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.

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

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.

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.

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 IU/mL are reported as negative, 8 and 9 IU/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 IgG 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 period. Performing quality control is also necessary after each new assay calibration and certain service procedures.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

BioPlex™ 2200 ToRC IgG Kit Performance Analysis

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" but rather describes various performance characteristics evaluated against predetermined principles (e.g., CLSI standards) or by comparison to predicate devices. The "reported device performance" is then presented as the outcome of these evaluations.

Based on the provided text, the most relevant performance characteristics and their reported outcomes are summarized below:

Performance Characteristic	Acceptance Criteria (Implicit/Explicit)	Reported Device Performance
Reproducibility	Based on CLSI EP5-A2 principles. Expectation of acceptable within-run and total precision (low % CV values).	Internal Reproducibility:- T. gondii IgG: Within-run 3.9%-9.5%, Total 6.6%-12.3%- Rubella IgG: Within-run 3.0%-5.0%, Total 5.2%-9.9%- CMV IgG: Within-run 1.8%-5.6%, Total 3.8%-8.7%External Reproducibility:- T. gondii IgG: Within-run 3.7%-7.7%, Total 4.8%-17.6%- Rubella IgG: Within-run 4.6%-6.6%, Total 7.2%-10.3%- CMV IgG: Within-run 2.5%-5.8%, Total 4.4%-12.1%Additional Rubella Reproducibility (near cut-off): Within-run 5.2%-9.7%
Linearity	Based on CLSI EP6-A principles. Expectation of acceptable dilution linearity, with all recoveries within ±20% of the predicted value.	Demonstrated acceptable dilution linearity for T. gondii (3-900 IU/mL), Rubella (1-250 IU/mL), and CMV (0.2-8.0 Al). All recoveries within ±20% of the predicted value. Acceptable dilution linearity through the cut-off for T. gondii and Rubella using WHO IgG standards.
Interfering Substances	Based on CLSI EP7-A2 principles. Expectation of no significant interference from tested substances at specified concentrations.	No significant interference observed with tested substances (Hemoglobin, Bilirubin, Cholesterol, Red Blood Cells, Gamma Globulin, Triglyceride, Total Protein, Ascorbic Acid, Heparin, EDTA) at maximum levels.
Cross-Reactivity	Expectation that various disease state samples do not cross-react with the three (3) assays in the BioPlex ToRC IgG kit.	Evaluated specimens positive for ANA, CMV, dsDNA (SLE), EBV VCA, hCG (pregnancy), HIV, HSV-1, HSV-2, Influenza, Mumps, Myeloma, Parvovirus B19, Rheumatoid Factor, Rubella, Rubeola, T. gondii, VZV. The results demonstrated that the various disease state samples evaluated do not cross-react with the three (3) assays. Most positive results were confirmed by reference assays. Only one equivocal result was noted and not counted as discrepant.
Correlation with CDC Evaluation Panels	Expectation of high agreement with CDC Reference Methods.	T. gondii IgG (N=100): BioPlex detected 70 Positives and 30 Negatives, matching CDC Reference Result (100% agreement).Rubella IgG (N=100): BioPlex detected 82 Positives and 18 Negatives across all 3 sites, matching CDC Reference Result (100% agreement).CMV IgG (N=100): BioPlex detected 60 Positives and 40 Negatives across all 3 sites, matching CDC Reference Result (100% agreement).
Performance Characteristics (vs. Predicate EIA)	High positive and negative percent agreement (PPA/NPA) with predicate commercial immunoassays, with narrow 95% Confidence Intervals. Specific numerical thresholds for "high" are not explicitly stated, but the reported values demonstrate strong concordance.	Rubella IgG (Pregnant Women, N=300): Exclusion of equivocal: PPA 97.2% (276/284), NPA 100% (8/8). Inclusion of equivocal: PPA 94.5% (276/292), NPA 100% (8/8).Rubella IgG (Clinical Samples, N=400): Exclusion of equivocal: PPA 96.5% (358/371), NPA 100% (12/12). Inclusion of equivocal: PPA 92.7% (358/386), NPA 85.7% (12/14).T. gondii IgG (Total, N=700): PPA 97.5% (118/121), NPA 98.8% (569/576).CMV IgG (Total, N=700): PPA 99.0% (394/398), NPA 98.7% (298/302).CMV IgG (HIV+, N=100): PPA 100% (86/86), NPA 100% (14/14).Retrospective Rubella IgG (N=280): Exclusion of equivocal: PPA 92.8% (90/97), NPA 100% (124/124). Discordant samples were mostly low positive or close to cut-off for predicate.

