Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

K183223 · Diasorin Molecular, LLC · OZZ · Dec 19, 2018 · Microbiology

Device Facts

• Record ID: K183223
• Device Name: Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
• Applicant: Diasorin Molecular, LLC
• Product Code: OZZ · Microbiology
• Decision Date: Dec 19, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3980
• Device Class: Class 2

Indications for Use

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. 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 Story

The Simplexa Bordetella Direct assay is a real-time PCR-based in vitro diagnostic test for the qualitative detection and differentiation of B. pertussis and B. parapertussis DNA. It processes unprocessed nasopharyngeal swab (NPS) specimens directly without nucleic acid extraction. The device operates on the LIAISON MDX instrument, which performs amplification and optical detection using fluorescent probes targeting the IS481 (B. pertussis) and IS1001 (B. parapertussis) insertional elements, plus an internal control. The system provides automated test interpretation and report generation. It is intended for use in clinical laboratory settings by trained personnel. Results are used alongside clinical and epidemiological data to aid in the diagnosis of Bordetella infection; they are not intended as the sole basis for patient management. The device benefits patients by providing rapid (approx. 1 hour) molecular confirmation of infection, facilitating timely clinical decision-making.

Clinical Evidence

Prospective study of 369 fresh NPS samples across 5 sites. Compared investigational Simplexa Bordetella Direct assay against Quidel AmpliVue reference method. Results: PPA 100.0% (95% CI: 90.4-100.0%); NPA 97.9% (95% CI: 95.7-99.0%).

Technological Characteristics

Real-time PCR assay; direct amplification without extraction. Targets: IS481 (B. pertussis, FAM dye, 495/520 nm), IS1001 (B. parapertussis, CFR610 dye, 590/610 nm), and DNA Internal Control (Q670 dye, 644/670 nm). Instrument: LIAISON MDX with LIAISON MDX Studio Software. Form factor: Direct Amplification Disc. Connectivity: Standalone instrument.

Indications for Use

Indicated for qualitative detection and differentiation of B. pertussis and B. parapertussis nucleic acids in nasopharyngeal swab (NPS) specimens from patients of any age presenting with signs and symptoms of respiratory tract Bordetella infection.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Simplexa Bordetella Direct (K173498)

Submission Summary (Full Text)

{0}

1

# SPECIAL 510(K): DEVICE MODIFICATION

## OIR DECISION SUMMARY

510(k) Number: K183223

This 510(k) submission contains information/data on modifications made to the applicant’s own class II or class I devices requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the applicant’s previously cleared device.

| 510(k) Number | Device Name | Clearance Date |
| --- | --- | --- |
| K173498 | Simplexa Bordetella Direct | 08/13/18 |

2. Applicant’s statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

This change was for the removal of the frozen specimen limitation.

3. There were no device MODIFICATION(S) made. Since no modifications were made, sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the device has not changed.

4. Comparison Information (similarities and differences) to applicant’s legally marketed predicate device including, labeling, intended use, physical characteristics, and comparison studies.

There were no changes to the device other than labeling for sample type as shown in Table 1. Justification for the added sample type is displayed in Table 2. Briefly, four hundred and sixty samples were prospectively collected from 5 sites from 14 MAY 2018 to 10 OCT 2018. Three samples were discarded for being handled outside of the Instructions for Use. Another 88 samples were discarded for various other disqualifying situations. The remaining 369 samples were tested with the investigational Simplexa Bordetella Direct assay and the Quidel AmpliVue as a reference method. The results of fresh sample testing for B. pertussis are presented in the table below.

Table 1. Proposed and Predicate device comparison.

| Device & Predicate Device(s): | K183223 (proposed) | K173498 (predicate) |
| --- | --- | --- |
| General Device Characteristics | | |
| 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 | 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 |

{1}

| Device & Predicate Device(s): | K183223 (proposed) | K173498 (predicate) |
| --- | --- | --- |
| | detection and differentiation of Bordetella pertussis and Bordetella parapertussis nucleic acids from 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. | 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. |

2

{2}

3

| Device & Predicate Device(s): | K183223 (proposed) | K173498 (predicate) |
| --- | --- | --- |
| | 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. | 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. |
| Specimen Type | Fresh and Frozen NPS | Frozen NPS |

Table 2. New comparison study data.

| | Quidel AmpliVue | | |
| --- | --- | --- | --- |
| Simplexa | | | |
| Detected | 36 | 7 | 43 |
| Not Detected | 0 | 326 | 326 |
| Total | 36 | 333 | 369 |
| | % PPA: 100.0% (36/36)
95% CI: 90.4 to 100.0% | %NPA 97.9% (326/333)
95% CI: 95.7 to 99.0% | |

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the applicant’s description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The applicant has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.