(98 days)
Not Found
No
The document describes a standard real-time PCR assay for detecting VZV DNA. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The analysis relies on established molecular biology techniques and statistical analysis of performance data.
No
Explanation: The device is an in vitro diagnostic (IVD) test intended for the qualitative detection of VZV DNA. It aids in diagnosis but does not directly treat or alleviate a disease, nor does it restore, modify, or correct body function.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "This test is intended as an aid in the diagnosis of VZV infections of the central nervous system (CNS)." This directly indicates its role in diagnosis.
No
The device description explicitly states that the system consists of the Simplexa™ VZV Direct assay, the LIAISON® MDX (with LIAISON® MDX Studio Software), the Direct Amplification Disc and associated accessories. This includes hardware components (LIAISON® MDX instrument, Direct Amplification Disc, accessories) in addition to the software (LIAISON® MDX Studio Software).
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 varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF)" and is intended as an "aid in the diagnosis of VZV infections of the central nervous system (CNS)." This clearly indicates it's used to test samples taken from the human body to provide information for diagnosis.
- Device Description: The description details a "real-time polymerase chain reaction (PCR) system" that amplifies and detects VZV DNA from "unprocessed cerebral spinal fluid (CSF) specimens." This describes a laboratory test performed on a biological sample.
- Professional Use Only: The statement "The assay is for professional use only" is typical for IVD devices, indicating it's used by trained healthcare professionals in a laboratory or clinical setting.
- Performance Studies: The document includes detailed performance studies (Clinical Agreement, Reproducibility, Analytical Sensitivity, etc.) which are standard requirements for demonstrating the analytical and clinical validity of an IVD.
- Predicate Device: The mention of a "Predicate Device(s)" (K160462; BioFire® FilmArray® Meningitis/Encephalitis (ME) Panel) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DiaSorin Molecular Simplexa™ VZV Direct assay is intended for use on the LIAISON® MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients with signs and/or symptoms of meningitis and/or encephalitis. This test is intended as an aid in the diagnosis of VZV infections of the central nervous system (CNS).
Negative results do not preclude VZV infection and should not be used as the sole basis for treatment or other patient management decisions.
The assay is not intended for use as a donor screening test. The assay is for professional use only.
The Simplexa™ VZV Positive Control Pack is intended to be used as a control with the Simplexa™ VZV Direct kit.
This control is not intended for use with other assays or systems.
Product codes (comma separated list FDA assigned to the subject device)
PLO, OOI
Device Description
The Simplexa™ VZV Direct assay is a real-time polymerase chain reaction (PCR) system that enables the direct amplification and detection of VZV DNA from unprocessed cerebral spinal fluid (CSF) specimens without nucleic acid extraction. The system consists of the Simplexa™ VZV Direct assay, the LIAISON® MDX (with LIAISON® MDX Studio Software), the Direct Amplification Disc and associated accessories. In the Simplexa™ VZV Direct assay, fluorescent probes are used together with corresponding forward and reverse primers to amplify VZV and internal control targets. A well-conserved region of the VZV DNA polymerase gene is targeted to identify VZV DNA in the specimen. An internal control is used to detect PCR failure and/or inhibition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Central nervous system (CNS)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use only.
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 total of six hundred thirty-seven (637) clinical samples, meeting inclusion criteria were obtained from prospective and prospectively banked collections from eight (8) collection sites from February 2018 to November 2018. The study was conducted using remnant cerebrospinal fluid (CSF) samples from human patients suspected of VZV infection of the central nervous system (CNS).
Due to the low prevalence of VZV infection in CSF samples, two hundred forty (240) contrived samples were included to supplement the number of positive samples were contrived across the clinical range of the Simplexa™ VZV Direct assay and thirty percent (30%) of the samples were contrived at approximately 2X LoD. The samples were stored at 2-8 °C for up to seven (7) days post collection and at 95% of the time.
For strain 9939, LoD was 2.03 TCID50/mL or 1,614 copies/mL.
For strain Ellen, LoD was 0.001 TCID50/mL or 1,505 copies/mL.
