DYNEX SmartPLEX MMRV IgG Assay Kit
Device Facts
| Record ID | K212769 |
|---|---|
| Device Name | DYNEX SmartPLEX MMRV IgG Assay Kit |
| Applicant | Dynex Technologies, Inc. |
| Product Code | OPL · Microbiology |
| Decision Date | Sep 29, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3510 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The DYNEX SmartPLEX MMRV IgG Assay Kit is a multiplex immunoassay intended for the qualitative detection of IgG antibodies to Measles, Mumps, Rubella, and Varicella-Zoster virus (VZV) in human serum. The DYNEX SmartPLEX MMRV IgG Assay Kit is intended for use with the DYNEX Multiplier Analyzer. The DYNEX SmartPLEX MMRV IgG Assay Kit is intended to be used as an aid in the determination of serological status to Measles, Mumps, Rubella, and Varicella-Zoster Virus (VZV) in human serum from adults and pediatrics age above 1 year. This kit is not intended for screening blood or plasma donors. The performance of this device has not been established for use in neonates, pediatric patients below 1 year of age, and immunocompromised patients, or for use at point of care facilities.
Device Story
Multiplex immunoassay for qualitative detection of IgG antibodies to Measles, Mumps, Rubella, and VZV in human serum. Uses 96-well microtiter plate with six polystyrene beads per well (four antigen-coated, two filler). Automated processing on Multiplier Analyzer: patient serum and reagents added; incubation at 37°C with shaking; wash cycles; addition of HRP-conjugated anti-human polyclonal IgG; luminol substrate addition. Chemiluminescence measured as light photons, converted to relative light intensity units (RLU). Software calculates index values by dividing sample RLU by mean calibrator RLU. Results reported as negative, equivocal, or positive. Used in clinical laboratories by trained personnel. Aids clinicians in assessing patient serological status based on infection or vaccination history.
Clinical Evidence
Clinical performance evaluated using 2,512 retrospective human serum samples (adults, pregnant women, pediatrics). Compared against FDA-cleared comparator tests. Equivocal results resolved via retesting and 2/3 consensus algorithm. PPA and NPA calculated per cohort. Measles PPA 87.0%, NPA 98.7% (adult/pediatric). Mumps PPA 94.7%, NPA 78.9%. Rubella PPA 92.4%, NPA 99.5%. VZV PPA 96.7%, NPA 88.0%. Bench testing included reproducibility, interference, and cross-reactivity studies.
Technological Characteristics
Multiplex immunoassay; 96-well microtiter plate with antigen-coated polystyrene beads. Chemiluminescent detection via integrated camera. Automated processing on DYNEX Multiplier Analyzer. Software-based RLU calculation and qualitative result interpretation. Traceable to WHO International Standard (Rubella) or internal standards (Measles, Mumps, VZV).
Indications for Use
Indicated for qualitative detection of IgG antibodies to Measles, Mumps, Rubella, and VZV in human serum. Intended as an aid in determining serological status in adults and pediatric patients >1 year. Not for blood/plasma donor screening. Not established for neonates, pediatric patients <1 year, or immunocompromised patients.
Regulatory Classification
Identification
Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).
Special Controls
*Classification.* Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards': (i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,” (ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,” (iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,” (iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and (v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,” (2) Centers for Disease Control's: (i) Low Titer Rubella Standard, (ii) Reference Panel of Well Characterized Rubella Sera, and (3) World Health Organization's International Rubella Standard.
Predicate Devices
- BioPlex 2200 MMRV IgG (k091616)
Related Devices
- K111072 — BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL · Bio-Rad Laboratories · Aug 23, 2011
- K091616 — BIOPLEX 2200 MMRV IGG · Bio-Rad Laboratories · Mar 29, 2010
- K092587 — BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM · Bio-Rad Laboratories · Dec 3, 2010
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY AND INSTRUMENT
## I Background Information:
A 510(k) Number
K212769/S002
B Applicant
Dynex Technologies Inc.
C Proprietary and Established Names
DYNEX SmartPLEX MMRV IgG Assay Kit
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| OPL | Class II | 21 CFR 866.3510; Rubella Virus Serological Reagents - | Microbiology |
## II Submission/Device Overview:
A Purpose for Submission:
Clearance of a new device
B Measurand:
IgG antibodies specific to Measles, Mumps, Rubella, and Varicella-Zoster Virus (VZV)
C Type of Test:
Qualitative multiplex immunoassay
## III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
The DYNEX SmartPLEX MMRV IgG Assay Kit is a multiplex immunoassay intended for the qualitative detection of IgG antibodies to Measles, Mumps, Rubella, and Varicella-Zoster Virus (VZV) in human serum. The DYNEX SmartPLEX MMRV IgG Assay Kit is intended for use with the DYNEX Multiplier Analyzer.
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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The DYNEX SmartPLEX MMRV IgG Assay Kit is intended to be used as an aid in the determination of serological status to Measles, Mumps, Rubella, and Varicella-Zoster Virus (VZV) in human serum from adults and pediatrics age above 1 year. This kit is not intended for screening blood or plasma donors.
The performance of this device has not been established for use in neonates, pediatric patients below 1 year of age, and immunocompromised patients, or for use at point of care facilities.
## C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
## D Special Instrument Requirements:
DYNEX Multiplier Analyzer
## IV Device/System Characteristics:
### A Device Description:
The DYNEX SmartPLEX MMRV IgG Assay Kit uses multiplex immunoassay, a methodology that greatly resembles traditional ELISA, while permits simultaneous detection and identification of different antibodies in a single well. The reaction is processed in a 96 well microtiter plate, with six polystyrene beads embedded in each well of the plate. Four (4) different beads are coated with antigens for the detection of IgG antibodies to Measles, Mumps, Rubella and Varicella-Zoster Virus in human serum. Two additional beads are included in each reaction well as filler beads. Specimen processing is fully automated on the DYNEX Multiplier Analyzer. The assay plate incorporates four beads in each well, each of which is individually coated with purified virus antigens to give targets for IgG binding to measles, mumps, rubella, and varicella- zoster antigens respectively. Unbound antibodies are removed in the wash step. Bound IgG is detected by the addition of rabbit anti-human IgG conjugated with horseradish peroxidase.
Excess conjugate is removed in a second wash step. Luminol substrate is then added to the wells. If IgG has bound, a chemiluminescent reaction takes place, which is detected by an integrated camera. The luminescent signal is proportional to the IgG concentration.
### B Principle of Operation:
The Multiplier Analyzer adds the human serum and reagents to each well of the 96 well plate, after which the mixture is incubated at 37°C. After a wash cycle, unbound antibodies are removed. Anti-human IgG conjugated to horseradish peroxidase (HRP) is added after which the mixture is incubated at 37°C with shaking. A second wash step removes excess conjugate, then luminol substrate is added to each well. The amount of antibody captured by the antigen is determined by the chemiluminescence produced by the antigen antibody bound HRP. Raw data are captured as light photons via an imaging camera. The amount of light photons are converted into relative light intensity units (RLU).
