(759 days)
No
The description details standard immunoassay technology and image analysis for calculating index values, without mentioning AI or ML algorithms for interpretation or decision making.
No
This device is an immunoassay kit designed for the qualitative detection of IgG antibodies, functioning as a diagnostic tool rather than a therapeutic one.
Yes
The device is described as an "aid in the determination of serological status," which indicates its role in diagnosing a patient's immune status concerning certain viruses.
No
The device is an assay kit that requires a specific hardware analyzer (DYNEX Multiplier Analyzer) to process samples and generate data. While software is used to analyze the data, it is an integral part of a larger hardware/reagent system, not a standalone software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of IgG antibodies to Measles, Mumps, Rubella, and Varicella-Zoster Virus (VZV) in human serum." This involves testing a sample taken from the human body (serum) to gain information about a person's health status (presence of antibodies).
- Purpose: It's intended to be used as an "aid in the determination of serological status," which directly relates to diagnosing or assessing a medical condition (immunity to MMRV).
- Device Description: The description details a laboratory-based assay using a microtiter plate and an analyzer to perform a chemical reaction on a human sample. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The document describes performance studies conducted to evaluate the device's accuracy and reliability in detecting these antibodies in human serum samples.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
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.
Product codes
OPL
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.
Mentions image processing
The Multiplier software analyzes the image and generates a report that details the mean RLU signal for each target bead (MMRV) by test sample.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults and pediatrics age above 1 year
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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).
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).
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 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 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.
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.
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).
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 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.
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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See Tables 11A-D. Example:
Table 11A: Clinical Performance per Cohort - Measles IgG
Pediatrics PPA (95% CI) 87.70% (83.4 - 91.0%), NPA (95% CI) 100% (93.0 - 100%)
Pregnant women PPA (95% CI) 84.30% (80.7 - 87.4%), NPA (95% CI) 100% (91.4 - 100%)
Pediatric and Adult PPA (95% CI) 87.00% (85.4 - 88.5%), NPA (95% CI) 98.70% (96.3 - 99.6%)
Table 11B: Clinical Performance per Cohort - Mumps IgG
Pediatrics PPA(95% CI) 94.40% (91.1 - 96.5%), NPA (95% CI) 76.00% (62.6 - 85.7%)
Pregnant women PPA(95% CI) 96.90% (94.9 - 98.1%), NPA (95% CI) 90.90% (72.2 - 97.5%)
Pediatric and Adult PPA(95% CI) 94.70% (93.6 - 95.7%), NPA (95% CI) 78.90% (73.3 - 83.5%)
Table 11C: Clinical Performance per Cohort – Rubella IgG
Pediatrics PPA (95% CI) 92.70%, NPA (95% CI) 100%
Pregnant women PPA (95% CI) 92.00%, NPA (95% CI) 100%
Pediatric and Adult PPA (95% CI) 92.40% (91.0 - 93.5%), NPA (95% CI) 99.50%
Table 11D: Clinical Performance per Cohort - VZV IgG
Pediatrics PPA (95% CI) 91.50% (87.2 – 94.4%), NPA (95% CI) 93.90% (87.3 – 97.2%)
Pregnant women PPA (95% CI) 97.20% (95.3 – 98.4%), NPA (95% CI) 84.80% (69.1 – 93.3%)
Pediatric and Adult PPA (95% CI) 96.70% (95.8 – 97.5%), NPA (95% CI) 88.00% (83.7 - 91.4%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3510 Rubella virus serological reagents.
(a)
Identification. Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).(b)
Classification. Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards':
(i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,”
(ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,”
(iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,”
(iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and
(v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,”
(2) Centers for Disease Control's:
(i) Low Titer Rubella Standard,
(ii) Reference Panel of Well Characterized Rubella Sera, and
(3) World Health Organization's International Rubella Standard.
0
Date: September 29, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features an abstract image of a human figure. To the right of this is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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.
Image /page/1/Picture/5 description: The image shows the name "Ryan C. Karsner -S" in a large, sans-serif font. The text is black and appears against a white background. The letters are bold and clearly legible. The background has a faint, light blue design.
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
2
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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3
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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, Rubella
virus, 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 |
4
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 0.9 -