(759 days)
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, pediative patients below 1 year of age, and immunocompromised patients, or for use at point of care facilities.
The DYNEX SmartPLEX MMRV IgG Assay Kit (SmartPLEX MMRV IgG Assay) 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 Multiplier Analyzer.
The Multiplier Analyzer adds the patient serum specimen and reagents to each well of the 96well plate, after which the mixture is incubated at 37°C with shaking. After a wash cycle, unbound antibodies from the patient's specimen are removed. Anti-human polyclonal IgG antibody conjugated to horseradish peroxidase (HRP) is added after which the mixture is incubated at 37°C with shaking. A second wash step removes excess conjuqate, then luminol substrate is added to each well. The amount of antibody captured by the antigen is determined by the chemiluminescence triggered by the attached HRP. Raw data is captured as light photons which 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 assay a calibrator is run. 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. The result is calculated in the Multiplier software by dividing the test sample RLU values by the mean calibrator RLU value to produce an index value for each target.
Here's an analysis of the acceptance criteria and study data for the DYNEX SmartPLEX MMRV IgG Assay Kit, as requested, based on the provided FDA 510(k) summary.
Device Name: DYNEX SmartPLEX MMRV IgG Assay Kit
Indications for Use: Qualitative detection of IgG antibodies to Measles, Mumps, Rubella, and Varicella-Zoster Virus (VZV) in human serum, as an aid in the determination of serological status. Intended for use with the DYNEX Multiplier Analyzer, in adults and pediatrics age above 1 year. Not intended for screening blood or plasma donors, neonates, pediatric patients below 1 year, or immunocompromised patients, or for point-of-care facilities.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria values (e.g., "PPA must be >X%"). Instead, it presents the performance results obtained from the study and implies that these results were deemed acceptable for clearance. For this table, I will use the reported Clinical Performance (Method Comparison) as the primary indicator of device performance, specifically the Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) values.
| Performance Metric | Category (Analyte) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Clinical Performance (Method Comparison) | |||
| Positive Percent Agreement (PPA) | Measles IgG (Pediatric and Adult) | High PPA to demonstrate positive agreement with comparator. | 87.00% (95% CI: 85.4 - 88.5%) |
| Negative Percent Agreement (NPA) | Measles IgG (Pediatric and Adult) | High NPA to demonstrate negative agreement with comparator. | 98.70% (95% CI: 96.3 - 99.6%) |
| Positive Percent Agreement (PPA) | Mumps IgG (Pediatric and Adult) | High PPA to demonstrate positive agreement with comparator. | 94.70% (95% CI: 93.6 - 95.7%) |
| Negative Percent Agreement (NPA) | Mumps IgG (Pediatric and Adult) | High NPA to demonstrate negative agreement with comparator. | 78.90% (95% CI: 73.3 - 83.5%) |
| Positive Percent Agreement (PPA) | Rubella IgG (Pediatric and Adult) | High PPA to demonstrate positive agreement with comparator. | 92.40% (95% CI: 91.0 - 93.5%) |
| Negative Percent Agreement (NPA) | Rubella IgG (Pediatric and Adult) | High NPA to demonstrate negative agreement with comparator. | 99.50% (95% CI: 96.6 - 100%) |
| Positive Percent Agreement (PPA) | VZV IgG (Pediatric and Adult) | High PPA to demonstrate positive agreement with comparator. | 96.70% (95% CI: 95.8 - 97.5%) |
| Negative Percent Agreement (NPA) | VZV IgG (Pediatric and Adult) | High NPA to demonstrate negative agreement with comparator. | 88.00% (95% CI: 83.7 - 91.4%) |
| Reproducibility | |||
| Total %CV (Mean over all samples) | Measles IgG | Low %CV to demonstrate consistency. | Max Total %CV: 10.3% (Sample 3) |
| Total %CV (Mean over all samples) | Mumps IgG | Low %CV to demonstrate consistency. | Max Total %CV: 11.1% (Sample 20) |
| Total %CV (Mean over all samples) | Rubella IgG | Low %CV to demonstrate consistency. | Max Total %CV: 9.0% (Sample 13) |
| Total %CV (Mean over all samples) | VZV IgG | Low %CV to demonstrate consistency. | Max Total %CV: 8.7% (Sample 13) |
| Within-Laboratory Precision | |||
| Total %CV (Mean over all samples) | Measles IgG | Low %CV to demonstrate consistency. | Max Total %CV: 8.5% (Sample 21) |
| Total %CV (Mean over all samples) | Mumps IgG | Low %CV to demonstrate consistency. | Max Total %CV: 11.1% (Sample 20) |
| Total %CV (Mean over all samples) | Rubella IgG | Low %CV to demonstrate consistency. | Max Total %CV: 6.0% (Sample 13) |
| Total %CV (Mean over all samples) | VZV IgG | Low %CV to demonstrate consistency. | Max Total %CV: 7.8% (Sample 13) |
| Potential Cross-Reactivity (Negative Agreement) | |||
| Negative Agreement | Specific interfering substances (e.g., ANA, CMV, EBV) for each Measurand | High negative agreement to indicate no false positives. | Generally 100% (e.g., 5/5, 6/6, 10/10). One exception: 2/3 for HSV2 on Mumps. |
| Interfering Substances | |||
| No Interference | For specified substances (Albumin, Bilirubin, Cholesterol, Hemoglobin, Triglyceride) | No significant interference. | No interference observed at maximum tested concentrations. |
| Shelf Life | |||
| Stability Period | 2-8°C storage | Stability for a defined period. | 18 months at 2-8°C. (Evaluated up to 25 months, stable for 19 months, assigned 18 months) |
Note: The acceptance criteria are "implied" as the document presents the results to demonstrate performance rather than explicitly stating pre-defined thresholds the device needed to meet for clearance.
2. Sample Sizes and Data Provenance
- Test Set Sample Size:
- Clinical Performance (Method Comparison): N = 2512 retrospective human serum specimens.
- Adults: N = 1676
- Pregnant Women: N = 500
- Pediatrics (age above 1 year): N = 336
- Reproducibility and Within-Laboratory Precision: 22 serum samples, each tested 240 replicates.
- Potential Cross-Reactivity: Variable N for each substance (e.g., ANA n=5, CMV n=6-8, EBV n=6-11).
- Clinical Performance (Method Comparison): N = 2512 retrospective human serum specimens.
- Data Provenance: Retrospective human serum specimens obtained from commercial vendors. The method comparison testing was performed at two US laboratory testing sites.
3. Number of Experts and Qualifications for Ground Truth
- The ground truth for clinical performance (method comparison) was established by FDA-cleared comparator tests, not through expert human readers or adjudicators for each individual case result. The agreement was measured against the results of these established assays.
- For specimens with equivocal results on the test device and comparator device, they were retested with two additional FDA-cleared methods.
4. Adjudication Method for the Test Set
- For equivocal results that remained equivocal after initial retesting with the comparator device, a "2/3 rule" was used to establish a consensus final comparator result. This means that if at least two out of the three comparator devices provided the same categorical result (Positive, Equivocal, or Negative), that result was taken as the consensus.
- Any remaining equivocal results (where no 2/3 consensus was reached or the consensus was still equivocal) were "counted against the clinical performance" of the SmartPLEX MMRV IgG Assay (this is implied by the 3x3 analysis where equivocal results from the test device are presented in comparison to the "Final Comparator Result").
5. MRMC Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes the performance of an in vitro diagnostic (IVD) assay kit, which directly measures antibodies in serum. These types of devices do not typically involve human readers interpreting images or data to the extent that an MRMC study would be applicable. The performance is assessed by comparison to established laboratory methods or ground truth.
