactivity

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| Potential<br>Cross-Reactant | N | Method | <i>T. gondii</i> IgG | Rubella IgG | CMV IgG |
|-----------------------------|----|--------------|----------------------|-------------|---------|
| ANA IgG | 10 | BioPlex 2200 | 4 | 9 | 8* |
| | 10 | Reference | 4 | 10 | 8 |
| | | Discordant | 0 | 1 | 0 |
| CMV IgG | 10 | BioPlex 2200 | 2 | 9 | 10 |
| | 10 | Reference | 2 | 9 | 10 |
| | | Discordant | 0 | 0 | 0 |
| dsDNA (SLE clinical) | 10 | BioPlex 2200 | 4 | 9 | 9 |
| | 10 | Reference | 4* | 9 | 9 |
| | | Discordant | 0 | 0 | 0 |
| EBV VCA IgG | 10 | BioPlex 2200 | 1 | 9 | 3 |
| | 10 | Reference | 1 | 9 | 3 |
| | | Discordant | 0 | 0 | 0 |
| hCG (pregnancy) | 10 | BioPlex 2200 | 4 | 9 | 10 |
| | 10 | Reference | 4 | 9 | 10 |
| | | Discordant | 0 | 0 | 0 |
| HIV IgG | 10 | BioPlex 2200 | 1 | 9 | 10 |
| | 10 | Reference | 1 | 9 | 10 |
| | | Discordant | 0 | 0 | 0 |
| HSV-1 IgG | 10 | BioPlex 2200 | 0 | 10 | 7 |
| | 10 | Reference | 0 | 10 | 6* |
| | | Discordant | 0 | 0 | 0 |
| HSV-2 IgG | 10 | BioPlex 2200 | 3 | 10 | 8* |
| | 10 | Reference | 3 | 10 | 9 |
| | | Discordant | 0 | 0 | 0 |
| Influenza IgG | 10 | BioPlex 2200 | 5 | 7 | 7 |
| | 10 | Reference | 5 | 7 | 7 |
| | | Discordant | 0 | 0 | 0 |
| Mumps IgG | 10 | BioPlex 2200 | 4 | 10 | 7 |
| | 10 | Reference | 4 | 10 | 7 |
| | | Discordant | 0 | 0 | 0 |
| Myeloma IgG | 10 | BioPlex 2200 | 3 | 7 | 9 |
| | 10 | Reference | 3 | 8 | 7 |
| | | Discordant | 0 | 1 | 2 |
| Parvovirus B19 IgG | 10 | BioPlex 2200 | 2 | 10 | 4 |
| | 10 | Reference | 2 | 10 | 5 |
| | | Discordant | 0 | 0 | 1 |
| Rheumatoid Factor<br>IgM | 10 | BioPlex 2200 | 1 | 10 | 9 |
| | 10 | Reference | 1 | 10 | 9 |
| | | Discordant | 0 | 0 | 0 |
| Rubella IgG | 10 | BioPlex 2200 | 3 | 10 | 7 |
| | 10 | Reference | 3 | 10 | 7 |
| | | Discordant | 0 | 0 | 0 |
| Rubeola (measles)<br>IgG | 10 | BioPlex 2200 | 0 | 10 | 5 |
| | 10 | Reference | 0 | 10 | 5 |
| | | Discordant | 0 | 0 | 0 |
| <i>T. gondii</i> IgG | 10 | BioPlex 2200 | 9 | 9 | 9 |
| | 10 | Reference | 9 | 9 | 9 |
| | | Discordant | 0 | 0 | 0 |
| VZV IgG | 10 | BioPlex 2200 | 3* | 10 | 7 |
| | 10 | Reference | 3* | 10 | 7 |
| | | Discordant | 0 | 0 | 0 |

*One equivocal result was not included in the count and was not considered as a false positive or negative discrepant. .

Bio-Rad Laboratories, Inc. 510(k) Additional Information - K080008

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## E. Correlation with CDC Evaluation Panels

A correlation study was performed to evaluate the characteristics of the BioPlex ToRC IgG kit with serum panels provided by the Centers for Disease Control (CDC) for T. gondii, Rubella and CMV. Three (3) panels were tested and the data were provided to the CDC for comparison against the CDC Reference Methods for the three (3) analytes. The results are presented in the tables below.

