(466 days)
No
The summary describes a multiplex flow immunoassay system that uses standard laboratory techniques for antibody detection and quantification. There is no mention of AI or ML in the device description, intended use, or performance studies. The data analysis involves calculating relative fluorescence intensity and comparing it to cut-off values, which is a traditional immunoassay method.
No
Explanation: The device is an in-vitro diagnostic (IVD) kit used for the qualitative detection of IgM antibodies to Rubella and Cytomegalovirus (CMV) in human samples, intending to aid in the diagnosis of infection. It is not designed to treat or alleviate a disease, but rather to diagnose it.
Yes
The kit is "intended as an aid in the diagnosis of a current or recent Rubella and/or CMV infection."
No
The device is a multiplex flow immunoassay kit intended for use with a specific instrument (Bio-Rad BioPlex 2200 System). The description details physical components like dyed beads, reagents, and incubation steps, indicating it is a hardware-based diagnostic system with associated software for analysis, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of IgM antibodies to Rubella and Cytomegalovirus (CMV) in human serum and potassium EDTA or sodium heparin plasma." This involves testing samples taken from the human body in vitro (outside the body).
- Aid in Diagnosis: The kit is intended as an "aid in the diagnosis of a current or recent Rubella and/or CMV infection." This is a key characteristic of an IVD, as it provides information used to help diagnose a disease.
- Clinical Laboratory Use: The intended user is the "clinical laboratory," which is where IVD tests are typically performed.
- Device Description: The description details a laboratory-based assay (multiplex flow immunoassay) that analyzes patient samples to detect specific antibodies.
- Performance Studies: The document describes performance studies conducted to evaluate the device's accuracy and reliability in a laboratory setting, comparing it to other commercially available IVD kits.
- Predicate Devices: The mention of predicate devices (ADVIA Centaur® Rubella IgM and bioMeriéux VIDAS® CMV IgM) which are known IVDs, further confirms the nature of this device.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BioPlex® 2200 Rubella and CMV IgM kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Rubella and Cytomegalovirus (CMV) in human serum and potassium EDTA or sodium heparin plasma.
The BioPlex 2200 Rubella and CMV IgM kit is intended for use with the Bio-Rad BioPlex 2200 System.
This kit is intended as an aid in the diagnosis of a current or recent Rubella and/or CMV infection, in individuals suspected of having one of the respective disease states including women of child bearing age.
This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors.
Performance characteristics for the Rubella and CMV IgM assays have not been evaluated in immunosupressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at point of care facilities.
BioPlex® 2200 Rubella and CMV IgM Calibrator Set
The BioPlex® 2200 Rubella and CMV IgM Calibrator Set is intended for the calibration of the BioPlex® 2200 Rubella and CMV IgM Reagent Pack.
BioPlex® 2200 Rubella and CMV IgM Control Set
The BioPlex® 2200 Rubella and CMV IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 instrument and BioPlex 2200 Rubella and CMV IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Rubella and CMV IgM Control Set has not been established with any other Rubella and CMV IgM assays.
Product codes (comma separated list FDA assigned to the subject device)
LFX, LKQ, LFZ, JIX, JJX
Device Description
The BioPlex® 2200 Rubella and CMV IgM kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional EIA, but permits simultaneous detection and identification of many antibodies in a single tube. Rubella and CMV IgM test is to detect antibodies to Rubella and Cytomegalovirus (CMV).
Two (2) different populations of dyed beads are coated with cell lysates bearing Rubella or CMV antigens. The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel; the mixture is incubated at 37°C. After a wash cycle, anti-human IgM antibody, conjugated to phycoerythrin (PE), is added to the dyed beads, and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data are reported as relative fluorescence intensity (RFI).
Three additional dyed beads, an Internal Standard Bead (ISB), a Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum or plasma to the reaction vessel and the absence of significant non-specific binding in serum or plasma.
