ProParaFlu+ Assay
Device Facts
| Record ID | K153223 |
|---|---|
| Device Name | ProParaFlu+ Assay |
| Applicant | Hologic, Inc. |
| Product Code | OOU · Microbiology |
| Decision Date | Dec 9, 2015 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 866.3980 |
| Device Class | Class 2 |
Indications for Use
The Prodesse® ProParaflu®+ Assay is a multiplex Real-Time PCR (RT-PCR) in vitro diagnostic test for the qualitative detection and discrimination of Parainfluenza 1 Virus, Parainfluenza 2 Virus and Parainfluenza 3 Virus (HPIV-1, HPIV-2 and HPIV-3) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections. This Assay targets the conserved regions of the Hemagglutinin-Neuraminidase (HN) gene of HPIV-1, HPIV-2 and HPIV-3, respectively. The detection and discrimination of HPIV-1, HPIV-2 and HPIV-3 nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings. This test is not intended to detect Parainfluenza 4a or Parainfluenza 4b Viruses. Negative test results are presumptive and should be confirmed by cell culture. Negative results do not preclude Parainfluenza 1, 2 or 3 virus infections and should not be used as the sole basis for treatment or other management decisions.
Device Story
The ProParaflu+ Assay is a multiplex RT-PCR diagnostic test for identifying HPIV-1, HPIV-2, and HPIV-3. Input consists of nasopharyngeal swab specimens collected in viral transport medium. A Universal Internal Control is added to monitor for inhibitors. Nucleic acids are isolated using either the Roche MagNA Pure LC or bioMérieux NucliSENS easyMAG system. Purified nucleic acids are combined with ProParaflu+ Supermix containing target-specific primers and dual-labeled probes. The Cepheid SmartCycler II instrument performs reverse transcription and PCR amplification. Taqman chemistry utilizes 5'-3' exonuclease activity to cleave probes, releasing reporter dyes and increasing fluorescent signal proportional to amplification. The instrument monitors fluorescence in real-time. Results are interpreted by laboratory personnel to aid in clinical diagnosis of respiratory infections. The assay provides qualitative detection; negative results are presumptive and require confirmation by cell culture. The device is intended for use in clinical laboratory settings.
Clinical Evidence
No clinical data provided. The submission relies on bench testing and analytical performance characterization, including the identification of limited reactivity with specific viral variants (CAP samples ID2-08 and ID2-02) via sequencing analysis.
Technological Characteristics
Multiplex nucleic acid amplification assay. Analyte: RNA. Instrumentation: bioMérieux NucliSENS easyMAG or Roche MagNA Pure (extraction) and Cepheid SmartCycler II (amplification). Controls: Internal control per sample; external control per batch. Time to result: ~4 hours.
Indications for Use
Indicated for the qualitative detection of HPIV-1, HPIV-2, and HPIV-3 RNA in nasopharyngeal swab specimens.
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.