6. Standalone Performance
- Yes, standalone performance was done. The entire study is a standalone performance evaluation of the DYNEX SmartPLEX MMRV IgG Assay Kit in relation to comparator methods. The device's output (qualitative detection of IgG antibodies) is directly compared to the output of other FDA-cleared IVD assays. There is no "human-in-the-loop" component for this type of diagnostic assay, as its output is a direct measurement.
7. Type of Ground Truth Used
- The ground truth for the clinical performance study was primarily based on the results from one or more FDA-cleared comparator immunoassay devices. For ambiguous cases (equivocal results), a consensus derived from multiple FDA-cleared comparator methods using a "2/3 rule" was employed. This is a common method for establishing reference values in IVD studies where a perfect "gold standard" may not exist for all samples, or where the goal is to show substantial equivalence to established methods.
8. Sample Size for the Training Set
- The document does not specify a separate "training set" sample size or details about a training phase. For IVD assay kits, the development and optimization process (analogous to training) typically involves internal experimentation, formulation adjustments, and preliminary testing, rather than a distinct "training set" of patient samples in the same way an AI/ML algorithm would use labeled data. The provided data represents the validation/test set used for regulatory submission.
9. How the Ground Truth for the Training Set was Established
- Since a distinct "training set" as understood in AI/ML was not explicitly used or described in the context of this IVD assay kit, the concept of establishing ground truth for a training set is not directly applicable here. The focus is on the performance of the final, developed kit. The development process would have involved establishing specifications and ensuring the assay's ability to accurately detect the target antibodies, perhaps using characterized positive/negative panels, but this is not typically detailed as "ground truth for training" in 510(k) summaries for such devices.
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Date: September 29, 2023
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Dynex Technologies Inc. Jeff Fisher Vice President, Quality Assurance & Regulatory Affairs 14340 Sullyfield Circle Chantilly, Virginia 20151
Re: K212769
Trade/Device Name: DYNEX SmartPLEX MMRV IgG Assay Kit Regulation Number: 21 CFR 866.3510; Rubella Virus Serological Reagents Regulation Name: Rubella virus serological reagents Regulatory Class: Class II Product Code: OPL Dated: December 7, 2022 Received: December 7, 2022
Dear Jeff Fisher:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part
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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
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Digitally signed by Ryan C. Karsner -S Date: 2023.09.29 07:43:51 -04'00'
Ryan Karsner, MD. Deputy Assistant Director Hepatitis and General Viral Infections Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212769
Device Name DYNEX SmartPLEX MMRV IgG Assay Kit
Indications for Use (Describe)
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, pediative patients below 1 year of age, and immunocompromised patients, or for use at point of care facilities.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. Submitter Information
DYNEX Technologies, Inc. 14340 Sullyfield Circle Chantilly, VA 20151 Phone: 703-803-1243 Fax: 703-803-1441
Establishment Registration Number: 1117676
2. Submission Correspondent:
Jeff Fisher Vice President, Quality Assurance & Regulatory Affairs Email: jfisher@dynex.com Phone: 703-803-1266 Fax: 703-803-1441
3. Date Prepared: June 12, 2023
4. Device Information
| Classification Name: | Multiplex immunoassay for Measles virus, Mumps virus, Rubellavirus, and Varicella-Zoster virus |
|---|---|
| Common Name: | DYNEX SmartPLEX MMRV IgG on the Multiplier Analyzer |
| Product Trade Name: | DYNEX SmartPLEX MMRV IgG Assay Kit |
| Device Class: | Class II |
| Classification Panel: | Microbiology |
| Regulation Number: | 866.3510 |
| Product Code: | OPI |
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Image /page/4/Picture/1 description: The image shows the logo for Dynex Technologies. The logo features a blue and silver circular icon with a stylized "D" inside. To the right of the icon, the word "DYNEX" is written in blue, with the word "TECHNOLOGIES" in gray underneath. A blue curved line extends from the icon over the text, adding a dynamic element to the design.
5. Legally Marketed Predicate Device Information
| Name: | BioPlex 2200 MMRV IgG |
|---|---|
| 510(k) Number: | K091616 |
| Decision Date: | 03/29/2010 |
This predicate has not been subject to a design-related recall according to the FDA Medical Devices Recall website as of August 23, 2021.
6. Device Description
The DYNEX SmartPLEX MMRV IgG Assay Kit (SmartPLEX MMRV IgG Assay) 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 Multiplier Analyzer.
The Multiplier Analyzer adds the patient serum specimen and reagents to each well of the 96well plate, after which the mixture is incubated at 37°C with shaking. After a wash cycle, unbound antibodies from the patient's specimen are removed. Anti-human polyclonal IgG antibody conjugated to horseradish peroxidase (HRP) is added after which the mixture is incubated at 37°C with shaking. A second wash step removes excess conjuqate, then luminol substrate is added to each well. The amount of antibody captured by the antigen is determined by the chemiluminescence triggered by the attached HRP. Raw data is captured as light photons which 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 assay a calibrator is run. 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. The result is calculated in the Multiplier software by dividing the test sample RLU values by the mean calibrator RLU value to produce an index value for each target.
Interpretation of results of the DYNEX SmartPLEX MMRV IgG Assay Kit:
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 Table 1 below:
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Table 1: Interpretation of Results of the DYNEX SmartPLEX MMRV IgG Assay Kit
| Result* | Status | Interpretation** |
|---|---|---|
| Index value:೭೦.9 | NEG | Negative: No detectable IgG antibodies to Measles, Mumps,Rubella or VZV detected. Such individual is presumed not tohave had a previous exposure to MMRV through infection orvaccination |
| Index value:>0.9 - <1.1 | EQV | Equivocal: Samples should be retested, if the result remainsequivocal, the samples should be tested on an alternativemethod |
| Index value:21.1 | POS | Positive: IqG antibodies to Measles, Mumps, Rubella, or VZVdetected. This may indicate that the individual was exposed toMMRV 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
Kit Components
The reagents contained in each SmartKit are sufficient to process 92 serum specimens.
Table 2: DYNEX SmartPLEX MMRV IgG Assay Kit Components
| Name | REF # | Description |
|---|---|---|
| SmartPLEX MMRV IgGTest Plate | 7100010 | 12 x SmartPLEX beaded MMRV strips in stripholder containing beads coated with antigens toMeasles virus, Mumps virus, Rubella virus, andVaricella-zoster virus. |
| SmartPLEX MMRV IgGAssay Kit Quality ControlCertificate | 7100011 | 1 x hard copy of the Quality Control certificatedescribing the performance characteristics ofthe assay |
| SmartPLEX Lot SpecificUniversal Serial Bus(USB) | 7100012 | Lot specific calibrationadjustment factors for each lot of reagents,Safety Data Sheet (SDS), Panel File, TranslatedInstructions for Use. |
| SmartPLEX MMRV IgGAssay Kit Instructions forUse (IFU) | 71000IFU | Instructions for Use |
| SmartPLEX MMRV IgGAssay Kit Cap Organizer | 90002140 | 1x Cap Organizer |
| SmartPLEX MMRV IgGAssay Kit Overlay withQR Code | 90003080 | 1X color-coded card placed to the top of areagent rack (SmartKit) to guide the user whereto place the reagents. |
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| MMRV Sample Diluent | 710004 | 2 x 60 mL bottles of phosphate buffered saline containing ProClin 300 (0.1%) as a preservative. |
|---|---|---|
| Wash Buffer (20x Concentrate) | 710008 | 1 x 55 mL bottle of phosphate buffered saline buffer containing ProClin 300 (0.1%) as a preservative. |
| MMRV IgG Calibrator | 710005 | 1 x 1.2 mL of diluted human serum containing ProClin 300 (0.1%) and sodium azide (<0.01%) as preservatives. |
| MMRV IgG Positive Control | 710007 | 1 x 1.2 mL of diluted human serum containing ProClin 300 (0.1%) and sodium azide (<0.01%) as preservatives. |
| MMRV IgG Negative Control | 710006 | 1 x 1.2 mL of diluted human serum containing ProClin 300 (0.1%) and sodium azide (<0.01%) as preservatives. |
| MMRV Conjugate | 710003 | 1 x 13 mL of purified peroxidase labelled rabbit anti-human polyclonal IgG antibody containing ProClin 300 (0.1%) as a preservative. |
| Luminol Substrate A | 710001 | 1 x 9.0 mL of Luminol substrate, buffers, stabilizers. |