The Multiplier software analyzes the image and generates a report that details the mean RLU signal for each target bead (MMRV) by test sample. In every plate a calibrator is included. The DYNEX SmartPLEX MMRV IgG Assay Kit is qualitative and produces a result defined as negative (NEG), equivocal (EQV) or positive (POS) for each target analyte.
Interpretation of results of the DYNEX SmartPLEX MMRV IgG Assay Kit:
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The results for each of the antibodies are expressed in Index units. For Measles, Mumps, Rubella and VZV antibodies, results with Index values ≤ 0.9 Index are reported as Negative, results between >0.9 and <1.1 Index are reported as Equivocal, and results of ≥ 1.1 Index are reported as positive, as indicated in the table below:
| Result* (Index value) | Status | Interpretation** |
| --- | --- | --- |
| ≤0.9 | NEG | Negative: No detectable IgG antibodies to Measles, Mumps, Rubella or VZV detected. Such individual is presumed not to have had a previous exposure to MMRV through infection or vaccination |
| >0.9 - <1.1 | EQV | Equivocal: Samples should be retested, if the result remains equivocal, the samples should be tested on an alternative method. |
| ≥1.1 | POS | Positive: IgG antibodies to Measles, Mumps, Rubella, or VZV detected. This may indicate that the individual was exposed to MMRV through infection or vaccination |
*The numeric Index value of the final result is not indicative of the amount of anti-Measles, Mumps, Rubella, or VZV IgG antibodies present.
**Test results should be interpreted in conjunction with the clinical history, epidemiological data and other information available to the attending physician in evaluating the patient
## C Instrument description Information
### 1. Instrument Name:
DYNEX Multiplier Analyzer
The Multiplier is a Multiplex ELISA Analyzer which measures chemiluminescent signal, allowing for the simultaneous measurement of multiple analytes in a single well.
The DYNEX Multiplier Analyzer automates the steps of Multiplex ELISA assays, performing liquid pipetting, plate washing and results reading of the DYNEX SmartPLEX MMRV IgG Assay Kit in addition to producing a result report. Sample distribution, incubation, reagent addition, washing and detection phases of the ELISA tests are fully automated.
The Multiplier hardware comprises of all the physical parts of the instrument that are controlled by the firmware and the Multiplier software. The hardware includes an arm, incubator, pipette, camera, barcode scanner, washer, and reader. The instrument also contains an embedded personal computer (PC) with its own hard drive that executes the Multiplier software.
The Multiplier software consists of five main parts: Grapevine (data access layer), System Control (software interface layer to hardware), Watchdog (a monitoring system), User Interface, and firmware.
### 2. Specimen Identification:
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An 1D scanner for reading barcoded sample tubes.
The only specimen type to be used with the DYNEX SmartPLEX MMRV IgG Assay Kit is serum.
V Substantial Equivalence Information:
A Predicate Device Name(s):
BioPlex 2200 MMRV IgG
B Predicate 510(k) Number(s):
K091616
C Comparison with Predicate(s):
| Device & Predicate Device(s): | Candidate Device K212769 | Predicate Device K091616 |
| --- | --- | --- |
| Device Trade Name | DYNEX SmartPLEX MMRV IgG Assay Kit | BioPlex 2200 MMRV IgG |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The DYNEX SmartPLEX MMRV IgG Assay Kit is a multiplex immunoassay intended for the qualitative detection of IgG antibodies to Measles, Mumps, Rubella, and Varicella-Zoster Virus (VZV) in human serum. The DYNEX SmartPLEX MMRV IgG Assay Kit is intended for use with the DYNEX Multiplier Analyzer. The DYNEX SmartPLEX MMRV IgG Assay Kit is intended to be used as an aid in the determination of serological status to Measles, Mumps, Rubella, and Varicella-Zoster Virus (VZV) in human serum from adults and pediatrics age above 1 year. This kit is not intended for screening blood or plasma donors. The performance of this device has not been established for use in neonates, pediatric patients below 1 year of age, and immunocompromised patients, or for use at point of care facilities. | The BioPlex 2200 MMRV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of IgG antibodies to Measles, Mumps, Rubella, and Varicella-zoster virus (VZV) in human serum and EDTA or heparinized plasma. The BioPlex 2200 MMRV 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 Measles, Mumps, Rubella, and VZV. This kit is not intended for use in screening blood or plasma donors. The performance of this assay has not been established for use in neonates, pediatrics and immunocompromised patients, or for use at point of care facilities. |
