(29 days)
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 nasopharyngeal swab (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™ 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.
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 provided text details the 510(k) summary for the Simplexa™ Bordetella Direct and Simplexa™ Bordetella Positive Control Pack, specifically focusing on the update to include fresh nasopharyngeal swab (NPS) samples. While the document mentions "acceptance criteria" and "design inputs" for the validation, it does not explicitly state the quantitative acceptance criteria for device performance (e.g., specific thresholds for PPA and NPA) in the provided sections. Instead, it presents the results of the clinical studies.
However, based on the provided data, we can infer that 100% PPA and a high NPA (above 95%) were considered acceptable, given the reported results.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As stated, the document does not explicitly list the acceptance criteria as specific numerical targets for PPA and NPA (e.g., "PPA must be ≥ 95%"). However, the reported performance is provided. We can infer that the observed performance was deemed acceptable by the FDA for the device's clearance.
| Metric (for Bordetella pertussis) | Acceptance Criteria (inferred, as not explicitly stated) | Reported Device Performance |
|---|---|---|
| Positive Percent Agreement (PPA) | High agreement (e.g., ≥90% or 100%) | 100.0% (36/36) |
| Negative Percent Agreement (NPA) | High agreement (e.g., ≥95%) | 97.9% (326/333) |
| Metric (for Bordetella parapertussis) | Acceptance Criteria (inferred, as not explicitly stated) | Reported Device Performance |
|---|---|---|
| Positive Percent Agreement (PPA) | High agreement (e.g., ≥90% or 100%) | 100.0% (2/2) |
| Negative Percent Agreement (NPA) | High agreement (e.g., ≥95%) | 100.0% (174/174) |
Note: The confidence intervals are provided in the source document but are not included in this table for brevity.
2. Sample Size Used for the Test Set and Data Provenance
Bordetella pertussis (Fresh Samples):
- Sample Size: 369 evaluable fresh samples.
- Data Provenance: Prospectively collected from five (5) geographically diverse sites in the US (inferred, as it's an FDA submission for a US company) from May 2018 to October 2018, from patients with signs and symptoms of Bordetella infection.
Bordetella parapertussis (Fresh Samples):
- Sample Size: 176 evaluable fresh samples (out of 178 collected).
- Data Provenance: Prospectively collected from six (6) geographically diverse sites in the US (inferred) between July 2017 and August 2017, from patients with signs and symptoms of Bordetella infections.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts or their qualifications used to establish the ground truth.
4. Adjudication Method for the Test Set
- For B. pertussis (Table 3): The reference method was an "FDA Cleared NAAT" (Nucleic Acid Amplification Test). The document does not describe the adjudication method if results between different reference tests varied or whether a composite ground truth derived from multiple tests was used, other than referencing a single FDA cleared NAAT.
- For B. parapertussis (Table 4): The reference method was a "composite reference method" consisting of "two well-characterized real-time PCR assays followed by confirmation of positive PCR amplification products with bidirectional 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. This describes an adjudication method that combines results from multiple tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) test for qualitative detection of nucleic acids, not an imaging device requiring human reader interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the performance presented is standalone algorithm performance. The Simplexa™ Bordetella Direct assay is an automated real-time PCR assay performed on the LIAISON® MDX instrument, which provides automated test interpretation and report generation. There is no human-in-the-loop performance described for the diagnostic decision-making process based on the assay's output.
7. The Type of Ground Truth Used
- For B. pertussis (Table 3): The ground truth was established by an "FDA Cleared reference method testing."
- For B. parapertussis (Table 4): The ground truth was established by a "composite reference method" combining two well-characterized real-time PCR assays and bidirectional sequencing confirmation. This is a form of expert-defined molecular diagnostic ground truth.
8. The Sample Size for the Training Set
The document does not provide information on a specific training set size. The studies described are for "Method Comparison" using prospectively collected samples, which typically serve as validation or test sets for device performance rather than training sets. For molecular diagnostic assays like this, the "training" usually involves optimizing primer/probe design and assay conditions, which isn't described in terms of a "training set" with ground truth in the same way an AI/ML model would be.
