BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM

K092587 · Bio-Rad Laboratories · LFX · Dec 3, 2010 · Microbiology

Device Facts

• Record ID: K092587
• Device Name: BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM
• Applicant: Bio-Rad Laboratories
• Product Code: LFX · Microbiology
• Decision Date: Dec 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3510
• Device Class: Class 2

Intended Use

The BioPlex™ 2200 Rubella and CMV IgM kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Rubella and Cytomegalovirus (CMV) in human serum and potassium EDTA or sodium heparin plasma. The BioPlex 2200 Rubella and CMV IgM kit is intended for use with the Bio-Rad BioPlex 2200 System. This kit is intended as an aid in the diagnosis of a current or recent Rubella and/or CMV infection, in individuals suspected of having one of the respective disease states including women of child bearing age. This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors. Performance characteristics for the Rubella and CMV IgM assays have not been evaluated in immunosupressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at point of care facilities. The BioPlex® 2200 Rubella and CMV IgM Calibrator Set is intended for the calibration of the BioPlex 2200® Rubella and CMV IgM Reagent Pack. The BioPlex® 2200 Rubella and CMV IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 instrument and BioPlex 2200® Rubella and CMV IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200® Rubella and CMV IgM Control Set has not been established with any other Rubella and CMV IgM assays.

Device Story

Multiplex flow immunoassay system for simultaneous detection of Rubella and CMV IgM antibodies. Input: patient serum or plasma sample. Process: sample, diluent, and antigen-coated dyed beads incubated; anti-human IgM-phycoerythrin (PE) conjugate added; bead mixture passed through detector. Detector identifies beads via dye fluorescence and quantifies captured antibody via PE fluorescence. Includes Internal Standard, Serum Verification, and Reagent Blank beads for quality control. Output: Relative Fluorescence Intensity (RFI) converted to antibody index (AI) values. Used in clinical laboratories by trained personnel. Results aid clinicians in diagnosing current or recent infections, supporting patient management decisions.

Clinical Evidence

Clinical performance evaluated via prospective and retrospective studies. Prospective study (N=700) compared results against commercial immunoassays; Rubella IgM positive percent agreement 66.7%, negative 95.6%; CMV IgM positive 53.8%, negative 97.7%. Retrospective study (N=336 presumptive positives) showed 96.3% positive agreement for Rubella and 91.3% for CMV. Reproducibility studies (CLSI EP5-A2) showed total precision CVs ranging from 2.3% to 14.2%. Matrix comparison (N=20) confirmed equivalence between serum and plasma (r ≥ 0.98).

Technological Characteristics

Multiplexed flow immunoassay using paramagnetic microbeads infused with fluorescent dyes. Antigens: Rubella and CMV lysates. Detection: Phycoerythrin-conjugated anti-human IgM. Energy: Fluorescence-based detection. Connectivity: Integrated with BioPlex 2200 System. Preservatives: ProClin 300, sodium azide, sodium benzoate. Form factor: Reagent pack with bead set, conjugate, and diluent.

Indications for Use

Indicated for qualitative detection of IgM antibodies to Rubella and CMV in human serum, potassium EDTA, or sodium heparin plasma. Intended as an aid in diagnosis of current or recent infection in individuals suspected of having these diseases, including women of childbearing age. Not for blood/plasma donor screening, neonatal screening, or point-of-care use. Not evaluated in immunosuppressed or organ transplant patients.

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

• ADVIA Centaur® Rubella IgM (K010668)
• bioMeriéux VIDAS® CMV IgM (K933549)

Submission Summary (Full Text)

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K092587

# 510(k) Summary for Bio-Rad Laboratories, Inc. BioPlex® 2200 Rubella and CMV IgM

DEC - 3 2010

## 1. APPLICANT/SPONSOR

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

| Contact Person: | Juang Wang |
|-----------------|--------------|
| Telephone: | 510-741-4609 |

Date Prepared: November 30, 2010

### 2. DEVICE NAME

| Proprietary Name: | BioPlex® 2200 Rubella and CMV IgM Kit<br>BioPlex® 2200 Rubella and CMV IgM Calibrator Set<br>BioPlex® 2200 Rubella and CMV IgM Control Set |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Multi-Analyte Detection System for Rubella IgM and<br>Cytomegalovirus (CMV) IgM |
| Classification Name: | Rubella virus serological reagents<br>Cytomegalovirus serological reagents<br>Calibrator, multi-analyte mixture<br>Single analyte controls, all kinds (assayed and unassayed) |

### 3. Predicate Devices

- ADVIA Centaur® Rubella IgM . K010668 bioMeriéux VIDAS® CMV IgM
- . K933549

# 4. DEVICE DESCRIPTION

The BioPlex® 2200 Rubella and CMV IgM 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. Rubella and CMV IgM test is to detect antibodies to Rubella and Cytomegalovirus (CMV).

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Two (2) different populations of dyed beads are coated with cell lysates bearing Rubella or CMV antigens. 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 IgM 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 reported as relative fluorescence intensity (RFI).