Analytical Reactivity/Cross Reactivity:
The analytical reactivity of the Simplexa™ VZV Direct assay was evaluated using different strains of VZV that were not used in the determination of the limit of detection (LoD) for the assay. Quantified viral material was spiked into negative CSF using a single dilution and assayed in triplicate. The Simplexa™ VZV Direct assay was able to detect other strains of VZV at 2X LoD. In addition, in silico BLAST analysis indicated that the assay should detect at least one hundred seventy-eight (178) additional VZV strains.
For VZV Strain 82, 3/3 detected.
For VZV Strain 275, 3/3 detected.
For VZV Strain 1700, 3/3 detected.
For VZV Isolate A, 3/3 detected.
For VZV Isolate B, 3/3 detected.
The Simplexa™ VZV Direct assay's analytical specificity was evaluated by testing the ability of the assay to exclusively identify VZV virus with no cross-reactivity to organisms that are closely related, or cause similar clinical symptoms or may be present in CSF. One hundred and fifty-nine (159) microorganisms were spiked into negative CSF and assayed in triplicate. Some organisms with low concentrations (
§ 866.3970 Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.
(a)
Identification. A device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid is a qualitative in vitro device intended for the detection and identification of microbial-associated nucleic acid sequences from patients suspected of meningitis or encephalitis. A device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid is intended to aid in the diagnosis of meningitis or encephalitis when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation, including the device components, ancillary reagents required but not provided, and a detailed explanation of the methodology, including primer/probe sequence, design, and rationale for sequence selection.
(2) Premarket notification submissions must include detailed documentation from the following analytical studies: Analytical sensitivity (limit of detection), inclusivity, reproducibility, interference, cross reactivity, and specimen stability.
(3) Premarket notification submissions must include detailed documentation from a clinical study. The study, performed on a study population consistent with the intended use population, must compare the device performance to results obtained from well-accepted comparator methods.
(4) Premarket notification submissions must include detailed documentation for device software, including, but not limited to, software applications and hardware-based devices that incorporate software.
(5) The Intended Use statement in the device labeling must include a statement that the device is intended to be used in conjunction with standard of care culture.
(6) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling.
(7) The device labeling must include a limitation stating that the negative results do not preclude the possibility of central nervous system infection.
(8) The device labeling must include a limitation stating that device results are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions.
(9) The device labeling must include a limitation stating that positive results do not mean that the organism detected is infectious or is the causative agent for clinical symptoms.
(10) As part of the risk management activities performed as part of your 21 CFR 820.30 design controls, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 13, 2019
DiaSorin Molecular LLC Sharon Young Principal Regulatory Affairs Specialist 11331 Valley View Street Cypress, California 90630
Re: K190219
Trade/Device Name: Simplexa VZV Direct, Simplexa VZV Positive Control Pack Regulation Number: 21 CFR 866.3970 Regulation Name: Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid Regulatory Class: Class II Product Code: PLO Dated: January 30, 2019 Received: February 4, 2019
Dear Sharon Young:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours.
for
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190219
Device Name
Simplexa VZV Direct, Simplexa VZV Positive Control Pack
Indications for Use (Describe)
The DiaSorin Molecular Simplexa™ VZV Direct assay is intended for use on the LIAISON® MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients signs and/or symptoms of meningitis and/or encephalitis. This test is intended as an aid in the diagnosis of VZV infections of the central nervous system (CNS).
Negative results do not preclude VZV infection and should not be used as the sole basis for treatment or other patient management decisions.
The assay is not intended for use as a donor screening test. The assay is for professional use only.
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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510(k) Summary
Simplexa™ VZV Direct Catalog No. MOL3650 Simplexa™ VZV Positive Control Pack Catalog No. MOL3660 May 3, 2019 Page 1 of 25
| Applicant | DiaSorin Molecular LLC.