9. How the Ground Truth for the Training Set was Established
As no training set is described in the provided document, the method for establishing its ground truth is also not applicable/not provided.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
December 19, 2018
DiaSorin Molecular LLC Sharon Young Principal Regulatory Affairs Specialist 11331 Valley View Street Cypress, California 90630
Re: K183223
Trade/Device Name: Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: Class II Product Code: OZZ, OOI Dated: November 16, 2018 Received: November 20, 2018
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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,
Steven R. Gitterman -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
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Indications for Use
510(k) Number (if known) K183223
Device Name
Simplexa™ Bordetella Direct MOL2750 and Simplexa™ Bordetella Positive Control Pack MOL2760
Indications for Use (Describe)
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 parapertussis nucleic acids from nasopharyngeal swab (NPS) specimens 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 with respiratory infection caused by B. pertussis, B. holmesii or B. bronchiseptica may vield positive test results in 19481 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. bronchisentica 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 prectude Bordetella infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the SimplexalM 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/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 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 company focused on molecular diagnostics or related fields.
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510(k) Summary
Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 November 16, 2018 Page 1 of 7
| Applicant | DiaSorin Molecular LLC.11331 Valley View StreetCypress, California 90630USA |
|---|---|
| Establishment Registration No. | 2023365 |
| Contact Person | Sharon Young, Principal Regulatory Affairs Specialisttel 562.240.6680fax 562.240.6529Sharon.Young@DiaSorin.com |
| Summary Date | November 6, 2018 |
| Proprietary Name | SimplexaTM Bordetella Direct and SimplexaTM Bordetella PositiveControl Pack |
| Generic Name | Bordetella nucleic acid |
| Classification | Class II |
| Predicate Devices | SimplexaTM Bordetella Direct (K173498) |
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 nasopharyngeal swab (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 quidelines.
Neqative 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 Simplexa™ Bordetella Direct assay, the LIAISON® MDX (with LIAISON® MDX Studio Software), the Direct Amplification Disc and associated accessories.
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Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 November 16, 2018
Page 2 of 7
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.
Kit Description
| Component Name | REF | EC SYMBOLON LABEL | AbbreviatedName | CapColor | Numberof Vials | Reactionsper Vial/Kit | Volumeper Vial | |
|---|---|---|---|---|---|---|---|---|
| Simplexa™Bordetella DirectReaction Mix | MOL2751 | REAG | A | RM | Brown | 24 | 1/24 | 50 μL |
| Kit Component | Component Description | ||||
|---|---|---|---|---|---|
| Contents | |||||
| Simplexa™Bordetella DirectReaction Mix (RM) | DNA polymerase, buffer, dNTPs, Internal Control template DNA, dye-labeled fluorescent probes and primersspecific for detection of Bordetella pertussis, Bordetella parapertussis and DNA Internal Control | ||||
| Target | ProbeFluorophore(Dye) | Excitation (nm) | Emission (nm) | TargetedGene | |
| Bordetella pertussis | FAM | 495 | 520 | IS481 | |
| Bordetellaparapertussis | CFR610 | 590 | 610 | IS1001 | |
| DNA Internal Control | Q670 | 644 | 670 | DNA IC | |
| Simplexa™Bordetella KitBarcode Card | Assay specific parameters |
MATERIALS SUPPLIED SEPARATELY
- Direct Amplification Disc Kit (REF MOL1455)
Direct Amplification Discs for use on the LIAISON® MDX a.