Three additional dyed beads, an Internal Standard Bead (ISB), a 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 three (3) distinct serum based calibrators. A negative and CMV IgM calibrator is used to calibrate CMV assay, and a negrative and rubella IgM calibrator is used to calibrate the rubella IgM assay, The cul-off value and assignment of the calibrators are determined by performing concordance and Receiver Operator Characteristic (ROC) analysis using the Centaur Rubella IgM and VIDAS CMV IgM predicate results as the standard. For Rubella and CMV, 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 Rubella and CMV IgM Control Set includes a negative control as well as a CMV IgM positive control and a Rubella IgM positive control. The BioPlex Rubella and CMV IgM Positive Controls are manufactured to give positive results, with values above the cut-off for each specific analyte. The BioPlex Rubella and CMV IgM Negative Control are 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 period. Performing quality control is also necessary after each new assay calibration and certain service procedures.

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# BioPlex® 2200 Rubella and CMV IgM Kit Components

The BioPlex 2200 Rubella and CMV IgM kit (665-1751) contains supplies sufficient for 100 tests.

| Vial | Description |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bead Set | One (1) 10 mL vial containing two (2) different populations of dyed beads coated with lysates of Rubella and CMV; an Internal Standard Bead (ISB), a Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) in buffer with Glycerol and protein stabilizers (bovine). ProClin ® 300 (0.3%) and sodium azide (<0.1%) as preservatives. |
| Conjugate | One (1) 5 mL vial, containing phycoerythrin-conjugated donkey polyclonal anti-human IgM antibody and phycoerythrin -conjugated murine monoclonal anti-human FXIII antibody, in buffer with stabilizers (bovine and equine). ProClin ® 300 (0.3%), sodium benzoate (0.1%) and sodium azide (<0.1%) as preservatives. |
| Sample Diluent | One (1) 10 mL vial, containing goat anti-human IgG antibody and protein stabilizers (bovine and equine) in buffer. ProClin ® 300 (0.3%) and sodium azide (<0.1%) as preservatives. |

| Additional Required Items. Available from Bio-Rad: | | | |
|----------------------------------------------------|--|--|--|
|----------------------------------------------------|--|--|--|

| Catalog # | Description |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 663-1701 | BioPlex 2200 Rubella and CMV IgM Calibrator Set: Three (3) 0.5<br>mL vials containing human IgM antibodies to Rubella and CMV, in<br>a human serum matrix made from defibrinated plasma. All<br>antibodies are derived from human disease state plasma. All<br>calibrators contain ProClin® 300 (0.3%), sodium benzoate (0.1%)<br>and sodium azide (<0.1%) as preservatives. |
| 663-1731 | BioPlex 2200 Rubella and CMV IgM Control Set: Two (2) 1.5 mL<br>Positive Control serum vials, containing human IgM antibodies to<br>CMV; two (2) 1.5 mL Positive Control serum vials, containing<br>human IgM antibodies to Rubella in a human serum matrix made<br>from defibrinated plasma; and two (2) 1.5 mL Negative Control<br>serum vials, in a human serum matrix made from defibrinated<br>plasma. All antibodies are derived from human disease state<br>plasma. All controls contain Amikacin (0.003%), Cycloheximide<br>(C15H23NO4) (0.009%), Amphotericin B (0.002%), Cefotaxime<br>Sodium (0.002%), Ciprofloxacin (0.005%), ProClin® 300 (<0.3%),<br>Sodium benzoate (<0.1%) and sodium azide (<0.1%). |
| 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® 300<br>(0.03%) and sodium azide (<0.1%) as preservatives. |
| 660-0000 | BioPlex 2200 Instrument and Software System. |

# 5. Intended Use

# BioPlex® 2200 Rubella and CMV IgM Kit

The BioPlex® 2200 Rubella and CMV IgM kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Rubella and Cytomegalovirus (MV) in human serum and potassium EDTA or sodium heparin plasma.

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The BioPlex 2200 Rubella and CMV IgM kit is intended for use with the Bio-Rad BioPlex 2200 System.

This kit is intended as an aid in the diagnosis of a current or recent Rubella and/or CMV infection, in individuals suspected of having one of the respective disease states including women of child bearing age.

This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors.

Performance characteristics for the Rubella and CMV IgM assays have not been evaluated in immunosupressed or organ transplant individuals. Performance characteristics of this kit in our of engall final duals. T enomance
use of peint of pare facilit use at point of care facilities.

# BioPlex® 2200 Rubella and CMV IgM Calibrator Set

The BioPlex 2200 Rubella and CMV IgM Calibrator Set is intended for calibration of the BioPlex 2200 Rubella and CMV IgM Reagent Pack.

