illumigene Mycoplasma DNA Amplification Assay
Device Facts
| Record ID | K152800 |
|---|---|
| Device Name | illumigene Mycoplasma DNA Amplification Assay |
| Applicant | Meridian Bioscience, Inc. |
| Product Code | OZX · Microbiology |
| Decision Date | Oct 23, 2015 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 866.3980 |
| Device Class | Class 2 |
Indications for Use
The illumigene Mycoplasma DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat and nasopharyngeal swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The illumigene Mycoplasma assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome. Results from the illumigene Mycoplasma DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management. Positive results do not rule out co-infection with other organisms and negative results in persons with respiratory tract infections may be due to pathogens not detected by this assay. Lower respiratory tract infections due to M. pneumoniae may not be detected by this assay. If lower respiratory tract infection due to M. pneumoniae is suspected, additional laboratory testing using methods other than the illumigene Mycoplasma DNA Amplification Assay may be necessary. illumigene Mycoplasma is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.
Device Story
The illumigene Mycoplasma DNA amplification assay is an in vitro diagnostic test for detecting Mycoplasma pneumoniae DNA in throat and nasopharyngeal swabs. The device utilizes loop-mediated isothermal DNA amplification (LAMP) technology to target specific genomic segments of M. pneumoniae. The assay is performed on the illumipro-10 instrument, which automates the amplification and detection process. It is intended for use by laboratory professionals in hospital, reference, or state laboratory settings. The output is a qualitative result used by clinicians alongside clinical presentation and other laboratory findings to aid in diagnosing M. pneumoniae infection. It is not intended as the sole basis for patient management. The device benefits patients by providing a rapid, specific molecular diagnostic tool for identifying M. pneumoniae in upper respiratory tract samples.
Clinical Evidence
No clinical data provided in the document. The document focuses on the regulatory clearance of the assay as a qualitative in vitro diagnostic test.
Technological Characteristics
The device utilizes loop-mediated isothermal DNA amplification (LAMP) technology. It is designed for use with the illumipro-10 instrument. The assay is a qualitative nucleic acid amplification test (NAAT) for the detection of M. pneumoniae DNA. It is intended for professional use in centralized laboratory environments.
Indications for Use
Indicated for qualitative detection of Mycoplasma pneumoniae DNA in human throat and nasopharyngeal swabs from patients suspected of M. pneumoniae infection. Not for point-of-care 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.