The instrument is calibrated using a set of three (3) distinct serum based calibrators. A negative and CMV IgM calibrator is used to calibrate CMV assay, and a negrative and rubella IgM calibrator is used to calibrate the rubella IgM assay, The cut-off value and assignment of the calibrators are determined by performing concordance and Receiver Operator Characteristic (ROC) analysis using the Centaur Rubella IgM and VIDAS CMV IgM predicate results as the standard. For Rubella and CMV, results of ≤ 0.8 Al are negative, 0.9 and 1.0 Al are equivocal and results of ≥ 1.1 Al are reported as positive.
The BioPlex 2200 Rubella and CMV IgM Control Set includes a negative control as well as a CMV IgM positive control and a Rubella IgM positive control. The BioPlex Rubella and CMV IgM Positive Controls are manufactured to give positive results, with values above the cut-off for each specific analyte. The BioPlex Rubella and CMV IgM Negative Control are manufactured to give negative results, with values below the cut-off for each specific analyte. The recommended frequency for performing quality control is once every 24-hour testing period. Performing quality control is also necessary after each new assay calibration and certain service procedures.
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)
A series of studies was conducted to evaluate the performance of the BioPlex® 2200 Rubelia and CMV IgM kit. The studies included reproducibility, interfering substances, cross-reactivity, expected values and method comparison. The results of all studies demonstrated that the BioPlex 2200 Rubella and CMV IgM kit performed according to its specifications.
A. Reproducibility:
- 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).
- External reproducibility study: Performed at three (3) clinical trial sites. Three lots of reagent packs, calibrators, and control set were evaluated. Three (3) panels made from serum and plasma (EDTA and heparinized) were tested in quadruplicate over five (5) days (4 replicates x 1 run x 5 days x 3 testing sites = 60 replicates per panel member).
- Key results: The within-run precision for rubella IgM samples ranged from 4.3% to 9.5% across matrices. The within-run precision for CMV IgM samples ranged from 4.9% to 12.8% across matrices. The total precision for positive samples (≥1.1 Al) for Rubella IgM was 2.3% to 13.5% and for CMV IgM was 3.0% to 14.2%.
B. Interfering Substances:
- Study conducted based on CLSI EP7-A2.
- Key results: No interference was observed with any of the substances tested (Hemoglobin, Bilirubin, Cholesterol, Red Blood Cells, Gamma Globulin, Triglycerides, Beta Carotene, Protein, Ascorbic Acid, Lithium Heparin, Sodium Heparin, EDTA, Sodium citrate at specified concentrations).
C. Cross-Reactivity:
- Study performed to determine if samples from various disease states and other potentially cross-reacting agents interfere with test results. Samples positive for potential cross-reactants were evaluated.
- Key results: No significant cross reactivity was observed except for potential cross reactivity of myeloma IgM samples tested with the rubella and CMV IgM assays, and EBV VCA and parvovirus B19 IgM and dsDNA samples tested with the CMV IgM assay.
D. IgM Detection:
- Rubella and CMV IgM-positive samples were selected and supplemented with matched specific IgG. Samples were treated with dithiothreitol (DTT) to inactivate IgM activity. IgM was measured using the Rubella and CMV IgM kit.
- Key results: DTT treatment significantly reduced IgM levels (e.g., Rubella IgM % recovery 5.6%-9.1%; CMV IgM % recovery 0.4%-7.7%).
E. Seroconversion Testing:
- Rubella IgM: Three Liquichek™ Rubella IgM seroconversion panels (RP001, RP011, RP014) were tested with the BioPlex 2200 Rubella and CMV IgM kit and compared to a commercial method.
- Key results: For panel RP001, the BioPlex 2200 detected Rubella IgM four days earlier, demonstrating greater sensitivity. For panels RP011 and RP014, comparable performance to a commercial method was observed, with one instance on day 40 for RP014 where the BioPlex 2200 showed equivocal results while the comparison test was positive (at cutoff).
- CMV IgM: One Bio-Rad Laboratories Liquichek™ CMV IgM Seroconversion panel (RP003) was assayed with BioPlex 2200 Rubella and CMV IgM kits and a commercial method.