| Prescription vs Over-the-Counter Use | Same | Prescription use only |
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| Technology | Multiplex immunoassay | Multiplex flow immunoassay |
| --- | --- | --- |
| Assay Processing | Automated on the Multiplier Analyzer | Automated on the BioPlex 2200 System |
| Controls | Same | Negative control and Multi-analyte Positive control |
| **General Device Characteristic Differences** | | |
| Target Population | Adults and pediatrics age above 1 year | Not indicated for use in the pediatric population |
| | Not to be used in neonates, pediatric patients below 1 year of age, and immunocompromised patients, or for use at point of care facilities. | Not to be used in neonates, pediatrics and immunocompromised patients, or at point of care facilities. |
| Reagents | Rabbit anti-human IgG conjugated to horseradish peroxidase | Murine anti-human IgG conjugated to phycoerythrin |
| Matrices | Serum | Serum and EDTA or Heparinized Plasma |
| Solid phase | 96-well microtiter plate – antigen coated polystyrene beads | Bead reagent - dyed antigen coated beads |
| Signal Detection | Chemiluminescence measured by an imaging camera | Fluorescence measured by spectrophotometer |
VI Standards/Guidance Documents Referenced:
62366-1: ANSI AAMI ISO - Medical Devices - Part 1: Application of Usability Engineering To Medical Devices (Edition 1) - 02/01/2015
62304: ANSI AAMI ISO - Medical Device Software - Software Life Cycle Processes (Edition 1.1) – 06/26/2015
EP05-A3: Clinical Laboratory Standards Institute - Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline (Third Edition) - 10/01/2014
61010-1: ANSI AAMI IEC - Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements (AMD1) - 01/10/2017
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
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# 1. Precision/Reproducibility:
# a. Within-Laboratory Precision Study:
A within-laboratory precision study was performed evaluating 22 serum samples using three lots of the DYNEX SmartPLEX MMRV IgG Assay Kit and 1 DYNEX Multiplier Analyzer. Samples were tested in duplicate, two times a day for 20 days, for a total of 240 replicates per sample across all three-reagent kit lots. Within laboratory precision results are reported for each analyte separately in tables 01 to 04 below:
Table 01: Within Laboratory Precision - Measles IgG
| Analyte Level for Anti-Measles | Samples | N | Mean (Index) | Within run | | Between run | | Between Day | | Between Lot | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Low Negative | 5 | 240 | 0.22 | 0.01 | 5.9% | 0.008 | 3.8% | 0.0.005 | 2.4% | 0.193 | 3.6% | 0.018 | 8.3% |
| | 6 | 240 | 0.38 | 0.03 | 6.8% | 0.018 | 4.8% | 0.0.009 | 2.5% | 0.001 | 0.3% | 0.033 | 8.7% |
| | 8 | 240 | 0.68 | 0.04 | 6.5% | 0.029 | 4.3% | 0.013 | 2.0% | 0.000 | 0.0% | 0.054 | 8.0% |
| High Negative | 10 | 240 | 0.70 | 0.04 | 6.3% | 0.028 | 3.9% | 0.016 | 2.3% | 0.000 | 0.0% | 0.055 | 7.8% |
| | 3 | 240 | 0.74 | 0.053 | 7.2% | 0.024 | 3.3% | 0.019 | 2.6% | 0.000 | 0.0% | 0.061 | 8.3% |
| | 2 | 240 | 0.82 | 0.048 | 5.8% | 0.035 | 4.3% | 0.020 | 2.4% | 0.188 | 3.7% | 0.069 | 8.4% |
| | 19 | 240 | 0.87 | 0.049 | 5.6% | 0.037 | 4.3% | 0.000 | 0.0% | 0.077 | 2.0% | 0.064 | 7.4% |
| | 21 | 240 | 0.89 | 0.062 | 7.0% | 0.041 | 4.6% | 0.014 | 1.5% | 0.003 | 0.4% | 0.076 | 8.5% |
| Equivocal | 14 | 240 | 0.92 | 0.060 | 6.6% | 0.039 | 4.2% | 0.010 | 1.1% | 0.071 | 2.2% | 0.075 | 8.2% |
| | 11 | 240 | 0.96 | 0.055 | 5.7% | 0.035 | 3.7% | 0.027 | 2.8% | 0.067 | 2.0% | 0.073 | 7.5% |
| | 1 | 240 | 1.01 | 0.055 | 5.5% | 0.045 | 4.4% | 0.021 | 2.1% | 0.139 | 3.0% | 0.080 | 7.9% |
| | 15 | 240 | 1.06 | 0.067 | 6.3% | 0.055 | 5.2% | 0.000 | 0.0% | 0.004 | 0.5% | 0.086 | 8.2% |
| Low Positive | 17 | 240 | 1.26 | 0.071 | 5.6% | 0.056 | 4.5% | 0.037 | 3.0% | 0.000 | 0.0% | 0.098 | 7.7% |
| | 16 | 240 | 1.28 | 0.077 | 6.0% | 0.060 | 4.7% | 0.000 | 0.0% | 0.116 | 2.7% | 0.103 | 8.0% |
| | 18 | 240 | 1.29 | 0.076 | 5.9% | 0.045 | 3.5% | 0.030 | 2.3% | 0.076 | 2.1% | 0.097 | 7.5% |
| Moderate Positive | 12 | 240 | 1.57 | 0.095 | 6.1% | 0.046 | 3.0% | 0.039 | 2.5% | 0.021 | 1.1% | 0.114 | 7.3% |
| | 20 | 240 | 1.61 | 0.086 | 5.4% | 0.071 | 4.4% | 0.046 | 2.8% | 0.089 | 2.3% | 0.126 | 7.8% |
| | 9 | 240 | 1.75 | 0.098 | 5.6% | 0.065 | 3.7% | 0.036 | 2.1% | 0.216 | 3.7% | 0.139 | 7.9% |
| | 7 | 240 | 2.14 | 0.118 | 5.5% | 0.079 | 3.7% | 0.000 | 0.0% | 0.044 | 1.4% | 0.145 | 6.8% |
| | 13 | 240 | 2.36 | 0.139 | 5.9% | 0.104 | 4.4% | 0.000 | 0.0% | 0.022 | 1.1% | 0.175 | 7.4% |
| High Positive | 22 | 240 | 2.90 | 0.136 | 4.7% | 0.100 | 3.5% | 0.078 | 2.7% | 0.073 | 1.8% | 0.193 | 6.7% |
| | 4 | 240 | 3.04 | 0.134 | 4.4% | 0.140 | 4.6% | 0.032 | 1.0% | 0.137 | 2.6% | 0.211 | 6.9% |
Table 02: Within Laboratory Precision - Mumps IgG
