Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on real-time PCR technology and standard analytical performance metrics. There is no mention of AI or ML algorithms being used for analysis or interpretation.

Therapeutic

No.

This device is an in vitro diagnostic test used for the qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis nucleic acids. It aids in the diagnosis of infection but does not provide therapy or treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the assay "is an in vitro diagnostic test intended for use on the LIAISON® MDX instrument for the qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis nucleic acids... as an aid in diagnosis of Bordetella infection."

SaMD (Software as a Medical Device)

No

The device is a real-time PCR assay system that includes reagents, a hardware instrument (LIAISON® MDX), and a software component (LIAISON® MDX Studio Software). It is not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The DiaSorin Molecular Simplexa™ Bordetella Direct MOL2750 assay is an in vitro diagnostic test intended for use on the LIAISON® MDX instrument..."
Nature of the Test: The device performs a test on a biological specimen (nasopharyngeal specimens) in vitro (outside the body) to detect and differentiate specific nucleic acids (Bordetella pertussis and Bordetella parapertussis) as an aid in the diagnosis of Bordetella infection. This is the core function of an in vitro diagnostic device.
Regulatory Context: The presence of a "Predicate Device(s)" section with a K number (K163626) indicates that this device has undergone a regulatory submission process (likely a 510(k) in the US) for medical devices, which is required for IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Simplexa™ Bordetella Direct

The DiaSorin Molecular Simplexa™ Bordetella Direct assay is an in vitro diagnostic test intended for use on the LIAISON® MDX instrument for the qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis nucleic acids from frozen nasopharyngeal (NPS) specimens from patients with signs and symptoms of Bordetella infection of the respiratory tract.

The Simplexa™ Bordetella Direct assay is performed on the LIAISON® MDX instrument and utilizes realtime PCR amplification to detect B. pertussis by targeting the IS481 insertional element of the B. pertussis genome and to detect B. parapertussis by targeting the IS1001 insertional element of the B. parapertussis genome. The IS481 insertional element can also be present in B. holmesii and B. bronchiseptica. Specimens collected from patients with respiratory infection caused by B. pertussis, B. holmesii or B. bronchiseptica may vield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines.

Negative results for the Simplexa™ Bordetella Direct assay do not preclude Bordetella infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Simplexa™ Bordetella Direct assay should be used with other clinical findings and epidemiological information as an aid in diagnosis of Bordetella infection. Test results should not be used as the sole basis for treatment or other patient management decisions.

Simplexa™ Bordetella Positive Control Pack

The Simplexa™ Bordetella Positive Control Pack is intended to be used as a control with the Simplexa™ Bordetella 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)

OZZ

Device Description

The Simplexa™ Bordetella Direct assay system is a real-time PCR assay that enables the direct amplification, detection and differentiation of Bordetella pertussis and Bordetella parapertussis DNA from unprocessed nasopharyngeal swabs (NPS) without nucleic acid extraction. The system consists of the Simplexa™ Bordetella Direct assay, the LIAISON® MDX (with LIAISON® MDX Studio Software), the Direct Amplification Disc and associated accessories.

In the Simplexa™ Bordetella Direct assay, primers and fluorescent probes are used together to amplify and detect Bordetella pertussis, Bordetella parapertussis and internal control targets. Insertion sequences IS481 and IS1001 are targeted to identify Bordetella pertussis and Bordetella parapertussis DNA respectively in the specimen. An internal control is used to detect PCR failure and/or inhibition.

The DiaSorin Molecular Simplexa™ Bordetella Direct kit contains sufficient reagents for 24 reactions.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

nasopharyngeal (NPS) specimens

Indicated Patient Age Range

Not Found

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

One thousand one hundred and forty-two (1142) samples were prospectively collected and frozen from five (5) geographically diverse sites between January 2017, from patients with signs and symptoms of Bordetella infections. Of the one thousand one hundred and forty-two (1142) samples, one hundred and thirteen (1113) samples were evaluable on Simplexa™ Bordetella Direct and a composite reference method. In addition, fifty-six (56) samples were contrived for Bordetella parapertussis at various concentrations across the clinical range of the assay (2-50 X LoD) and randomized among fifty-six (56) negatives for a total of one hundred and twelve (112) additional samples, which were evaluable on Simplexa™ Direct and a composite reference method. The composite reference method consisted of two well-characterized real-time PCR assays followed by confirmation of positive PCR amplification products with bi-directional sequencing, per target. Samples were characterized as positive if one or both composite reference methods were positive and confirmed by bi-directional sequencing. Samples were characterized as negative if both composite reference methods were negative. Samples were tested on Simplexa™ Bordetella Direct at the collection sites and the composite reference method was performed at DiaSorin Molecular.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

METHOD COMPARISON

One thousand one hundred and forty-two (1142) samples were prospectively collected and frozen from five (5) geographically diverse sites between January 2017, from patients with signs and symptoms of Bordetella infections. Of the one thousand one hundred and forty-two (1142) samples, one hundred and thirteen (1113) samples were evaluable on Simplexa™ Bordetella Direct and a composite reference method. In addition, fifty-six (56) samples were contrived for Bordetella parapertussis at various concentrations across the clinical range of the assay (2-50 X LoD) and randomized among fifty-six (56) negatives for a total of one hundred and twelve (112) additional samples, which were evaluable on Simplexa™ Direct and a composite reference method. The composite reference method consisted of two well-characterized real-time PCR assays followed by confirmation of positive PCR amplification products with bi-directional sequencing, per target. Samples were characterized as positive if one or both composite reference methods were positive and confirmed by bi-directional sequencing. Samples were characterized as negative if both composite reference methods were negative. Samples were tested on Simplexa™ Bordetella Direct at the collection sites and the composite reference method was performed at DiaSorin Molecular. The Bordetella pertussis prospectively banked frozen sample results are shown in Table 1. The Bordetella parapertussis prospectively banked frozen sample results are shown in Table 2 and the Bordetella parapertussis contrived sample results are shown in Table 3.

REPRODUCIBILITY

Three (3) investigative laboratory testing sites assessed the device's inter-day and interlintraassay reproducibility. Each of the laboratories tested a panel of six (6) members that included contrived Bordetella pertussis A639, and Bordetella parapertussis A747 samples at the following concentrations; low positive (LP) approximately 1-2 X LoD and a medium positive sample (MP) approximately 3-4 X LoD. A positive and negative control was also included in the panel. Each sample panel member was tested in triplicate per run for two (2) runs per day for five (5) non-consecutive days per site. Two (2) runs per day were each performed by a different operator. In total ninety (90) replicates X 2 runs X 5 days X 3 sites) were tested for each sample panel member. Combined results for all sites are presented in Table 4. The data in Table 4 show that the Simplexa™ Bordetella Direct is 100% in agreement with the expected results demonstrating the reproducibility of the assay for both Bordetella pertussis and Bordetella parapertussis targets.

