(30 days)
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 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.
Alere™ i Influenza A & B is a rapid, instrument-based isothermal tests for the qualitative detection and differentiation of influenza A and influenza B from nasal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients presenting with signs and symptoms of respiratory infection. The Alere™ i Influenza A & B system utilizes isothermal nucleic acid amplification technology and is comprised of:
- Sample Receiver - single use, disposable containing the elution buffer
- . Test Base - single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet
- Transfer Cartridge - single use, disposable for transfer of the eluted sample to the Test Base, and
- Alere™ i Instrument – repeat use reader
The reaction tubes in the Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. Alere™ i Influenza A & B utilizes a pair of templates (similar to primers) for the specific amplification of RNA from influenza A and B and a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets.
Alere™ i Influenza A & B is performed within the confinement of the Test Base, and no other part of the Alere™ i Instrument has contact with the sample during the amplification process. This reduces the risk of instrument contamination and sample carry-over between measurements.
To perform the assay, the Sample Receiver and Test Base are inserted into the Alere™ i Instrument and the elution buffer is automatically heated by the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating target amplification. Heating and detection by fluorescence is provided by the instrument, with results automatically reported.
Results are displayed by the Alere™ i Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the Alere™ i Instrument by the operator, and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Alere™ Universal Printer can be attached via USB to the Alere™ i Instrument to print test results.
The document describes the Alere™ i Influenza A & B device, a rapid molecular in vitro diagnostic test. The acceptance criteria and the study proving the device meets these criteria are detailed in the provided text, particularly in the section regarding the modifications and comparison to the predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to a predicate device rather than outright acceptance criteria with specific performance thresholds. However, the intent of the study was to show that the modified device performs similarly to the predicate. The "Device Comparison" table implicitly sets the "acceptance criteria" as matching the predicate device's performance for the listed parameters.
| Parameter | Acceptance Criteria (Implicit) | Reported Device Performance (Modified Device) |
|---|---|---|
| FDA Product Code | Same as K151464 (OCC, OZE, OOI) | OCC, OZE, OOI |
| Assay Target | Same as K151464 (Influenza A, Influenza B) | Influenza A, Influenza B |
| Intended Use | Same as K151464 (See detailed description) | Same as K151464 (Detailed description provided) |
| Intended Env for Use | Same as K151464 (Professional use, medical lab or point of care) | Professional use, in a medical laboratory or point of care |
| Instrumentation | Same as K151464 (Alere™ i Instrument) | Alere™ i Instrument |
| Self-Contained System | Same as K151464 (Integrated PC, Software, Touch Screen Display) | Integrated PC, Software, and Touch Screen Display |
| Automated Assay | Same as K151464 (Yes. Sample prep, amplification, detection, result interp.) | Yes. Sample preparation, amplification, detection, and result interpretation. |
| Sample Type | Same as K151464 (Nasal Swab and Nasal or Nasopharyngeal Swabs Eluted in Viral Transport Media) | Nasal Swab and Nasal or Nasopharyngeal Swabs Eluted in Viral Transport Media |
| Influenza A Viral Target | Same as K151464 (PB2 segment) | PB2 segment |
| Influenza B Viral Target | Same as K151464 (PA segment) | PA segment |
| Technology | Same as K151464 (Isothermal nucleic acid amplification) | Isothermal nucleic acid amplification for detecting the presence/absence of viral RNA in clinical specimens |
| Detection Method | Same as K151464 (Different reporter dyes for each target) | Assay uses different reporter dyes for each target |
| Internal Control | Same as K151464 (Yes) | Yes |
| Result Interpretation | Same as K151464 (Automated) | Automated |
| Assay Result | Same as K151464 (Qualitative) | Qualitative |
| Time to Result | Same as K151464 ( |
§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.
(a)
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.
(b)
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.