- Key results: The BioPlex 2200 Rubella and CMV IgM test was able to detect CMV IgM where the commercial method showed equivocal or negative results, demonstrating higher sensitivity.
F. Expected Values:
- Observed prevalence for Rubella and CMV IgM was determined using samples submitted for testing (300 US for Rubella, 400 (300 US + 100 Europe) for CMV IgM).
- Key results: Overall prevalence for Rubella IgM (US) was 4.0%. Overall prevalence for CMV IgM (US) was 3.0% and (EU) was 4.0%.
G. Method Comparison:
- Prospective Study: Performance against corresponding commercially available Rubella and CMV kits. Three clinical sites tested 700 prospective samples (300 for Rubella IgM (US), 400 for CMV IgM (300 US + 100 Europe)). 71 pregnant women were included in the Rubella IgM samples.
- Key results: For Rubella IgM, positive percent agreement was 66.7% (2/3) (95% CI 20.8 - 93.9%), and negative percent agreement was 95.6% (282/295) (95% CI 92.6 - 97.4%). For pregnant women, negative percent agreement was 96.8% (70/71) (95% CI 92.8% - 99.8%). For CMV IgM, positive percent agreement was 53.8% (7/13), and negative percent agreement was 97.7% (377/386).
- Retrospective Study: Performance evaluated against corresponding commercially available Rubella and CMV IgM immunoassays. Three clinical sites tested 107 Rubella presumptive IgM positive samples and 229 CMV presumptive IgM positive samples.
- Key results: For Rubella IgM, positive % Agreement was 96.3% (103/107) (95% CI 90.3 – 98.5%). For CMV IgM, positive % Agreement was 91.3% (209/229) (95% CI 86.9 - 94.3 %).
Matrix Comparison:
- Matched serum and plasma (potassium EDTA and sodium heparin) samples drawn from 20 individual donors were acquired from commercial sources. All samples were evaluated in replicates of 10.
- Key results: All assays pass the slope specification of 1.0 ± 0.2, and correlation coefficient (r) of ≥ 0.98. Scatter plots and regression analysis (y = 1.0369x - 0.0077, r = 0.9971 for Rubella IgM EDTA vs Serum; y = 1.0219x - 0.0123, r = 0.9976 for Rubella IgM Heparin vs Serum; y = 1.0000x - 0.0000, r = 0.9945 for CMV IgM Heparin vs Serum) confirmed the compliance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive percent agreement:
- Rubella IgM (Prospective): 66.7% (2/3) (95% CI 20.8 - 93.9%)
- CMV IgM (Prospective): 53.8% (7/13)
- Rubella IgM (Retrospective): 96.3% (103/107) (95% CI 90.3 – 98.5%)
- CMV IgM (Retrospective): 91.3% (209/229) (95% CI 86.9 - 94.3%)
Negative percent agreement:
- Rubella IgM (Prospective): 95.6% (282/295) (95% CI 92.6 - 97.4%)
- Rubella IgM (Pregnant Women, Prospective): 96.8% (70/71) (95% CI 92.8% - 99.8%)
- CMV IgM (Prospective): 97.7% (377/386)
Predicate Device(s)
ADVIA Centaur® Rubella IgM . K010668, bioMeriéux VIDAS® CMV IgM . K933549
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary for Bio-Rad Laboratories, Inc. BioPlex® 2200 Rubella and CMV IgM
DEC - 3 2010
1. APPLICANT/SPONSOR
Bio-Rad Laboratories, Inc. BioPlex Division 5500 East Second Street Benicia, CA 94510
| Contact Person: | Juang Wang |
|---|---|
| Telephone: | 510-741-4609 |
Date Prepared: November 30, 2010
2. DEVICE NAME
| Proprietary Name: | BioPlex® 2200 Rubella and CMV IgM Kit
BioPlex® 2200 Rubella and CMV IgM Calibrator Set
BioPlex® 2200 Rubella and CMV IgM Control Set |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Multi-Analyte Detection System for Rubella IgM and
Cytomegalovirus (CMV) IgM |
| Classification Name: | Rubella virus serological reagents
Cytomegalovirus serological reagents
Calibrator, multi-analyte mixture
Single analyte controls, all kinds (assayed and unassayed) |
3. Predicate Devices
4. DEVICE DESCRIPTION
The BioPlex® 2200 Rubella and CMV IgM kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional EIA, but permits simultaneous detection and identification of many antibodies in a single tube. Rubella and CMV IgM test is to detect antibodies to Rubella and Cytomegalovirus (CMV).