ANALYTICAL SENSITIVITY/LIMIT OF DETECTION

The Limit of Detection (LoD) was determined for the Simplexa™ Bordetella Direct assay using quantified stocks of two (2) strains of Bordetella pertussis (A639 & BAA-589) and Bordetella parapertussis (A747 & E595) serially diluted into native nasopharyngeal swab matrix in Universal Transport Media (UTM). LoD is the lowest concentration that could be detected as positive > 95% of the time.

ANALYTICAL REACTIVITY / CROSS REACTIVITY

Analytical Reactivity for Simplexa™ Bordetella Direct was assessed using eighteen (18) Bordetella strains including twelve (12) Bordetella pertussis strains and six (6) Bordetella parapertussis strains that were not tested as a part of the Limit of Detection (LoD) study. All eighteen (18) strains were detected as positive for Bordetella pertussis at or below 80 CFU/mL or for Bordetella parapertussis at or below 590 CFU/mL. In addition to the strains that were tested, in silico BLAST analysis demonstrated that the assay should detect at least two hundred and ninety-four (294) additional Bordetella pertussis and five (5) additional Bordetella parapertussis strains. The results of the testing are summarized in Table 6 for Bordetella pertussis and in Table 7 for Bordetella parapertussis.

Analytical specificity was evaluated for the Simplexa™ Bordetella Direct by testing cross reactivity to organisms that are closely related, or cause similar clinical symptoms, or are present as normal flora in the nasopharynx. Negative specimens were spiked with potentially cross reactive organisms at the concentrations indicated in Table 8. The spiked specimens were examined for reactivity with Simplexa™ Bordetella Direct. Ninety-seven (97) organisms were tested. No cross reactivity was found with the exception of Bordetella holmseli which was expected due to the presence of the IS481 element in Bordetella holmesii. The results are shown in Table 8.

INTERFERENCE

The performance of Simplexa™ Bordetella Direct was evaluated with potentially interfering substances that may be present in the nasopharynx. The potentially interfering substances were evaluated in a contrived sample that contained Bordetella pertussis and Bordetella parapertussis at approximately 2-4 X LoD. There was no evidence of interference caused by the substances at the concentrations listed in Table 9 (Bordetella pertussis) and Table 10 (Bordetella parapertussis).

COMPETITIVE INTERFERENCE

The Simplexa™ Bordetella Direct assay was evaluated for competitive interference by testing whether the presence of a clinically relevant high concentration of either Bordetella pertussis or Bordetella parapertussis could affect the detection of the other Bordetella species when present at a low level. A low positive sample was contrived for each target by spiking Bordetella pertussis or Bordetella parapertussis separately (at approximately 2 X LoD) into nasopharyngeal swab matrix in Universal Transport Media (UTM) and a baseline Ct was determined for each sample. High concentrations of the other Bordetella strain were then spiked into the low level sample and tested. No competitive interference was observed. The results showed that a low level of Bordetella pertussis was detected in the presence of a high level of Bordetella parapertussis; similarly, a low level of Bordetella parapertussis was detected in the presence of a high level of Bordetella pertussis. The results are shown in Table 11.

INHIBITION BY OTHER MICROORGANISMS

Simplexa™ Bordetella Direct was tested for the ability to identify Bordetella when potentially inhibitory organisms were present. The panel of ninety-seven (97) potentially inhibitory organisms was individually spiked into a pool with a low concentration (approximately 2X LoD) of Bordetella pertussis and Bordetella parapertussis. The organisms were spiked into the matrix at the concentrations indicated in Table 12. Bordetella pertussis and Bordetella parapertussis were tested separately (data not shown) and as a dual Below are the results of the dual positive Bordetella pertussis and Bordetella positive sample. parapertussis sample in Table 12. No inhibitory effects were observed for Simplexa™ Bordetella Direct at the concentrations tested.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Simplexa™ Bordetella Direct Bordetella pertussis Results Versus PCR/Bi-Directional Sequencing Method Prospectively Banked Frozen Samples

Detected

PPA: 91.9%(68/74) (95% CI: 83.4% to 96.2%)

Not Detected

NPA: 98.7%(1026/1039) (95% CI: 97.9% to 99.3%)

Simplexa™ Bordetella Direct Bordetella parapertussis Results versus PCR/Bi-Directional Sequencing Method Prospectively Collected Frozen Samples

Detected

PPA: 100.0%(13/13) (95% Cl: 77.2% to 100.0%)

Not Detected

NPA: 99.6%(1096/1100) (95% CI: 99.1% to 99.9%)

Simplexa™ Bordetella Direct Bordetella parapertussis results versus PCR/Bi-Directional Sequencing Method Contrived Frozen Samples

Detected

PPA: 100.0%(56/56) (95% CI: 93.6% to 100.0%)

Not Detected

NPA: 100.0%(56/56) (95% CI: 93.6% to 100.0%)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

ARIES® Bordetella Assay for use with the ARIES® Systems (K163626)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.

(a)
Identification. A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B;
(2) Influenza A subtype H1 and Influenza A subtype H3;
(3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B;
(4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;
(5) Human Metapneumovirus;
(6) Rhinovirus; and
(7) Adenovirus.
(b)
Classification. Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;”
(2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and
(3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 13, 2018

DiaSorin Molecular LLC Sharon Young Senior Regulatory Affairs Specialist 11331 Valley View Street Cypress, CA 90630

Re: K173498

Trade/Device Name: Simplexa Bordetella Direct MOL2750. Simplexa Bordetella Positive Control Pack MOL2760 Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory Viral Panel Multiplex Nucleic Acid Assay Regulatory Class: Class II Product Code: OZZ Dated: November 16, 2017 Received: November 17, 2017

Dear Ms. 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. 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 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

1

Page 2 - Sharon Young

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Kristian M. Roth -S

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)

Device Name

Simplexa™ Bordetella Direct MOL2750 and Simplexa™ Bordetella Positive Control Pack MOL 2760

Indications for Use (Describe)

Simplexa™ Bordetella Direct MOL2750

The DiaSorin Molecular Simplexa™ Bordetella Direct MOL2750 assay is an in vitro diagnostic test intended for use on the LIAISON® MDX instrument for the qualitative detection and differentiation of Bordetella parapertussis nucleic acids from frozen nasopharyngeal (NPS) specimens with signs and symptoms of Bordetella infection of the respiratory tract.

The Simplexa™ Bordetella Direct MOL2750 assay is performed on the LIAISON® MDX instrument and utilizes realtime PCR amplification to detect B. pertussis by targeting the IS481 insertional element of the B. pertussis genome and to detect B. parapertussis by targeting the IS1001 insertional element of the B. parapertussis genome. The IS481 insertional element can also be present in B. holmesii and B. bronchiseptica. Specimens with respiratory infection caused by B. pertussis, B. holmesii or B. bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines.

Negative results for the Simplexa™ Bordetella Direct MOL2750 assay do not prectude Bordetella infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the SimplexaTM Direct MOL2750 assay should be used with other clinical findings and epidemiological information as an aid in diagnosis of Bordetella infection. Test results should not be used as the sole basis for treatment or other patient management decisions.