2. Sample Size Used for the Test Set and Data Provenance

The primary test sets for evaluating performance characteristics (agreement with predicate devices) are described as:

Prospective Samples:
- Pregnant Women: 300 samples (150 from the U.S., 150 from Europe).
- Clinical Samples submitted for ToRC IgG testing: 1200 samples (400 for Rubella IgG, 700 for T. gondii IgG, 700 for CMV IgG - likely overlapping sets for the total of 1200).
- Immunocompromised/AIDS patients (for CMV testing): 100 samples.
- Provenance: Samples from the U.S. and Europe, some from specific clinical populations (pregnant women, immunocompromised/AIDS patients), and others from general clinical submissions. All appear to be prospective collections relative to the study.
Retrospective Samples:
- Rubella IgG: 280 samples (50 low positive, 50 high positive, 130 negative).
- Provenance: Retrospective collection from U.S. clinical sites with known Rubella IgG status.
CDC Evaluation Panels:
- T. gondii IgG: 100 samples.
- Rubella IgG: 100 samples.
- CMV IgG: 100 samples.
- Provenance: Provided by the Centers for Disease Control (CDC).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The ground truth for the test set was established primarily through comparison to predicate commercial immunoassays (e.g., bioMerieux VIDAS® TOXO IgG II, Rubella IgG, and CMV IgG kits) and CDC Reference Methods.

Number of Experts: Not explicitly stated. For predicate assays, the "expert" is essentially the predicate test itself, which has previously undergone its own validation. For CDC Reference Methods, the expertise would be inherent in the established CDC methodology. There is no mention of individual experts reviewing results for ground truth establishment.
Qualifications of Experts: Not applicable in the context of this document, as it relies on established assays and CDC reference methods rather than individual expert consensus.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving human review or consensus for discrepant results between the BioPlex 2200 ToRC IgG kit and the predicate devices. Instead, it reports percent agreements excluding equivocal results and including equivocal results from the BioPlex device. The discrepancies where the BioPlex 2200 disagreed with the predicate were simply reported as "Agreement" percentages. For the retrospective Rubella study, it's noted that "Most of the discordant samples were low positive or close to the cut-off for the predicate assay," providing some context, but not an adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable to this device. The BioPlex™ 2200 ToRC IgG kit is an automated in vitro diagnostic immunoassay system. It does not involve human "readers" interpreting images or clinical cases in a way that an MRMC study, typical for AI-powered diagnostic imaging, would be relevant. Its performance is evaluated against other diagnostic assays, not based on human interpretation improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the studies described are all standalone performance evaluations of the BioPlex™ 2200 ToRC IgG kit. The device is an automated system designed to provide results without human intervention in the assay interpretation step. The "Total" percentages of agreement with predicate assays represent the device's standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth was established primarily using:

Reference Devices/Predicate Assays: Results from other commercially available, FDA-cleared TOXO IgG, Rubella IgG, and CMV IgG immunoassays (bioMerieux VIDAS® kits) were used as the comparator "truth."
CDC Reference Methods: For the correlation study, CDC-provided panels were used, with their results presumably representing a highly validated reference standard.

It is not based on pathology, expert consensus (beyond the validation of the reference assays themselves), or outcomes data.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a "training set" in the context of developing the BioPlex 2200 ToRC IgG Kit. This type of immunoassay development typically involves extensive characterization and optimization using various reagent lots, calibrators, and control materials, rather than a "training set" in the machine learning sense. The performance studies described are for validation of the finalized device.