1
Two (2) different populations of dyed beads are coated with cell lysates bearing Rubella or CMV antigens. The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel; the mixture is incubated at 37°C. After a wash cycle, anti-human IgM antibody, conjugated to phycoerythrin (PE), is added to the dyed beads, and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data are reported as relative fluorescence intensity (RFI).
Three additional dyed beads, an Internal Standard Bead (ISB), a Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum or plasma to the reaction vessel and the absence of significant non-specific binding in serum or plasma.
The instrument is calibrated using a set of three (3) distinct serum based calibrators. A negative and CMV IgM calibrator is used to calibrate CMV assay, and a negrative and rubella IgM calibrator is used to calibrate the rubella IgM assay, The cul-off value and assignment of the calibrators are determined by performing concordance and Receiver Operator Characteristic (ROC) analysis using the Centaur Rubella IgM and VIDAS CMV IgM predicate results as the standard. For Rubella and CMV, results of ≤ 0.8 Al are negative, 0.9 and 1.0 Al are equivocal and results of ≥ 1.1 Al are reported as positive.
The BioPlex 2200 Rubella and CMV IgM Control Set includes a negative control as well as a CMV IgM positive control and a Rubella IgM positive control. The BioPlex Rubella and CMV IgM Positive Controls are manufactured to give positive results, with values above the cut-off for each specific analyte. The BioPlex Rubella and CMV IgM Negative Control are manufactured to give negative results, with values below the cut-off for each specific analyte. The recommended frequency for performing quality control is once every 24-hour testing period. Performing quality control is also necessary after each new assay calibration and certain service procedures.
2
BioPlex® 2200 Rubella and CMV IgM Kit Components
The BioPlex 2200 Rubella and CMV IgM kit (665-1751) contains supplies sufficient for 100 tests.
| Vial | Description |
|---|---|
| Bead Set | One (1) 10 mL vial containing two (2) different populations of dyed beads coated with lysates of Rubella and CMV; an Internal Standard Bead (ISB), a Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) in buffer with Glycerol and protein stabilizers (bovine). ProClin ® 300 (0.3%) and sodium azide (4.0 (Pos) |
| 24 | 7.95 (Pos) |
| 28 | 1.87 (Pos) |
| 31 | 4.92 (Pos) |
| 35 | 7.31 (Pos) |
| 38 | 3.54 (Pos) |
| 42 | 2.43 (Pos) |
| 45 | 1.83 (Pos) |
| 50 | 1.95 (Pos) |
The BioPlex 2200 Rubella and CMV IgM test detected Rubella IgM four days earlier demonstrating greater sensitivity.