| Analyte Level for Anti-Mump | Samples | N | Mean (Index) | Within Run | | Between Run | | Between Day | | Between Lot | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Low Negative | 19 | 240 | 0.37 | 0.022 | 5.9% | 0.016 | 4.3% | 0.000 | 0.0% | 0.437 | 6.4% | 0.036 | 9.7% |
| | 2 | 240 | 0.47 | 0.027 | 5.7% | 0.012 | 2.5% | 0.007 | 1.5% | 0.497 | 6.3% | 0.042 | 9.0% |
| | 3 | 240 | 0.53 | 0.031 | 5.9% | 0.019 | 3.6% | 0.003 | 0.6% | 0.360 | 5.2% | 0.046 | 8.7% |
| | 8 | 240 | 0.56 | 0.029 | 5.1% | 0.019 | 3.3% | 0.000 | 0.0% | 0.322 | 4.2% | 0.042 | 7.4% |
| | 1 | 240 | 0.60 | 0.034 | 5.6% | 0.020 | 3.3% | 0.005 | 0.8% | 0.379 | 5.1% | 0.050 | 8.3% |
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Table 03: Within Laboratory Precision - Rubella IgG
| Analyte Level for Anti-Rubella | Samples | N | Mean (Index) | Within Run | | Between Run | | Between Day | | Between Lot | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Low Negative | 6 | 240 | 0.42 | 0.019 | 4.4% | 0.010 | 2.5% | 0.008 | 2.0% | 0.111 | 1.9% | 0.024 | 5.8% |
| | 5 | 240 | 0.50 | 0.020 | 4.0% | 0.005 | 1.1% | 0.011 | 2.3% | 0.099 | 1.6% | 0.025 | 5.0% |
| | 19 | 240 | 0.60 | 0.024 | 4.0% | 0.013 | 2.1% | 0.015 | 2.5% | 0.094 | 1.7% | 0.033 | 5.5% |
| High Negative | 8 | 240 | 0.61 | 0.028 | 4.5% | 0.012 | 1.9% | 0.012 | 1.9% | 0.172 | 2.4% | 0.035 | 5.8% |
| | 12 | 240 | 0.61 | 0.025 | 4.0% | 0.013 | 2.2% | 0.005 | 0.9% | 0.133 | 1.8% | 0.03 | 5.0% |
| | 9 | 240 | 0.62 | 0.025 | 4.1% | 0.021 | 3.4% | 0.005 | 0.9% | 0.116 | 1.9% | 0.035 | 5.7% |
| | 13 | 240 | 0.62 | 0.031 | 5.0% | 0.021 | 3.4% | 0.000 | 0.0% | 0.018 | 0.8% | 0.037 | 6.0% |
| | 3 | 240 | 0.75 | 0.029 | 3.9% | 0.013 | 1.7% | 0.014 | 1.9% | 0.137 | 1.8% | 0.037 | 5.0% |
| | 2 | 240 | 0.86 | 0.032 | 3.7% | 0.023 | 2.6% | 0.019 | 2.2% | 0.026 | 0.8% | 0.044 | 5.1% |
| Equivocal | 1 | 240 | 0.96 | 0.039 | 4.1% | 0.020 | 2.1% | 0.021 | 2.2% | 0.008 | 0.4% | 0.049 | 5.1% |
| | 18 | 240 | 1.00 | 0.038 | 3.8% | 0.015 | 1.5% | 0.014 | 1.4% | 0.029 | 0.7% | 0.043 | 4.4% |
| | 15 | 240 | 1.05 | 0.039 | 3.8% | 0.022 | 2.1% | 0.009 | 0.9% | 0.135 | 1.7% | 0.049 | 4.7% |
| Moderate Positive | 7 | 240 | 1.08 | 0.036 | 3.3% | 0.016 | 1.5% | 0.028 | 2.6% | 0.047 | 1.0% | 0.049 | 4.6% |
| | 11 | 240 | 1.18 | 0.042 | 3.6% | 0.029 | 2.4% | 0.017 | 1.4% | 0.058 | 1.1% | 0.055 | 4.7% |
| | 20 | 240 | 1.34 | 0.063 | 4.7% | 0.014 | 1.0% | 0.032 | 2.4% | 0.037 | 1.1% | 0.074 | 5.5% |
| High Negative | 14 | 240 | 1.52 | 0.048 | 3.2% | 0.035 | 2.3% | 0.029 | 1.9% | 0.036 | 0.8% | 0.067 | 4.4% |
| | 17 | 240 | 1.68 | 0.049 | 2.9% | 0.034 | 2.0% | 0.028 | 1.6% | 0.000 | 0.0% | 0.066 | 3.9% |
| Moderate Positive | 10 | 240 | 2.01 | 0.063 | 3.1% | 0.040 | 2.0% | 0.027 | 1.3% | 0.000 | 0.0% | 0.079 | 3.9% |
| | 4 | 240 | 2.44 | 0.063 | 2.6% | 0.064 | 2.6% | 0.028 | 1.1% | 0.000 | 0.0% | 0.094 | 3.9% |
| | 10 | 240 | 2.44 | 0.063 | 2.6% | 0.064 | 2.6% | 0.028 | 1.1% | 0.000 | 0.0% | 0.094 | 3.9% |
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Table 04: Within Laboratory Precision - VZV IgG
| Analyte Level for Anti-VZV | Samples | N | Mean (Index) | Within Run | | Between Run | | Between Day | | Between Lot | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Low Negative | 7 | 240 | 0.26 | 0.015 | 5.9% | 0.005 | 2.0% | 0.009 | 3.3% | 0.086 | 2.2% | 0.019 | 7.4% |
| | 13 | 240 | 0.26 | 0.018 | 6.9% | 0.004 | 1.6% | 0.006 | 2.2% | 0.079 | 2.2% | 0.020 | 7.8% |
| High Negative | 2 | 240 | 0.63 | 0.033 | 5.2% | 0.018 | 2.8% | 0.011 | 1.8% | 0.079 | 1.8% | 0.040 | 6.4% |
| | 8 | 240 | 0.83 | 0.042 | 5.0% | 0.024 | 2.9% | 0.014 | 1.7% | 0.199 | 3.0% | 0.056 | 6.7% |
| | 19 | 240 | 0.84 | 0.040 | 4.8% | 0.021 | 2.5% | 0.024 | 2.9% | 0.154 | 2.6% | 0.056 | 6.7% |
| Equivocal | 12 | 240 | 1.00 | 0.045 | 4.5% | 0.027 | 2.7% | 0.022 | 2.2% | 0.104 | 1.9% | 0.060 | 6.0% |
| Low Positive | 15 | 240 | 1.22 | 0.050 | 4.1% | 0.037 | 3.0% | 0.014 | 1.1% | 0.093 | 1.7% | 0.067 | 5.5% |
| | 17 | 240 | 1.24 | 0.059 | 4.7% | 0.026 | 2.1% | 0.003 | 0.2% | 0.156 | 2.2% | 0.070 | 5.6% |
| | 18 | 240 | 1.29 | 0.057 | 4.4% | 0.024 | 1.9% | 0.020 | 1.6% | 0.118 | 1.8% | 0.069 | 5.4% |
| | 1 | 240 | 1.31 | 0.064 | 4.9% | 0.032 | 2.4% | 0.028 | 2.2% | 0.055 | 1.4% | 0.079 | 6.1% |
| | 9 | 240 | 1.35 | 0.059 | 4.4% | 0.042 | 3.1% | 0.000 | 0.0% | 0.124 | 2.0% | 0.078 | 5.7% |
| Moderate Positive | 20 | 240 | 1.63 | 0.079 | 4.9% | 0.044 | 2.7% | 0.027 | 1.6% | 0.139 | 2.3% | 0.102 | 6.2% |
| | 6 | 240 | 1.69 | 0.074 | 4.4% | 0.049 | 2.9% | 0.000 | 0.0% | 0.118 | 1.9% | 0.094 | 5.6% |
| | 5 | 240 | 2.00 | 0.082 | 4.1% | 0.055 | 2.8% | 0.043 | 2.2% | 0.269 | 3.3% | 0.126 | 6.3% |
| | 3 | 240 | 2.45 | 0.095 | 3.9% | 0.059 | 2.4% | 0.046 | 1.9% | 0.082 | 1.5% | 0.126 | 5.2% |
| High Positive | 21 | 240 | 2.62 | 0.104 | 4.0% | 0.076 | 2.9% | 0.071 | 2.7% | 0.050 | 1.3% | 0.151 | 5.8% |
| | 22 | 240 | 2.63 | 0.097 | 3.7% | 0.070 | 2.7% | 0.055 | 2.1% | 0.209 | 2.6% | 0.148 | 5.6% |