9. How the Ground Truth for the Training Set was Established

As there is no distinct "training set" described in the context of an algorithm or machine learning for this immunoassay, information on how its ground truth was established is not provided and is likely not applicable in the conventional sense for this type of device. The ground truth for the device's calibration and controls is established by defining concentrations or expected results for these internal control materials, which are then used to standardize assay performance.

Summary

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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: 510-741-5702 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 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 populationsof dyed beads coated with lysates (tachyzoites, Vero cell andnuclear) of T. gondii, Rubella and CMV; plus an InternalStandard Bead (ISB), a Serum Verification Bead (SVB) and aReagent Blank Bead (RBB); with protein stabilizers (bovine)in a saline buffer. ProClin® 300 (0.3%), sodium benzoate(0.1%) and sodium azide (<0.1%) as preservatives.
Conjugate	One (1) 5 mL vial, containing murine monoclonal anti-humanIgG/phycoerythrin conjugate, in a phosphate buffer. ProClin®300 (0.3%), sodium benzoate (0.1%) and sodium azide(<0.1%) as preservatives.
Sample Diluent	One (1) 10 mL vial, containing protein stabilizers (bovine andmurine) in a saline buffer. ProClin® 300 (0.3%), sodiumbenzoate (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 vialscontaining antibodies to T. gondii, Rubella and CMV derivedfrom human disease state plasma, in a human serum matrixmade from defibrinated plasma. ProClin® 300 (0.3%),sodium benzoate (0.1%) and sodium azide (<0.1%) aspreservatives.
663-1630	BioPlex 2200 ToRC IgG Control Set: Two (2) 1.5 mL vials ofLow Positive Control containing antibodies to T. gondii,Rubella and CMV; two (2) 1.5 mL vials of High PositiveControl containing antibodies to T. gondii and Rubella; andtwo (2) 1.5 mL vials of Negative Control Serum. All controlsin a human serum matrix made from defibrinated plasma,with ProClin® 300 (0.3%), sodium benzoate (0.1%) andsodium azide (<0.1%) as preservatives. All antibodies arederived from human disease state plasma.
660-0817	BioPlex 2200 Sheath Fluid: Two (2) 4 L bottles containingPhosphate Buffered Saline (PBS). ProClin® 300 (0.03%) andsodium azide (<0.1%) as preservatives.
660-0818	BioPlex 2200 Wash Solution: One (1) 10 L bottle containingPhosphate Buffered Saline (PBS) and Tween 20. ProClin®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

