Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a multiplex flow immunoassay system and its components, focusing on the biological and chemical processes involved in detecting antibodies. There is no mention of AI or ML in the intended use, device description, or performance studies. The data analysis appears to be based on relative fluorescence intensity and comparison to calibrated values and cut-offs, which are standard immunoassay procedures.

Therapeutic

No
Explanation: This device is for diagnostic purposes, specifically for detecting IgG antibodies to certain viruses and organisms. It aids in determining serological status but does not treat or prevent disease, which are characteristics of a therapeutic device.

Diagnostic

Yes

Explanation: The device is intended "as an aid in the determination of serological status to T. gondii, Rubella and CMV," which directly contributes to diagnosing a patient's condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a system that includes physical components such as dyed beads coated with antigens, reaction vessels, and a detector. It also describes the use of calibrator and control sets, which are physical reagents. While software is undoubtedly involved in processing the data from the detector, the core of the device is a physical immunoassay system.

IVD (In Vitro Diagnostic)

Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the kit is 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." This involves testing biological samples (serum and plasma) in vitro (outside the body) to provide information about a person's health status (serological status to T. gondii, Rubella, and CMV).
Device Description: The description details a laboratory-based assay using a multiplex flow immunoassay methodology to detect antibodies in patient samples. This is a typical characteristic of an IVD.
Intended User / Care Setting: It is intended for use in the "clinical laboratory," which is where IVD testing is performed.
Performance Studies: The document describes performance studies conducted to evaluate the device's accuracy and reliability in a clinical setting, which is a requirement for IVDs.
Predicate Devices: The mention of predicate devices (other commercially available IVDs for similar testing) further confirms its classification as an IVD.

The entire context of the document describes a product designed and evaluated for use in a clinical laboratory to diagnose or provide information about a person's health status by testing samples in vitro.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

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

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

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.

Product codes (comma separated list FDA assigned to the subject device)

OMI, JIX, JJY

Device Description

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

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

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

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

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinical laboratory

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Reproducibility:

Internal Reproducibility Study:
- Study Type: Reproducibility study based on CLSI EP5-A2.
- Sample Size: Three (3) panels made from serum and plasma (EDTA and heparinized).
- Protocol: Assayed two (2) times in two (2) separate daily runs over 20 days (n=80).
- Key Results:
  - Within-run precision for positive samples (> cut-off) in all matrices:
    - T. gondii IgG: 3.9% to 9.5%
    - Rubella IgG: 3.0% to 5.0%
    - CMV IgG: 1.8% to 5.6%
  - Total precision for positive samples (> cut-off) in all matrices:
    - T. gondii IgG: 6.6% to 12.3%
    - Rubella IgG: 5.2% to 9.9%
    - CMV IgG: 3.8% to 8.7%
External Reproducibility Study:
- Study Type: Reproducibility study based on CLSI EP5-A2, performed at three (3) U.S. testing facilities.
- Sample Size: Three (3) panels made from serum and plasma (EDTA and heparinized).
- Protocol: Assayed two (2) times on two (2) separate daily runs over five (5) days at the three (3) sites (N=60).
- Key Results:
  - Within-run precision for positive samples (> cut-off) in all matrices:
    - T. gondii IgG: 3.7% to 7.7%
    - Rubella IgG: 4.6% to 6.6%
    - CMV IgG: 2.5% to 5.8%
  - Total precision for positive samples (> cut-off) in all matrices:
    - T. gondii IgG: 4.8% to 17.6%
    - Rubella IgG: 7.2% to 10.3%
    - CMV IgG: 4.4% to 12.1%
Additional External Rubella Reproducibility Study:
- Study Type: Reproducibility study performed at three (3) U.S. testing facilities.
- Sample Size: A panel of three (3) Rubella IgG samples measuring near cut-off.
- Protocol: Assayed in replicates of 40 in one run at each site.
- Key Results: Within-run precision ranged from 5.2% to 9.7%.