Simplexa™ Bordetella Positive Control Pack MOL 2760

The Simplexa™ Bordetella Positive Control Pack MOL2760 is intended to be used as a control with the Simplexa™ Bordetella Direct kit. This control is not intended for use with other assays or systems.

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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Image /page/3/Picture/1 description: The image shows the logo for DiaSorin Molecular. The logo consists of a DNA helix graphic in green and blue on the left, with the text "DiaSorin" in dark blue on the top right. Below "DiaSorin" is the word "Molecular" in green.

510(k) Summary

Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 August 7, 2018 Page 1 of 17

| Applicant | DiaSorin Molecular LLC.
11331 Valley View Street
Cypress, California 90630
USA |
|--------------------------------|-----------------------------------------------------------------------------------------|
| Establishment Registration No. | 2023365 |
| Contact Person | Sharon Young
tel 562.240.6680
fax 562.240.6529
Sharon.Young@DiaSorin.com |
| Summary Date | August 7, 2018 |
| Proprietary Name | Simplexa™ Bordetella Direct and Simplexa™ Bordetella Positive
Control Pack |
| Generic Name | Bordetella nucleic acid |
| Classification | Class II |
| Predicate Devices | ARIES® Bordetella Assay for use with the ARIES® Systems |

Intended Use

Simplexa™ Bordetella Direct

The DiaSorin Molecular Simplexa™ Bordetella Direct assay is an in vitro diagnostic test intended for use on the LIAISON® MDX instrument for the qualitative detection and differentiation of Bordetella perfussis and Bordetella parapertussis nucleic acids from frozen nasopharyngeal (NPS) specimens from patients with signs and symptoms of Bordetella infection of the respiratory tract.

The Simplexa™ Bordetella Direct assay is performed on the LIAISON® MDX instrument and utilizes realtime PCR amplification to detect B. pertussis by targeting the IS481 insertional element of the B. pertussis genome and to detect B. parapertussis by targeting the IS1001 insertional element of the B. parapertussis genome. The IS481 insertional element can also be present in B. holmesii and B. bronchiseptica. Specimens collected from patients with respiratory infection caused by B. pertussis, B. holmesii or B. bronchiseptica may vield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines.

Negative results for the Simplexa™ Bordetella Direct assay do not preclude Bordetella infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Simplexa™ Bordetella Direct assay should be used with other clinical findings and epidemiological information as an aid in diagnosis of Bordetella infection. Test results should not be used as the sole basis for treatment or other patient management decisions.

Simplexa™ Bordetella Positive Control Pack

The Simplexa™ Bordetella Positive Control Pack is intended to be used as a control with the Simplexa™ Bordetella Direct kit.

This control is not intended for use with other assays or systems

Device Description

The Simplexa™ Bordetella Direct assay system is a real-time PCR assay that enables the direct amplification, detection and differentiation of Bordetella pertussis and Bordetella parapertussis DNA from unprocessed nasopharyngeal swabs (NPS) without nucleic acid extraction. The system consists of the

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Image /page/4/Picture/1 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 helix is the company name, "DiaSorin," in a dark blue, serif font. Below "DiaSorin" is the word "Molecular" in a lighter green sans-serif font.

510(k) Summary

Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 August 7, 2018 Page 2 of 17

Simplexa™ Bordetella Direct assay, the LIAISON® MDX (with LIAISON® MDX Studio Software), the Direct Amplification Disc and associated accessories.

In the Simplexa™ Bordetella Direct assay, primers and fluorescent probes are used together to amplify and detect Bordetella pertussis, Bordetella parapertussis and internal control targets. Insertion sequences IS481 and IS1001 are targeted to identify Bordetella pertussis and Bordetella parapertussis DNA respectively in the specimen. An internal control is used to detect PCR failure and/or inhibition.

The DiaSorin Molecular Simplexa™ Bordetella Direct kit contains sufficient reagents for 24 reactions. Upon receipt, store at -10 to -30ºC (do not use a frost-free freezer). Each vial contains sufficient material for a single reaction. Use within 30 minutes of thawing.

Kit Description

| Component Name | REF | EC SYMBOL
ON LABEL | | Abbreviated
Name | Cap
Color | Number
of Vials | Reactions Volume
per Vial/Kit per Vial | |
|------------------------------------------------|---------|-----------------------|--|---------------------|--------------|--------------------|-----------------------------------------------|-------|
| Simplexa™
Bordetella Direct
Reaction Mix | MOL2751 | REAG | | RM | Brown | 24 | 1/24 | 50 ul |

Component Description

Kit Component	Contents
	DNA polymerase, buffer, dNTPs, Internal Control template DNA, dye-labeled fluorescent probes and primers
specific for detection of Bordetella pertussis , Bordetella parapertussis and DNA Internal Control
Simplexa™
Bordetella Direct
Reaction Mix (RM)	Target	Probe
Fluorophore
(Dye)	Excitation (nm)	Emission (nm)	Targeted
Gene
	Bordetella pertussis	FAM	495	520	IS481
	Bordetella
parapertussis	CFR610	590	610	IS1001
	DNA Internal Control	Q670	644	670	DNA IC
Simplexa™
Bordetella Kit
Barcode Card	Assay specific parameters

MATERIALS SUPPLIED SEPARATELY

1. Direct Amplification Disc Kit (REF MOL1455)
- a) Direct Amplification Discs for use on the LIAISON® MDX

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Image /page/5/Picture/0 description: The image shows the logo for DiaSorin Molecular. The word "DiaSorin" is in a dark blue font, and the word "Molecular" is in a light green font. To the left of the text is a green and blue DNA strand graphic.

510(k) Summary

Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 August 7, 2018 Page 3 of 17