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

	BioPlex™ 2200ToRC IgG Kit	bioMerieux, Inc. VIDAS®TOXO IgG II (K993319)	bioMerieux, Inc. VIDAS®Rubella IgG (K902925)	bioMerieux, Inc. VIDAS®CMV IgG (K920661)
Intended Use	- The BioPlex™ 2200 ToRCIgG kit is a multiplex flowimmunoassay intended for thequantitative detection of IgGantibodies to Toxoplasmagondii ( T. gondii ) and Rubella,and the qualitative detection ofIgG antibodies toCytomegalovirus (CMV) inhuman serum and EDTA orheparinized plasma.- The ToRC IgG kit is intendedfor use with the Bio-RadBioPlex 2200 System.- This kit is intended as an aidin the determination ofserological status to T. gondii ,Rubella and CMV. This kit isnot intended for use in thescreening of blood or plasmadonors.	VIDAS® Toxo IgG II (TXG) isan automated quantitative testfor use on the VIDAS analyzerfor the measurement of anti-Toxoplasma IgG in humanserum using the ELFAtechnique. It is intended foruse as an aid in determinationof immune status.	VIDAS® Rubella IgG (RBG)assay is intended for use witha VIDAS (VitekImmunoDiagnostic AssaySystem) instrument as anautomated qualitativeenzyme-linked fluorescentimmunoassay (ELFA) for thedetection of IgG antibodies torubella virus in human serum.	VIDAS® Cytomegalovirus IgG(CMVG) is intended for usewith the VIDAS (VitekImmunoDiagnostic AssaySystem) instrument as a semi-quantitative automatedenzyme-linked fluorescentimmunoassay (ELFA)for thedetection of IgG antibodies toCytomegalovirus in humanserum.
Antigen	Partially purified cell lysates ofT. gondii , Rubella, and CMV	Membrane and cytotoxicToxoplasma antigen(RH Sabin Strain)	Inactivated Rubella virus(HPV-77)	Purified and inactivated CMVantigen (Strain AD 169)
Assay Type	Quantitative detection forT. gondii , Rubella, andqualitative for CMV		Same	Same
Analyte Detected	Human IgG antibodiesto T. gondii , Rubella, andCMV		Same	Same
Signal Detection	Fluorescence		Same	Same
Item	BioPlex™ 2200TORC IgG Kit	bioMerieux, Inc. VIDAS®TOXO IgG II (K993319)	bioMerieux, Inc. VIDAS®Rubella IgG (K902925)	bioMerieux, Inc. VIDAS®CMV IgG (K920661)
Number of AnalytesSimultaneouslyDetected	Multiple (3)	Single	Single	Single
Enzyme Conjugate	Phycoerythrin conjugated		Horseradish peroxidase conjugated
Matrices	Serum and plasma (EDTAand heparin)	Serum and plasma (EDTAand heparin)	Serum
Assay Technology	Multiplex flow immunoassay		Two-step enzyme immunoassay sandwich method with fluorescent detection (ELFA)
Solid Phase	Antigen-coated paramagneticmicrobead reagent.Microbeads are infused withred and infrared fluorescentdyes for bead classification.Green fluorescence from theimmunoassay label is used foranalyte measurement.		Antigen-coated solid phase receptacles
Calibrator(s)	Multiple Calibrators		Single Calibrator
Controls	Negative Control and multi-analyte Positive Controls	Negative Control and PositiveControl specific for T. gondii	Negative Control and PositiveControl specific for rubellavirus	Negative Control and PositiveControl specific for CMV virus

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

510(k) Summary

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

서비스 - 대부 - 대부분 - 대부분 - 대부분 - 대통령 - 대한민국 - 대한민국 -

PotentialCross-Reactant	N	Method	T. gondii 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 FactorIgM	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)IgG	10	BioPlex 2200	0	10	5
	10	Reference	0	10	5
		Discordant	0	0	0
T. gondii 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

.. & R W .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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510(k) Summary 10 of 17

{10}------------------------------------------------

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 (-)
T. gondii 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
		BioPlexPos (+)	BioPlexNeg (-)	BioPlexPos (+)	BioPlexNeg (-)	BioPlexPos (+)	BioPlexNeg (-)
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	T. gondii IgGUSPos/Total	T. gondii IgGUS% Prevalence	T. gondii IgGEuropePos/Total	T. gondii IgGEurope% Prevalence	Rubella IgGPos/Total	Rubella IgG% Prevalence	CMV IgGPos/Total	CMV IgG% 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

. . . . . . . . Rubena, fostils of a 7 ran

Prevalence of Dual Assay Positive in Pregnant Women

Age	T. gondii IgG /Rubella IgG US		T. gondii IgG /Rubella IgG Europe		T. gondii IgG /CMV IgG US		T. gondii IgG /CMV IgG Europe		Rubella IgG /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/orGender		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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Bio-Rad Laboratories, Inc. 510(k) Additional Information – K080008

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

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/orGender		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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රි.

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

ﺮ ﺍ

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

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 (+)% Agreement	95% ConfidenceInterval	Neg (-)% Agreement	95% ConfidenceInterval	Pos (+)% Agreement	95% ConfidenceInterval	Neg (-)% Agreement	95% ConfidenceInterval
BioPlex 2200 ToRC IgG	Rubella IgG	PregnantWomen(N = 300)	Pos (+)	276	0	0	97.2%(276/284)	94.5-98.6%	100%(8/8)	67.6-100%	94.5%(276/292)	91.3-96.6%	100%(8/8)	67.6-100%
			Neg (-)	8	8	2
			Equivocal	6	0	0
			Total	290	8	2
		ClinicalSamplesSubmittedfor Testing(N = 400)	Pos (+)	358	0	1	96.5%(358/371)	94.1-97.9%	100%(12/12)	75.8-100%	92.7%(358/386)	89.7-94.9%	85.7%(12/14)	61.1-96.0%
			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}------------------------------------------------