| Panel RP011 | Rubella IgM | |
|---|---|---|
| Day | Commercial Method | BioPlex 2200 Rubella |
| Index | and CMV IgM kit | |
| AI | ||
| 0 | 0.21 (Neg) | 0.2 (Neg) |
| 3 | 0.00 (Neg) | 0.2 (Neg) |
| 9 | 0.02 (Neg) | 0.2 (Neg) |
| 12 | 0.00 (Neg) | 0.2 (Neg) |
| 16 | 1.64 (Pos) | 1.1 (Pos) |
| 19 | 5.94 (Pos) | >4.0 (Pos) |
| 24 | 8.95 (Pos) | >4.0 (Pos) |
| 27 | 7.69 (Pos) | >4.0 (Pos) |
| 31 | 4.50 (Pos) | 3.7 (Pos) |
| 36 | 2.70 (Pos) | 2.4 (Pos) |
| 39 | 1.78 (Pos) | 1.8 (Pos) |
| 43 | 1.12 (Pos) | 1.2 (Pos) |
| 46 | 0.77 (Neg) | 0.8 (Neg) |
| 50 | 0.43 (Neg) | 0.8 (Neg) |
| 53 | 0.32 (Neg) | 0.6 (Neg) |
| 57 | 0.32 (Neg) | 0.6 (Neg) |
| 60 | 0.13 (Neg) | 0.4 (Neg) |
| 64 | 0.37 (Neg) | 0.5 (Neg) |
| 67 | 0.00 (Neg) | 0.4 (Neg) |
| 71 | 0.00 (Neg) | 0.5 (Neg) |
The BioPlex 2200 Rubella and CMV IgM test showed comparable performance to a commercial method.
| Panel RP014 | Rubella IgM | |
|---|---|---|
| Day | Commercial Method | |
| Index | BioPlex 2200 Rubella | |
| and CMV IgM kit | ||
| AI | ||
| 0 | 0.00 (Neg) | 2.44 (Pos) |
| 21 | 2.55 (Pos) | 2.4 (Pos) |
| 26 | 2.58 (Pos) | 2.2 (Pos) |
| 28 | 2.15 (Pos) | 1.8 (Pos) |
| 33 | 1.5 (Pos) | 1.6 (Pos) |
| 35 | 1.5 (Pos) | 1.2 (Pos) |
| 40 | 1.00 (Pos) | 1.0 (Eq) |
| 42 | 0.76 (Neg) | 0.8 (Neg) |
The BioPlex 2200 Rubella and CMV IgM test showed comparable performance to a commercial method, except for the day 40 sample which scored equivocal in the BioPlex 2200 Rubella and CMV IgM test and positive (at the cutoff) in the comparison test.
CMV IgM
Bio-Rad Laboratories Liquichek™ CMV IgM Seroconversion panel was assayed with BioPlex 2200 Rubella and CMV IgM kits and a commercial method. The results are shown in below. The BioPlex 2200 Rubella and CMV IgM test was able to detect CMV IgM in the Libr Ion LEGO Rubella and CMV IgM test was able equivocal at 59 days.
| Panel RP003 | CMV IgM | |
|---|---|---|
| Day | Commercial Methos | |
| Index | BioPlex 2200 Rubella | |
| and CMV IgM kit | ||
| AI | ||
| 1 | 1.16 (Pos) | >4.0 (Pos) |
| 4 | 1.62 (Pos) | >4.0 (Pos) |
| 8 | 2.44 (Pos) | >4.0 (Pos) |
| 51 | 1.16 (Pos) | 3.4 (Pos) |
| 55 | 1.04 (Pos) | 3.0 (Pos) |
| 59 | 0.84 (Eq) | 2.1 (Pos) |
| 65 | 0.85 (Eq) | 2.3 (Pos) |
| 67 | 0.75 (Eq) | 2.0 (Pos) |
| 72 | 0.68 (Neg) | 1.7 (Pos) |
| 74 | 0.62 (Neg) | 1.5 (Pos) |
| 79 | 0.64 (Neg) | 1.8 (Pos) |
| 84 | 0.54 (Neg) | 1.7 (Pos) |
| 88 | 0.72 (Eq) | 2.1 (Pos) |
| 95 | 0.59 (Neg) | 1.7 (Pos) |
| 99 | 0.65 (Neg) | 1.6 (Pos) |
12
ட் Expected Values
The observed prevalence for the Rubella and CMV IgM using the BioPlex 2200 Rubella and CMV IgM assay was determined using samples submitted for Rubella (300, US) or CMV IgM (400, 300 US +100 Europe) testing. The results are presented in the tables below. The predictive values of the test are dependent on the prevalence. As rubella incidence decreases, the predicative positive value of rubella igM results decreases.