11331 Valley View Street
Cypress, California 90630
USA |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration No. | 2023365 |
| Contact Person | Sharon Young
Principal Regulatory Affairs Specialist
tel 562.240.6680
fax 562.240.6529
Sharon.Young@DiaSorin.com |
| Summary Date | May 3, 2019 |
| Proprietary Name | Simplexa™ VZV Direct and Simplexa™ VZV Positive Control Pack |
| US Product Codes/Names and
Regulation Numbers | PLO / Device to detect and identify microbial pathogen nucleic acids
in cerebrospinal fluid / 21 CFR 866.3970
OOI / Real Time Nucleic Acid Amplification System / 21 CFR 862.2570 |
| Classification | Class II |
Intended Use
Simplexa™ VZV Direct REF MOL3650
The DiaSorin Molecular Simplexa™ VZV Direct assay is intended for use on the LIAISON® MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients with signs and/or symptoms of meningitis and/or encephalitis. This test is intended as an aid in the diagnosis of VZV infections of the central nervous system (CNS).
Neqative results do not prection and should not be used as the sole basis for treatment or other patient management decisions.
The assay is not intended for use as a donor screening test. The assay is for professional use only.
Simplexa™ VZV Positive Control Pack REF MOL3660
The Simplexa™ VZV Positive Control Pack is intended to be used as a control with the Simplexa™ VZV Direct kit.
This control is not intended for use with other assays or systems.
Device Description
The Simplexa™ VZV Direct assay is a real-time polymerase chain reaction (PCR) system that enables the direct amplification and detection of VZV DNA from unprocessed cerebral spinal fluid (CSF) specimens without nucleic acid extraction. The system consists of the Simplexa™ VZV Direct assay, the LIAISON® MDX (with LIAISON® MDX Studio Software), the Direct Amplification Disc and associated accessories. In the Simplexa™ VZV Direct assay, fluorescent probes are used together with corresponding forward and reverse primers to amplify VZV and internal control targets. A well-conserved region of the VZV DNA polymerase gene is targeted to identify VZV DNA in the specimen. An internal control is used to detect PCR failure and/or inhibition.
4
Image /page/4/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo consists of a stylized DNA double helix on the left, colored in a gradient from green to blue. To the right of the helix are the words "DiaSorin" in a dark blue, sans-serif font, with the word "Molecular" underneath in a lighter green color. The logo is clean and modern, suggesting a focus on molecular diagnostics or related fields.
510(k) Summary
Simplexa™ VZV Direct Catalog No. MOL3650 Simplexa™ VZV Positive Control Pack Catalog No. MOL3660 May 3, 2019 Page 2 of 25
Simplexa™ VZV Direct REF MOL3650
| Component Name | REF | EC
SYMBOL
ON
LABEL | | Abbreviated
Name | Cap
Color | Number
of Vials | Reactions
per
Vial/Kit | Volume
per Vial |
|--------------------------------------|---------|-----------------------------|---|---------------------|--------------|--------------------|------------------------------|--------------------|
| Simplexa™ VZV
Direct Reaction Mix | MOL3651 | REAG | C | RM | Purple | 24 | 1/24 | 50 μL |
Simplexa™ VZV Direct Components and Descriptions
| Kit Component | Contents | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Simplexa™ VZV Direct Reaction Mix (RM) | DNA polymerase, buffer, dNTPs, template DNA (Internal Control), dye-labeled fluorescent probes and primers specific for detection of VZV and for the DNA Internal Control. |
Target Probe Fluorophore (Dye) Excitation (nm) Emission (nm) Targeted Gene VZV FAM 495 520 VZV DNA polymerase Internal Control DNA Q670 644 670 DNA (IC) | | | | | | | | | | | | | | | |
| Simplexa™ VZV Direct Kit Barcode Card | Assay specific parameters and lot information. | | | | | | | | | | | | | | | |
