Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
Device Facts
| Record ID | K173932 |
|---|---|
| Device Name | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 |
| Applicant | Alere Scarborough, Inc. |
| Product Code | OCC · Microbiology |
| Decision Date | Jan 26, 2018 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 866.3980 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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 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
Alere i system performs rapid molecular isothermal nucleic acid amplification for respiratory pathogens (Flu A/B, Strep A, RSV). System comprises disposable Sample Receiver, Test Base (with lyophilized reagents), Transfer Cartridge, and reusable Alere i Instrument. Operator inserts components into instrument; instrument automatically heats elution buffer, mixes sample, and performs isothermal amplification. Fluorescence detection identifies target nucleic acids. Results displayed on instrument, stored in on-board archive, and optionally printed via USB. Used in professional medical labs or point-of-care settings. Software update modifies algorithm to mitigate false invalid results caused by low baseline values misidentified as empty tube values. No changes to assay chemistry.
Clinical Evidence
No clinical data presented; submission is a software modification to address technical performance (false invalid results) of the existing, cleared assay platform.
Technological Characteristics
Isothermal nucleic acid amplification; fluorescence-based detection; automated heating and mixing; disposable sample receiver/test base/cartridge; reusable reader instrument; USB connectivity for printing; software-based qualitative result interpretation.
Indications for Use
Indicated for qualitative detection of influenza A/B viral RNA (nasal/nasopharyngeal swabs), Streptococcus pyogenes (throat swabs), or RSV viral RNA (nasopharyngeal swabs) in patients with respiratory infection symptoms. RSV indication includes children <18 and adults ≥60 years. Negative results do not preclude infection; not for sole diagnostic use.
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 (K163266)
- Alere™ i Strep A (K151690)
- Alere™ i RSV (K161375)
- Alere™ i Influenza A & B 2 (K171792)