#### Characteristics of CDC T. gondii Reference Sera (N=100)

| CDC Samples | Reference Result | BioPlex Pos (+) | BioPlex Neg (-) |
|----------------------|------------------|-----------------|-----------------|
| <i>T. gondii</i> IgG | Pos (+) | 70 | 0 |
| | Neg (-) | 0 | 30 |

#### Characteristics of CDC Rubella Reference Sera (N=100)

| CDC Samples | Reference Result | Site 1 | | Site 2 | | Site 3 | |
|-------------|------------------|--------------------|--------------------|--------------------|--------------------|--------------------|--------------------|
| | | BioPlex<br>Pos (+) | BioPlex<br>Neg (-) | BioPlex<br>Pos (+) | BioPlex<br>Neg (-) | BioPlex<br>Pos (+) | BioPlex<br>Neg (-) |
| Rubella IgG | Pos (+) | 82 | 0 | 82 | 0 | 82 | 0 |
| | Neg (-) | 0 | 18 | 0 | 18 | 0 | 18 |

## Characteristics of CDC CMV Reference Sera (N=100)

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|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CMV laG | | | |
| | A 400 400 - 13.00 - 10.000 - 10.000 - 10.000 | | |

{11}------------------------------------------------

#### F. Expected Values/Prevalence

The observed prevalence for each of the ToRC IgG assays, individually and in dual infection, was determined using samples collected from pregnant women in the U.S. and Europe as well as in clinical samples submitted for T. gondii, Rubella, or CMV IgG testing. For T. gondii, results of ≤ 9 IU/mL are negative, 10 and 11 IU/mL are equivocal, and results of ≥ 12 IU/mL are reported as positive. For Rubella, results of ≤ 7 |U/mL are reported as negative, 8 and 9 IU/mL are equivocal, and ≥ 10 IU/mL are reported as positive. For CMV, results of ≤ 0.8 Al are negative, 0.9 and 1.0 Al are equivocal, and ≥ 1.1 Al are reported as positive. Results from all sites are shown and summarized in the tables below.

| Age | <i>T. gondii</i> IgG<br>US<br>Pos/Total | <i>T. gondii</i> IgG<br>US<br>% Prevalence | <i>T. gondii</i> IgG<br>Europe<br>Pos/Total | <i>T. gondii</i> IgG<br>Europe<br>% Prevalence | Rubella IgG<br>Pos/Total | Rubella IgG<br>% Prevalence | CMV IgG<br>Pos/Total | CMV IgG<br>% Prevalence |
|-------|-----------------------------------------|--------------------------------------------|---------------------------------------------|------------------------------------------------|--------------------------|-----------------------------|----------------------|-------------------------|
| 16-25 | 5/42 | 11.9 | 9/31 | 29.0 | 71/73 | 97.3 | 41/73 | 56.2 |
| 26-35 | 5/89 | 5.6 | 33/83 | 39.8 | 155/172 | 90.1 | 90/172 | 52.3 |
| 36-45 | 1/19 | 5.3 | 16/36 | 44.4 | 50/55 | 90.9 | 28/55 | 50.9 |
| Total | 11/150 | 7.3 | 58/150 | 38.7 | 276/300 | 92.0 | 159/300 | 53.0 |

#### Prevalence of Individual Assay Positive in Pregnant Women

Note: There was 1 equivocal result for T. gondii and 6 equivocal results for Rubella

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#### Prevalence of Dual Assay Positive in Pregnant Women