Predicate Device Information

Item	Device
Name		Simplexa™ Bordetella Direct
		REF MOL2750
	ARIES® Bordetella Assay for use with	And
	the ARIES® Systems (K163626)	Simplexa™ Bordetella Positive Control
		Pack REF MOL2760
Intended Use	The ARIES® Bordetella Assay is a real-
time polymerase chain reaction (PCR)
based qualitative in vitro diagnostic test
for the direct detection and identification
of Bordetella pertussis (B. pertussis) and
Bordetella parapertussis (B.
parapertussis) nucleic acid in
nasopharyngeal swab (NPS) specimens
obtained from individuals suspected of
having a respiratory tract infection
attributable to B. pertussis or B.
parapertussis. The ARIES® Bordetella
Assay targets the B. pertussis toxin
promoter and the B. parapertussis
IS1001 insertion element in the
genomes. When clinical factors suggest
that B. pertussis or B. parapertussis may
not be the cause of respiratory infection,
other clinically appropriate
investigation(s) should be carried out in
accordance with published guidelines.
Negative results for the ARIES®
Bordetella Assay do not preclude B.
pertussis or B. parapertussis infection
and positive results do not rule out co-
infections with other respiratory
pathogens. The direct detection and
identification of B. pertussis and B.
parapertussis nucleic acids from
symptomatic patients aids in the
diagnosis of B. pertussis and B.
parapertussis respiratory infection in
conjunction with other clinical findings
and epidemiological information. The
ARIES® Bordetella Assay is indicated for
use with the ARIES® Systems.	Simplexa™ Bordetella Direct
The DiaSorin Molecular Simplexa™
Bordetella Direct assay is an in vitro
diagnostic test intended for use on the
LIAISON® MDX instrument for the qualitative
detection and differentiation of Bordetella
pertussis and Bordetella parapertussis
nucleic acids from frozen nasopharyngeal
(NPS) specimens from patients with signs
and symptoms of Bordetella infection of the
respiratory tract.
The Simplexa™ Bordetella Direct assay is
performed on the LIAISON® MDX instrument
and utilizes real-time PCR amplification to
detect B. pertussis by targeting the IS481
insertional element of the B. pertussis
genome and to detect B. parapertussis by
targeting the IS1001 insertional element of
the B. parapertussis genome. The IS481
insertional element can also be present in B.
holmesii and B. bronchiseptica. Specimens
collected from patients with respiratory
infection caused by B. pertussis, B. holmesii
or B. bronchiseptica may yield positive test
results in IS481 assays. B. holmesii infection
may cause clinical illness similar to B.
pertussis, and mixed outbreaks involving
both B. pertussis and B. holmesii infection
have been reported. Additional testing
should be performed if necessary to
differentiate B. holmesii and B. pertussis. B.
bronchiseptica is a rare cause of infection in
humans. When clinical factors suggest that
B. pertussis may not be the cause of
respiratory infection, other clinically
appropriate investigation(s) should be carried
out in accordance with published guidelines.
Negative results for the Simplexa TM
Bordetella Direct assay do not preclude
Bordetella infection and positive results do
not rule out co-infection with other respiratory
pathogens. Results from the Simplexa™
Item	Device
Name	ARIES® Bordetella Assay for use with
the ARIES® Systems (K163626)	Simplexa™ Bordetella Direct
REF MOL2750
And
Simplexa™ Bordetella Positive Control
Pack REF MOL2760
		Bordetella Direct assay should be used with
other clinical findings and epidemiological
information as an aid in diagnosis of
Bordetella infection. Test results should not
be used as the sole basis for treatment or
other patient management decisions.
Simplexa™ Bordetella Positive Control Pack
		The Simplexa™ Bordetella Positive Control
Pack is intended to be used as a control with
the Simplexa™ Bordetella Direct kit.
This control is not intended for use with other
assays or systems.

Assay Targets	B. pertussis Target B. pertussis and B. parapertussis toxin promoter (ptxA-pr),
B. parapertussis Target IS1001 insertion
element .	The Simplexa™ Bordetella Direct assay
detects the following multi-copy insertion
sequence targets: Bordetella pertussis target
IS481 and Bordetella parapertussis target
IS1001.
Sample Types	Nasopharyngeal swabs in UTM™, M5®,
M6™ and ESwab.	Nasopharyngeal swabs in Remel M4, Remel
M4RT, Remel M5, Remel M6, UTM, VTM
and Liquid Aimes (ESwab).
Instrument	ARIES® System, ARIES® M1 System.	LIAISON® MDX.
Extraction Methods	None.	None.
Assay Methodology	Real-time system for detecting the
presence / absence of Bordetella pertussis and Bordetella parapertussis
DNA in clinical specimens.	PCR-based system for detecting the
presence / absence of Bordetella pertussis
and Bordetella parapertussis DNA in clinical
specimens.
Detection Techniques	Different fluorescent reporter dyes for
each target and melt analysis.	Multiplex assay using different reporter dyes
for each target.
Item	Device
Name	ARIES® Bordetella Assay for use with
the ARIES® Systems (K163626)	Simplexa™ Bordetella Direct
REF MOL2750
And
Simplexa™ Bordetella Positive Control
Pack REF MOL2760
Optical
Detection	Fluorescence Emissions and Detection.	Fluorescence.
Time to result	Less than 2 hours.	Approximately 1 hour
Test
Interpretation	Automated test interpretation and report
generation.	Automated test interpretation and report
generation.

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510(k) Summary

Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 August 7, 2018 Page 4 of 17

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510(k) Summary

Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 August 7, 2018 Page 5 of 17

METHOD COMPARISON

One thousand one hundred and forty-two (1142) samples were prospectively collected and frozen from five (5) geographically diverse sites between January 2017, from patients with signs and symptoms of Bordetella infections. Of the one thousand one hundred and forty-two (1142) samples, one hundred and thirteen (1113) samples were evaluable on Simplexa™ Bordetella Direct and a composite reference method. In addition, fifty-six (56) samples were contrived for Bordetella parapertussis at various concentrations across the clinical range of the assay (2-50 X LoD) and randomized among fifty-six (56) negatives for a total of one hundred and twelve (112) additional samples, which were evaluable on Simplexa™ Direct and a composite reference method. The composite reference method consisted of two well-characterized real-time PCR assays followed by confirmation of positive PCR amplification products with bi-directional sequencing, per target. Samples were characterized as positive if one or both composite reference methods were positive and confirmed by bi-directional sequencing. Samples were characterized as negative if both composite reference methods were negative. Samples were tested on Simplexa™ Bordetella Direct at the collection sites and the composite reference method was performed at DiaSorin Molecular. The Bordetella pertussis prospectively banked frozen sample results are shown in Table 1. The Bordetella parapertussis prospectively banked frozen sample results are shown in Table 2 and the Bordetella parapertussis contrived sample results are shown in Table 3.

Table 1. Simplexa™ Bordetella Direct Bordetella pertussis Results Versus PCR/Bi-Directional Sequencing Method Prospectively Banked Frozen Samples

| Simplexa™
Bordetella Direct

B. pertussis	PCR/Bi-directional Sequencing
	Detected	Not Detected	Total
Detected	68	13	81
Not Detected	6	1026	1032
Total	74	1039	1113
	%PPA
91.9%(68/74)
95% CI: 83.4% to 96.2%	%NPA
98.7%(1026/1039)
95% CI: 97.9% to 99.3%

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510(k) Summary

Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 August 7, 2018 Page 6 of 17

Table 2. Simplexa™ Bordetella Direct Bordetella parapertussis Results versus PCR/Bi-Directional Sequencing Method Prospectively Collected Frozen Samples

Simplexa™	PCR/Bi-directional Sequencing
Bordetella Direct
B. parapertussis	Detected	Not Detected	Total
Detected
13		4	17
Not Detected	O	1096	1096
Total	13	1100	1113
	%PPA
100.0%(13/13)
95% Cl: 77.2% to 100.0%	%NPA
99.6%(1096/1100)
95% CI: 99.1% to 99.9%