Linearity:

Study Type: Linearity study based on CLSI EP6-A.
Sample Size: Five (5) high positive serum samples for each analyte.
Protocol: Serial dilutions prepared using negative serum. Linear and polynomial regression analysis performed.
Key Results: Acceptable dilution linearity, as all recoveries were within ±20% of the predicted value.
Study Type: Linearity study using WHO IgG standards.
Sample Size: Dilutions of anti-Toxoplasma serum, 3rd International Standard (TOXM), and anti-Rubella, immunoglobulin, 1st International Standard (RUBI-1-94).
Protocol: Tested in the respective assay.
Key Results: Acceptable dilution linearity through the cut-off, as all recoveries were within ±20% of the predicted value.

Interfering Substances:

Study Type: Interfering substances study based on CLSI EP7-A2.
Protocol: Evaluated potential interference of specific endogenous and exogenous substances.
Key Results: No significant interference observed with any of the substances tested (Hemoglobin, Bilirubin Unconjugated, Bilirubin Conjugated, Cholesterol, Red Blood Cells, Gamma Globulin, Triglyceride, Total Protein (albumin), Ascorbic Acid, Heparin Lithium, Heparin Sodium, EDTA).

Cross-Reactivity:

Study Type: Cross-reactivity study.
Sample Size: A panel of ten (10) specimens positive for each cross reactant.
Protocol: Evaluated for possible cross-reactivity with each of the three (3) BioPlex ToRC IgG assays and tested with reference ToRC IgG assays.
Key Results: The various disease state samples evaluated do not cross-react with the three (3) assays in the BioPlex ToRC IgG kit. Most samples that elicited a positive result were confirmed by corresponding reference assays.

Correlation with CDC Evaluation Panels:

Study Type: Correlation study.
Sample Size: Three (3) serum panels (N=100 each for T. gondii, Rubella, and CMV) provided by CDC.
Protocol: Panels tested with the BioPlex ToRC IgG kit, and data provided to CDC for comparison against CDC Reference Methods.
Key Results:
- T. gondii IgG (N=100): 70 BioPlex Pos / 0 BioPlex Neg for CDC Pos; 0 BioPlex Pos / 30 BioPlex Neg for CDC Neg.
- Rubella IgG (N=100): For CDC Pos, 82 BioPlex Pos / 0 BioPlex Neg across 3 sites. For CDC Neg, 0 BioPlex Pos / 18 BioPlex Neg across 3 sites.
- CMV IgG (N=100): Not clearly tabulated, but implied full agreement from the table structure.

Expected Values/Prevalence:

Study Type: Prevalence study.
Sample Source: Samples collected from pregnant women in the U.S. and Europe, and clinical samples submitted for ToRC IgG testing.
Key Results: Prevalence data for T. gondii, Rubella, and CMV IgG individually and in dual infection, stratified by age and gender.

Performance Characteristics (Prospective Study):

Study Type: Prospective study for agreement against commercially available immunoassays.
Sample Size:
- 300 prospective samples from pregnant women (150 U.S., 150 Europe).
- 1200 prospective samples submitted for T. gondii, Rubella, and/or CMV IgG testing.
- 100 prospective samples from immunocompromised/AIDS patients submitted for CMV testing.
Key Results (Agreement excluding equivocal results):
- Rubella IgG - Pregnant Women (N=300):
  - Positive Agreement: 97.2% (276/284), 95% CI: 94.5-98.6%
  - Negative Agreement: 100% (8/8), 95% CI: 67.6-100%
- Rubella IgG - Clinical Samples (N=400):
  - Positive Agreement: 96.5% (358/371), 95% CI: 94.1-97.9%
  - Negative Agreement: 100% (12/12), 95% CI: 75.8-100%
- T. gondii IgG - Total (N=700):
  - Positive Agreement: 97.5% (118/121), 95% CI: 93.0-99.2%
  - Negative Agreement: 98.8% (569/576), 95% CI: 97.5-99.4%
- CMV IgG - Total (N=700):
  - Positive Agreement: 99.0% (394/398), 95% CI: 97.4-99.6%
  - Negative Agreement: 98.7% (298/302), 95% CI: 96.6-99.5%
- CMV IgG - HIV+ (N=100):
  - Positive Agreement: 100% (86/86), 95% CI: 95.8-100%
  - Negative Agreement: 100% (14/14), 95% CI: 76.8-100%

Performance Characteristics (Retrospective Study - Rubella IgG):

Study Type: Retrospective study evaluating the kit against an FDA-cleared assay.
Sample Size: 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 (

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.