# BioPlex® 2200 Rubella and CMV IgM Control Set

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

# 6. Technological Characteristics and Substantial Equivalence

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

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# BioPlex® 2200 Rubella and CMV IgM Kit vs. Predicate Devices -Similarities

| Item | BioPlex® 2000<br>Rubella and CMV IgM Kit | ADVIA Centaur<br>Rubella IgM (K010668) | bioMeriéux, Inc. VIDAS®<br>CMV IgM (K933549) |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The BioPlex™ 2200 Rubella and<br>CMV IgM kit is a multiplex flow<br>immunoassay intended for the<br>qualitative detection of IgM<br>antibodies to Rubella, and<br>Cytomegalovirus (CMV) in human<br>serum and EDTA or heparinized<br>plasma.<br>The BioPlex™ 2200 Rubella and<br>CMV IgM kit is intended for use with<br>the Bio-Rad BioPlex 2200 System.<br>This kit is intended as an aid in the<br>diagnosis of a current or recent<br>Rubella and/or CMV infection, in<br>individuals suspected of having one<br>of the respective disease states<br>including women of child bearing<br>age. | The ADVIA Centaur and<br>ADVIA Centaur XP Rubella<br>IgM assay is an IgM antibody<br>capture microparticle direct<br>chemiluminometric in vitro<br>diagnostic immunoassay for<br>the qualitative detection of IgM<br>antibodies to the rubella virus<br>in serum or plasma (EDTA,<br>heparin) as an aid in the<br>presumptive diagnosis of<br>current or recent infection with<br>rubella.<br>WARNING: The calculated<br>values for rubella IgM in a<br>given specimen, as<br>determined by assays from<br>different manufacturers, can<br>vary due to differences in<br>assay methods and reagent<br>specificity. | VIDAS® CMV IgM (CMVM)<br>assay is intended for use with<br>a VIDAS (VITEK<br>ImmunoDiagnostic Assay<br>System) instrument as an<br>automated enzyme-linked<br>fluorescent immunoassay<br>(ELFA) for the qualitative<br>detection of anti-CMV IgM<br>antibodies in human serum. It<br>is intended to be used as an<br>aid in the diagnosis of<br>cytomegalovirus infection. It<br>is not intended for use in<br>testing (screening) blood or<br>plasma donors. |
| Antigen | Partially purified cell lysates of<br>Rubella, and CMV | Inactivated Rubella virus<br>(HPV-77) | Purified and inactivated CMV<br>antigen (Strain AD 169) |
| Assay Type | Qualitative detection for<br>Rubella and CMV IgM | Same | Same |
| Analyte Detected | Human IgM antibodies<br>to Rubella and CMV | Same | Same |
| Signal Detection | Fluorescence | Same | Same |
| Matrices | Serum and plasma (EDTA and<br>heparin) | Serum and plasma (EDTA<br>and heparin) | Same |

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# BioPlex® 2200 Rubella and CMV IgM Kit vs. Predicate Devices -Differences

| Item | BioPlex® 2200<br>Rubella and CMV IgM Kit | ADVIA Centaur<br>Rubella IgM (K010668) | bioMeriéux, Inc. VIDAS®<br>CMV IgM (K933549) |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Number of Analytes<br>Simultaneously<br>Detected | Multiple (2) | Single | Single |
| Enzyme Conjugate | Phycoerythrin conjugated | Rubella antigen labeled with<br>acridinium ester | Alkaline phosphatase<br>conjugated |
| Matrices | Serum and plasma (EDTA<br>and heparin) | | Serum |
| Assay Technology | Multiplex flow immunoassay | Sandwich immunoassay using<br>direct, chemiluminometric<br>technology | Two-step enzyme<br>immunoassay sandwich<br>method with fluorescent<br>detection (ELFA) |
| Signal Detection | Fluorescence | chemiluminescence | |
| 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. | anti-human IgMFC monoclonal<br>antibody is covalently coupled to<br>paramagnetic particles | Antigen-coated solid phase<br>receptacles |
| Calibrator(s) | Multiple Calibrators | Single Calibrator | Single Calibrator |
| Controls | Negative Control and two<br>separate Positive Controls for<br>rubella and CMV IgM | Negative Control and Positive<br>Control specific for rubella IgM | Negative Control and Positive<br>Control specific for CMV IgM |

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# 7. Performance Testing

A series of studies was conducted to evaluate the performance of the BioPlex® 2200 Rubelia and CMV IgM kit. The studies included reproducibility, interfering substances, cross-reactivity, expected values and method comparison. The results of all studies demonstrated that the BioPlex 2200 Rubella and CMV IgM kit performed according to its specifications.

#### A. Reproducibility

Separate internal and external reproducibility studies were conducted to evaluate the reproducibility of the BioPlex 2200 Rubella and CMV JgM 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 within-run, 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 rubella IgM samples ranged from 4.3% to 5.5% in a serum matrix, 6.3% to 6.9% for EDTA and 4.8% to 9.5% for heparin plasma matrices. The within-run precision for CMV IgM samples range 1 from 5.3% to 9.2% in a serum matrix, 4.9% to 11.8% for EDTA and 5.2% to 12.8% for heparin plasma matrices

The external reproducibility study was performed at three (3) clinical trial sites. Three lots of reagent packs, three lots of the BioPlex 2200 Rubella and CMV IgM Calibrator Set and three lots of BioPlex 2200 Rubella and CMV IgM Control Set were evaluated. Three (3) panels made from serum and plasma (EDTA and heparinized) were tested in quadruplicate over five (5) days (4 replicates x 1 run x 5 days x 3 testing sites = 60 replicates per panel member).