Table 3. Simplexa™ Bordetella Direct Bordetella parapertussis results versus PCR/Bi-Directional Sequencing Method Contrived Frozen Samples

| Simplexa™
Bordetella Direct

B. parapertussis	PCR/Bi-directional Sequencing
	Detected	Not Detected	Total
Detected	56	0	56
Not Detected	0	56	56
Total	56	56	112
	%PPA
100.0%(56/56)
95% CI: 93.6% to 100.0%	%NPA
100.0%(56/56)
95% CI: 93.6% to 100.0%

REPRODUCIBILITY

Three (3) investigative laboratory testing sites assessed the device's inter-day and interlintraassay reproducibility. Each of the laboratories tested a panel of six (6) members that included contrived Bordetella pertussis A639, and Bordetella parapertussis A747 samples at the following concentrations; low positive (LP) approximately 1-2 X LoD and a medium positive sample (MP) approximately 3-4 X LoD. A positive and negative control was also included in the panel. Each sample panel member was tested in triplicate per run for two (2) runs per day for five (5) non-consecutive days per site. Two (2) runs per day were each performed by a different operator. In total ninety (90) replicates X 2 runs X 5 days X 3 sites) were tested for each sample panel member. Combined results for all sites are presented in Table 4. The data in Table 4 show that the Simplexa™ Bordetella Direct is 100% in agreement with the expected results demonstrating the reproducibility of the assay for both Bordetella pertussis and Bordetella parapertussis targets.

9

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Image /page/9/Picture/1 description: The image shows the logo for DiaSorin Molecular. The logo features a green and blue DNA helix on the left side. To the right of the helix, the words "DiaSorin" are written in blue, and below that, the word "Molecular" is written in green.

510(k) Summary

Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 August 7, 2018 Page 7 of 17

		Site 1		Site 2
Sample Panel
Member	%
Agreement
with
Expected
Results	Avg.
Ct	%CV	%
Agreement
with
Expected
Results	Avg.
Ct	%CV	%
Agreement
with
Expected
Results	Avg.
Ct	%CV	Total %	95% Cl
Bordetella
pertussis
A639 - LP
(FAM)	100.0%
(30/30)	33.9	3.4	100.0%
(30/30)	34.2	3.3	100.0%
(30/30)	34.9	2.6	100.0%
(90/90)	95.9%
to
100.0%
Bordetella
pertussis
A639 - MP
(FAM)	100.0%
(30/30)	32.9	2.5	100.0%
(30/30)	33.8	2.9	100.0%
(30/30)	33.9	2.7	100.0%
(90/90)	95.9%
to
100.0%
Bordetella
para-
pertussis
A747 - LP
(CFR 610)	100.0%
(30/30)	33.9	3.9	100.0%
(30/30)	34.3	2.7	100.0%
(30/30)	35.4	3.5	100.0%
(90/90)	95.9%
to
100.0%
Bordetella
para-
pertussis
A747 - MP
(CFR 610)	100.0%
(30/30)	33.0	2.7	100.0%
(30/30)	33.5	2.6	100.0%
(30/30)	33.7	2.0	100.0%
(90/90)	95.9%
to
100.0%
Native
negative
naso-
pharyngeal
swab (UTM)	100.0%
(30/30)	N/A	N/A	100.0%
(30/30)	N/A	N/A	100.0%
(30/30)	N/A	N/A	100.0%
(90/90)	95.9%
to
100.0%
Positive
Control
(FAM)	100.0%
(30/30)	24.0	0.8	100.0%
(30/30)	22.0	1.1	100.0%
(30/30)	23.3	0.7	100.0%
(90/90)	95.9%
to
100.0%
Positive
Control
(CFR 610)	100.0%
(30/30)	23.6	0.9	100.0%
(30/30)	20.8	1.0	100.0%
(30/30)	22.4	0.7	100.0%
(90/90)	95.9%
to
100.0%
Total
Agreement	100.0% (180/180)			100.0% (180/180)	100.0% (180/180)	100.0% (540/540)
99.3% to 100.0%

ANALYTICAL SENSITIVITY/LIMIT OF DETECTION

The Limit of Detection (LoD) was determined for the Simplexa™ Bordetella Direct assay using quantified stocks of two (2) strains of Bordetella pertussis (A639 & BAA-589) and Bordetella parapertussis (A747 & E595) serially diluted into native nasopharyngeal swab matrix in Universal Transport Media (UTM). LoD is the lowest concentration that could be detected as positive > 95% of the time. The LoD concentrations for the Bordetella strains are summarized in Table 5.

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510(k) Summary Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 August 7, 2018 Page 8 of 17

Bordetella species	Bordetella strain	LoD Concentration (CFU/mL)
Bordetella pertussis	A639	14.7
Bordetella pertussis	BAA-589	20.9
Bordetella parapertussis	A747	347.3
Bordetella parapertussis	E595	239.0

Table 5. Simplexa™ Bordetella Direct Limit of Detection

ANALYTICAL REACTIVITY / CROSS REACTIVITY

Analytical Reactivity

Analytical Reactivity for Simplexa™ Bordetella Direct was assessed using eighteen (18) Bordetella strains including twelve (12) Bordetella pertussis strains and six (6) Bordetella parapertussis strains that were not tested as a part of the Limit of Detection (LoD) study. All eighteen (18) strains were detected as positive for Bordetella pertussis at or below 80 CFU/mL or for Bordetella parapertussis at or below 590 CFU/mL. In addition to the strains that were tested, in silico BLAST analysis demonstrated that the assay should detect at least two hundred and ninety-four (294) additional Bordetella pertussis and five (5) additional Bordetella parapertussis strains. The results of the testing are summarized in Table 6 for Bordetella pertussis and in Table 7 for Bordetella parapertussis.

			Table 6. Simplexa™ Bordetella Direct Analytical Reactivity - Bordetella pertussis

| Bordetella Strain | Concentration | Bordetella pertussis
(IS481)
Result (# detected/# tested) |
|---------------------------------|---------------|-----------------------------------------------------------------|
| Bordetella pertussis BAA-1335 | 35.6 CFU/mL | 3/3 |
| Bordetella pertussis ATCC 8467 | 35.6 CFU/mL | 3/3 |
| Bordetella pertussis ATCC 9306 | 79.7 CFU/mL | 3/3 |
| Bordetella pertussis ATCC 12742 | 35.6 CFU/mL | 3/3 |
| Bordetella pertussis ATCC 51445 | 35.6 CFU/mL | 3/3 |
| Bordetella pertussis ATCC 53894 | 79.7 CFU/mL | 3/3 |
| Bordetella pertussis ATCC 8478 | 35.6 CFU/mL | 3/3 |
| Bordetella pertussis ATCC 12743 | 35.6 CFU/mL | 3/3 |
| Bordetella pertussis ATCC 9340 | 35.6 CFU/mL | 3/3 |
| Bordetella pertussis ATCC 9797 | 35.6 CFU/mL | 3/3 |
| Bordetella pertussis ATCC 10380 | 35.6 CFU/mL | 3/3 |
| Bordetella pertussis E431 | 35.6 CFU/mL | 3/3 |