Simplexa™ VZV Positive Control Pack REF MOL3660 Component and Description
| Component Name | REF | Description | Cap
Color | Number
of Vials | Reactions
per
Vial/Kit | Volume
per Vial |
|------------------------------------------|---------|------------------------------------------|--------------|--------------------|------------------------------|--------------------|
| Simplexa™ VZV Direct
Positive Control | MOL3661 | Inactivated
varicella zoster
virus | Red | 10 | 1/10 | 50 μL |
Materials Supplied Separately
Direct Amplification Disc Kit (REF MOL1455) Direct Amplification Discs for use on the LIAISON® MDX
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510(k) Summary
Simplexa™ VZV Direct Catalog No. MOL3650 Simplexa™ VZV Positive Control Pack Catalog No. MOL3660 May 3, 2019 Page 3 of 25
| Comparison to Predicate Device | ||
|---|---|---|
| Comparison to | ||
| Predicate Device | Predicate Device: | |
| BioFire® FilmArray® | ||
| Meningitis/Encephalitis (ME) Panel | ||
| K160462 | Candidate Device: | |
| Simplexa™ VZV Direct and Simplexa™ | ||
| VZV Positive Control Pack | ||
| Product Code | PLO | Same |
| Regulation | ||
| Number | 21 CFR 866.3970 – Device to detect | |
| and identify microbial pathogen nucleic | ||
| acids in cerebrospinal fluid. | Same | |
| Organism | ||
| Detected | varicella zoster virus | Same |
| Measurand | DNA from varicella zoster virus | Same |
| Intended Use | The FilmArray Meningitis/Encephalitis | |
| (ME) Panel is a qualitative multiplexed | ||
| nucleic acid-based in vitro diagnostic | ||
| test intended for use with FilmArray | ||
| and FilmArray 2.0 systems. The | ||
| FilmArray ME Panel is capable of | ||
| simultaneous detection and | ||
| identification of multiple bacterial, viral, | ||
| and yeast nucleic acids directly from | ||
| cerebrospinal fluid (CSF) specimens | ||
| obtained via lumbar puncture from | ||
| individuals with signs and/or symptoms | ||
| of meningitis and/or encephalitis. The | ||
| following organisms are identified using | ||
| the FilmArray ME Panel: Bacteria: | ||
| Escherichia coli K1 Haemophilus | ||
| influenzae Listeria monocytogenes | ||
| Neisseria meningitidis (encapsulated) | ||
| Streptococcus agalactiae | ||
| Streptococcus pneumoniae Viruses: | ||
| Cytomegalovirus Enterovirus Herpes | ||
| simplex virus 1 Herpes simplex virus 2 | ||
| Human herpesvirus 6 Human | ||
| parechovirus Varicella zoster virus | ||
| Yeast: Cryptococcus neoformans/gattii | ||
| The FilmArray ME Panel is indicated as | ||
| an aid in the diagnosis of specific | ||
| agents of meningitis and/or | ||
| encephalitis and results are meant to | ||
| be used in conjunction with other | ||
| clinical, epidemiological, and laboratory | ||
| data. Results from the FilmArray ME | ||
| Panel are not intended to be used as | ||
| the sole basis for diagnosis, treatment, | Simplexa™ VZV Direct REF MOL3650 | |
| The DiaSorin Molecular Simplexa™ VZV | ||
| Direct assay is intended for use on the | ||
| LIAISON® MDX instrument for the | ||
| qualitative detection of varicella-zoster | ||
| virus (VZV) DNA in cerebrospinal fluid | ||
| (CSF) from patients with signs and/or | ||
| symptoms of meningitis and/or | ||
| encephalitis. This test is intended as an | ||
| aid in the diagnosis of VZV infections of | ||
| the central nervous system (CNS). | ||
| Negative results do not preclude VZV | ||
| infection and should not be used as the | ||
| sole basis for treatment or other patient | ||
| management decisions. | ||
| The assay is not intended for use as a | ||
| donor screening test. The assay is for | ||
| professional use only. | ||
| Simplexa™ VZV Positive Control Pack | ||
| REF MOL3660 | ||
| The Simplexa™ VZV Positive Control | ||
| Pack is intended to be used as a control | ||
| with the Simplexa™ VZV Direct kit. | ||
| This control is not intended for use with | ||