| Luminol Substrate B | 710002 | 1 x 9.0 mL of Hydrogen peroxide |
Table 3: Additional Required Materials, Available from DYNEX Technologies
| Name | REF # |
|---|---|
| Multiplier Analyzer | 63000 |
| DYNEX Sample Pipette Tips (432/box) | 65910 |
| DYNEX Reagent Pipette Tips (432/box) | 65920 |
| DYNEX Deep-well dilution strips | 62910 |
| Reusable SmartKit Rack | MSK009 |
Table 4:Additional Required Materials, Not Available from DYNEX Technologies
| Name |
|---|
| Distilled or deionized water ASTM Type II or higher |
| 1 L graduated or measuring cylinder |
| 50 mL graduated or measuring cylinder |
7. Intended 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.
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Image /page/7/Picture/0 description: The image shows the text "DYNEX SmartPLEX MMRV IgG Assay Kit". The text is in bold and is black. The text is centered in the image.
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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.
8. Comparison of Characteristics
Table 5 below summarize the similarities and differences between the DYNEX SmartPLEX MMRV IgG Assay Kit and the predicate, BioPlex 2200 MMRV IgG.
| Similarities | |||
|---|---|---|---|
| Predicate DeviceK091616 | Candidate DeviceK212769 | ||
| Trade Name | BioPlex 2200 MMRV IgG | DYNEX SmartPLEX MMRV IgGAssay Kit | |
| Intended use | The BioPlex 2200 MMRV IgGkit is a multiplex flowimmunoassay intended for thequalitative detection of IgGantibodies to Measles, Mumps,Rubella, and Varicella-zostervirus (VZV) in human serumand EDTA or heparinizedplasma. The BioPlex 2200MMRV IgG kit is intended foruse with the Bio-Rad BioPlex2200 System.This kit is intended as an aid inthe determination of serologicalstatus to Measles, Mumps,Rubella, and VZV. This kit isnot intended for use inscreening blood or plasmadonors. | The DYNEX SmartPLEX MMRV IgGAssay Kit is a multiplex immunoassayintended for the qualitative detection ofIgG antibodies to Measles, Mumps,Rubella, and Varicella-Zoster Virus(VZV) in human serum. The DYNEXSmartPLEX MMRV IgG Assay Kit isintended for use with the DYNEXMultiplier Analyzer.The DYNEX SmartPLEX MMRV IgGAssay Kit is intended to be used as anaid in the determination of serologicalstatus to Measles, Mumps, Rubella, andVaricella-Zoster Virus (VZV) in humanserum from adults and pediatrics ageabove 1 year. This kit is not intended forscreening blood or plasma donors.The performance of this device has notbeen established for use in neonates,pediatric patients below 1 year of age,and immunocompromised patients, orfor use at point of care facilities. | |
| DYNEX SmartPLEX MMRV IgG Assay Kit | Revision 3 | ||
| VOLUME 5 - 510(k) SUMMARY | Page 6 of 21 | ||
| The performance of this assayhas not been established foruse in neonates, pediatrics,and immunocompromisedpatients, or for use at point ofcare facilities. | |||
| Reagents | Sample diluent, Wash buffer | Same | |
| Controls | Negative control and Multi-analyte Positive control. | Same | |
| Calibrators | Calibrators | Same | |
| AnalyteDetection | Qualitative detection of IgGantibodies to Measles, Mumps,Rubella and Varicella-zostervirus. | Same | |
| Differences | |||
| Predicate DeviceK091616 | Candidate DeviceK212769 | ||
| Trade Name | BioPlex 2200 MMRV IgG | DYNEX SmartPLEX MMRV IgGAssay Kit | |
| Solid Phase | Bead reagent - dyed antigencoated beads | 96 well microplate - antigen coatedpolystyrene beads | |
| Reagents | Conjugate: Murine anti-humanIgG/phycoerythrin | Conjugate: Rabbit anti-human IgGconjugated to horseradish peroxidase,chemiluminescent luminol substrate | |
| Sheath Fluid | Sheath fluid is used to suspendbead reagent and introduceinto the detector | Not used | |
| Matrices | Serum, EDTA, or HeparinizedPlasma | Serum | |
| Signal Detection | Fluorescence measured byspectrophotometer | Chemiluminescence measured by animaging camera |
Table 5: Comparison of the SmartPLEX MMRV IgG Assay Kit with Predicate
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Image /page/9/Picture/2 description: The image shows the logo for Dynex Technologies. The logo features a blue and silver circular emblem with a stylized "D" inside. To the right of the emblem, the word "DYNEX" is written in bold, blue letters, with the word "TECHNOLOGIES" underneath in a smaller, lighter font. A blue swoosh arcs over the logo.
9. Performance Characteristics
The following performance data were provided in support of the substantial equivalence determination.
A. Distribution of qualitative results for each of the analytes detected by the DYNEX SmartPLEX MMRV IgG Assay Kit.
The distribution of qualitative results for each of the analytes detected by the DYNEX SmartPLEX MMRV IgG Assay Kit were determined by using retrospective human serum specimens (N= 2512). Results, per cohort and sex, are shown in Table 6 below.