11

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510(k) Summary

Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 August 7, 2018 Page 9 of 17

Table 7. Simplexa™ Bordetella Direct Analytical Reactivity - Bordetella parapertussis

| Bordetella Strain | Concentration | Bordetella parapertussis
(IS1001)
Result (# detected/# tested) |
|-------------------------------------|---------------|----------------------------------------------------------------------|
| Bordetella parapertussis ATCC 15311 | 586.3 CFU/mL | 3/3 |
| Bordetella parapertussis ATCC 15237 | 586.3 CFU/mL | 3/3 |
| Bordetella parapertussis ATCC 15989 | 586.3 CFU/mL | 3/3 |
| Bordetella parapertussis BAA-587 | 586.3 CFU/mL | 3/3 |
| Bordetella parapertussis C510 | 586.3 CFU/mL | 3/3 |
| Bordetella parapertussis E838 | 586.3 CFU/mL | 3/3 |

Cross Reactivity (Analytical Specificity)

Analytical specificity was evaluated for the Simplexa™ Bordetella Direct by testing cross reactivity to organisms that are closely related, or cause similar clinical symptoms, or are present as normal flora in the nasopharynx. Negative specimens were spiked with potentially cross reactive organisms at the concentrations indicated in Table 8. The spiked specimens were examined for reactivity with Simplexa™ Bordetella Direct. Ninety-seven (97) organisms were tested. No cross reactivity was found with the exception of Bordetella holmseli which was expected due to the presence of the IS481 element in Bordetella holmesii. The results are shown in Table 8.

Table 8. Simplexa™ Bordetella Direct Cross Reactivity

| Cross Reactant (IS481)
% Detection
(# Detected/# Tested) (IS1001)
% Detection
(# Detected/# Tested) |
|----------------------- | Acinetobacter baumannii | Acinetobacter Iwoffi | Adenovirus 1 | Adenovirus 31 | Arcanobacterium haemolyticum | Bacillus cereus | Bacteroides fragilis | Bordetella avium | Bordetella bronchiseptica RB50 | Bordetella hinzi | Bordetella holmseii F061 | Bordetella petri | Bordetella trematum | Burkholderia cenocepacia | Burkholderia cepacia | Burkholderia multivorans | Burkholderia thailandensis | Cross Reactant (IS481)
% Detection
(# Detected/# Tested) (IS1001)
% Detection
(# Detected/# Tested) |
| Candida albicans | Candida glabrata | Chlamydia pneumoniae | Chlamydia trachmomatis | Citrobacter freundii | Clostridium difficile | Coronavirus 229E | Coronavirus NL63* | Coronavirus OC43 | Corynebacterium diptheriae | Coxsackievirus A16 | Coxsackievirus B4 | Cytomegalovirus | Echovirus 6 | Echovirus 7 | Echovirus 9 | Echovirus 11 | Enterobacter aerogenes Z052 | Enterobacter cloacae | Enterococcus faecalis vanB | Enterovirus 70 | Enterovirus 71 | Epstein-Barr Virus | Escherichia coli | Fusobacterium necrophorum | Haemophilus influenzae | Haemophilus parainfluenzae | HSV-1 (MacIntyre) | HSV-2 (G) | Influenza A/Swine/lowa/15/30
H1N1* | 1 x 104 TCID50/mL | Influenza B/Malaysia/2506/04* | Klebsiella oxytoca | Klebsiella pneumoniae | Lactobacillus acidophilus | Lactobacillus plantarum 17-5 | Legionella longbeachae | Cross Reactant (IS481)
% Detection
(# Detected/# Tested) (IS1001)
% Detection
(# Detected/# Tested) |
| Legionella pneumophila
(Philadelphia) | Listeria monocytogenes | Measles | Metapneumovirus-9 | Moraxella catarrhalis Ne 11 | Morganella morganii | Mumps | Mycobacterium avium | Mycobacterium tuberculosis
(genomic DNA) | 1 x 106 genome
copies/mL | 0% (0/3) | Mycoplasma hominis | Mycoplasma pneumoniae Strain
M129 | 1 x 106 CCU/mL | Neisseria elongata | Neisseria gonorrhoeae | Neisseria meningitidis | Neisseria mucosa | Parainfluenza 1 | Parainfluenza 2 | Parainfluenza 3* | Parainfluenza 4* | Parvimonas micra | Peptostreptococcus anaerobius | Proteus mirabilis Z050 | Proteus vulgaris | Pseudomonas aeruginosa | Pseudomonas fluorescens | Rhinovirus 1A* | RSV A | RSV B WV/14617/85 | Serratia liquefaciens | Serratia marcescens | Staphylococcus aureus (MRSA) | Staphylococcus epidermidis
(MRSE) | 1 x 106 CFU/mL | Stenotrophomonas maltophilia | Streptococcus anginosus | Streptococcus canis | Cross Reactant (IS481)
% Detection
(# Detected/# Tested) (IS1001)
% Detection
(# Detected/# Tested) |
| Streptococcus dysgalactiae | Streptococcus intermedius | Streptococcus mitis | Streptococcus mutans | Streptococcus pneumoniae | Streptococcus pyogenes M1 | Streptococcus salivarius | Ureaplasma urealyticum | Varicella Zoster Virus* | Concentration | Bordetella pertussis
| Bordetella parapertussis
----------------------|-----------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------|
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 100% (8/8) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| Concentration | Bordetella pertussis
| Bordetella parapertussis
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 IFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 IFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 104 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 copies/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 0% (0/3) | 0% (0/3) |
| 1 x 104 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| Concentration | Bordetella pertussis
| Bordetella parapertussis
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 104 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 104 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 104 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 105 TCID50/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| Concentration | Bordetella pertussis
| Bordetella parapertussis
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CFU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 106 CCU/mL | 0% (0/3) | 0% (0/3) |
| 1 x 104 TCID50/mL | 0% (0/3) | 0% (0/3) |

12

Image /page/12/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, the word "DiaSorin" is written in a dark blue, sans-serif font, with the word "Molecular" underneath in a lighter green color.

510(k) Summary

Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 August 7, 2018 Page 10 of 17

13

Image /page/13/Picture/0 description: The image contains the logo for DiaSorin Molecular. The logo features a stylized DNA strand in shades of green and blue on the left. To the right of the DNA strand 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™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 August 7, 2018 Page 11 of 17

14

Image /page/14/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo consists of a stylized DNA double helix on the left, rendered in shades of green and blue. To the right of the helix, the word "DiaSorin" is written in a dark blue, sans-serif font. Below "DiaSorin", the word "Molecular" is written in a lighter green, sans-serif font.

510(k) Summary

Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 August 7, 2018 Page 12 of 17

The testing concentration of these viruses is lower due to the lack of a high titer stock.