The data were analyzed for within-run, 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 or equal to the cut-off (≥ 1.1 Al) in all sample matrices ranged from 2.7% to 13.3% for Rubella IgM and

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2.8% to 13.5% for CMV IgM. The total precision for positive samples greater than or equal to the cut-off (≥1.1 Al) ranged from 2.3% to 13.5% for Rubella India 3.0% to 14.2% for CMV IgM.

#### B. Interfering Substances

An interfering substances study was conducted to evaluate the potential interference of specific endogenous and exogenous substances with the BioPlex 2200 Rubella and CMV IgM 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 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 | ≤ 20 mg/dL |
| Bilirubin, Conjugated | ≤ 30 mg/dL |
| Cholesterol | ≤ 500 mg/dL |
| Red Blood Cells | ≤ 0.4% (v/v) |
| Gamma Globulin | ≤ 6 g/dL |
| Triglycerides | ≤ 3300 mg/dL |
| Beta Carotene | ≤ 0.6 mg/dL |
| Protein (total) | ≤ 12 g/dL |
| Ascorbic Acid | ≤ 3 mg/dL |
| Lithium Heparin | ≤ 8000 units/dL |
| Sodium Heparin | ≤ 8000 units/dL |
| EDTA | ≤ 800 mg/dL |
| Sodium citrate | ≤ 1000 mg/dL |

### Interfering Substances

#### C. Cross-Reactivity

A cross-reactivity study was performed to determine if samples from various disease states and other potentially cross-reacting agents interfere with test results when tested with the BioPlex 2200 Rubella and CMV IgM kit. Samples known to be positive for each of the potential cross-reactants, as determined by FDA cleared devices, were evaluated with the BioPlex 2200 Rubella and CMV IgM assay. All samples were pre-tested by the predicate devices and only those that tested negative by the predicate devices were further evaluated by the BioPlex 2200 Rubella and CMV IgG. The table below summarizes the number of samples scored negative by the BioPlex 2200 Rubella and CMV IgM assay within each of the crossreactant panels. No significant cross reactivity was observed except for potential

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cross reactivity of myeloma IgM samples tested with the rubella and CMV IgM assays, and EBV VCA and parvovirus B19 IgM and dsDNA samples tested with the CMV IgM assay.

| Potential<br>Cross-Reactant | BioPlex 2200 Rubella and CMV IgM<br>Results | | | |
|---------------------------------|---------------------------------------------|----------------|----|------------|
| | N | Rubella<br>IgM | N | CMV<br>IgM |
| ANA Screen | 10 | 10 | 10 | 9 |
| CMV IgM | 10 | 10 | 0 | N/A |
| dsDNA (SLE clinical) | 10 | 10 | 10 | 9ᵇ |
| EBV VCA IgM | 10 | 9 | 8 | 6 |
| hCG (pregnancy) | 10 | 10 | 10 | 10ª |
| HIV IgG | 10 | 10 | 10 | 10 |
| HSV-1 or 2 IgM | 9 | 8 | 10 | 10ᵇ |
| Hypergammaglobulinemia IgM | 10 | 9 | 10 | 10 |
| Influenza (compliment fixation) | 10 | 10 | 10 | 10 |
| Measles IgM | 10 | 10 | 10 | 10 |
| Mumps IgM | 10 | 10 | 10 | 9 |
| Myeloma IgM | 9 | 7 | 7 | 5 |
| Parvovirus B19 IgM | 10 | 10ª | 9 | 4 |
| Rheumatoid Factor (Total) | 9 | 9 | 10 | 9ª |
| Rubella IgM | 0 | N/A | 10 | 10 |
| T. gondii IgM | 10 | 10 | 10 | 10 |
| VZV IgM | 10 | 10 | 10 | 10 |

## Cross-Reactivity

a One BioPlex 2200 equivocal result

b Two BioPlex 2200 equivocal results

Note: The highlighted arcas indicate that the potential cross reactivity with either Rubella or CMV IgM could
not be ruled out not be ruled out.

#### D. lgM Detection

Rubella and CMV IgM-positive samples were selected and supplemented with matched specific IgG. The sample pools were scieced and supplemented with dithiothreitol (DTT) which inactivates IgM activity. The samples were assayed heat and diluted into assay range in replicates of two. Into samples were assayed head.
and OMM has measured in replicates of two. IgM was measured using Rubella and CMV IgM kit. The results are shown in below.

| BioPlex 2200 Rubella and CMV IgM kit - Rubella IgM Specificity | | | | |
|----------------------------------------------------------------|--|--|--|--|
|----------------------------------------------------------------|--|--|--|--|

| Sample | Rubella IgM (AI)<br>Before Treatment | DTT Treatment<br>AI (% recovery) |
|----------|--------------------------------------|----------------------------------|
| Sample 1 | 3.6 | 0.2 (5.6%) |