Note: Each laboratory should establish frequency distributions for their specific patient populations.
| Age | Gender | Rubella IgM
(US) | | CMV IgM
(US) | | CMV IgM
(EU) | |
|---------|--------|---------------------|----------------------------------|-----------------|---------------|-----------------|---------------|
| | | Pos/Tota | % revalence Trevalence Station | os/Tota | revalenc
% | Pos/Tota | Prevalen
% |
| 0 - 10 | F | 0/13 | 0.0% | 0/4 | 0.0% | 0/0 | N/A |
| | M | 0/1 1 | 0.0% | Ole | 0.0% | 0/2 | 0.0% |
| 11 - 20 | F | 0/44 | 0.0% | 1/19 | 5.3% | 0/4 | 0.0% |
| | M | 0/12 | 0.0% | 0/20 | 0.0% | 0/1 | 0.0% |
| 21 - 30 | F | 4/80 | 5.0% | 1/41 | 2.4% | 1/36 | 2.8% |
| | M | 018 | 0.0% | 0/10 | 0.0% | 0/2 | 0.0% |
| 31 - 40 | F | 4/55 | 7.3% | 1/34 | 2.9% | 3/42 | 7.1% |
| | M | 0/8 | 0.0% | 3/17 | 17.6% | 0/1 | 0.0% |
| 41 - 50 | F | 3/26 | 11.5% | 1/35 | 2.9% | 0/6 | 0.0% |
| | M | 1/12 | 8.3% | 0/19 | 0.0% | 0/2 | 0.0% |
| 51 - 60 | F | 0/19 | 0.0% | 1/23 | 4.3% | 0/1 | 0.0% |
| | M | 0/0 | 0.0% | 1/33 | 0.0% | 0/1 | 0.0% |
| 61 - 70 | F | 0/1 | 0.0% | 0/16 | 0.0% | 0/1 | 0.0% |
| | M | 0/1 | 0.0% | 0/14 | 0.0% | 0/0 | N/A |
| 71 + | F | 0/0 | N/A | 0/2 | 0.0% | 0/0 | N/A |
| | M | 0/1 | 0.0% | 077 | 0.0% | 0/1 | 0.0% |
| | Total | | 4.0%** | 9/300 | 3.0% | 4/100 | 4.0% |
Expected values using the BioPlex 2200 Rubella and CMV IgM kit in test ordered population
*One of pregnant women (N=71) was Rubella IgM positive.
**Since 2001 The ingidonea of Dubelle
13
Method Comparison G.
Performance of the BioPlex 2200 Rubella and CMV IgM kit was evaluated against corresponding commercially available Rubella and CMV kits. Three clinical sites tested 700 prospective samples submitted for: Rubella (300 - U.S.), and CMV IgM testing (400,300 U.S. + 100 Europe). Of the 300 samples submitted for Rubella IgM testing, 71 females were pregnant women. Results are shown in the table below:
Of the 300 clinical ordered samples test for Rubella IgM, the positive percent agreement was 66.7% and the negative percent agreement was 95.6%.
Of the 71 clinical ordered pregnancy samples test for Rubella IgM, the negative percent agreement was 96.8%.
Of the 400 clinical ordered samples tested for CMV IgM, the positive percent agreement was 53.8% and the negative percent agreement was 97.7%.