Table 6: Distribution of Qualitative Results for Each of the Analytes Detected by the DYNEX SmartPLEX MMRV IgG Assay Kit
| Result | Cohort | Sex | Age | N | Positive (%) | Equivocal (%) | Negative (%) |
|---|---|---|---|---|---|---|---|
| Measles | Overall | Female | 1-88 | 1544 | 1171 (75.8%) | 78 (5.1%) | 295 (19.1%) |
| Male | 1-88 | 968 | 753 (77.8%) | 41 (4.2%) | 174 (18.0%) | ||
| Total | 2512 | 1924 (76.6%) | 119 (4.7%) | 469 (18.7%) | |||
| Pediatric | Female | 1-21 | 134 | 95 (70.9%) | 4 (3.0%) | 35 (26.1%) | |
| Male | 1-21 | 202 | 155 (76.7%) | 8 (4.0%) | 39 (19.3%) | ||
| Total | 336 | 250 (74.4%) | 12 (3.6%) | 74 (22.0%) | |||
| Adult | Female | 22-88 | 910 | 688 (75.6%) | 39 (4.3%) | 183 (20.1%) | |
| Male | 22-88 | 766 | 598 (78.1%) | 33 (4.3%) | 135 (17.6%) | ||
| Total | 1676 | 1286 (76.7%) | 72 (4.3%) | 318 (19.0%) | |||
| PregnantWomen | Female | 16-21 | 24 | 17 (70.8%) | 3 (12.5%) | 4 (16.7%) | |
| Female | 22-47 | 476 | 371 (77.9%) | 32 (6.7%) | 73 (15.3%) | ||
| Total | 500 | 388 (77.6%) | 35 (7.0%) | 77 (15.4%) | |||
| Mumps | Overall | Female | 1-88 | 1544 | 1342 (86.9%) | 43 (2.8%) | 159 (10.3%) |
| Male | 1-88 | 968 | 818 (84.5%) | 27 (2.8%) | 123 (12.7%) | ||
| Total | 2512 | 2160 (86.0%) | 70 (2.8%) | 282 (11.2%) | |||
| Pediatric | Female | 1-21 | 134 | 107 (79.9%) | 4 (3.0%) | ||
| Male | 1-21 | 202 | 169 (83.7%) | 7 (3.5%) | |||
| Total | 336 | 276 (82.1%) | 11 (3.5%) | ||||
| Adult | Female | 22-88 | 910 | 770 (84.6%) | 33 (3.6%) | ||
| Rubella | Male | 22-88 | 766 | 649 (84.7%) | 20 (2.6%) | 97 (12.7%) | |
| Total | 1676 | 1419 (84.7%) | 53 (3.2%) | 204 (12.2%) | |||
| PregnantWomen | Female | 16-21 | 24 | 22 (91.7%) | 0 (0%) | ||
| Female | 22-47 | 476 | 443 (93.1%) | 6 (1.3%) | |||
| Total | 500 | 465 (93.0%) | 6 (1.2%) | ||||
| Overall | Female | 1-88 | 1544 | 1317 (85.3%) | 49 (3.2%) | ||
| Male | 1-88 | 968 | 788 (81.4%) | 28 (2.9%) | |||
| Total | 2512 | 2105 (83.8%) | 77 (3.1%) | ||||
| Pediatric | Female | 1-21 | 134 | 107 (79.9%) | 7 (5.2%) | ||
| Male | 1-21 | 202 | 171 (84.7%) | 6 (3.0%) | |||
| Total | 336 | 278 (82.7%) | 13 (3.9%) | ||||
| Adult | Female | 22-88 | 910 | 760 (83.5%) | 27 (3.0%) | ||
| Male | 22-88 | 766 | 617 (80.5%) | 22 (2.9%) | |||
| Total | 1676 | 1377 (82.2%) | 49 (2.9%) | ||||
| VZV | PregnantWomen | Female | 16-21 | 24 | 21 (87.5%) | 1 (4.2%) | 2 (8.3%) |
| Female | 22-47 | 476 | 429 (90.1%) | 14 (2.9%) | |||
| Total | 500 | 450 (90.0%) | 15 (3.0%) | ||||
| Overall | Female | 1-88 | 1544 | 1334 (86.4%) | 37 (2.4%) | ||
| Male | 1-88 | 968 | 805 (83.2%) | 26 (2.7%) | |||
| Total | 2512 | 2139 (85.2%) | 63 (2.5%) | ||||
| Pediatric | Female | 1-21 | 134 | 85 (63.4%) | 7 (5.2%) | ||
| Male | 1-21 | 202 | 131 (64.9%) | 11 (5.4%) | |||
| Total | 336 | 216 (64.3%) | 18 (5.4%) | ||||
| Adult | Female | 22-88 | 910 | 794 (87.3%) | 20 (2.2%) | ||
| Male | 22-88 | 766 | 674 (88.0%) | 15 (2.0%) | |||
| Total | 1676 | 1468 (87.6%) | 35 (2.1%) | ||||
| PregnantWomen | Female | 16-21 | 24 | 19 (79.2%) | 1 (4.2%) | ||
| Female | 22-47 | 476 | 436 (91.6%) | 9 (1.9%) | |||
| Total | 500 | 455 (91.0%) | 10 (2.0%) | 35 (7.0%) |
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Image /page/10/Picture/0 description: The image contains the logo for Dynex Technologies. The logo features a blue circular icon with a white "D" inside, followed by the company name "DYNEX" in bold blue letters. Below the name, the word "TECHNOLOGIES" is written in a smaller, lighter blue font.
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B. Reproducibility study
A reproducibility of the DYNEX SmartPLEX MMRV IgG Assay Kit was conducted evaluating 22 serum samples at three sites located in the US using one kit and one
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Image /page/11/Picture/2 description: The image is a logo for Dynex Technologies. The logo features a blue and silver circular icon with a stylized "D" inside. To the right of the icon is the word "DYNEX" in a bold, blue sans-serif font, with the word "TECHNOLOGIES" in a smaller, light gray font underneath. A blue swoosh arcs over the logo.
Multiplier Analyzer per site. Samples were tested in duplicate, two times a day, over 20 days for a total of 240 replicates per sample (one sample x two replicates x two runs per day x 20 days x 3 sites = 240 results per sample). The mean, standard deviation, and %CV were calculated for intra and inter-assay precision and inter-site precision for Measles, Mumps, Rubella and VZV, as shown in Tables 7A-7D below.
| Category | Sample | N | Mean | 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% | |
| 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% | |
| High Negative | 3 | 240 | 0.73 | 0.064 | 8.8% | 0.039 | 5.3% | 0.000 | 0.0% | 0.000 | 0.0% | 0.075 | 10.3% |
| 2 | 240 | 0.82 | 0.038 | 4.6% | 0.044 | 5.3% | 0.000 | 0.0% | 0.150 | 2.9% | 0.063 | 7.6% | |
| 19 | 240 | 0.85 | 0.054 | 6.3% | 0.035 | 4.1% | 0.000 | 0.0% | 0.040 | 1.5% | 0.066 | 7.7% | |
| 21 | 240 | 0.88 | 0.061 | 7.0% | 0.031 | 3.5% | 0.000 | 0.0% | 0.083 | 2.3% | 0.072 | 8.2% | |
| 14 | 240 | 0.91 | 0.058 | 6.4% | 0.041 | 4.5% | 0.000 | 0.0% | 0.062 | 2.0% | 0.074 | 8.1% | |
| Equivocal | 11 | 240 | 0.95 | 0.055 | 5.7% | 0.040 | 4.2% | 0.018 | 1.9% | 0.166 | 3.3% | 0.076 | 8.0% |
| 1 | 240 | 1.02 | 0.057 | 5.6% | 0.056 | 5.5% | 0.000 | 0.0% | 0.153 | 3.3% | 0.087 | 8.5% | |
| 15 | 240 | 1.05 | 0.056 | 5.4% | 0.047 | 4.4% | 0.004 | 0.4% | 0.056 | 1.7% | 0.075 | 7.2% | |
| 17 | 240 | 1.23 | 0.095 | 7.7% | 0.054 | 4.4% | 0.017 | 1.4% | 0.000 | 0.0% | 0.111 | 9.0% | |
| Low Positive | 18 | 240 | 1.25 | 0.066 | 5.3% | 0.050 | 4.0% | 0.033 | 2.6% | 0.145 | 2.9% | 0.097 | 7.7% |
| 16 | 240 | 1.27 | 0.085 | 6.7% | 0.040 | 3.1% | 0.006 | 0.5% | 0.085 | 2.2% | 0.098 | 7.7% | |
| 12 | 240 | 1.55 | 0.088 | 5.7% | 0.051 | 3.3% | 0.000 | 0.0% | 0.072 | 1.8% | 0.106 | 6.8% | |
| 20 | 240 | 1.59 | 0.100 | 6.3% | 0.038 | 2.4% | 0.029 | 1.8% | 0.102 | 2.4% | 0.117 | 7.4% | |
| Moderate Positive | 9 | 240 | 1.73 | 0.108 | 6.3% | 0.057 | 3.3% | 0.036 | 2.1% | 0.361 | 5.6% | 0.159 | 9.2% |
| 7 | 240 | 2.11 | 0.103 | 4.9% | 0.080 | 3.8% | 0.046 | 2.2% | 0.050 | 1.5% | 0.142 | 6.7% | |
| 13 | 240 | 2.33 | 0.136 | 5.8% | 0.071 | 3.1% | 0.050 | 2.1% | 0.078 | 2.0% | 0.168 | 7.2% | |
| 22 | 240 | 2.33 | 0.148 | 5.2% | 0.082 | 2.9% | 0.079 | 2.8% | 0.158 | 2.8% | 0.204 | 7.1% | |
| High Positive | 4 | 240 | 2.99 | 0.153 | 5.1% | 0.092 | 3.1% | 0.016 | 0.5% | 0.210 | 3.1% | 0.202 | 6.7% |
Table 7A: Measles Reproducibility Data
Table 7B: Mumps Reproducibility Data
| Category | Sample | N | Mean | Within Run | Between Run | Between Day | Between Site/ lot | Total | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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% | |
| 1 | 240 | 0.60 | 0.035 | 5.8% | 0.023 | 3.8% | 0.022 | 3.6% | 0.055 | 1.9% | 0.048 | 8.1% |
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Image /page/12/Picture/0 description: The image shows the Dynex Technologies logo. The logo features a blue and white circular emblem with a stylized "D" inside. To the right of the emblem, the word "DYNEX" is written in a bold, blue font, with the word "TECHNOLOGIES" underneath in a smaller, lighter blue font. A blue swoosh arcs over the logo.