| Age | <i>T. gondii</i> IgG /<br>Rubella IgG US | | <i>T. gondii</i> IgG /<br>Rubella IgG Europe | | <i>T. gondii</i> IgG /<br>CMV IgG US | | <i>T. gondii</i> IgG /<br>CMV IgG Europe | | Rubella IgG /<br>CMV IgG | |
|-------|------------------------------------------|--------------|----------------------------------------------|--------------|--------------------------------------|--------------|------------------------------------------|--------------|--------------------------|--------------|
| | Pos/Total | % Prevalence | Pos/Total | % Prevalence | Pos/Total | % Prevalence | Pos/Total | % Prevalence | Pos/Total | % Prevalence |
| 16-25 | 5/42 | 11.9 | 9/31 | 29.0 | 2/42 | 4.8 | 4/31 | 12.9 | 39/73 | 53.4 |
| 26-35 | 4/89 | 4.5 | 31/83 | 37.3 | 2/89 | 2.2 | 19/83 | 22.9 | 79/172 | 45.9 |
| 36-45 | 1/19 | 5.3 | 16/36 | 44.4 | 1/19 | 5.3 | 6/36 | 16.7 | 25/55 | 45.5 |
| Total | 10/150 | 6.7 | 56/150 | 37.3 | 5/150 | 3.3 | 29/150 | 19.3 | 143/300 | 47.7 |

\$\frac{1}{4}\$

Bio-Rad Laboratories, Inc. 510(k) Additional Information - K080008

{12}------------------------------------------------

#### Prevalence of Individual Assay Positive in Samples Submitted for ToRC IgG Testing

| Age | Gender | T. gondii IgG | % Prevalence | Rubella IgG | % Prevalence | CMV IgG | % Prevalence |
|------------------------------|--------|---------------|--------------|-------------|--------------|----------|--------------|
| 1-10 | Female | 1/9 | 11.1 | 8/9 | 88.9 | 3/9 | 33.3 |
| | Male | 1/8 | 12.5 | 7/8 | 87.5 | 0/8 | 0.0 |
| 11-20 | Female | 2/63 | 3.2 | 54/63 | 85.7 | 34/63 | 54.0 |
| | Male | 1/31 | 3.2 | 28/31 | 90.3 | 16/31 | 51.6 |
| 21-30 | Female | 30/232 | 12.9 | 214/232 | 92.2 | 123/232 | 53.0 |
| | Male | 6/56 | 10.7 | 50/56 | 89.3 | 33/56 | 58.9 |
| 31-40 | Female | 31/250 | 12.4 | 222/250 | 88.8 | 125/250 | 50.0 |
| | Male | 19/83 | 22.9 | 63/83 | 75.9 | 54/83 | 65.1 |
| 41-50 | Female | 8/86 | 9.3 | 78/86 | 90.7 | 60/86 | 69.8 |
| | Male | 16/96 | 16.7 | 78/96 | 81.3 | 64/96 | 66.7 |
| 51-60 | Female | 5/57 | 8.8 | 54/57 | 94.7 | 37/57 | 64.9 |
| | Male | 26/99 | 26.3 | 91/99 | 91.9 | 62/99 | 62.6 |
| 61-70 | Female | 12/44 | 27.3 | 38/44 | 86.4 | 36/44 | 81.8 |
| | Male | 15/50 | 30.0 | 49/50 | 98.0 | 35/50 | 70.0 |
| 71+ | Female | 8/12 | 66.7 | 12/12 | 100.0 | 12/12 | 100.0 |
| | Male | 5/14 | 35.7 | 12/14 | 85.7 | 10/14 | 71.4 |
| Unknown Age and/or<br>Gender | | 1/10 | 10.0 | 8/10 | 80.0 | 6/10 | 60.0 |
| Total | | 187/1200 | 15.6 | 1066/1200 | 88.8 | 710/1200 | 59.2 |

Note: There were 5 equivocal results for T. gondii, 31 equivocal results for Rubella, and 1 equivocal result for CMV. Comments of the country of the county of the station of

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#### Prevalence of Dual Assay Positive in Samples Submitted for ToRC IgG Testing