| | 14 | 240 | 2.69 | 0.100 | 3.7% | 0.070 | 2.6% | 0.062 | 2.3% | 0.133 | 2.0% | 0.147 | 5.5% |
| | 11 | 240 | 3.01 | 0.107 | 3.6% | 0.106 | 3.5% | 0.000 | 0.0% | 0.115 | 1.8% | 0.161 | 5.3% |
| | 16 | 240 | 3.03 | 0.113 | 3.7% | 0.084 | 2.8% | 0.013 | 0.4% | 0.156 | 2.0% | 0.154 | 5.1% |
| | 10 | 240 | 3.06 | 0.111 | 3.6% | 0.075 | 2.5% | 0.060 | 2.0% | 0.160 | 2.1% | 0.160 | 5.2% |
| | 4 | 240 | 3.31 | 0.120 | 3.6% | 0.108 | 3.3% | 0.059 | 1.8% | 0.147 | 2.2% | 0.186 | 5.6% |
# b. Reproducibility:
The reproducibility of the DYNEX SmartPLEX MMRV IgG Assay Kit was evaluated using 22 serum samples, in duplicate, twice a day, over 20 days, at three sites located in the US, using one reagent kit lot per site. Reproducibility results are reported for each analyte separately in tables 05 to 08 below:
Table 05: Reproducibility - Measles IgG
| Analyte Level for Anti-Measles | Samples | N | Mean (Index) | Within Run | | Between Run | | Between Day | | Between Site/ Lot | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Low Negative | 5 | 240 | 0.21 | 0.014 | 6.4% | 0.009 | 4.3% | 0.004 | 1.7% | 0.115 | 2.8% | 0.018 | 8.4% |
| | 6 | 240 | 0.38 | 0.029 | 7.8% | 0.013 | 3.5% | 0.007 | 1.9% | 0.033 | 1.6% | 0.034 | 8.9% |
| High Negative | 8 | 240 | 0.67 | 0.043 | 6.4% | 0.026 | 3.9% | 0.011 | 1.7% | 0.000 | 0.0% | 0.051 | 7.7% |
| | 10 | 240 | 0.69 | 0.045 | 6.6% | 0.030 | 4.4% | 0.015 | 2.2% | 0.035 | 1.5% | 0.058 | 8.3% |
| | 3 | 240 | 0.73 | 0.064 | 8.8% | 0.039 | 5.3% | 0.000 | 0.0% | 0.000 | 0.0% | 0.075 | 10.3% |
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Table 06: Reproducibility - Mumps IgG
| Analyte Level for Anti-Mumps | Samples | N | Mean (Index) | Within Run | Between Run | Between Day | Between Site/ Lot | Total |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Low Negative | 19 | 240 | 0.37 | 0.023 | 6.2% | 0.011 | 3.1% | 0.013 | 3.5% | 0.112 | 2.7% | 0.030 | 8.2% |
| 2 | 240 | 0.47 | 0.024 | 5.2% | 0.018 | 3.8% | 0.011 | 2.4% | 0.211 | 3.6% | 0.036 | 7.7% |
| 3 | 240 | 0.53 | 0.028 | 5.3% | 0.019 | 3.6% | 0.013 | 2.5% | 0.205 | 3.5% | 0.040 | 7.7% |
| 8 | 240 | 0.57 | 0.038 | 6.6% | 0.020 | 3.5% | 0.000 | 0.0% | 0.127 | 2.9% | 0.046 | 8.0% |
| High Negative | 1 | 240 | 0.60 | 0.035 | 5.8% | 0.023 | 3.8% | 0.022 | 3.6% | 0.055 | 1.9% | 0.048 | 8.1% |
| 6 | 240 | 0.64 | 0.034 | 5.4% | 0.018 | 2.9% | 0.008 | 1.2% | 0.000 | 0.0% | 0.040 | 6.2% |
| 18 | 240 | 0.68 | 0.035 | 5.1% | 0.026 | 3.9% | 0.025 | 3.7% | 0.151 | 3.1% | 0.054 | 8.0% |
| 12 | 240 | 0.71 | 0.037 | 5.2% | 0.028 | 3.9% | 0.019 | 2.7% | 0.076 | 2.0% | 0.052 | 7.3% |
| 13 | 240 | 0.75 | 0.045 | 5.9% | 0.038 | 5.0% | 0.000 | 0.0% | 0.078 | 2.2% | 0.061 | 8.1% |
| Low Positive | 7 | 240 | 0.78 | 0.044 | 5.7% | 0.031 | 4.0% | 0.024 | 3.0% | 0.176 | 3.5% | 0.065 | 8.3% |
| 11 | 240 | 0.99 | 0.064 | 6.5% | 0.021 | 2.2% | 0.028 | 2.8% | 0.273 | 4.5% | 0.086 | 8.7% |
| Moderate Positive | 20 | 240 | 1.00 | 0.067 | 6.6% | 0.047 | 4.7% | 0.000 | 0.0% | 0.057 | 2.0% | 0.084 | 8.4% |
| 9 | 240 | 1.06 | 0.056 | 5.3% | 0.039 | 3.7% | 0.031 | 3.0% | 0.046 | 1.6% | 0.077 | 7.3% |
| 16 | 240 | 1.36 | 0.073 | 5.4% | 0.051 | 3.8% | 0.011 | 0.8% | 0.150 | 2.8% | 0.097 | 7.2% |
| High Negative | 22 | 240 | 1.39 | 0.065 | 4.7% | 0.057 | 4.1% | 0.033 | 2.3% | 0.285 | 4.2% | 0.109 | 7.8% |
| 15 | 240 | 1.47 | 0.084 | 5.7% | 0.062 | 4.3% | 0.055 | 3.7% | 0.000 | 0.0% | 0.118 | 8.0% |
| 21 | 240 | 1.51 | 0.079 | 5.3% | 0.054 | 3.6% | 0.036 | 2.4% | 0.039 | 1.4% | 0.104 | 6.9% |
| Moderate Positive | 5 | 240 | 1.55 | 0.072 | 4.6% | 0.075 | 4.8% | 0.000 | 0.0% | 0.156 | 2.9% | 0.113 | 7.3% |
| 10 | 240 | 2.37 | 0.131 | 5.5% | 0.114 | 4.8% | 0.000 | 0.0% | 0.039 | 1.5% | 0.177 | 7.5% |
| 14 | 240 | 2.47 | 0.121 | 4.9% | 0.084 | 3.4% | 0.059 | 2.4% | 0.265 | 3.8% | 0.185 | 7.5% |
| High Positive | 17 | 240 | 3.05 | 0.288 | 9.5% | 0.145 | 4.8% | 0.020 | 0.6% | 0.046 | 2.3% | 0.331 | 10.9% |
| 4 | 240 | 3.52 | 0.165 | 4.7% | 0.146 | 4.2% | 0.062 | 1.8% | 0.119 | 2.4% | 0.244 | 6.9% |
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Table 07: Reproducibility - Rubella IgG
| Analyte Level for Anti-Rubella | Samples | N | Mean (Index) | Within Run | | Between Run | | Between Day | | Between Site/ Lot | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Low Negative | 6 | 240 | 0.41 | 0.017 | 4.0% | 0.013 | 3.1% | 0.003 | 0.8% | 0.192 | 2.5% | 0.023 | 5.7% |
| | 5 | 240 | 0.50 | 0.021 | 4.2% | 0.012 | 2.3% | 0.003 | 0.6% | 0.125 | 1.8% | 0.026 | 5.2% |
| | 19 | 240 | 0.59 | 0.026 | 4.4% | 0.015 | 2.5% | 0.009 | 1.5% | 0.190 | 2.6% | 0.035 | 5.9% |
| | 12 | 240 | 0.60 | 0.024 | 4.1% | 0.018 | 3.0% | 0.009 | 1.4% | 0.007 | 0.4% | 0.031 | 5.2% |
| High Negative | 9 | 240 | 0.60 | 0.026 | 4.3% | 0.016 | 2.7% | 0.011 | 1.8% | 0.026 | 0.9% | 0.033 | 5.5% |