The results are presented in the table below.
| Commercially Available Immunoassay | Test Ordered | BioPlex 2200 Rubella and CMV IgM kit | ||||||
|---|---|---|---|---|---|---|---|---|
| Rubella IgM | Test Ordered | Pos (+) | Eqv | Neg (-) | Total | Pos (+) | ||
| % Agreement | Neg (-) | |||||||
| % Agreement | ||||||||
| Pos (+) | 2 | 0 | 1 | 3 | 66.7% | |||
| (2/3) | ||||||||
| 95% CI | ||||||||
| 20.8 - 93.9% | 95.6% | |||||||
| (282/295) | ||||||||
| 95% CI | ||||||||
| 92.6 - 97.4% | ||||||||
| Eqv | 0 | 2 | 0 | 2 | ||||
| Neg (-) | 10 | 3 | 282 | 295 | ||||
| Total | 12 | 5 | 283 | 300 | ||||
| Pregnant Women* | Pos (+) | 0 | 0 | 0 | 0 | N/A | 96.8% | |
| (70/71) | ||||||||
| 95%CI | ||||||||
| 92.8% - 99.8% | ||||||||
| Eqv | 0 | 0 | 0 | 0 | ||||
| Neg (-) | 1 | 0 | 70 | 71 | ||||
| Total | 1 | 0 | 70 | 71 | ||||
| Pos (+) | 7a | 0 | 3a | 10 | 53.8% | |||
| (7/13) | 97.7% | |||||||
| (377/386) |
Method Comparison: Prospective Study
14
| Eqv | 1 | 1 | 3 | 5 |
|---|---|---|---|---|
| Neg (-) | 5b | 3 | 377a | 385 |
| Total | 13 | 4 | 383 | 400 |
a. One sample that was equivocal by the predicate device was adjudicated by two out of three FDA cleared devices.
b. Two samples that were equivocal by the predicated by two out of three HDA cleared devices
- Pregnant women is the subset of the test ordered population.
Comparative Testing: Retrospective Study
Performance of the Rubella and CMV IgM kit was evaluated against corresponding commercially available Rubella and CMV IgM immunoassays. Three clinical sites tested 107 Rubella (45 females with 89% in 15-45 age group, 49 males and 13 with unknown gender) and 229 CMV (144 females with 84% in 15-45 age group and 85 males) presumptive IgM positive samples. Positive samples for Rubella and CMV IgM were selected by another FDA cleared test and the respective commercially available immunoassays used for the comparative analysis. The results are presented in the table below.
| Presumptive Positive | BioPlex Rubella and CMV IgM kit | ||||||
|---|---|---|---|---|---|---|---|
| for Rubella or CMV | |||||||
| IgM | Pos(+) | Eqv | Neg(-) | Total | Pos(+) | ||
| % Agreement | |||||||
| Commercially Available Immunoassay | Rubella IgM | Pos(+) | 103 | 1 | 3 | 107 | 96.3% |
| Eqv | 0 | 0 | 0 | 0 | (103/107) | ||
| Neg(-) | 0 | 0 | 0 | 0 | 95% CI | ||
| Total | 103 | 1 | 3 | 107 | 90.3 – 98.5% | ||
| CMV IgM | Pos(+) | 209a | 3 | 17b | 229 | 91.3% | |
| Eqv | 0 | 0 | 0 | 0 | (209/229) | ||
| Neg(-) | 0 | 0 | 0 | 0 | 95% CI | ||
| Total | 209 | 3 | 17 | 229 | 86.9 - 94.3% |
Characteristics of Samples with Presumptive Positive Status
e that was equivocal by the predicate device was adjudicated by two out of three FDA cleared devices.
15
Matrix Comparison
Matched serum and plasma (potassium EDTA and sodium heparin) samples drawn from 20 individual donors were acquired from commercial sources. All samples were evaluated in replicates of 10. Mean plasma Al values were compared to matched mean serum Al values. Scatter plots comparing the performance of serum samples against potassium EDTA and sodium heparin plasma samples along with the corresponding slopes of regression and correlation coefficient (r) are shown in below. All assays pass the slope specification and correlation
specification of + 0.2, and correction as the slope specification of 1.0 ± 0.2, in specification of ± 0.2, and correlation coefficient (r) of ≥ 0.98.
Image /page/15/Figure/3 description: The image shows a scatter plot titled "Matrix Comparison Mean Test vs Mean Comparison". The x-axis is labeled "Serum (Al)" and ranges from 0 to 2.5. The y-axis is labeled "EDTA Plasma (Al)" and ranges from 0 to 2.5. A linear regression line is plotted through the data points, with the equation y = 1.0369x - 0.0077 and an r-value of 0.9971.