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| High Negative | 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% | |
| 7 | 240 | 0.78 | 0.044 | 5.7% | 0.031 | 4.0% | 0.024 | 3.0% | 0.176 | 3.5% | 0.065 | 8.3% | |
| Equivocal | 11 | 240 | 0.99 | 0.064 | 6.5% | 0.021 | 2.2% | 0.028 | 2.8% | 0.273 | 4.5% | 0.086 | 8.7% |
| 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% | |
| Low Positive | 16 | 240 | 1.36 | 0.073 | 5.4% | 0.051 | 3.8% | 0.011 | 0.8% | 0.150 | 2.8% | 0.097 | 7.2% |
| 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% |
Table 7C: Rubella Reproducibility Data
| Category | Sample | N | Mean | Within Run | Between Run | Between Day | BetweenSite/ 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% | |
| 11 | 240 | 1.17 | 0.043 | 3.7% | 0.029 | 2.5% | 0.021 | 1.8% | 0.000 | 0.0% | 0.055 | 4.8% | |
| Low Positive | 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% | |
| 14 | 240 | 1.50 | 0.044 | 2.9% | 0.031 | 2.1% | 0.023 | 1.5% | 0.011 | 0.4% | 0.059 | 3.9% | |
| Moderate Positive | 17 | 240 | 1.65 | 0.103 | 6.2% | 0.000 | 0.0% | 0.016 | 1.0% | 0.068 | 1.7% | 0.108 | 6.5% |
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Image /page/13/Picture/0 description: The image is a logo for Dynex Technologies. The logo features a blue and white circular emblem with a stylized "D" inside. To the right of the emblem is the word "DYNEX" in blue, with the word "TECHNOLOGIES" in gray underneath. A blue swoosh arcs over the logo.
VOLUME 5 - 510(k) SUMMARY
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| 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 7D: VZV Reproducibility Data
| Category | Sample | N | Mean | 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% |
| Low Negative | 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% |
| High Negative | 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% |
| 15 | 240 | 1.22 | 0.048 | 3.9% | 0.047 | 3.8% | 0.006 | 0.5% | 0.000 | 0.0% | 0.067 | 5.5% | |
| Low Positive | 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% | |
| 20 | 240 | 1.63 | 0.083 | 5.1% | 0.052 | 3.2% | 0.000 | 0.0% | 0.014 | 0.7% | 0.099 | 6.1% | |
| Moderate Positive | 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% | |
| 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% | |
| High Positive | 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% |
C. Within-Laboratory Precision study
A within-laboratory precision study was conducted 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 (one sample x two replicates x two runs x 20 days x three reagent kit lots = 240 results per sample) to measure reagent lot-to-lot precision, as shown in Tables 8A-8D below.
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Image /page/14/Picture/0 description: The image shows the logo for Dynex Technologies. The logo features a blue circle with a white "D" inside, followed by the word "DYNEX" in blue, and the word "TECHNOLOGIES" in gray below it. A blue swoosh arcs over the logo.
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Table 8A: Measles Within-Laboratory Precision Data
| Category | Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Low Negative | 5 | 240 | 0.22 | 0.013 | 5.9% | 0.008 | 3.8% | 0.005 | 2.4% | 0.193 | 3.6% | 0.018 | 8.3% |
| Low Negative | 6 | 240 | 0.38 | 0.026 | 6.8% | 0.018 | 4.8% | 0.009 | 2.5% | 0.001 | 0.3% | 0.033 | 8.7% |
| Low Negative | 8 | 240 | 0.68 | 0.044 | 6.5% | 0.029 | 4.3% | 0.013 | 2.0% | 0.000 | 0.0% | 0.054 | 8.0% |
| High Negative | 10 | 240 | 0.70 | 0.044 | 6.3% | 0.028 | 3.9% | 0.016 | 2.3% | 0.000 | 0.0% | 0.055 | 7.8% |
| High Negative | 3 | 240 | 0.74 | 0.053 | 7.2% | 0.024 | 3.3% | 0.019 | 2.6% | 0.000 | 0.0% | 0.061 | 8.3% |
| High Negative | 2 | 240 | 0.82 | 0.048 | 5.8% | 0.035 | 4.3% | 0.020 | 2.4% | 0.188 | 3.7% | 0.069 | 8.4% |
| High Negative | 19 | 240 | 0.87 | 0.049 | 5.6% | 0.037 | 4.3% | 0.000 | 0.0% | 0.077 | 2.0% | 0.064 | 7.4% |
| High Negative | 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% |
| Equivocal | 11 | 240 | 0.96 | 0.055 | 5.7% | 0.035 | 3.7% | 0.027 | 2.8% | 0.067 | 2.0% | 0.073 | 7.5% |
| Equivocal | 1 | 240 | 1.01 | 0.055 | 5.5% | 0.045 | 4.4% | 0.021 | 2.1% | 0.139 | 3.0% | 0.080 | 7.9% |
| Low Positive | 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% |
| Low Positive | 16 | 240 | 1.28 | 0.077 | 6.0% | 0.060 | 4.7% | 0.000 | 0.0% | 0.116 | 2.7% | 0.103 | 8.0% |
| Low Positive | 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% |
| Moderate Positive | 20 | 240 | 1.61 | 0.086 | 5.4% | 0.071 | 4.4% | 0.046 | 2.8% | 0.089 | 2.3% | 0.126 | 7.8% |
| Moderate Positive | 9 | 240 | 1.75 | 0.098 | 5.6% | 0.065 | 3.7% | 0.036 | 2.1% | 0.216 | 3.7% | 0.139 | 7.9% |
| Moderate Positive | 7 | 240 | 2.14 | 0.118 | 5.5% | 0.079 | 3.7% | 0.000 | 0.0% | 0.044 | 1.4% | 0.145 | 6.8% |
| High Positive | 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% |
| High Positive | 4 | 240 | 3.04 | 0.134 | 4.4% | 0.140 | 4.6% | 0.032 | 1.0% | 0.137 | 2.6% | 0.211 | 6.9% |
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Image /page/15/Picture/0 description: The image is a logo for Dynex Technologies. The logo features a blue and white circular icon with a stylized "D" inside. To the right of the icon is the word "DYNEX" in blue, with the word "TECHNOLOGIES" in gray underneath. A blue swoosh arcs over the logo.