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| Sample2 | 3.3 | 0.2 (6.1%) |
|----------|-----|------------|
| Sample3 | 3 | 0.2 (6.7%) |
| Sample4 | 2.7 | 0.2 (7.4%) |
| Sample5 | 2.6 | 0.2 (7.7%) |
| Sample6 | 2.5 | 0.2 (8%) |
| Sample7 | 2.3 | 0.2 (8.7%) |
| Sample8 | 2.2 | 0.2 (9.1%) |
| Sample9 | 2.2 | 0.2 (9.1%) |
| Sample10 | 2.2 | 0.2 (9.1%) |

# BioPlex 2200 Rubella and CMV IgM kit - CMV IgM Specificity

| Sample | CMV IgM (AI)*<br>Before Treatment | DTT Treatment<br>AI (% recovery) |
|----------|-----------------------------------|----------------------------------|
| Sample1 | 460 | 30.2 (6.6%)* |
| Sample2 | 341.5 | 26.4 (7.7%)* |
| Sample3 | 109 | 0.4 (0.4%) |
| Sample4 | 107 | 0.7 (0.7%) |
| Sample5 | 85.5 | 0.7 (0.8%) |
| Sample6 | 37.1 | 0.6 (1.6%) |
| Sample7 | 35.5 | 0.6 (1.7%) |
| Sample8 | 28.1 | 0.3 (1.1%) |
| Sample9 | 23.8 | 0.3 (1.3%) |
| Sample10 | 22.5 | 0.7 (3.1%) |

*Values derived from dilution

#### E. Seroconversion Testing

### Rubella IgM

Three Liquichek ™ Rubella IgM seroconversion panels obtained from Bio-Rad Laboratories were tested with the BioPlex 2200 Rubella and CMV IgM kit. The results shown in below were compared to a commercial method

| Panel RP001 | Rubella IgM | |
|-------------|----------------------------|-----------------------------------------------|
| Day | Commercial Method<br>Index | BioPlex 2200 Rubella<br>and CMV IgM kit<br>Al |
| O | 0.20 (Nea) | 0.3 (Neg) |
| 2 | 0.10 (Neg) | 0.2 (Neg) |
| 7 | 0.15 (Nea) | 0.2 (Neg) |
| ರಿ | 0.00 (Neg) | 0.2 (Neg) |
| 14 | 0.29 (Neg) | 0.3 (Nea) |

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| 17 | 0.91 (Eq) | 1.1 (Pos) |
|----|------------|------------|
| 21 | 9.57 (Pos) | >4.0 (Pos) |
| 24 | 7.95 (Pos) | >4.0 (Pos) |
| 28 | 1.87 (Pos) | 1.9 (Pos) |
| 31 | 4.92 (Pos) | 3.7 (Pos) |
| 35 | 7.31 (Pos) | 3.1 (Pos) |
| 38 | 3.54 (Pos) | 1.8 (Pos) |
| 42 | 2.43 (Pos) | 1.7 (Pos) |
| 45 | 1.83 (Pos) | 1.3 (Pos) |
| 50 | 1.95 (Pos) | 1.2 (Pos) |

The BioPlex 2200 Rubella and CMV IgM test detected Rubella IgM four days earlier demonstrating greater sensitivity.

| Panel RP011 | Rubella IgM | |
|-------------|-------------------|----------------------|
| Day | Commercial Method | BioPlex 2200 Rubella |
| | Index | and CMV IgM kit |
| | | AI |
| 0 | 0.21 (Neg) | 0.2 (Neg) |
| 3 | 0.00 (Neg) | 0.2 (Neg) |
| 9 | 0.02 (Neg) | 0.2 (Neg) |
| 12 | 0.00 (Neg) | 0.2 (Neg) |
| 16 | 1.64 (Pos) | 1.1 (Pos) |
| 19 | 5.94 (Pos) | >4.0 (Pos) |
| 24 | 8.95 (Pos) | >4.0 (Pos) |
| 27 | 7.69 (Pos) | >4.0 (Pos) |
| 31 | 4.50 (Pos) | 3.7 (Pos) |
| 36 | 2.70 (Pos) | 2.4 (Pos) |
| 39 | 1.78 (Pos) | 1.8 (Pos) |
| 43 | 1.12 (Pos) | 1.2 (Pos) |
| 46 | 0.77 (Neg) | 0.8 (Neg) |
| 50 | 0.43 (Neg) | 0.8 (Neg) |
| 53 | 0.32 (Neg) | 0.6 (Neg) |
| 57 | 0.32 (Neg) | 0.6 (Neg) |
| 60 | 0.13 (Neg) | 0.4 (Neg) |
| 64 | 0.37 (Neg) | 0.5 (Neg) |
| 67 | 0.00 (Neg) | 0.4 (Neg) |
| 71 | 0.00 (Neg) | 0.5 (Neg) |

The BioPlex 2200 Rubella and CMV IgM test showed comparable performance to a commercial method.

| Panel RP014 | Rubella IgM | |
|-------------|----------------------------|-----------------------------------------------|
| Day | Commercial Method<br>Index | BioPlex 2200 Rubella<br>and CMV IgM kit<br>AI |
| 0 | 0.00 (Neg) | <0.2 (Neg) |
| 5 | 0.00 (Neg) | <0.2 (Neg) |
| 7 | 0.00 (Neg) | <0.2 (Neg) |