Simplexa™ Bordetella Positive Control Pack REF MOL2760
| Component Name | REF | Description | Cap Color | Number of Vials | Reactions per Vial/Kit | Volume per Vial |
|---|---|---|---|---|---|---|
| Simplexa™ Bordetella Direct Positive Control | MOL2761 | Inactivated Bordetella bacteria | Red | 10 | 1/10 | 100 μL |
Direct Amplification Disc kit REF MOL1455
| Component Name | REF | Description | Number ofDiscs | Reactionsper Disc/Kit |
|---|---|---|---|---|
| Direct Amplification Disc | MOL1452 | Direct Amplification Disc for theprocessing of up to 8 individual controlsor specimens | 3 | 8/24 |
Component Description
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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 dark blue above the word "Molecular" in green on the right. The logo is clean and modern, with a focus on the company's expertise in molecular diagnostics.
510(k) Summary Simplexa™ Bordetella Direct Catalog Ńo. MOL2750
Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 November 16, 2018 Page 3 of 7
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Predicate Device Information
Table 1, Differences
| Item | Device | |
|---|---|---|
| Name | K173498Simplexa™ Bordetella DirectREF MOL2750AndSimplexa™ Bordetella Positive ControlPack REF MOL2760 | Candidate DeviceSimplexa™ Bordetella DirectREF MOL2750AndSimplexa™ Bordetella Positive Control PackREF MOL2760 |
| Intended Use | Simplexa™ Bordetella DirectThe DiaSorin Molecular Simplexa™ BordetellaDirect assay is an in vitro diagnostic testintended for use on the LIAISON® MDXinstrument for the qualitative detection anddifferentiation of Bordetella pertussis andBordetella parapertussis nucleic acids fromfrozen nasopharyngeal (NPS) specimens frompatients with signs and symptoms ofBordetella infection of the respiratory tract.The Simplexa™ Bordetella Direct assay isperformed on the LIAISON® MDX instrumentand utilizes real-time PCR amplification todetect B. pertussis by targeting the IS481insertional element of the B. pertussis genomeand to detect B. parapertussis by targeting theIS1001 insertional element of the B.parapertussis genome. The IS481 insertionalelement can also be present in B. holmesii andB. bronchiseptica . Specimens collected frompatients with respiratory infection caused by B.pertussis , B. holmesii or B. bronchisepticamay yield positive test results in IS481 assays.B. holmesii infection may cause clinical illnesssimilar to B. pertussis , and mixed outbreaksinvolving both B. pertussis and B. holmesiiinfection have been reported. Additionaltesting should be performed if necessary todifferentiate B. holmesii and B. pertussis . B.bronchiseptica is a rare cause of infection inhumans. When clinical factors suggest that B.pertussis may not be the cause of respiratoryinfection, other clinically appropriateinvestigation(s) should be carried out in | Simplexa™ Bordetella DirectThe DiaSorin Molecular Simplexa™ BordetellaDirect assay is an in vitro diagnostic test intendedfor use on the LIAISON® MDX instrument for thequalitative detection and differentiation ofBordetella pertussis and Bordetella parapertussisnucleic acids from frozen nasopharyngeal (NPS)specimens from patients with signs and symptomsof Bordetella infection of the respiratory tract.The Simplexa™ Bordetella Direct assay isperformed on the LIAISON® MDX instrument andutilizes real-time PCR amplification to detect B.pertussis by targeting the IS481 insertionalelement of the B. pertussis genome and to detectB. parapertussis by targeting the IS1001insertional element of the B. parapertussisgenome. The IS481 insertional element can alsobe present in B. holmesii and B. bronchiseptica .Specimens collected from patients with respiratoryinfection caused by B. pertussis , B. holmesii or B.bronchiseptica may yield positive test results inIS481 assays. B. holmesii infection may causeclinical illness similar to B. pertussis , and mixedoutbreaks involving both B. pertussis and B.holmesii infection have been reported. Additionaltesting should be performed if necessary todifferentiate B. holmesii and B. pertussis . B.bronchiseptica is a rare cause of infection inhumans. When clinical factors suggest that B.pertussis may not be the cause of respiratoryinfection, other clinically appropriateinvestigation(s) should be carried out inaccordance with published guidelines.Negative results for the Simplexa™ Bordetella |
| Item | Device | |