Page 13 of 21
Table 8B: Mumps Within-Laboratory Precision Data
| Category | Specimen | N | Mean | 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% | |
| High Negative | 6 | 240 | 0.63 | 0.031 | 4.9% | 0.022 | 3.5% | 0.015 | 2.3% | 0.130 | 2.5% | 0.044 | 6.9% |
| 18 | 240 | 0.68 | 0.037 | 5.4% | 0.021 | 3.0% | 0.014 | 2.1% | 0.434 | 5.7% | 0.059 | 8.7% | |
| 12 | 240 | 0.71 | 0.037 | 5.2% | 0.020 | 2.8% | 0.019 | 2.6% | 0.045 | 1.4% | 0.047 | 6.7% | |
| 13 | 240 | 0.74 | 0.040 | 5.4% | 0.028 | 3.8% | 0.000 | 0.0% | 0.231 | 3.6% | 0.055 | 7.5% | |
| 7 | 240 | 0.78 | 0.043 | 5.5% | 0.023 | 2.9% | 0.011 | 1.4% | 0.359 | 4.8% | 0.062 | 8.0% | |
| Equivocal | 11 | 240 | 0.99 | 0.049 | 4.9% | 0.033 | 3.3% | 0.018 | 1.8% | 0.471 | 5.8% | 0.084 | 8.5% |
| 20 | 240 | 1.01 | 0.081 | 8.0% | 0.000 | 0.0% | 0.053 | 5.2% | 0.261 | 5.7% | 0.113 | 11.1% | |
| 9 | 240 | 1.06 | 0.052 | 4.9% | 0.039 | 3.7% | 0.029 | 2.8% | 0.245 | 3.8% | 0.082 | 7.8% | |
| Low Positive | 16 | 240 | 1.36 | 0.073 | 5.4% | 0.043 | 3.2% | 0.000 | 0.0% | 0.321 | 4.3% | 0.102 | 7.5% |
| 22 | 240 | 1.39 | 0.063 | 4.5% | 0.046 | 3.3% | 0.030 | 2.1% | 0.454 | 5.5% | 0.113 | 8.1% | |
| ModeratePositive | 15 | 240 | 1.43 | 0.079 | 5.5% | 0.054 | 3.8% | 0.005 | 0.4% | 0.052 | 1.6% | 0.099 | 6.9% |
| 21 | 240 | 1.52 | 0.079 | 5.2% | 0.046 | 3.0% | 0.040 | 2.7% | 0.157 | 2.8% | 0.108 | 7.2% | |
| 5 | 240 | 1.54 | 0.071 | 4.6% | 0.044 | 2.8% | 0.024 | 1.6% | 0.325 | 3.9% | 0.105 | 6.8% | |
| High Positive | 10 | 240 | 2.35 | 0.111 | 4.7% | 0.056 | 2.4% | 0.042 | 1.8% | 0.160 | 2.4% | 0.143 | 6.1% |
| 14 | 240 | 2.49 | 0.121 | 4.9% | 0.048 | 1.9% | 0.061 | 2.5% | 0.479 | 5.5% | 0.199 | 8.0% | |
| 17 | 240 | 2.99 | 0.152 | 5.1% | 0.081 | 2.7% | 0.026 | 0.9% | 0.212 | 3.0% | 0.196 | 6.6% | |
| 4 | 240 | 3.48 | 0.163 | 4.7% | 0.102 | 2.9% | 0.000 | 0.0% | 0.186 | 2.6% | 0.213 | 6.1% |
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Image /page/16/Picture/0 description: The image is a logo for Dynex Technologies. The logo features a blue circle with a white "D" inside of it. To the right of the circle is the word "DYNEX" in blue, with the word "TECHNOLOGIES" in gray underneath it. A blue swoosh arcs over the logo.
Page 14 of 21
Table 8C: Rubella Within-Laboratory Precision Data
| Category | Sample | N | Mean | Within Run | Between Run | Between Day | Between Lot | Total | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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% |
| Low Negative | 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% | |
| 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% | 0.030 | 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% | |
| High Negative | 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% | |
| 21 | 240 | 0.90 | 0.036 | 4.0% | 0.022 | 2.5% | 0.018 | 2.0% | 0.058 | 1.3% | 0.047 | 5.2% | |
| 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% | |
| Equivocal | 15 | 240 | 1.05 | 0.039 | 3.8% | 0.022 | 2.1% | 0.009 | 0.9% | 0.135 | 1.7% | 0.049 | 4.7% |
| 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% | |
| Low Positive | 20 | 240 | 1.34 | 0.063 | 4.7% | 0.014 | 1.0% | 0.032 | 2.4% | 0.037 | 1.1% | 0.074 | 5.5% |
| 16 | 240 | 1.34 | 0.048 | 3.6% | 0.026 | 1.9% | 0.025 | 1.9% | 0.008 | 0.4% | 0.061 | 4.5% | |
| 14 | 240 | 1.52 | 0.048 | 3.2% | 0.035 | 2.3% | 0.029 | 1.9% | 0.036 | 0.8% | 0.067 | 4.4% | |
| ModeratePositive | 17 | 240 | 1.68 | 0.049 | 2.9% | 0.034 | 2.0% | 0.028 | 1.6% | 0.000 | 0.0% | 0.066 | 3.9% |
| 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% | |
| High Positive | 22 | 240 | 3.37 | 0.101 | 3.0% | 0.065 | 1.9% | 0.069 | 2.1% | 0.100 | 1.4% | 0.146 | 4.3% |
Table 8D: VZV Within-Laboratory Precision Data
| Category | Sample | N | Mean | Within Run | Between Run | Between Day | Between Lot | Total | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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% |
| Low Negative | 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% |
| High Negative | 8 | 240 | 0.83 | 0.042 | 5.0% | 0.024 | 2.9% | 0.014 | 1.7% | 0.199 | 3.0% | 0.056 | 6.7% |
| High Negative | 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% |
| Equivocal | 15 | 240 | 1.22 | 0.050 | 4.1% | 0.037 | 3.0% | 0.014 | 1.1% | 0.093 | 1.7% | 0.067 | 5.5% |
| Low Positive | 17 | 240 | 1.24 | 0.059 | 4.7% | 0.026 | 2.1% | 0.003 | 0.2% | 0.156 | 2.2% | 0.070 | 5.6% |
| Low Positive | 18 | 240 | 1.29 | 0.057 | 4.4% | 0.024 | 1.9% | 0.020 | 1.6% | 0.118 | 1.8% | 0.069 | 5.4% |
| Low Positive | 1 | 240 | 1.31 | 0.064 | 4.9% | 0.032 | 2.4% | 0.028 | 2.2% | 0.055 | 1.4% | 0.079 | 6.1% |
| Low Positive | 9 | 240 | 1.35 | 0.059 | 4.4% | 0.042 | 3.1% | 0.000 | 0.0% | 0.124 | 2.0% | 0.078 | 5.7% |
| Low 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% |
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| DYNEX SmartPLEX MMRV IgG Assay Kit | Revision 3 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| VOLUME 5 - 510(k) SUMMARY | Page 15 of 21 | ||||||||||||
| ModeratePositive | 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% |
D. Method Comparison Testing
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 method comparison testing was performed at two US laboratory testing sites using a total of 2512 retrospective human serum specimens obtained from commercial vendors (Table 9).
| Table 9: Category of Specimens Tested in the Study | |
|---|---|
| ---------------------------------------------------- | -- |
| Category | Specimennumber | Total (%) |
|---|---|---|
| Overall Human Serum Specimens Obtained from all CommercialVendors | 2512 | 100.0% |
| Overall Human Serum Specimens Obtained from CommercialVendors from Pediatrics Normal | 336 | 13.4% |
| Overall Human Serum Specimens Obtained from CommercialVendors from MMRV Adults | 1676 | 66.7% |
| Overall Human Serum Specimens Obtained from CommercialVendors from Pregnant Women | 500 | 19.9% |
To demonstrate the clinical performance of the DYNEX SmartPLEX MMRV IgG Assay Kit, Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
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between the results of the DYNEX SmartPLEX MMRV IqG Assay Kit and an FDAcleared comparator tests were calculated.