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| 12 | 0.00 (Neg) | <0.2 (Neg) |
|----|-------------------|------------------|
| 14 | 0.23 (Neg) | 0.7 (Neg) |
| 19 | <b>2.44 (Pos)</b> | <b>2.3 (Pos)</b> |
| 21 | 2.55 (Pos) | 2.4 (Pos) |
| 26 | 2.58 (Pos) | 2.2 (Pos) |
| 28 | 2.15 (Pos) | 1.8 (Pos) |
| 33 | 1.5 (Pos) | 1.6 (Pos) |
| 35 | 1.5 (Pos) | 1.2 (Pos) |
| 40 | 1.00 (Pos) | <b>1.0 (Eq)</b> |
| 42 | <b>0.76 (Neg)</b> | 0.8 (Neg) |

The BioPlex 2200 Rubella and CMV IgM test showed comparable performance to a commercial method, except for the day 40 sample which scored equivocal in the BioPlex 2200 Rubella and CMV IgM test and positive (at the cutoff) in the comparison test.

### CMV IgM

Bio-Rad Laboratories Liquichek™ CMV IgM Seroconversion panel was assayed with BioPlex 2200 Rubella and CMV IgM kits and a commercial method. The results are shown in below. The BioPlex 2200 Rubella and CMV IgM test was able to detect CMV IgM in the Libr Ion LEGO Rubella and CMV IgM test was able equivocal at 59 days.

| Panel RP003 | CMV IgM | |
|-------------|----------------------------|-----------------------------------------------|
| Day | Commercial Methos<br>Index | BioPlex 2200 Rubella<br>and CMV IgM kit<br>AI |
| 1 | 1.16 (Pos) | >4.0 (Pos) |
| 4 | 1.62 (Pos) | >4.0 (Pos) |
| 8 | 2.44 (Pos) | >4.0 (Pos) |
| 51 | 1.16 (Pos) | 3.4 (Pos) |
| 55 | 1.04 (Pos) | 3.0 (Pos) |
| 59 | 0.84 (Eq) | 2.1 (Pos) |
| 65 | 0.85 (Eq) | 2.3 (Pos) |
| 67 | 0.75 (Eq) | 2.0 (Pos) |
| 72 | 0.68 (Neg) | 1.7 (Pos) |
| 74 | 0.62 (Neg) | 1.5 (Pos) |
| 79 | 0.64 (Neg) | 1.8 (Pos) |
| 84 | 0.54 (Neg) | 1.7 (Pos) |
| 88 | 0.72 (Eq) | 2.1 (Pos) |
| 95 | 0.59 (Neg) | 1.7 (Pos) |
| 99 | 0.65 (Neg) | 1.6 (Pos) |

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

#### ட் Expected Values

The observed prevalence for the Rubella and CMV IgM using the BioPlex 2200 Rubella and CMV IgM assay was determined using samples submitted for Rubella (300, US) or CMV IgM (400, 300 US +100 Europe) testing. The results are presented in the tables below. The predictive values of the test are dependent on the prevalence. As rubella incidence decreases, the predicative positive value of rubella igM results decreases.

Note: Each laboratory should establish frequency distributions for their specific patient populations.

| Age | Gender | Rubella IgM<br>(US) | | CMV IgM<br>(US) | | CMV IgM<br>(EU) | |
|---------|--------|---------------------|----------------------------------|-----------------|---------------|-----------------|---------------|
| | | Pos/Tota | % revalence Trevalence Station | os/Tota | revalenc<br>% | Pos/Tota | Prevalen<br>% |
| 0 - 10 | F | 0/13 | 0.0% | 0/4 | 0.0% | 0/0 | N/A |
| | M | 0/1 1 | 0.0% | Ole | 0.0% | 0/2 | 0.0% |
| 11 - 20 | F | 0/44 | 0.0% | 1/19 | 5.3% | 0/4 | 0.0% |
| | M | 0/12 | 0.0% | 0/20 | 0.0% | 0/1 | 0.0% |
| 21 - 30 | F | 4/80 | 5.0% | 1/41 | 2.4% | 1/36 | 2.8% |
| | M | 018 | 0.0% | 0/10 | 0.0% | 0/2 | 0.0% |
| 31 - 40 | F | 4/55 | 7.3% | 1/34 | 2.9% | 3/42 | 7.1% |
| | M | 0/8 | 0.0% | 3/17 | 17.6% | 0/1 | 0.0% |
| 41 - 50 | F | 3/26 | 11.5% | 1/35 | 2.9% | 0/6 | 0.0% |
| | M | 1/12 | 8.3% | 0/19 | 0.0% | 0/2 | 0.0% |
| 51 - 60 | F | 0/19 | 0.0% | 1/23 | 4.3% | 0/1 | 0.0% |
| | M | 0/0 | 0.0% | 1/33 | 0.0% | 0/1 | 0.0% |
| 61 - 70 | F | 0/1 | 0.0% | 0/16 | 0.0% | 0/1 | 0.0% |
| | M | 0/1 | 0.0% | 0/14 | 0.0% | 0/0 | N/A |
| 71 + | F | 0/0 | N/A | 0/2 | 0.0% | 0/0 | N/A |
| | M | 0/1 | 0.0% | 077 | 0.0% | 0/1 | 0.0% |
| | Total | | 4.0%** | 9/300 | 3.0% | 4/100 | 4.0% |

