ID NOW Influenza A & B 2
Device Facts
| Record ID | K190204 |
|---|---|
| Device Name | ID NOW Influenza A & B 2 |
| Applicant | Alere Scarborough, Inc. |
| Product Code | OZE · Microbiology |
| Decision Date | Mar 18, 2019 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 866.3980 |
| Device Class | Class 2 |
Indications for Use
The ID NOW Influenza A & B 2 assay performed on the ID NOW 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 or nasopharyngeal 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. 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
ID NOW Influenza A & B 2 is a rapid, instrument-based molecular diagnostic system for detecting influenza A and B. Input: nasal or nasopharyngeal swabs (direct or in transport media). Operation: system uses isothermal nucleic acid amplification technology within a disposable Test Base containing lyophilized reagents. The ID NOW Instrument provides automated heating, mixing, and fluorescence-based detection of amplified RNA targets using molecular beacons. Output: qualitative results displayed on the instrument, stored in an on-board archive, and optionally printed via USB. Used in professional medical laboratories or point-of-care settings by healthcare providers. The device aids in differential diagnosis by providing rapid results to inform clinical decision-making and patient management. The system design, with testing confined to the disposable Test Base, minimizes instrument contamination and carry-over risk.
Clinical Evidence
Bench testing only. The submission is a labeling modification to expand specimen storage instructions; no new clinical performance data was required to support this change.
Technological Characteristics
Isothermal nucleic acid amplification technology; targets PB2 segment (Flu A) and PA segment (Flu B). Instrumentation: ID NOW Instrument. Sample types: nasal/nasopharyngeal swabs (direct or in VTM). Automated result interpretation. Qualitative output. Time to result: ≤13 minutes.
Indications for Use
Indicated for qualitative detection and discrimination of influenza A and B viral RNA in patients with signs and symptoms of respiratory infection. Specimens include direct nasal or nasopharyngeal swabs and swabs eluted in viral transport media. 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 2 (K173932)