			PredicateT. gondii IgG Assay			BioPlex 2200 Agreement
	Antibody/Population		Pos (+)	Neg (-)	Equivocal	Pos (+)% Agreement	95%ConfidenceInterval	Neg (-)% Agreement	95%ConfidenceInterval
BioPlex 2200 ToRCT. gondii IgG	Total(N = 700)	Pos (+)	118	0	6	97.5%(118/121)	93.0-99.2%	98.8%(569/576)	97.5-99.4%
		Neg (-)	1	569	1
		Equivocal	1	1	3
	Total		120	570	10

BioPlex T. gondii IgG vs. EIA: Prospective

BioPlex CMV IgG vs. ElA: Prospective

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

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

・

です。 2017年 10月 10:00 10:00 10:00 10:00 10:00 1 . . . - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -Bio-Rad Laboratories, Inc. 510(k) February 18, 2009 Additional Information - K080008 .

and the comments of the country

: 上一篇:

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

Retrospective Study: Performance of the ToRC IgG kit was evaluated using samples with confirmed known Rubella IgG status against a commercially available Rubella IgG immunoassay. Rubella IgG status was determined in clinical laboratories using an FDA-cleared assay for Rubella IgG. Two (2) U.S. clinical sites tested a combined: 50 Rubella IgG low positive samples (10-20 IU/mL), 50 Rubella IgG high positive samples (> 20 IU/mL) and 130 Rubella IgG negative samples (< 10 IU/mL). All samples were preselected based on the assay result falling in the ranges described. Results are shown in the table below.

Preselected Samples		PredicateRubella IgG Assay			BioPlex 2200 Agreement ExcludingEquivocal Results		BioPlex 2200 Agreement IncludingEquivocal Results
		Pos (+)	Neg (-)	Equivocal	Pos (+)% Agreement	95% ConfidenceInterval	Neg (-)% Agreement	95% ConfidenceInterval
BioPlex 2200 ToRC IgGRubella IgG	Pos (+)	90	0	1	92.8%(90/97)	85.8-96.5%	100%(124/124)	97.0-100%
	Neg (-)	7	124	2
	Equivocal	5	0	1
	Total	102	124	4

BioPlex Rubella IgG vs. EIA: Retrospective

*Most of the discordant samples were low positive or close to the cut-off for the predicate assay.

Bio-Rad Laboratories, Inc. 510(k) Additional Information - K080008 510(k) Summary 17 of 17

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Cynthia Sinclair, RAC Principal Consultant, Regulatory Services Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

FEB 2 3 2009

Re: K080008

Trade/Device Name: BioPlex™ 2200 ToRC IgG Regulation Number: 21 CFR 866.3510 Regulation Name: Rubella virus serological reagents Regulatory Class: Class II Product Code: OMI, JIX, JJY Dated: February 18, 2009 Received: February 19, 2009

Dear Ms. Sinclair:

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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the 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

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

Page 2 -

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sally attayma

Sally A. Hoivat, 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

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

Indications for Use

510(k) Number (if known): K080008

Device Name: BioPlex™ 2200 System ToRC IgG Kit on the BioPlex™ 2200 Multi-Analyte Detection System BioPlex™ 2200 ToRC IgG Calibrator Set BioPlex™ 2200 ToRC IgG Control Set

Indications for Use:

BioPlex™ 2200 ToRC IgG Kit

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.

BioPlex™ 2200 ToRC IqG 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 IqG 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 ToRG 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.

Prescription Use × (21 CFR Part 801 Subpart D)

And/Or

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

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

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

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

Um Schaf

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

2080008 510(k)

Regulation Number and Section

§ 866.3510 Rubella virus serological reagents.

(a)
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).(b)
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.