# Expected values using the BioPlex 2200 Rubella and CMV IgM kit in test ordered population

*One of pregnant women (N=71) was Rubella IgM positive.
**Since 2001 The ingidonea of Dubelle

{13}------------------------------------------------

#### Method Comparison G.

Performance of the BioPlex 2200 Rubella and CMV IgM kit was evaluated against corresponding commercially available Rubella and CMV kits. Three clinical sites tested 700 prospective samples submitted for: Rubella (300 - U.S.), and CMV IgM testing (400,300 U.S. + 100 Europe). Of the 300 samples submitted for Rubella IgM testing, 71 females were pregnant women. Results are shown in the table below:

Of the 300 clinical ordered samples test for Rubella IgM, the positive percent agreement was 66.7% and the negative percent agreement was 95.6%.

Of the 71 clinical ordered pregnancy samples test for Rubella IgM, the negative percent agreement was 96.8%.

Of the 400 clinical ordered samples tested for CMV IgM, the positive percent agreement was 53.8% and the negative percent agreement was 97.7%.

The results are presented in the table below.

| Commercially Available Immunoassay | Test Ordered | | BioPlex 2200 Rubella and CMV IgM kit | | | | | |
|------------------------------------|-----------------|--------------|--------------------------------------|-----|---------|-------|------------------------------------------|----------------------------------------------|
| | Rubella IgM | Test Ordered | Pos (+) | Eqv | Neg (-) | Total | Pos (+)<br>% Agreement | Neg (-)<br>% Agreement |
| | | Pos (+) | 2 | 0 | 1 | 3 | 66.7%<br>(2/3)<br>95% CI<br>20.8 - 93.9% | 95.6%<br>(282/295)<br>95% CI<br>92.6 - 97.4% |
| | | Eqv | 0 | 2 | 0 | 2 | | |
| | | Neg (-) | 10 | 3 | 282 | 295 | | |
| | | Total | 12 | 5 | 283 | 300 | | |
| | Pregnant Women* | Pos (+) | 0 | 0 | 0 | 0 | N/A | 96.8%<br>(70/71)<br>95%CI<br>92.8% - 99.8% |
| | | Eqv | 0 | 0 | 0 | 0 | | |
| | | Neg (-) | 1 | 0 | 70 | 71 | | |
| | | Total | 1 | 0 | 70 | 71 | | |
| | | Pos (+) | 7a | 0 | 3a | 10 | 53.8%<br>(7/13) | 97.7%<br>(377/386) |

# Method Comparison: Prospective Study

{14}------------------------------------------------

| Eqv | 1 | 1 | 3 | 5 |
|---------|----|---|------|-----|
| Neg (-) | 5b | 3 | 377a | 385 |
| Total | 13 | 4 | 383 | 400 |

a. One sample that was equivocal by the predicate device was adjudicated by two out of three FDA cleared devices.

b. Two samples that were equivocal by the predicated by two out of three HDA cleared devices

* Pregnant women is the subset of the test ordered population.

# Comparative Testing: Retrospective Study

Performance of the Rubella and CMV IgM kit was evaluated against corresponding commercially available Rubella and CMV IgM immunoassays. Three clinical sites tested 107 Rubella (45 females with 89% in 15-45 age group, 49 males and 13 with unknown gender) and 229 CMV (144 females with 84% in 15-45 age group and 85 males) presumptive IgM positive samples. Positive samples for Rubella and CMV IgM were selected by another FDA cleared test and the respective commercially available immunoassays used for the comparative analysis. The results are presented in the table below.

| Presumptive Positive | | BioPlex Rubella and CMV IgM kit | | | | | |
|------------------------------------|-------------|---------------------------------|------|--------|-------|-----------------------|--------------|
| for Rubella or CMV<br>IgM | | Pos(+) | Eqv | Neg(-) | Total | Pos(+)<br>% Agreement | |
| Commercially Available Immunoassay | Rubella IgM | Pos(+) | 103 | 1 | 3 | 107 | 96.3% |
| | | Eqv | 0 | 0 | 0 | 0 | (103/107) |
| | | Neg(-) | 0 | 0 | 0 | 0 | 95% CI |
| | | Total | 103 | 1 | 3 | 107 | 90.3 – 98.5% |
| | CMV IgM | Pos(+) | 209a | 3 | 17b | 229 | 91.3% |
| | | Eqv | 0 | 0 | 0 | 0 | (209/229) |
| | | Neg(-) | 0 | 0 | 0 | 0 | 95% CI |
| | | Total | 209 | 3 | 17 | 229 | 86.9 - 94.3% |

# Characteristics of Samples with Presumptive Positive Status

e that was equivocal by the predicate device was adjudicated by two out of three FDA cleared devices.