At the end of the study, specimens with reported Equivocal results on the test device (DYNEX SmartPLEX MMRV IgG Assay Kit) and comparator device were identified and retested in accordance with their Instructions for Use (IFUs). If the Equivocal Specimens remain Equivocal on the comparator device, they were retested with two additional FDA cleared methods. Specimen results from all 3 comparator devices were interpreted by a "2/3 rule" in which a comparator algorithm was used to obtain a consensus. The results from the comparator algorithm were then compared to the SmartPLEX MMRV IgG Assay results using a 3 by 3 analysis approach in which any remaining equivocal results were counted against the clinical performance of the SmartPLEX MMRV IgG Assay. The 3 by 3 analysis approach was used to calculate the Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) for the SmartPLEX MMRV IgG Assay Kit and the "Final Comparator Result".
| Measure | AdultFemales(N=910) | AdultMales(N=766) | All Adults(N=1676) | PediatricFemales(N=134) | PediatricMales(N=202) | AllPediatrics(N=336) | PregnantWomen(N=500) | All Subjects(N=2512) |
|---|---|---|---|---|---|---|---|---|
| Age (years) | ≥ 22 | ≥ 22 | ≥ 22 | ≥1 and≤ 21 | ≥1 and≤ 21 | ≥1 and≤ 21 | ≥ 16 | 1-88 |
| N | 910 | 766 | 1676 | 134 | 202 | 336 | 500 | 2512 |
| Mean | 36.4 | 42.2 | 39.1 | 15 | 13.6 | 14.1 | 32.3 | 34.4 |
| StandardDeviation(SD) | 11.0 | 14.9 | 13.3 | 5.4 | 5.7 | 5.6 | 6.2 | 14.1 |
| Median | 34.0 | 39.0 | 35.0 | 16.5 | 15.0 | 14.1 | 32.0 | 32.0 |
| Min | 22.0 | 22.0 | 22.0 | 1.0 | 0.0 | 1.0 | 16.0 | 1.0 |
| Max | 84.0 | 88.0 | 88.0 | 21.0 | 21.0 | 21 | 47.0 | 88.0 |
Table 10: Demographic information per Cohort
Performance results are shown in the tables below.
Table 11A: Clinical Performance per Cohort - Measles IgG
| Cohort | Measles IgG | Final comparator results | Percentage Agreement | |||||
|---|---|---|---|---|---|---|---|---|
| Positive | Equivocal | Negative | Total | PPA(95% CI) | NPA(95% CI) | |||
| Pediatrics | SmartPLEXMMRV | Positive | 250 | 0 | 0 | 250 | 87.70% | 100% |
| Equivocal | 12 | 0 | 0 | 12 | 250/285 | 51/51 |
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Image /page/19/Picture/0 description: The image shows the logo for Dynex Technologies. The logo features a blue circular icon with a white "D" inside, followed by the word "DYNEX" in blue, with a registered trademark symbol. Below "DYNEX" is the word "TECHNOLOGIES" in gray, with a thin gray line above it. A blue curved line extends from the left side of the circular icon, arching over the text and ending on the right side of the logo.
VOLUME 5 - 510(k) SUMMARY
Revision 3
Page 17 of 21
| Negative | 18 | 5 | 51 | 74 | (83.4 - 91.0%) | (93.0 - 100%) | ||
|---|---|---|---|---|---|---|---|---|
| Total | 280 | 5 | 51 | 336 | ||||
| Positive | Equivocal | Negative | Total | PPA(95% CI) | NPA(95% CI) | |||
| Positive | 387 | 0 | 0 | 387 | 84.30% | 100% | ||
| Pregnant women | SmartPLEXMMRV | Equivocal | 34 | 0 | 0 | 34 | 387/459 | 41/41 |
| Negative | 31 | 7 | 41 | 79 | (80.7 -87.4%) | (91.4 - 100%) | ||
| Total | 452 | 7 | 41 | 500 | ||||
| Positive | Equivocal | Negative | Total | PPA(95% CI) | NPA(95% CI) | |||
| Positive | 1545 | 0 | 1 | 1546 | 87.00% | 98.70% | ||
| Pediatric andAdult | SmartPLEXMMRV | Equivocal | 70 | 0 | 2 | 72 | 1545/1775 | 234/237 |
| Negative | 137 | 23 | 234 | 394 | (85.4 -88.5%) | (96.3 -99.6%) | ||
| Total | 1752 | 23 | 237 | 2012 |
Table 11B: Clinical Performance per Cohort - Mumps IgG
| Cohort | Mumps IgG | Final comparator results | Percentage Agreement | ||||
|---|---|---|---|---|---|---|---|
| Positive | Equivocal | Negative | Total | PPA(95% CI) | NPA (95% CI) | ||
| Pediatrics | SmartPLEXMMRV | 270 | 0 | 6 | 276 | 94.40% | 76.00% |
| 5 | 0 | 6 | 11 | 270/286 | 38/50 | ||
| 8 | 3 | 38 | 49 | (91.1 -96.5%) | (62.6 - 85.7%) | ||
| Total | 283 | 3 | 50 | 336 | |||
| Pregnantwomen | SmartPLEXMMRV | 463 | 0 | 2 | 465 | 96.90% | 90.90% |
| 5 | 0 | 0 | 5 | 463/478 | 20/22 | ||
| 5 | 5 | 20 | 30 | (94.9 -98.1%) | (72.2 - 97.5%) | ||
| Total | 473 | 5 | 22 | 500 | |||
| Pediatricand Adult | SmartPLEXMMRV | 1672 | 2 | 22 | 1696 | 94.70% | 78.90% |
| 32 | 1 | 28 | 61 | 1672/1765 | 194/246 | ||
| 47 | 14 | 194 | 255 | (93.6 -95.7%) | (73.3 - 83.5%) | ||
| Total | 1751 | 17 | 244 | 2012 |
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Image /page/20/Picture/0 description: The image is a logo for Dynex Technologies. The logo features a blue circle with a white "D" inside, followed by the word "DYNEX" in blue, and the word "TECHNOLOGIES" in gray below it. A blue swoosh arcs over the logo.