| | 13 | 240 | 0.60 | 0.043 | 7.0% | 0.026 | 4.4% | 0.000 | 0.0% | 0.147 | 3.4% | 0.054 | 9.0% |
| | 8 | 240 | 0.61 | 0.027 | 4.5% | 0.023 | 3.8% | 0.000 | 0.0% | 0.013 | 0.7% | 0.036 | 5.9% |
| | 3 | 240 | 0.75 | 0.029 | 3.8% | 0.022 | 3.0% | 0.000 | 0.0% | 0.074 | 1.4% | 0.038 | 5.1% |
| | 2 | 240 | 0.85 | 0.037 | 4.3% | 0.018 | 2.1% | 0.010 | 1.2% | 0.255 | 2.9% | 0.049 | 5.8% |
| | 21 | 240 | 0.88 | 0.032 | 3.7% | 0.021 | 2.4% | 0.015 | 1.7% | 0.037 | 0.9% | 0.043 | 4.8% |
| Equivocal | 1 | 240 | 0.96 | 0.039 | 4.0% | 0.031 | 3.2% | 0.020 | 2.1% | 0.170 | 2.5% | 0.059 | 6.1% |
| | 18 | 240 | 0.98 | 0.035 | 3.5% | 0.031 | 3.2% | 0.000 | 0.0% | 0.068 | 1.3% | 0.048 | 4.9% |
| | 15 | 240 | 1.04 | 0.043 | 4.1% | 0.025 | 2.4% | 0.000 | 0.0% | 0.040 | 1.0% | 0.051 | 4.9% |
| | 7 | 240 | 1.06 | 0.038 | 3.6% | 0.036 | 3.4% | 0.000 | 0.0% | 0.133 | 1.9% | 0.056 | 5.3% |
| Low Positive | 11 | 240 | 1.17 | 0.043 | 3.7% | 0.029 | 2.5% | 0.021 | 1.8% | 0.000 | 0.0% | 0.055 | 4.8% |
| | 20 | 240 | 1.31 | 0.058 | 4.4% | 0.000 | 0.0% | 0.017 | 1.3% | 0.168 | 2.1% | 0.066 | 5.1% |
| | 16 | 240 | 1.33 | 0.045 | 3.4% | 0.031 | 2.3% | 0.000 | 0.0% | 0.080 | 1.2% | 0.057 | 4.3% |
| Moderate Positive | 14 | 240 | 1.50 | 0.044 | 2.9% | 0.031 | 2.1% | 0.023 | 1.5% | 0.011 | 0.4% | 0.059 | 3.9% |
| | 17 | 240 | 1.65 | 0.103 | 6.2% | 0.000 | 0.0% | 0.016 | 1.0% | 0.068 | 1.7% | 0.108 | 6.5% |
| | 10 | 240 | 1.97 | 0.060 | 3.1% | 0.061 | 3.1% | 0.000 | 0.0% | 0.000 | 0.0% | 0.085 | 4.3% |
| | 4 | 240 | 2.40 | 0.063 | 2.6% | 0.063 | 2.6% | 0.000 | 0.0% | 0.011 | 0.4% | 0.089 | 3.7% |
| High Positive | 22 | 240 | 3.36 | 0.111 | 3.3% | 0.069 | 2.0% | 0.000 | 0.0% | 0.000 | 0.0% | 0.130 | 3.9% |
Table 08: Reproducibility - VZV IgG
| Analyte Level for Anti-VZV | Samples | N | Mean (Index) | Within Run | | Between Run | | Between Day | | Between Site/ Lot | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Low Negative | 7 | 240 | 0.26 | 0.016 | 6.2% | 0.007 | 2.8% | 0.006 | 2.1% | 0.065 | 1.9% | 0.019 | 7.4% |
| | 13 | 240 | 0.27 | 0.020 | 7.3% | 0.011 | 4.1% | 0.006 | 2.2% | 0.000 | 0.0% | 0.024 | 8.7% |
| High Negative | 2 | 240 | 0.63 | 0.038 | 6.0% | 0.017 | 2.7% | 0.013 | 2.0% | 0.020 | 1.0% | 0.044 | 7.0% |
| | 8 | 240 | 0.83 | 0.050 | 6.1% | 0.023 | 2.8% | 0.014 | 1.7% | 0.013 | 0.8% | 0.058 | 6.9% |
| | 19 | 240 | 0.85 | 0.044 | 5.2% | 0.036 | 4.3% | 0.011 | 1.3% | 0.000 | 0.0% | 0.058 | 6.8% |
| Equivocal | 12 | 240 | 1.02 | 0.043 | 4.2% | 0.036 | 3.5% | 0.018 | 1.8% | 0.135 | 2.3% | 0.063 | 6.2% |
| Low Positive | 15 | 240 | 1.22 | 0.048 | 3.9% | 0.047 | 3.8% | 0.006 | 0.5% | 0.000 | 0.0% | 0.067 | 5.5% |
| | 17 | 240 | 1.25 | 0.083 | 6.6% | 0.035 | 2.8% | 0.007 | 0.5% | 0.084 | 2.2% | 0.094 | 7.5% |
| | 18 | 240 | 1.28 | 0.057 | 4.4% | 0.043 | 3.4% | 0.042 | 3.3% | 0.000 | 0.0% | 0.083 | 6.4% |
| | 1 | 240 | 1.32 | 0.062 | 4.7% | 0.063 | 4.8% | 0.000 | 0.0% | 0.000 | 0.0% | 0.088 | 6.7% |
| | 9 | 240 | 1.35 | 0.058 | 4.3% | 0.051 | 3.7% | 0.028 | 2.1% | 0.000 | 0.0% | 0.082 | 6.1% |
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| Moderate Positive | 20 | 240 | 1.63 | 0.083 | 5.1% | 0.052 | 3.2% | 0.000 | 0.0% | 0.014 | 0.7% | 0.099 | 6.1% |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 6 | 240 | 1.69 | 0.069 | 4.1% | 0.060 | 3.5% | 0.011 | 0.7% | 0.158 | 2.4% | 0.100 | 5.9% |
| | 5 | 240 | 1.98 | 0.091 | 4.6% | 0.076 | 3.8% | 0.000 | 0.0% | 0.008 | 0.5% | 0.119 | 6.0% |
| | 3 | 240 | 2.48 | 0.105 | 4.2% | 0.061 | 2.5% | 0.051 | 2.0% | 0.233 | 2.9% | 0.150 | 6.1% |
| High Positive | 22 | 240 | 2.65 | 0.100 | 3.8% | 0.085 | 3.2% | 0.000 | 0.0% | 0.270 | 3.0% | 0.153 | 5.8% |
| | 21 | 240 | 2.66 | 0.117 | 4.4% | 0.057 | 2.2% | 0.040 | 1.5% | 0.313 | 3.4% | 0.164 | 6.2% |
| | 14 | 240 | 2.7 | 0.103 | 3.8% | 0.053 | 2.0% | 0.073 | 2.7% | 0.267 | 3.0% | 0.159 | 5.9% |
| | 11 | 240 | 3.01 | 0.115 | 3.8% | 0.072 | 2.4% | 0.081 | 2.7% | 0.193 | 2.6% | 0.176 | 5.9% |
| | 10 | 240 | 3.03 | 0.114 | 3.8% | 0.093 | 3.1% | 0.037 | 1.2% | 0.157 | 2.2% | 0.166 | 5.5% |
| | 16 | 240 | 3.06 | 0.126 | 4.1% | 0.070 | 2.3% | 0.039 | 1.3% | 0.366 | 3.7% | 0.188 | 6.2% |
| | 4 | 240 | 3.34 | 0.128 | 3.8% | 0.106 | 3.2% | 0.090 | 2.7% | 0.207 | 2.9% | 0.212 | 6.4% |
2. Linearity:
Not applicable
3. Analytical Specificity/Interference:
a. Potential Cross-reactivity:
Potential cross-reactivity for the DYNEX SmartPLEX MMRV IgG Assay Kit was determined by testing serum samples from individuals containing antibodies to other microorganisms or with medical conditions unrelated to MMRV infections. The data showed no cross reactivity with various disease state specimens evaluated, except for one specimen for HSV 2 IgG which gave an equivocal result on the assay for Mumps IgG. Additional testing of negative samples for measles, mumps, rubella and VZV IgG remained negative when the other three measurands in the well were positive.
