Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument
Device Facts
| Record ID | K163266 |
|---|---|
| Device Name | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument |
| Applicant | Alere Scarborough, Inc. |
| Product Code | OCC · Microbiology |
| Decision Date | Dec 21, 2016 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 866.3980 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K163266 · Dec 21, 2016 | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument | Alere Scarborough, Inc. | Retrospective clinical viral transport media (VTM) samples | Retrospective clinical samples with known influenza status (determined by PCR) were used to evaluate and compare the clinical sensitivity and specificity of the modified Alere i Influenza A & B assay against the current (predicate) assay. | Retrospective clinical samples; Clinical performance comparison; Sensitivity and specificity |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Clinical Sample Evaluation; Retrospective comparative study | Clinical samples with known influenza status; Sample Size: 128 samples | Current Alere i Influenza A & B assay | Sensitivity and specificity for Influenza A and B |
Indications for Use
The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in direct nasal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2012-2013 and the 2014-2015 influenza seasons when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Device Story
Rapid molecular in vitro diagnostic test; utilizes isothermal nucleic acid amplification technology; detects/discriminates influenza A and B viral RNA. Input: direct nasal swabs or nasal/nasopharyngeal swabs eluted in viral transport media. Modification: added molecular beacon to address Flu B strain mismatch; modified sugar excipient for lyophilization. Operation: performed on Alere i Instrument; automated results interpretation; time to result < 15 minutes. Output: qualitative detection of influenza A and B. Used in clinical settings to aid differential diagnosis; results used alongside clinical/epidemiological risk factors. Benefits: rapid identification of influenza A/B to inform patient management.
Clinical Evidence
Retrospective clinical study comparing modified assay to predicate using viral transport media samples (n=128). Flu A sensitivity 88.9%, specificity 100%. Flu B sensitivity 100%, specificity 100%. Invalid rate 0.8%. Bench testing included limit of detection (LoD) equivalency and analytical reactivity (inclusivity) studies across multiple influenza strains, demonstrating superior sensitivity for Flu B compared to predicate.
Technological Characteristics
Isothermal nucleic acid amplification; targets PB2 gene (Flu A) and PA gene (Flu B). Uses molecular beacons with reporter dyes. Automated detection on Alere i Instrument. Lyophilized reagents with modified sugar excipient. Shelf-life validated to at least four months.
Indications for Use
Indicated for patients with signs and symptoms of respiratory infection to aid in the differential diagnosis of influenza A and B viral infections. Not intended for influenza C detection.
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
- Alere™ i Influenza A & B (K151464)