INTERFERENCE

The performance of Simplexa™ Bordetella Direct was evaluated with potentially interfering substances that may be present in the nasopharynx. The potentially interfering substances were evaluated in a contrived sample that contained Bordetella pertussis and Bordetella parapertussis at approximately 2-4 X LoD. There was no evidence of interference caused by the substances at the concentrations listed in Table 9 (Bordetella pertussis) and Table 10 (Bordetella parapertussis).

			Table 9. Simplexa™ Bordetella Direct Interference - Bordetella pertussis
--	--	--	--------------------------------------------------------------------------

| Potentially Interfering Substance | Active Ingredient | Interferent
Concentration | B. pertussis (IS481)
% Detection |
|---------------------------------------|-------------------------------------------|------------------------------|-------------------------------------|
| Albuterol sulfate | Albuterol sulfate | 10 mg/mL | 100% (3/3) |
| Ampicillin powder | Ampicillin | 10 mg/mL | 100% (3/3) |
| Azithromycin powder | Azithromycin | 10 mg/mL | 100% (3/3) |
| Beclomethasone dipropionate | Beclomethasone
dipropionate | 10 mg/mL | 100% (3/3) |
| Blood | NA | 10% v/v | 100% (3/3) |
| Chloraseptic sore throat spray | Phenol | 10% v/v | 100% (3/3) |
| Ciprofloxacin | Ciprofloxacin | 1.25 mg/mL | 100% (3/3) |
| Erythromycin | Erythromycin | 10 mg/mL | 100% (3/3) |
| Flonase Nasal Spray | Fluticasone propionate-
corticosteroid | 10% v/v | 100% (3/3) |
| Mucin | Mucin | 10 mg/mL | 100% (3/3) |
| Mupirocin | Mupirocin | 10 mg/mL | 100% (3/3) |
| Rifampicin | Rifampicin | 2.5 mg/mL | 100% (3/3) |
| Robitussin DM | Robitussin DM | 10% v/v | 100% (3/3) |
| Saline Nasal spray-Sodium
chloride | Sodium chloride | 10% v/v | 100% (3/3) |

15

Image /page/15/Picture/0 description: The image contains the word "orin" in a dark blue font. The letters are bold and slightly spaced apart. There is a dot above the "i" in "orin."

510(k) Summary

Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 August 7, 2018 Page 13 of 17

| Potentially Interfering Substance | Active Ingredient | Interferent
Concentration | B. pertussis (IS481)
% Detection |
|-----------------------------------|-------------------|------------------------------|-------------------------------------|
| Sudafed PE | Phenylephrine | 10 mg/mL | 100% (3/3) |
| Zicam 12 hrs spray | Oxymetazoline HCl | 10% v/v | 100% (3/3) |

Table 10. Simplexa™ Bordetella Direct Interference - Bordetella parapertussis

| Potentially Interfering Substance | Active Ingredient | Interferent
Concentration | B. parapertussis
(IS1001)
% Detection |
|---------------------------------------|-------------------------------------------|------------------------------|---------------------------------------------|
| Albuterol sulfate | Albuterol sulfate | 10 mg/mL | 100% (3/3) |
| Ampicillin powder | Ampicillin | 10 mg/mL | 100% (3/3) |
| Azithromycin powder | Azithromycin | 10 mg/mL | 100% (3/3) |
| Beclomethasone dipropionate | Beclomethasone
dipropionate | 10 mg/mL | 100% (3/3) |
| Blood | NA | 10% v/v | 100% (3/3) |
| Chloraseptic sore throat spray | Phenol | 10% v/v | 100% (3/3) |
| Ciprofloxacin | Ciprofloxacin | 1.25 mg/mL | 100% (3/3) |
| Erythromycin | Erythromycin | 10 mg/mL | 100% (3/3) |
| Flonase Nasal Spray | Fluticasone propionate-
corticosteroid | 10% v/v | 100% (3/3) |
| Mucin | Mucin | 10 mg/mL | 100% (3/3) |
| Mupirocin | Mupirocin | 10 mg/mL | 100% (3/3) |
| Rifampicin | Rifampicin | 5 mg/mL | 100% (8/8)* |
| Robitussin DM | Robitussin DM | 10% v/v | 100% (3/3) |
| Saline Nasal spray-Sodium
chloride | Sodium chloride | 10% v/v | 100% (3/3) |
| Sudafed PE | Phenylephrine | 10 mg/mL | 100% (3/3) |
| Zicam 12 hrs spray | Oxymetazoline HCl | 10% v/v | 100% (3/3) |

The initial three (3) replicates of Rifampicin at 5 mg/mL were valid but not detected for Bordetella parapertussus. An additional five (5) replicates were performed with no interference for Bordetella parapertussis at 5 mg/mL.

COMPETITIVE INTERFERENCE

The Simplexa™ Bordetella Direct assay was evaluated for competitive interference by testing whether the presence of a clinically relevant high concentration of either Bordetella pertussis or Bordetella parapertussis could affect the detection of the other Bordetella species when present at a low level. A low positive sample was contrived for each target by spiking Bordetella pertussis or Bordetella parapertussis separately (at approximately 2 X LoD) into nasopharyngeal swab matrix in Universal Transport Media (UTM) and a baseline Ct was determined for each sample. High concentrations of the other Bordetella strain were then spiked into the low level sample and tested. No competitive interference was observed. The results showed that a low level of Bordetella pertussis was detected in the presence of a high level of Bordetella parapertussis; similarly, a low level of Bordetella parapertussis was detected in the presence of a high level of Bordetella pertussis. The results are shown in Table 11.

16

Image /page/16/Picture/1 description: The image contains the logo for DiaSorin Molecular. The logo consists of a stylized DNA double helix on the left, colored in shades of green and blue. To the right of the helix, the word "DiaSorin" is written in a dark blue, sans-serif font. Below "DiaSorin", the word "Molecular" is written in a lighter green, sans-serif font.

510(k) Summary

Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 August 7, 2018 Page 14 of 17

| | Baseline
(Low Concentration) | Competitive Interferent
(High Concentration) | | Bordetella pertussis
(IS481)
(#Detected/#Total) | Bordetella parapertussis
(IS1001)
(#Detected/#Total) |
|---------------------------------|---------------------------------|-------------------------------------------------|--------------|--------------------------------------------------------------|-------------------------------------------------------------------|
| Species | 2 X LoD
CFU/mL | Species | CFU/mL | | |
| Bordetella pertussis | 29.4 CFU/mL | Bordetella parapertussis | 2x107 CFU/mL | 3/3 | 3/3 |
| Bordetella parapertussis | 694.6 CFU/mL | Bordetella pertussis | 1X107 CFU/mL | 3/3 | 3/3 |

Table 11. Simplexa™ Bordetella Direct Competitive Interference

INHIBITION BY OTHER MICROORGANISMS

Simplexa™ Bordetella Direct was tested for the ability to identify Bordetella when potentially inhibitory organisms were present. The panel of ninety-seven (97) potentially inhibitory organisms was individually spiked into a pool with a low concentration (approximately 2X LoD) of Bordetella pertussis and Bordetella parapertussis. The organisms were spiked into the matrix at the concentrations indicated in Table 12. Bordetella pertussis and Bordetella parapertussis were tested separately (data not shown) and as a dual Below are the results of the dual positive Bordetella pertussis and Bordetella positive sample. parapertussis sample in Table 12. No inhibitory effects were observed for Simplexa™ Bordetella Direct at the concentrations tested.