| other assays or systems. | ||
| Comparison to | ||
| Predicate Device | Predicate Device: | |
| BioFire® FilmArray® | ||
| Meningitis/Encephalitis (ME) Panel | ||
| K160462 | Candidate Device: | |
| Simplexa™ VZV Direct and Simplexa™ | ||
| VZV Positive Control Pack | ||
| decisions. Positive results do not rule | ||
| out co-infection with organisms not | ||
| included in the FilmArray ME Panel. | ||
| The agent detected may not be the | ||
| definite cause of the disease. Negative | ||
| results do not preclude central nervous | ||
| system (CNS) infection. Not all agents | ||
| of CNS infection are detected by this | ||
| test and sensitivity in clinical use may | ||
| differ from that described in the | ||
| package insert. The FilmArray ME | ||
| Panel is not intended for testing of | ||
| specimens collected from indwelling | ||
| CNS medical devices. The FilmArray | ||
| ME Panel is intended to be used in | ||
| conjunction with standard of care | ||
| culture for organism recovery, | ||
| serotyping, and antimicrobial | ||
| susceptibility testing. | ||
| Automated | ||
| System (Sample | ||
| to Answer) | Yes | Yes |
| Instrumentation | FilmArray or FilmArray 2.0 system | LIAISON® MDX |
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Image /page/6/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo consists of a stylized DNA double helix in green and blue on the left, with the words "DiaSorin" in blue on the top right and "Molecular" in green below it. The logo is clean and modern, with a focus on the company's expertise in molecular diagnostics.
510(k) Summary
Simplexa™ VZV Direct Catalog No. MOL3650 Simplexa™ VZV Positive Control Pack Catalog No. MOL3660 May 3, 2019 Page 4 of 25
CLINICAL AGREEMENT
A total of six hundred thirty-seven (637) clinical samples, meeting inclusion criteria were obtained from prospective and prospectively banked collections from eight (8) collection sites from February 2018 to November 2018. The study was conducted using remnant cerebrospinal fluid (CSF) samples from human patients suspected of VZV infection of the central nervous system (CNS).
Due to the low prevalence of VZV infection in CSF samples, two hundred forty (240) contrived samples were included to supplement the number of positive samples were contrived across the clinical range of the Simplexa™ VZV Direct assay and thirty percent (30%) of the samples were contrived at approximately 2X LoD. The samples were stored at 2-8 °C for up to seven (7) days post collection and at 95% of the time.
| Table 3. Simplexa™ VZV Direct Limit of Detection | ||||||
|---|---|---|---|---|---|---|
| -- | -------------------------------------------------- | -- | -- | -- | -- | -- |
| VZV strain | Concentration | |
|---|---|---|
| TCID50/mL | copies/mL | |
| 9939 | 2.03 TCID50/mL | 1,614 |
| Ellen | 0.001 TCID50/mL | 1,505 |
ANALYTICAL REACTIVITY/CROSS REACTIVITY
Analytical Reactivity
The analytical reactivity of the Simplexa™ VZV Direct assay was evaluated using different strains of VZV that were not used in the determination of the limit of detection (LoD) for the assay. Quantified viral material was spiked into negative CSF using a single dilution and assayed in triplicate. The Simplexa™ VZV Direct assay was able to detect other strains of VZV at 2X LoD. The results are presented in Table 4. In addition, in silico BLAST analysis indicated that the assay should detect at least one hundred seventy-eight (178) additional VZV strains.
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Image /page/9/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo features a stylized DNA double helix in shades of green and blue on the left. To the right of the DNA graphic are the words "DiaSorin" in a dark blue, sans-serif font, stacked above the word "Molecular" in a lighter green, sans-serif font.