| Age | Gender | T.gondii IgG/ Rubella IgG | | T.gondii IgG/ CMV IgG | | Rubella IgG /CMV IgG | |
|------------------------------|--------|---------------------------|--------------|-----------------------|--------------|----------------------|--------------|
| | | Pos/Total | % Prevalence | Pos/Total | % Prevalence | Pos/Total | % Prevalence |
| 1-10 | Female | 1/9 | 11.1 | 0/9 | 0.0 | 2/9 | 22.2 |
| 1-10 | Male | 1/8 | 12.5 | 0/8 | 0.0 | 0/8 | 0.0 |
| 11-20 | Female | 2/63 | 3.2 | 2/63 | 3.2 | 28/63 | 44.4 |
| 11-20 | Male | 1/31 | 3.2 | 1/31 | 3.2 | 14/31 | 45.2 |
| 21-30 | Female | 29/232 | 12.5 | 24/232 | 10.3 | 120/232 | 51.7 |
| 21-30 | Male | 5/56 | 8.9 | 3/56 | 5.4 | 31/56 | 55.4 |
| 31-40 | Female | 30/250 | 12.0 | 17/250 | 6.8 | 115/250 | 46.0 |
| 31-40 | Male | 15/83 | 18.1 | 13/83 | 15.7 | 43/83 | 51.8 |
| 41-50 | Female | 8/86 | 9.3 | 6/86 | 7.0 | 54/86 | 62.8 |
| 41-50 | Male | 14/96 | 14.6 | 12/96 | 12.5 | 52/96 | 54.2 |
| 51-60 | Female | 5/57 | 8.8 | 4/57 | 7.0 | 35/57 | 61.4 |
| 51-60 | Male | 24/99 | 24.2 | 15/99 | 15.2 | 57/99 | 57.6 |
| 61-70 | Female | 12/44 | 27.3 | 12/44 | 27.3 | 30/44 | 68.2 |
| 61-70 | Male | 15/50 | 30.0 | 11/50 | 22.0 | 34/50 | 68.0 |
| 71+ | Female | 8/12 | 66.7 | 8/12 | 66.7 | 12/12 | 100.0 |
| 71+ | Male | 5/14 | 35.7 | 5/14 | 35.7 | 9/14 | 64.3 |
| Unknown Age and/or<br>Gender | | 1/10 | 10.0 | 1/10 | 10.0 | 4/10 | 40.0 |
| Total | | 176/1200 | 14.7 | 134/1200 | 11.2 | 640/1200 | 53.3 |

#### Prevalence of CMV in Immunocompromised/AIDS Patient Samples Submitted for CMV IgG Testing

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| Age | Gender | CMV IgG | |
|-------|--------|-----------|--------------|
| | | Pos/Total | % Prevalence |
| 1-10 | Female | 0/0 | 0.0 |
| | Male | 1/1 | 100 |
| 11-20 | Female | 4/8 | 50.0 |
| | Male | 2/6 | 33.3 |
| 21-30 | Female | 2/2 | 100 |
| | Male | 5/5 | 100 |
| 31-40 | Female | 10/10 | 100 |
| | Male | 12/14 | 85.7 |
| 41-50 | Female | 8/8 | 100 |
| | Male | 21/23 | 91.3 |
| 51-60 | Female | 3/4 | 75.0 |
| | Male | 10/11 | 90.9 |
| 61-70 | Female | 4/4 | 100 |
| | Male | 4/4 | 100 |
| 71+ | Female | 0/0 | 0.0 |
| | Male | 0/0 | 0.0 |
| Total | | 86/100 | 86.0 |

Bio-Rad Laboratories, Inc. 510(k) Additional Information - K080008

.

February 18, 2009 - Page - Call - Ca 11:40 PM IST 11:00

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#### G. Performance Characteristics

Prospective Study: Performance of the ToRC IgG kit was evaluated against corresponding commercially available T. gondii, Rubella, and CMV immunoassays. U.S. clinical sites tested a combined: 300 prospective samples from pregnant women (150 U.S. and 150 Europe), 1200 prospective samples submitted for T. gondii, Rubella, and/or CMV IgG testing, and 100 prospective samples from immunocompromised/AIDS patients submitted for CMV testing. Results from all sites are shown and summarized in the tables below.