Table 12. Summary of Results for the Microbial Inhibition Study
Bordetella pertussis and Bordetella parapertussis at 2 X LoD

| Organism | Concentration | Bordetella
pertussis (IS481)
% Detection
(# Detected/# Tested) | Bordetella
parapertussis (IS1001)
% Detection
(# Detected/# Tested) |
|---------------------------------------------|-----------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Baseline | N/A | 100% (45/45) | 100% (45/45) |
| Acinetobacter baumannii | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Acinetobacter Iwoffi | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Adenovirus 1 | 1 x 105 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Adenovirus 31 | 1 x 105 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Arcanobacterium haemolyticum | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Bacillus cereus | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Bacteroides fragilis | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Bordetella avium | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Bordetella bronchiseptica | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Bordetella hinzi | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Bordetella holmseii F061 | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Bordetella petri | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Bordetella trematum | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Burkholderia cenocepacia | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Organism | Concentration | Bordetella
pertussis (IS481)
% Detection
(# Detected/# Tested) | Bordetella
parapertussis (IS1001)
% Detection
(# Detected/# Tested) |
| Burkholderia cepacia | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Burkholderia multivorans | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Burkholderia thailandensis | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Candida albicans | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Candida glabrata | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Chlamydia pneumoniae | 1 x 10° IFU/mL | 100% (3/3) | 100% (3/3) |
| Chlamydia trachmomatis | 1 x 10° IFU/mL | 100% (3/3) | 100% (3/3) |
| Citrobacter freundii | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Clostridium difficile | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Coronavirus 229E | 1 x 105 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Coronavirus NL63* | 1 x 104 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Coronavirus OC43 | 1 x 10° TCID50/mL | 100% (3/3) | 100% (3/3) |
| Corynebacterium diptheriae | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Coxsackievirus A16 | 1 x 105 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Coxsackievirus B4 | 1 x 105 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Cytomegalovirus | 1 x 105 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Echovirus 6 | 1 x 105 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Echovirus 7 | 1 x 105 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Echovirus 9 | 1 x 10° TCID50/mL | 100% (3/3) | 100% (3/3) |
| Echovirus 11 | 1 x 10 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Enterobacter aerogenes Z052 | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Enterobacter cloacae | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Enterococcus faecalis vanB | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Enterovirus 70 | 1 x 105 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Enterovirus 71 | 1 x 10 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Epstein-Barr Virus | 1 x 10° copies/mL | 100% (3/3) | 100% (3/3) |
| Escherichia coli | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Fusobacterium necrophorum | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Haemophilus influenzae | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Haemophilus parainfluenzae | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| HSV-1 (MacIntyre) | 1 x 105 TCID50/mL | 100% (3/3) | 100% (3/3) |
| HSV-2 (G) | 1 x 10 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Influenza A/Swine/lowa/15/30
H1N1* | 1 x 104 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Organism | Concentration | Bordetella
pertussis (IS481)
% Detection
(# Detected/# Tested) | Bordetella
parapertussis (IS1001)
% Detection
(# Detected/# Tested) |
| Influenza B/Malaysia/2506/04* | 1 x 104 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Klebsiella oxytoca | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Klebsiella pneumoniae | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Lactobacillus acidophilus | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Lactobacillus plantarum 17-5 | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Legionella longbeachae | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Legionella pneumophila
(Philadelphia) | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Listeria monocytogenes | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Measles | 1 x 105 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Metapneumovirus-9 | 1 x 105 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Moraxella catarrhalis Ne 11 | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Morganella morganii | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Mumps | 1 x 105 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Mycobacterium avium | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Mycobacterium tuberculosis
(genomic DNA) | 1 x 106 genome
copies/mL | 100% (3/3) | 100% (3/3) |
| Mycoplasma hominis | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Mycoplasma pneumoniae Strain
M129 | 1 x 106 CCU/mL | 100% (3/3) | 100% (3/3) |
| Neisseria elongata | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Neisseria gonorrhoeae | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Neisseria meningitidis | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Neisseria mucosa | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Parainfluenza 1 | 1 x 105 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Parainfluenza 2 | 1 x 105 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Parainfluenza 3* | 1 x 104 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Parainfluenza 4* | 1 x 104 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Parvimonas micra | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Peptostreptococcus anaerobius | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Proteus mirabilis Z050 | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Proteus vulgaris | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Pseudomonas aeruginosa | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Pseudomonas fluorescens | 1 x 106 CFU/mL | 100% (3/3) | 100% (3/3) |
| Rhinovirus 1A* | 1 x 104 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Organism | Concentration | Bordetella
pertussis (IS481)
% Detection
(# Detected/# Tested) | Bordetella
parapertussis (IS1001)
% Detection
(# Detected/# Tested) |
| RSV A | 1 x 105 TCID50/mL | 100% (3/3) | 100% (3/3) |
| RSV B WV/14617/85 | 1 x 108 TCID50/mL | 100% (3/3) | 100% (3/3) |
| Serratia liquefaciens | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Serratia marcescens | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Staphylococcus aureus (MRSA) | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Staphylococcus epidermidis
(MRSE) | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Stenotrophomonas maltophilia | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Streptococcus anginosus | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Streptococcus canis | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Streptococcus dysgalactiae | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Streptococcus intermedius | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Streptococcus mitis | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Streptococcus mutans | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Streptococcus pneumoniae | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Streptococcus pyogenes M1 | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Streptococcus salivarius | 1 x 10° CFU/mL | 100% (3/3) | 100% (3/3) |
| Ureaplasma urealyticum | 1 x 10° CCU/mL | 100% (3/3) | 100% (3/3) |
| Varicella Zoster Virus* | 1 x 104 TCID50/mL | 100% (3/3) | 100% (3/3) |

17

Image /page/17/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo consists of a green and blue DNA helix graphic on the left, with the text "DiaSorin" in dark blue on the top right and "Molecular" in green below it. The text is in a serif font and is aligned to the right of the DNA helix graphic.

510(k) Summary

Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 August 7, 2018 Page 15 of 17

18

Image /page/18/Picture/0 description: The image shows 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 a dark blue serif font, with the word "Molecular" underneath in a lighter green sans-serif font.

510(k) Summary

Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 August 7, 2018
Page 16 of 17

19

Image /page/19/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo features a stylized DNA strand in shades of green and blue on the left. To the right of the DNA strand are the words "DiaSorin" in dark blue on the top line and "Molecular" in green on the bottom line.

510(k) Summary

Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 August 7, 2018 Page 17 of 17

The testing concentration of these viruses is lower due to the lack of a high titer stock.

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.