Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

{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.