Image /page/15/Figure/4 description: The image is titled "Figure 1. Rubella IgM: EDTA vs. Serum (N=20)". The figure is comparing Rubella IgM levels in EDTA versus serum samples. The sample size is N=20.
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Figure 2. Rubella lgM: Heparin vs. Serum (N=20)
Image /page/16/Figure/1 description: This image is a scatter plot titled "Matrix Comparison Mean Test vs Mean Comparison". The x-axis is labeled "Serum (Al)" and ranges from 0 to 2.5. The y-axis is labeled "Heparin Plasma (Al)" and ranges from 0 to 2.5. A line of best fit is plotted on the scatter plot, and the equation for the line is y = 1.0219x - 0.0123, with an r value of 0.9976.
Figure 3. CMV IgM: EDTA vs. Serum (N=20)
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Image /page/17/Figure/0 description: This image is a scatter plot titled "Matrix Comparison Mean Test vs Mean Comparison". The x-axis is labeled "Serum (Al)" and ranges from 0 to 2, while the y-axis is labeled "Heparin Plasma-(Al)" and also ranges from 0 to 2. The plot shows a strong positive correlation between the two variables, with data points clustered closely around a straight line, and the equation of the line is y = 1.0000x - 0.0000, and the r value is 0.9945.
Figure 4. CMV IgM: Heparin vs. Serum (N=20)
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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Bio- Rad Laboratories, Inc. BioPlex 2200 Division c/o Juang Wang Regulatory Affairs Representative 5500 East Second Street Benicia, CA 94510
DEC - 3 2010
Re: K092587
Trade/Device Name: BioPlex® 2200 Rubella and CMV IgM Kit on the BioPlex® 2200 Multi Analyte Detection System Regulation Number: 21CFR§866.3510 Regulation Name: Rubella Virus Serological Reagents Regulatory Class: Class II Product Code: LFX, LKQ, LFZ, JIX, JJX Dated: November 30, 2010 Received: December 1, 2010
Dear Mr. Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 'The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
19
Page 2 - Juang Wang
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Sma!l Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jouga Hoynes
Sally A. Hojvat, M.Sc., Ph.D Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication(s) for use
DEC - 3 2010
510(k) Number (if known): K092587
Device Name:BioPlex® 2200 Rubella and CMV IgM Kit on the BioPlex® 2200 Multi Analyte
Detection System
BioPlex® 2200 Rubella and CMV IgM Calibrator Set BioPlex® 2200 Rubella and CMV IgM Control Set
Indications for Use:
The BioPlex® 2200 Rubella and CMV IgM kit
The BioPlex® 2200 Rubella and CMV IgM kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Rubella and Cytomegalovirus (CMV) in human serum and potassium EDTA or sodium heparin plasma.
The BioPlex 2200 Rubella and CMV IgM kit is intended for use with the Bio-Rad BioPlex 2200 System.
This kit is intended as an aid in the diagnosis of a current or recent Rubella and/or CMV infection, in individuals suspected of having one of the respective disease states including women of child bearing age.
This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors.
Performance characteristics for the Rubella and CMV IgM assays have not been evaluated in immunosupressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at point of care facilities.
BioPlex® 2200 Rubella and CMV IgM Calibrator Set
The BioPlex® 2200 Rubella and CMV IgM Calibrator Set is intended for the calibration of the BioPlex® 2200 Rubella and CMV IgM Reagent Pack.
BioPlex® 2200 Rubella and CMV IgM Control Set
The BioPlex® 2200 Rubella and CMV IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 instrument and BioPlex 2200 Rubella and CMV IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Rubella and CMV IgM Control Set has not been established with any other Rubella and CMV IgM assays.
Over-the-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(Please do not write below this line-Continue on another page if needed)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Une Schif
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092587