Summary

0

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

1

4. DEVICE DESCRIPTION

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

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

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

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

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

2

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

BioPlex™ 2200 ToRC IgG Kit Components

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

Vial	Description
Bead Set	One (1) 10 mL vial containing three (3) different populations
of dyed beads coated with lysates (tachyzoites, Vero cell and
nuclear) of T. gondii, Rubella and CMV; plus an Internal
Standard Bead (ISB), a Serum Verification Bead (SVB) and a
Reagent Blank Bead (RBB); with protein stabilizers (bovine)
in a saline buffer. ProClin® 300 (0.3%), sodium benzoate
(0.1%) and sodium azide (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 the
screening of blood or plasma
donors. | VIDAS® Toxo IgG II (TXG) is
an automated quantitative test
for use on the VIDAS analyzer
for the measurement of anti-
Toxoplasma IgG in human
serum using the ELFA
technique. It is intended for
use as an aid in determination
of immune status. | VIDAS® Rubella IgG (RBG)
assay is intended for use with
a VIDAS (Vitek
ImmunoDiagnostic Assay
System) instrument as an
automated qualitative
enzyme-linked fluorescent
immunoassay (ELFA) for the
detection of IgG antibodies to
rubella virus in human serum. | VIDAS® Cytomegalovirus IgG
(CMVG) is intended for use
with the VIDAS (Vitek
ImmunoDiagnostic Assay
System) instrument as a semi-
quantitative automated
enzyme-linked fluorescent
immunoassay (ELFA)for the
detection of IgG antibodies to
Cytomegalovirus in human
serum. |
| Antigen | Partially purified cell lysates of
T. gondii , Rubella, and CMV | Membrane and cytotoxic
Toxoplasma antigen
(RH Sabin Strain) | Inactivated Rubella virus
(HPV-77) | Purified and inactivated CMV
antigen (Strain AD 169) |
| Assay Type | Quantitative detection for
T. gondii , Rubella, and
qualitative for CMV | | Same | Same |
| Analyte Detected | Human IgG antibodies
to T. gondii , Rubella, and
CMV | | Same | Same |
| Signal Detection | Fluorescence | | Same | Same |
| Item | BioPlex™ 2200
TORC IgG Kit | bioMerieux, Inc. VIDAS®
TOXO IgG II (K993319) | bioMerieux, Inc. VIDAS®
Rubella IgG (K902925) | bioMerieux, Inc. VIDAS®
CMV IgG (K920661) |
| Number of Analytes
Simultaneously
Detected | Multiple (3) | Single | Single | Single |
| Enzyme Conjugate | Phycoerythrin conjugated | | Horseradish peroxidase conjugated | |
| Matrices | Serum and plasma (EDTA
and heparin) | Serum and plasma (EDTA
and heparin) | Serum | |
| Assay Technology | Multiplex flow immunoassay | | Two-step enzyme immunoassay sandwich method with fluorescent detection (ELFA) | |
| Solid Phase | Antigen-coated paramagnetic
microbead reagent.
Microbeads are infused with
red and infrared fluorescent
dyes for bead classification.
Green fluorescence from the
immunoassay label is used for
analyte measurement. | | Antigen-coated solid phase receptacles | |
| Calibrator(s) | Multiple Calibrators | | Single Calibrator | |
| Controls | Negative Control and multi-
analyte Positive Controls | Negative Control and Positive
Control specific for T. gondii | Negative Control and Positive
Control specific for rubella
virus | Negative Control and Positive
Control specific for CMV virus |