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

### Matrix Comparison

Matched serum and plasma (potassium EDTA and sodium heparin) samples drawn from 20 individual donors were acquired from commercial sources. All samples were evaluated in replicates of 10. Mean plasma Al values were compared to matched mean serum Al values. Scatter plots comparing the performance of serum samples against potassium EDTA and sodium heparin plasma samples along with the corresponding slopes of regression and correlation coefficient (r) are shown in below. All assays pass the slope specification and correlation
specification of + 0.2, and correction as the slope specification of 1.0 ± 0.2, in specification of ± 0.2, and correlation coefficient (r) of ≥ 0.98.

Image /page/15/Figure/3 description: The image shows a scatter plot titled "Matrix Comparison Mean Test vs Mean Comparison". The x-axis is labeled "Serum (Al)" and ranges from 0 to 2.5. The y-axis is labeled "EDTA Plasma (Al)" and ranges from 0 to 2.5. A linear regression line is plotted through the data points, with the equation y = 1.0369x - 0.0077 and an r-value of 0.9971.

Image /page/15/Figure/4 description: The image is titled "Figure 1. Rubella IgM: EDTA vs. Serum (N=20)". The figure is comparing Rubella IgM levels in EDTA versus serum samples. The sample size is N=20.

{16}------------------------------------------------

Figure 2. Rubella lgM: Heparin vs. Serum (N=20)

Image /page/16/Figure/1 description: This image is a scatter plot titled "Matrix Comparison Mean Test vs Mean Comparison". The x-axis is labeled "Serum (Al)" and ranges from 0 to 2.5. The y-axis is labeled "Heparin Plasma (Al)" and ranges from 0 to 2.5. A line of best fit is plotted on the scatter plot, and the equation for the line is y = 1.0219x - 0.0123, with an r value of 0.9976.

Figure 3. CMV IgM: EDTA vs. Serum (N=20)

{17}------------------------------------------------

Image /page/17/Figure/0 description: This image is a scatter plot titled "Matrix Comparison Mean Test vs Mean Comparison". The x-axis is labeled "Serum (Al)" and ranges from 0 to 2, while the y-axis is labeled "Heparin Plasma-(Al)" and also ranges from 0 to 2. The plot shows a strong positive correlation between the two variables, with data points clustered closely around a straight line, and the equation of the line is y = 1.0000x - 0.0000, and the r value is 0.9945.

Figure 4. CMV IgM: Heparin vs. Serum (N=20)

{18}------------------------------------------------

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Bio- Rad Laboratories, Inc. BioPlex 2200 Division c/o Juang Wang Regulatory Affairs Representative 5500 East Second Street Benicia, CA 94510

DEC - 3 2010

Re: K092587

Trade/Device Name: BioPlex® 2200 Rubella and CMV IgM Kit on the BioPlex® 2200 Multi Analyte Detection System Regulation Number: 21CFR§866.3510 Regulation Name: Rubella Virus Serological Reagents Regulatory Class: Class II Product Code: LFX, LKQ, LFZ, JIX, JJX Dated: November 30, 2010 Received: December 1, 2010

Dear Mr. Wang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 'The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), 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); medical device reporting (reporting of

{19}------------------------------------------------

### Page 2 - Juang Wang

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Sma!l 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 vours.

Jouga Hoynes

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

{20}------------------------------------------------

# Indication(s) for use

DEC - 3 2010

# 510(k) Number (if known): k092587

Device Name:BioPlex® 2200 Rubella and CMV IgM Kit on the BioPlex® 2200 Multi Analyte

Detection System

BioPlex® 2200 Rubella and CMV IgM Calibrator Set BioPlex® 2200 Rubella and CMV IgM Control Set

Indications for Use:

The BioPlex® 2200 Rubella and CMV IgM kit

The BioPlex® 2200 Rubella and CMV IgM kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Rubella and Cytomegalovirus (CMV) in human serum and potassium EDTA or sodium heparin plasma.

The BioPlex 2200 Rubella and CMV IgM kit is intended for use with the Bio-Rad BioPlex 2200 System.

This kit is intended as an aid in the diagnosis of a current or recent Rubella and/or CMV infection, in individuals suspected of having one of the respective disease states including women of child bearing age.

This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors.

Performance characteristics for the Rubella and CMV IgM assays have not been evaluated in immunosupressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at point of care facilities.

BioPlex® 2200 Rubella and CMV IgM Calibrator Set

The BioPlex® 2200 Rubella and CMV IgM Calibrator Set is intended for the calibration of the BioPlex® 2200 Rubella and CMV IgM Reagent Pack.

### BioPlex® 2200 Rubella and CMV IgM Control Set

The BioPlex® 2200 Rubella and CMV IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 instrument and BioPlex 2200 Rubella and CMV IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Rubella and CMV IgM Control Set has not been established with any other Rubella and CMV IgM assays.

Over-the-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(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 (OVD)

Une Schif

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

510(k) k092587