Table 09: Potential Cross-reactivity
| Sample Type | Measles IgG | | Mumps IgG | | Rubella IgG | | VZV IgG | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | N | Negative Agreement | N | Negative Agreement | N | Negative Agreement | N | Negative Agreement |
| Anti-nuclear antibody (ANA) IgG | 5 | 5/5 | 5 | 5/5 | 5 | 5/5 | 5 | 5/5 |
| Cytomegalovirus (CMV) IgG | 6 | 6/6 | 5 | 5/5 | 5 | 5/5 | 8 | 8/8 |
| Epstein-Barr virus (EBV) IgG | 10 | 10/10 | 11 | 11/11 | 8 | 8/8 | 6 | 6/6 |
| Hepatitis B virus (HBV) Anti-HBs | 5 | 5/5 | 0 | - | 1** | 1/1 | 0 | - |
| Hepatitis C virus (HCV) IgG** | 7 | 7/7 | 2 | 2/2 | 4 | 4/4 | 1 | 1/1 |
| HSV 1 IgG** | 3 | 3/3 | 1 | 1/1 | 3 | 3/3 | 3 | 3/3 |
| HSV 2 IgG** | 1 | 1/1 | 3 | 2/3* | 2 | 2/2 | 3 | 3/3 |
| Parvovirus B19 IgG** | 2 | 2/2 | 1 | 1/1 | 0 | - | 1 | 1/1 |
| Toxoplasma IgG** | 2 | 2/2 | 0 | - | 1 | 1/1 | 2 | 2/2 |
| Myeloma IgG | 7 | 7/7 | 10 | 10/10 | 7 | 7/7 | 6/6 | 6/6 |
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| Mumps, Rubella, & VZV IgGs*** | 7 | 7/7 | - | N/A | - | N/A | - | N/A |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Measles, Rubella, & VZV IgGs*** | - | N/A | 6 | 6/6 | - | N/A | - | N/A |
| Measles, Mumps, & VZV IgGs*** | - | N/A | - | N/A | 18 | 18/18 | - | N/A |
| Measles, Mumps, & Rubella IgGs*** | - | N/A | - | N/A | - | N/A | 14 | 14/14 |
* One HSV 2 IgG sample had an Equivocal result for Mumps IgG with the DYNEX SmarPLEX MMRV Assay Kit while had a high negative result for Mumps IgG with the predicate.
** Potential cross-reactivity was not well assessed due to limited sample size.
*** Three measurands were evaluated together for potential cross reactivity
b. Potential Interfering endogenous substances:
The DYNEX SmartPLEX MMRV IgG Assay Kit was evaluated for potential interference of endogenous substances using negative, low positive, and high positive serum samples for Measles, Mumps, Rubella, and VZV IgG antibodies in the presence and absence of potential endogenous interference substances. No interference was observed at the maximum concentrations reported below in the table.
Table 10: Interference tested
| Interfering Substance | Concentration |
| --- | --- |
| Bilirubin (conjugated) | 5 mg/dL |
| Bilirubin (unconjugated) | 40 mg/dL |
| Cholesterol total | 250 mg/dL |
| Triglycerides total | 500 mg/dL |
| Albumin | 50 g/dL |
| Hemoglobin | 500 mg/dL |
4. Assay Reportable Range: Not Applicable
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Calibrator:
- The Rubella calibrator and control of the DYNEX SmartPLEX MMRV IgG Assay Kit are traceable to the WHO International Standard Anti-Rubella Immunoglobulin, Human NIBSC code: RUBI-1-94,
- The Measles, Mumps, VZV calibrator and controls are traceable to a DYNEX internal standard.
Sample Stability:
The data support the following storage conditions for the serum samples to be tested with the DYNEX SmartPLEX MMRV IgG Assay Kit:
Table 14: Sample stability
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| Storage Temperature/Condition | Storage Time (or cycles number) |
| --- | --- |
| Room Temperature | Up to 24 hours |
| 2-8°C | Up to 7 days |
| -20°C | Up to 3 months |
| Freeze/Thaw Cycles | Up to 5 cycles |
6. Detection Limit:
Not applicable
7. Assay Cut-Off:
A study to establish the DYNE SmartPLEX MMRV IgG Assay Kit cutoff was performed using 669 serum samples.
The cut-off values and assignment of the calibrators were determined by performing concordance and Receiver Operator Characteristic (ROC) analysis, using predicate results as the standard.
8. Accuracy:
Not Applicable
9. Sample Carry-Over:
The DYNEX SmartPLEX MMRV IgG Assay Kit is not susceptible to within-assay sample carryover.
10. High Dose Hook Effect:
The DYNEX SmartPLEX MMRV IgG Assay Kit is not susceptible to high dose hook effect (or interference from specimens with high levels MMRV antibodies).
B Comparison Studies:
1. Method Comparison with Predicate Device:
Performance of the DYNEX SmartPLEX MMRV IgG Assay Kit was evaluated against corresponding commercially available Measles, Mumps, Rubella and VZV immunoassays using a total of 2512 retrospective serum samples. Serum specimens from adults (N=1676), pregnant woman (N=500) and pediatric (N=336) were evaluated. The study was conducted at two sites. To demonstrate the clinical performance of the DYNEX SmartPLEX MMRV IgG Assay Kit, Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) between the results of the DYNEX SmartPLEX MMRV IgG Assay Kit and an FDA-cleared comparator tests were calculated.
The demographic information of the populations tested is listed below:
Table 15: Demographic information
| Specimen Cohort | Sex | Age Range | Total (N) |
| --- | --- | --- | --- |
| Adult | Female | 22-88 | 910 |
| | Male | 22-84 | 766 |
| Pediatric | Female | 1-21 | 134 |
| | Male | 1-21 | 202 |
| Pregnant | Female | 16-47 | 500 |
| Total | | | 2512 |
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The clinical performance results for all populations are shown in Tables 16 to 19, below.