Page 18 of 21
Table 11C: Clinical Performance per Cohort – Rubella IgG
| Cohort | Rubella IgG | Final comparator results | Percentage Agreement | ||||
|---|---|---|---|---|---|---|---|
| Positive | Equivocal | Negative | Total | PPA (95% CI) | NPA (95% CI) | ||
| Pediatrics | Positive | 278 | 0 | 0 | 278 | 92.70% | 100% |
| Equivocal | 14 | 0 | 0 | 14 | 278/300 | 36/36 | |
| SmartPLEX MMRV | Negative | 8 | 0 | 36 | 44 | (89.1 - 95.1%) | |
| Total | 300 | 0 | 36 | 336 | |||
| Pregnant women | Positive | 449 | 0 | 0 | 449 | 92.00% | 100% |
| Equivocal | 15 | 0 | 0 | 15 | 449/488 | 12/12 | |
| SmartPLEX MMRV | Negative | 24 | 0 | 12 | 36 | (89.3 - 94.1%) | |
| Total | 488 | 0 | 12 | 500 | |||
| Pediatric and Adult | Positive | 1656 | 0 | 1 | 1657 | 92.40% | 99.50% |
| Equivocal | 61 | 0 | 0 | 61 | 1656/1793 | 218/219 | |
| SmartPLEX MMRV | Negative | 71 | 5 | 218 | 294 | (91.0 - 93.5%) | |
| Total | 1788 | 5 | 219 | 2012 |
Table 11D: Clinical Performance per Cohort - VZV IgG
| Cohort | VZV IgG | Final comparator results | Percentage Agreement | ||||
|---|---|---|---|---|---|---|---|
| Positive | Equivocal | Negative | Total | PPA (95% CI) | NPA (95% CI) | ||
| Pediatrics | Positive | 215 | 0 | 2 | 217 | 91.50% | 93.90% |
| Equivocal | 11 | 3 | 4 | 18 | 215/235 | 92/98 | |
| Negative | 4 | 5 | 92 | 101 | (87.2 –94.4%) | (87.3 –97.2%) | |
| Total | 230 | 8 | 98 | 336 | |||
| Pregnantwomen | Positive | 453 | 2 | 1 | 456 | 97.20% | 84.80% |
| Equivocal | 6 | 1 | 2 | 9 | 453/466 | 28/33 | |
| Negative | 5 | 2 | 28 | 35 | (95.3 –98.4%) | (69.1 –93.3%) | |
| Total | 464 | 5 | 31 | 500 |
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| VOLUME 5 - 510(k) SUMMARY | Page 19 of 21 | |||||||
|---|---|---|---|---|---|---|---|---|
| Positive | Equivocal | Negative | Total | PPA(95% CI) | NPA(95% CI) | |||
| Pediatricand Adult | SmartPLEXMMRV | Positive | 1667 | 8 | 11 | 1686 | 96.70% | 88.00% |
| Equivocal | 27 | 13 | 14 | 54 | 1667/1723 | 243/276 | ||
| Negative | 17 | 12 | 243 | 272 | (95.8 –97.5%) | (83.7 -91.4%) | ||
| Total | 1711 | 33 | 268 | 2012 |
Revision 3
E. 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. This study was performed to determine whether IgG antibodies in serum specimens from patients with known infectious diseases interfere with the reported results of the DYNEX SmartPLEX MMRV IgG Assay Kit generating false positive results. Serum specimens that were IgG antibody positive for the infectious disease agents shown in Table 12 were used for the study. These specimens were obtained from vendors and confirmed neqative with the predicate MMRV assays prior to testing with the DYNEX SmartPLEX MMRV IgG Assay Kit. All potential cross-reactants samples were tested in duplicate, with the DYNEX SmartPLEX MMRV IgG Assay. The results were compared to the results obtained from the predicate test (summarized in the table below). All specimens evaluated were negative with both assays, except one specimen for HSV 2. The HSV 2 sample had an Equivocal result for Mumps with the DYNEX SmartPLEX MMRV IgG Assay Kit while had a high negative result with the Trinity predicate assay.
The DYNEX SmartPLEX MMRV IgG Assay Kit cross reactivity study was not evaluated sufficiently for Hepatitis C Virus (HCV), Hepatitis B Surface Antigen (HBsAg), Herpes Simplex Virus 1 (HSV1), Herpes Simplex Virus 2 (HSV2), Toxoplasma gondii due to the lack of samples availability of samples that are positive for the disease states but negative for each of the measurands.
| Measles IgG | Mumps IgG | Rubella IgG | VZV IgG | |||||
|---|---|---|---|---|---|---|---|---|
| Specimen Type | N | NegativeAgreement | N | NegativeAgreement | N | NegativeAgreement | N | NegativeAgreement |
| Antinuclear antibodies (ANA) | 5 | 5/5 | 5 | 5/5 | 5 | 5/5 | 5 | 5/5 |
| Anti-Cytomegalovirus (CMV) | 6 | 6/6 | 5 | 5/5 | 5 | 5/5 | 8 | 8/8 |
| Anti-Epstein-Barr Viral CapsidAntigen (EBV) | 10 | 10/10 | 11 | 11/11 | 8 | 8/8 | 6 | 6/6 |
Table 12: Potential Cross-Reactivity
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Revision 3
Image /page/22/Picture/2 description: The image is a logo for Dynex Technologies. The logo features a blue and silver circular icon with a stylized "D" inside. To the right of the icon is the word "DYNEX" in blue, with the word "TECHNOLOGIES" in a smaller font size underneath. A blue swoosh extends from the icon over the text.
VOLUME 5 - 510(k) SUMMARY
Page 20 of 21
| Anti-HBs, [Hepatitis B Surface Antigen (HbsAg)] | 5 | 5/5 | 0 | - | 1 | 1/1 | 0 | - |
|---|---|---|---|---|---|---|---|---|
| Anti-Hepatitis C (HCV) | 7 | 7/7 | 2** | 2/2 | 4** | 4/4 | 1** | 1/1 |
| Anti-Herpes Simplex Virus 1 (HSV 1) | 3** | 3/3 | 1** | 1/1 | 3** | 3/3 | 3** | 3/3 |
| Anti-Herpes Simplex 2 (HSV 2) | 1** | 1/1 | 3** | 2/3* | 2** | 2/2 | 3** | 3/3 |
| Anti-Parvovirus B19 | 2** | 2/2 | 1** | 1/1 | 0 | - | 1** | 1/1 |
| Anti-Toxoplasma gondii | 2** | 2/2 | 0 | - | 1** | 1/1 | 2** | 2/2 |
| Anti-Myeloma M-protein | 7 | 7/7 | 10 | 10/10 | 7 | 7/7 | 6 | 6/6 |
| Anti-Mumps, anti-Rubella, and anti-VZV‡ | 7 | 7/7 | - | N/A | - | N/A | - | N/A |
| Anti-Measles, anti-Rubella, and anti-VZV‡ | - | N/A | 6 | 6/6 | - | N/A | - | N/A |
| Anti-Measles, anti-Mumps, and anti-VZV‡ | - | N/A | - | N/A | 18 | 18/18 | - | N/A |
| Anti-Measles, anti-Rubella, and anti-Rubellat | - | N/A | - | N/A | N/A | - | 14 | 14/14 |
Note: * One HSV 2 sample had an Equivocal result for Mumps with the DYNEX SmartPLEX MMRV IgG Assay Kit while had a high negative result with the Trinity predicate assay.
** Potential cross-reactivity was not well assessed due to limited sample size.
‡ Three measurands were evaluated together for potential cross reactivity.
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Image /page/23/Picture/2 description: The image shows the logo for Dynex Technologies. The logo features a blue circle with a white "D" inside, followed by the word "DYNEX" in blue, and the word "TECHNOLOGIES" in gray underneath. A blue swoosh arcs over the logo.
F. Interfering Substances
The DYNEX SmartPLEX MMRV IgG Assay Kit was evaluated for potential interference of endogenous substances using neqative, low positive, and high positive serum samples for Measles, Mumps, Rubella, and VZV antibodies spiked with potential interfering substances. A non-spiked sample was used as a control for each measurand. No interference was observed at the maximum concentrations listed in Table 13.
| Interfering Substance | Concentration |
|---|---|
| Albumin | 50 g/dL |
| Bilirubin (conjugated) | 5 mg/dL |
| Bilirubin (unconjugated) | 40 mg/dL |
| Cholesterol total | 250 mg/dL |
| Hemoglobin | 500 mg/dL |
| Triglyceride total | 500 mg/dL |
G. Shelf Life
The shelf-life stability of the DYNEX SmartPLEX MMRV IgG Assay Kit was evaluated for storage at 2-8°C for up to 25 months. Unopened test kits were stored and tested at one month intervals using human specimens. The results demonstrated that unopened SmartPLEX MMRV IgG Assay Kit is stable at 2-8°C for up to 19 months. The self-life storage of the unopened DYNEX SmartPLEX MMRV IgG Assay Kit is assigned as 18 months at the recommended storage temperature of 2-8°C.
10. CONCLUSION:
The performance data as documented above demonstrates that the DYNEX SmartPLEX MMRV IgG Assay Kit performs comparably to the predicate device that is currently marketed for the same intended use.
§ 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.