| Name | K173498Simplexa™ Bordetella DirectREF MOL2750AndSimplexa™ Bordetella Positive ControlPack REF MOL2760 | Candidate DeviceSimplexa™ Bordetella DirectREF MOL2750AndSimplexa™ Bordetella Positive Control PackREF MOL2760 |
| accordance with published guidelines.Negative results for the Simplexa™ BordetellaDirect assay do not preclude Bordetellainfection and positive results do not rule outco-infection with other respiratory pathogens.Results from the Simplexa™ Bordetella Directassay should be used with other clinicalfindings and epidemiological information as anaid in diagnosis of Bordetella infection. Testresults should not be used as the sole basisfor treatment or other patient managementdecisions. | Direct assay do not preclude Bordetella infectionand positive results do not rule out co-infectionwith other respiratory pathogens. Results from theSimplexa™ Bordetella Direct assay should beused with other clinical findings andepidemiological information as an aid in diagnosisof Bordetella infection. Test results should not beused as the sole basis for treatment or otherpatient management decisions. | |
| Physical stateof the naso-pharyngealswab sample | Frozen | Fresh and Frozen |
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Image /page/7/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 DNA helix are the words "DiaSorin" in a dark blue, sans-serif font, stacked above the word "Molecular" in a lighter green, sans-serif font.
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510(k) Summary
Simplexa™ Bordetella Direct Catalog Ńo. MOL2750
Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 November 16, 2018
Page 4 of 7
Table 2. Similarities
| Item | Device | |
|---|---|---|
| Name | K173498Simplexa™ Bordetella DirectREF MOL2750AndSimplexa™ Bordetella Positive ControlPack REF MOL2760 | Candidate DeviceSimplexa™ Bordetella DirectREF MOL2750AndSimplexa™ Bordetella Positive Control PackREF MOL2760 |
| AssayTargets | The Simplexa™ Bordetella Direct assaydetects the following multi-copy insertionsequence targets: Bordetella pertussis targetIS481 and Bordetella parapertussis targetIS1001. | Same |
| Item | Device | |
| Name | K173498Simplexa™ Bordetella DirectREF MOL2750AndSimplexa™ Bordetella Positive Control Pack REF MOL2760 | Candidate DeviceSimplexa™ Bordetella DirectREF MOL2750AndSimplexa™ Bordetella Positive Control PackREF MOL2760 |
| Sample Types | Nasopharyngeal swabs in Remel M4, Remel M4RT, Remel M5, Remel M6, UTM, VTM and Liquid Aimes (ESwab). | Same |
| Instrument | LIAISON® MDX Instrument with LIAISON® MDX Studio Software | Same |
| Extraction Methods | None | Same |
| Assay Methodology | PCR-based system for detecting the presence / absence of Bordetella pertussis and Bordetella parapertussis DNA in clinical specimens. | Same |
| Detection Techniques | Multiplex assay using different reporter dyes for each target. | Same |
| Optical Detection | Fluorescence | Same |
| Time to result | Approximately 1 hour | Same |
| Test Interpretation | Automated test interpretation and report generation | Same |
| Simplexa™ Bordetella Positive Control Pack (MOL2760) | 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. | Same |
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Image /page/8/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 helix are the words "DiaSorin" in dark blue, with the word "Molecular" underneath in green. The logo is clean and modern, suggesting a company focused on molecular diagnostics or related fields.
Image /page/8/Picture/1 description: The image contains a large, bold, black letter 'K' on a white background. The letter is in uppercase and appears to be a sans-serif font. The letter is positioned slightly to the left within the frame.
Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 November 16, 2018
Page 5 of 7
METHOD COMPARISON
Fresh Bordetella pertussis and Bordetella parapertussis Samples
Three hundred and sixty-nine (369) evaluable fresh Bordetella pertussis samples were prospectively collected from five (5) geographically diverse sites from May 2018 to October 2018, from patients with signs and symptoms of Bordetella infection. All three hundred and sixty-nice (369) samples were tested on the Simplexa™ Direct at five (5) collection sites and an FDA Cleared reference method testing was performed at two (2) collection sites within seventy-two (72) hours of collection. The Bordetella pertussis prospectively collected fresh sample results are shown in Table 3.