510(k) Summary Simplexa™ VZV Direct Catalog No. MOL3650 Simplexa™ VZV Positive Control Pack Catalog No. MOL3660 May 3, 2019 Page 7 of 25
| VZV Strain | Agreement with
Expected Results
(#Detected/#Total) |
|-----------------|----------------------------------------------------------|
| VZV Strain 82 | 3/3 |
| VZV Strain 275 | 3/3 |
| VZV Strain 1700 | 3/3 |
| VZV Isolate A | 3/3 |
| VZV Isolate B | 3/3 |
Table 4. Simplexa™ VZV Direct Analytical Reactivity
Cross-Reactivity (Analytical Specificity)
The Simplexa™ VZV Direct assay's analytical specificity was evaluated by testing the ability of the assay to exclusively identify VZV virus with no cross-reactivity to organisms that are closely related, or cause similar clinical symptoms or may be present in CSF. One hundred and fifty-nine (159) microorganisms were spiked into negative CSF and assayed in triplicate. Some organisms with low concentrations (intermedius | 1 x 106 CFU/mL | 100.0% (3/3) |
| 149 | Ellen | Streptococcus mutans | 1 x 106 CFU/mL | 100.0% (3/3) |
| | 9939 | Streptococcus mutans | 1 x 106 CFU/mL | 100.0% (3/3) |
| 150 | NA | Streptococcus oralis ** | NA | NA |
| 151 | Ellen | Streptococcus pneumoniae | 1 x 106 CFU/mL | 100.0% (3/3) |
| | 9939 | Streptococcus pneumoniae | 1 x 106 CFU/mL | 100.0% (3/3) |
| 152 | NA | Streptococcus pseudopneumoniae ** | NA | NA |
| 153 | Ellen | Streptococcus pyogenes
Z018 | 1 x 106 CFU/mL | 100.0% (3/3) |
| | 9939 | Streptococcus pyogenes
Z018 | 1 x 106 CFU/mL | 100.0% (3/3) |
| 154 | Ellen | Streptococcus salivarius | 1 x 106 CFU/mL | 100.0% (3/3) |
| | 9939 | Streptococcus salivarius | 1 x 106 CFU/mL | 100.0% (3/3) |
| 155 | NA | Streptococcus sanguinis ** | NA | NA |
| 156 | Ellen | Toxoplasma gondii | 1 x 106 Tachyzoites/mL | 100.0% (3/3) |
| | 9939 | Toxoplasma gondii | 1 x 106 Tachyzoites/mL | 100.0% (3/3) |
| 157 | NA | Treponema pallidum ** | NA | NA |
| 158 | NA | Tropheryma whipplei ** | NA | NA |
| 159 | Ellen | West Nile virus | 1 x 105 TCID50/mL | 100.0% (3/3) |
| | 9939 | West Nile virus | 1 x 105 TCID50/mL | 100.0% (3/3) |
| 160 | Ellen | White blood cells
(Human genomic DNA) | 1 x 106 cells/mL | 100.0% (3/3) |
| | 9939 | White blood cells
(Human genomic DNA) | 1 x 106 cells/mL | 100.0% (3/3) |
Table 6. Simplexa™ VZV Direct Interference
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510(k) Summary
Simplexa™ VZV Direct Catalog No. MOL3650 Simplexa™ VZV Positive Control Pack Catalog No. MOL3660 May 3, 2019 Page 14 of 25
INHIBITION BY OTHER MICROORGANISMS
The Simplexa™ VZV Direct assay was evaluated by testing the ability to identify VZV virus when other potentially inhibitory organisms are present. The panel of one hundred and sixty (160) potentially inhibitory organisms was individually spiked into a pool with a low concentration at approximately 2 times LoD (based on ≥ 95% detection rate) in CSF. No inhibition by other organisms was observed for VZV at the concentrations indicated in Table 7.
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Image /page/17/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo features a stylized DNA helix in shades of green and blue on the left. To the right of the helix are the words "DiaSorin" in dark blue, with "Molecular" underneath in green. The logo is clean and modern, suggesting a company focused on molecular diagnostics or biotechnology.
510(k) Summary
Simplexa™ VZV Direct Catalog No. MOL3650 Simplexa™ VZV Positive Control Pack Catalog No. MOL3660 May 3, 2019 Page 15 of 25
Table 7. Simplexa™ VZV Direct Interference
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510(k) Summary
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Image /page/19/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo consists of a DNA helix graphic on the left, with the text "DiaSorin" in blue to the right of the helix. Below "DiaSorin" is the word "Molecular" in green.