Table 16: Clinical Performance per Cohort - Measles IgG
| Cohort | Measles IgG Results | Comparator Final Results | | | | Percentage Agreement | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Equiv | Negative | Total | PPA (95% CI) | NPA (95% CI) |
| Pediatrics | DYNEX Smart PLEX MMRV IgG Assay Kit | Positive | 250 | 0 | 0 | 250 | 87.70% 250/285 (83.4 – 91.0%) | 100% 51/51 (93.0 - 100%) |
| | | Equivocal | 12 | 0 | 0 | 12 | | |
| | | Negative | 18 | 5 | 51 | 74 | | |
| | | Total | 280 | 5 | 51 | 336 | | |
| | | | Positive | Equiv | Negative | Total | PPA (95% CI) | NPA (95% CI) |
| Pregnant women | DYNEX Smart PLEX MMRV IgG Assay Kit | Positive | 387 | 0 | 0 | 387 | 84.30% 387/459 (80.7 – 87.4%) | 100% 41/41 (91.4 - 100%) |
| | | Equivocal | 34 | 0 | 0 | 34 | | |
| | | Negative | 31 | 7 | 41 | 79 | | |
| | | Total | 452 | 7 | 41 | 500 | | |
| | | | Positive | Equiv | Negative | Total | PPA (95% CI) | NPA (95% CI) |
| Pediatric and Adult | DYNEX Smart PLEX MMRV IgG Assay Kit | Positive | 1545 | 0 | 1 | 1546 | 87.00% 1545/1775 (85.4 – 88.5%) | 98.70% 234/237 (96.3 – 99.6%) |
| | | Equivocal | 70 | 0 | 2 | 72 | | |
| | | Negative | 137 | 23 | 234 | 394 | | |
| | | Total | 1752 | 23 | 237 | 2012 | | |
Table 17: Clinical Performance per Cohort - Mumps IgG
| Cohort | Mumps IgG Results | Comparator Final Results | | | | Percentage Agreement | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Equiv | Negative | Total | PPA (95% CI) | NPA (95% CI) |
| Pediatrics | DYNEX Smart PLEX MMRV IgG Assay Kit | Positive | 270 | 0 | 6 | 276 | 94.40% 270/286 (91.1 - 96.5%) | 76.00% 38/50 (62.6 - 85.7%) |
| | | Equivocal | 5 | 0 | 6 | 11 | | |
| | | Negative | 8 | 3 | 38 | 49 | | |
| | | Total | 283 | 3 | 50 | 336 | | |
| | | | Positive | Equiv | Negative | Total | PPA (95% CI) | NPA (95% CI) |
| Pregnant women | DYNEX Smart PLEX MMRV IgG Assay Kit | Positive | 463 | 0 | 2 | 465 | 96.90% 463/478 (94.9 – 98.1%) | 90.90% 20/22 (72.2 – 97.5%) |
| | | Equivocal | 5 | 0 | 0 | 5 | | |
| | | Negative | 5 | 5 | 20 | 30 | | |
| | | Total | 473 | 5 | 22 | 500 | | |
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Table 18: Clinical Performance per Cohort - Rubella IgG
| Cohort | Rubella IgG Results | Comparator Final Results | | | | Percentage Agreement | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Equiv | Negative | Total | PPA (95% CI) | NPA (95% CI) |
| Pediatrics | DYNEX Smart PLEX MMRV IgG Assay Kit | Positive | 278 | 0 | 0 | 278 | 92.70%
278/300
(89.1 – 95.1%) | 100%
36/36
(90.4 - 100%) |
| | | Equivocal | 14 | 0 | 0 | 14 | | |
| | | Negative | 8 | 0 | 36 | 44 | | |
| | | Total | 300 | 0 | 36 | 336 | | |
| | | | Positive | Equiv | Negative | Total | PPA (95% CI) | NPA (95% CI) |
| Pregnant women | DYNEX Smart PLEX MMRV IgG Assay Kit | Positive | 449 | 0 | 0 | 449 | 92.00%
449/488
(89.3 – 94.1%) | 100%
12/12
(75.8 - 100%) |
| | | Equivocal | 15 | 0 | 0 | 15 | | |
| | | Negative | 24 | 0 | 12 | 36 | | |
| | | Total | 488 | 0 | 12 | 500 | | |
| | | | Positive | Equiv | Negative | Total | PPA (95% CI) | NPA (95% CI) |
| Pediatric and Adult | DYNEX Smart PLEX MMRV IgG Assay Kit | Positive | 1656 | 0 | 1 | 1657 | 92.40%
1656/1793
(91.0 – 93.5%) | 99.50%
218/219
(97.5 – 99.9%) |
| | | Equivocal | 61 | 0 | 0 | 61 | | |
| | | Negative | 71 | 5 | 218 | 294 | | |
| | | Total | 1788 | 5 | 219 | 2012 | | |
Table 19: Clinical Performance per Cohort - VZV IgG
| Cohort | VZV IgG Results | Comparator Final Results | | | | Percentage Agreement | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Positive | Equiv | Negative | Total | PPA (95% CI) | NPA (95% CI) |
| Pediatrics | DYNEX Smart PLEX MMRV IgG Assay Kit | Positive | 215 | 0 | 2 | 217 | 91.50%
215/235
(87.2 – 94.4%) | 93.90%
92/98
(87.3 – 97.2%) |
| | | Equivocal | 11 | 3 | 4 | 18 | | |
| | | Negative | 4 | 5 | 92 | 101 | | |
| | | Total | 230 | 8 | 98 | 336 | | |
| | | | Positive | Equiv | Negative | Total | PPA (95% CI) | NPA (95% CI) |
K212769 - Page 15 of 16
{15}
| Pregnant women | DYNEX Smart PLEX MMRV IgG Assay Kit | Positive | 453 | 2 | 1 | 456 | 97.20%
453/466
(95.3 – 98.4%) | 84.80%
28/33
(69.1 – 93.3%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Equivocal | 6 | 1 | 2 | 9 | | |
| | | Negative | 5 | 2 | 28 | 35 | | |
| | | Total | 464 | 5 | 31 | 500 | | |
| | | | Positive | Equiv | Negative | Total | PPA
(95% CI) | NPA
(95% CI) |
| Pediatric and Adult | DYNEX Smart PLEX MMRV IgG Assay Kit | Positive | 1667 | 8 | 11 | 1686 | 96.70%
1667/1723
(95.8 – 97.5%) | 88.00%
243/276
(83.7 – 91.4%) |
| | | Equivocal | 27 | 13 | 14 | 54 | | |
| | | Negative | 17 | 12 | 243 | 272 | | |
| | | Total | 1711 | 33 | 268 | 2012 | | |
2. **Matrix Comparison:**
Not applicable. Serum is the only matrix claimed.
C **Clinical Studies:**
1. **Clinical Sensitivity:**
Not applicable
2. **Clinical Specificity:**
Not applicable
3. **Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):**
Not applicable
D **Clinical Cut-Off:**
See Assay Cut-Off
E **Expected Values/Reference Range:**
Not Applicable
VIII **Proposed Labeling:**
The labeling supports the finding of substantial equivalence for this device.
IX **Conclusion:**
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
K212769 - Page 16 of 16