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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 helix are the words "DiaSorin" in a dark blue, sans-serif font, stacked above the word "Molecular" in a lighter green, sans-serif font.
Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 November 16, 2018 Page 6 of 7
Table 3. Simplexa™ Bordetella Direct Bordetella pertussis Results Versus FDA Cleared NAAT Prospectively Collected Fresh Samples
| Simplexa™Bordetella Direct B. pertussis | FDA Cleared NAAT | ||
|---|---|---|---|
| Detected | Not Detected | Total | |
| Detected | 36 | 7 | 43 |
| Not Detected | 0 | 326 | 326 |
| Total | 36 | 333 | 369 |
| %PPA100.0 %(36/36)95% CI: 90.4% to 100.0% | %NPA97.9%(326/333)95% CI: 95.7% to 99.0% |
One hundred and seventy-eight (178) samples were prospectively collected fresh six (6) geographically diverse sites between July 2017 and August 2017. from patients with signs and symptoms of Bordetella infections. Of the one hundred and seventy-eight (178) samples, one hundred and seventy-six (176) samples were evaluable on Simplexa™ Bordetella 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 bidirectional 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 Bordetussis prospectively collected fresh sample results are shown in Table 4.
Table 4 Simplexa™ Bordetella Direct Bordetella parapertussis results versus PCR/Bi-Directional Sequencing Method Prospectively Collected Fresh Samples
| Simplexa™Bordetella DirectB. parapertussis | PCR/Bi-directional Sequencing | ||
|---|---|---|---|
| Detected | Not Detected | Total | |
| Detected | 2 | 0 | 2 |
| Not Detected | 0 | 174 | 174 |
| Total | 2 | 174 | 176 |
| %PPA100.0%(2/2)95% CI: 34.2% to 100.0% | %NPA100.0%(174/174)95% CI: 97.8% to 100.0% |
REPRODUCIBILITY
There have been no changes since K173498.
ANALYTICAL SENSITIVITY/LIMIT OF DETECTION
There have been no changes since K173498.
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Simplexa™ Bordetella Direct Catalog No. MOL2750 Simplexa™ Bordetella Positive Control Pack Catalog No. MOL2760 November 16, 2018 Page 7 of 7
ANALYTICAL REACTIVITY / CROSS REACTIVITY
Analytical Reactivity
There have been no changes since K173498.
Cross Reactivity (Analytical Specificity)
There have been no changes since K173498.
INTERFERENCE
There have been no changes since K173498.
COMPETITIVE INTERFERENCE
There have been no changes since K173498.
INHIBITION BY OTHER MICROORGANISMS
There have been no changes since K173498.
SUMMARY OF DESIGN CONTROL ACTIVITIES
Design controls in accordance with 21 CFR 820.30 were conducted to update the sample state ffrom frozen nasopharyngeal swabs (NPS) to fresh and frozen nasopharyngeal swabs NPS)] that can be used with the Simplexa™ Bordetella Direct. Validation included protocols with defined acceptance criteria (design inputs), conducting a clinical study and documenting the results of the clinical study to predetermined acceptance criteria (design outputs). The results of the validation show the data met the acceptance criteria and that performance of the Simplexa™ Bordetella using fresh samples was not affected.
The expanded sample type was assessed using risk management included Application FMEA, Process FMEA, and Design FMEA. For each FMEA the risk analysis included risk analysis of failure modes, potential hazards (harm) Severity, potential cause of the failure, occurrence, risk control measure, residual risk acceptability and clinical risk.
A declaration of conformity to design controls in accordance to 21 CFR 820.30 is included in the K18XXXX Simplexa™ Bordetella Direct MOL2750 and Simplexa™ Bordetella Positive Control Pack MOL2760 Special 510(k) submission. The declaration of conformity was signed by the individuals responsible for the activities.
§ 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.