510(k) Summary
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Image /page/20/Picture/0 description: The image contains the logo for DiaSorin Molecular. The logo consists of a stylized DNA double helix in shades of green and blue on the left. To the right of the helix are the words "DiaSorin" in dark blue above the word "Molecular" in green.
510(k) Summary
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Image /page/21/Picture/0 description: The image shows the logo for DiaSorin Molecular. The word "DiaSorin" is written in dark blue, and the word "Molecular" is written in green. To the left of the words is a green and blue DNA helix.
510(k) Summary
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510(k) Summary
Simplexa™ VZV Direct Catalog No. MOL3650 Simplexa™ VZV Positive Control Pack Catalog No. MOL3660 May 3, 2019 Page 20 of 25
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Image /page/23/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo consists of a DNA helix graphic on the left, with the text "DiaSorin" in blue to the right of the helix. Below "DiaSorin" is the word "Molecular" in green.
510(k) Summary
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Image /page/24/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo consists of a DNA helix graphic on the left, with the text "DiaSorin" in blue to the right of the helix. Below "DiaSorin" is the word "Molecular" in green.
510(k) Summary
Simplexa™ VZV Direct Catalog No. MOL3650 Simplexa™ VZV Positive Control Pack Catalog No. MOL3660 May 3, 2019 Page 22 of 25
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Image /page/25/Picture/0 description: The image contains the logo for DiaSorin Molecular. The logo consists of a stylized DNA double helix in shades of green and blue on the left. To the right of the helix are the words "DiaSorin" in dark blue above the word "Molecular" in green.
510(k) Summary
Simplexa™ VZV Direct Catalog No. MOL3650 Simplexa™ VZV Positive Control Pack Catalog No. MOL3660 May 3, 2019 Page 23 of 25
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Image /page/26/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo features a stylized DNA helix in shades of green and blue on the left. To the right of the helix are the words "DiaSorin" in a dark blue, sans-serif font, with the word "Molecular" underneath in a lighter green color.
510(k) Summary
Simplexa™ VZV Direct Catalog No. MOL3650 Simplexa™ VZV Positive Control Pack Catalog No. MOL3660 May 3, 2019 Page 24 of 25
- Any organisms with low titer stock were analyzed in silico by BLAST (Basic Local Alignment Search Tool, NCBI, NIH). ** Tested in silico due to unavailability of the organism.
CARRY-OVER CONTAMINATION
An amplification carry-over for the Simplexa™ assays has been assessed. The study was designed by alternately placing high positive and negative samples on each disc. No evidence of carry-over contamination was observed.
EXPECTED VALUES
The prevalence of VZV as determined by the Simplexa™ VZV Direct assay in a multi-site clinical study with prospectively collected specimens is shown in Table 8 below. The expected values for VZV per site varied between 0% and 7.4%. The overall prevalence for all sites was 2.2% (fourteen of six hundred thirty-seven (14/637).
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Image /page/27/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo features a stylized DNA helix in shades of green and blue on the left. To the right of the helix are the words "DiaSorin" in dark blue, with the word "Molecular" underneath in light green. The logo is clean and modern, suggesting a company focused on molecular diagnostics or related fields.
510(k) Summary Simplexa™ VZV Direct Catalog No. MOL3650 Simplexa™ VZV Positive Control Pack Catalog No. MOL3660 May 3, 2019 Page 25 of 25
Table 8. Prospective VZV prevalence as determined by Simplexa™ VZV Direct
| Site ID | Total | Simplexa™ VZV Direct
Positive Samples | VZV Prevalence |
|---------|-------|------------------------------------------|----------------|
| 1 | 199 | 3 | 1.5% |
| 3 | 181 | 2 | 1.1% |
| 6 | 27 | 2 | 7.4% |
| 7 | 71 | 0 | 0% |
| 8 | 20 | 0 | 0% |
| 10 | 139 | 7 | 5% |
| All | 637 | 14 | 2.2% |