.. ... . . . . . . . . . . . . . . . . . .

| | | | | Predicate Rubella IgG Assay | | | BioPlex 2200 Agreement Excluding Equivocal Results | | | | BioPlex 2200 Agreement Including Equivocal Results | | | |
|-----------------------|-------------|--------------------------------------------------------------|-----------|-----------------------------|---------|-----------|----------------------------------------------------|----------------------------|------------------------|----------------------------|----------------------------------------------------|----------------------------|------------------------|----------------------------|
| Antibody/Population | | | | Pos (+) | Neg (-) | Equivocal | Pos (+)<br>% Agreement | 95% Confidence<br>Interval | Neg (-)<br>% Agreement | 95% Confidence<br>Interval | Pos (+)<br>% Agreement | 95% Confidence<br>Interval | Neg (-)<br>% Agreement | 95% Confidence<br>Interval |
| BioPlex 2200 ToRC IgG | Rubella IgG | Pregnant<br>Women<br>(N = 300) | Pos (+) | 276 | 0 | 0 | 97.2%<br>(276/284) | 94.5-<br>98.6% | 100%<br>(8/8) | 67.6-<br>100% | 94.5%<br>(276/292) | 91.3-<br>96.6% | 100%<br>(8/8) | 67.6-<br>100% |
| | | | Neg (-) | 8 | 8 | 2 | | | | | | | | |
| | | | Equivocal | 6 | 0 | 0 | | | | | | | | |
| | | | Total | 290 | 8 | 2 | | | | | | | | |
| | | Clinical<br>Samples<br>Submitted<br>for Testing<br>(N = 400) | Pos (+) | 358 | 0 | 1 | 96.5%<br>(358/371) | 94.1-<br>97.9% | 100%<br>(12/12) | 75.8-<br>100% | 92.7%<br>(358/386) | 89.7-<br>94.9% | 85.7%<br>(12/14) | 61.1-<br>96.0% |
| | | | Neg (-) | 13 | 12 | 3 | | | | | | | | |
| | | | Equivocal | 12 | 1 | 0 | | | | | | | | |
| | | | Total | 383 | 13 | 4 | | | | | | | | |

#### BioPlex Rubella IgG vs. EIA: Prospective

*Due to the low prevalence of Rubella IgG negative samples, a retrospective study also was conducted.

{15}------------------------------------------------

| | | | | Predicate<br><i>T. gondii</i> IgG Assay | | | BioPlex 2200 Agreement | | | |
|-------------------------------------------|---------------------|-----------|--|-----------------------------------------|---------|-----------|------------------------|-------------------------------|------------------------|-------------------------------|
| | Antibody/Population | | | Pos (+) | Neg (-) | Equivocal | Pos (+)<br>% Agreement | 95%<br>Confidence<br>Interval | Neg (-)<br>% Agreement | 95%<br>Confidence<br>Interval |
| BioPlex 2200 ToRC<br><i>T. gondii</i> IgG | Total<br>(N = 700) | Pos (+) | | 118 | 0 | 6 | 97.5%<br>(118/121) | 93.0-<br>99.2% | 98.8%<br>(569/576) | 97.5-<br>99.4% |
| | | Neg (-) | | 1 | 569 | 1 | | | | |
| | | Equivocal | | 1 | 1 | 3 | | | | |
| | Total | | | 120 | 570 | 10 | | | | |

# BioPlex T. gondii IgG vs. EIA: Prospective

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#### BioPlex CMV IgG vs. ElA: Prospective

| | | | Predicate<br>CMV IgG Assay | | | BioPlex 2200 Agreement | | | | |
|-----------------------|---------|--------------------|----------------------------|---------|-----------|------------------------|----------------------------|------------------------|----------------------------|----------------|
| Antibody/Population | | | Pos (+) | Neg (-) | Equivocal | Pos (+)<br>% Agreement | 95% Confidence<br>Interval | Neg (-)<br>% Agreement | 95% Confidence<br>Interval | |
| BioPlex 2200 ToRC IgG | CMV IgG | Total<br>(N = 700) | Pos (+) | 394 | 2 | 2 | 99.0%<br>(394/398) | 97.4-<br>99.6% | 98.7%<br>(298/302) | 96.6-<br>99.5% |
| | | | Neg (-) | 4 | 298 | 0 | | | | |
| | | | Equivocal | 0 | 0 | 0 | | | | |
| | | | Total | 398 | 300 | 2 | | | | |
| | | HIV+<br>(N = 100) | Pos (+) | 86 | 0 | 0 | 100%<br>(86/86) | 95.8-<br>100% | 100%<br>(14/14) | 76.8-<br>100% |
| |…