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:

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

510(k) Summary

,

February 18, 2009

5

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

6

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

7

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.

miemational Slandaile

8

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

9

Cross-Reactivity

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

| Potential

Cross-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 Factor
IgM	10	BioPlex 2200	1	10	9
	10	Reference	1	10	9
		Discordant	0	0	0
Rubella IgG	10	BioPlex 2200	3	10	7
	10	Reference	3	10	7
		Discordant	0	0	0
Rubeola (measles)
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
		BioPlex
Pos (+)	BioPlex
Neg (-)	BioPlex
Pos (+)	BioPlex
Neg (-)	BioPlex
Pos (+)	BioPlex
Neg (-)
Rubella IgG	Pos (+)	82	0	82	0	82	0
	Neg (-)	0	18	0	18	0	18

Characteristics of CDC CMV Reference Sera (N=100)

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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 IgG
US
Pos/Total | T. gondii IgG
US
% Prevalence | T. gondii IgG
Europe
Pos/Total | T. gondii IgG
Europe
% Prevalence | Rubella IgG
Pos/Total | Rubella IgG
% Prevalence | CMV IgG
Pos/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

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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/or
Gender		1/10	10.0	8/10	80.0	6/10	60.0
Total		187/1200	15.6	1066/1200	88.8	710/1200	59.2

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

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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/or
Gender		1/10	10.0	1/10	10.0	4/10	40.0
Total		176/1200	14.7	134/1200	11.2	640/1200	53.3

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

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

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

.

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

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
Antibody/Population				Pos (+)	Neg (-)	Equivocal	Pos (+)
% Agreement	95% Confidence
Interval	Neg (-)
% Agreement	95% Confidence
Interval	Pos (+)
% Agreement	95% Confidence
Interval	Neg (-)
% Agreement	95% Confidence
Interval
BioPlex 2200 ToRC IgG	Rubella IgG	Pregnant
Women
(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
		Clinical
Samples
Submitted
for 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

| | | | | Predicate
T. gondii IgG Assay | | | BioPlex 2200 Agreement | | | |
|-------------------------------------------|---------------------|-----------|--|-----------------------------------------|---------|-----------|------------------------|-------------------------------|------------------------|-------------------------------|
| | Antibody/Population | | | Pos (+) | Neg (-) | Equivocal | Pos (+)
% Agreement | 95%
Confidence
Interval | Neg (-)
% Agreement | 95%
Confidence
Interval |
| BioPlex 2200 ToRC
T. 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

:

i

BioPlex CMV IgG vs. ElA: Prospective

| | | | Predicate
CMV IgG Assay | | | BioPlex 2200 Agreement | | | | |
|-----------------------|---------|--------------------|----------------------------|---------|-----------|------------------------|----------------------------|------------------------|----------------------------|----------------|
| Antibody/Population | | | Pos (+) | Neg (-) | Equivocal | Pos (+)
% Agreement | 95% Confidence
Interval | Neg (-)
% Agreement | 95% Confidence
Interval | |
| 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 (

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

§ 866.3510 Rubella virus serological reagents.

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

1. Applicant/Sponsor

2. Device Name

3. Predicate Devices

4. DEVICE DESCRIPTION

BioPlex™ 2200 ToRC IgG Kit Components

7. Performance Testing

A. Reproducibility

B. Linearity

C. Interfering Substances

Interfering Substances

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

Cross-Reactivity

E. Correlation with CDC Evaluation Panels

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

Characteristics of CDC Rubella Reference Sera (N=100)

Characteristics of CDC CMV Reference Sera (N=100)

1000 1

F. Expected Values/Prevalence

Prevalence of Individual Assay Positive in Pregnant Women

Prevalence of Dual Assay Positive in Pregnant Women

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

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

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

G. Performance Characteristics

BioPlex Rubella IgG vs. EIA: Prospective

BioPlex T. gondii IgG vs. EIA: Prospective

BioPlex CMV IgG vs. ElA: Prospective

1000
1