K160829 is an FDA 510(k) clearance for the illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10. This device is classified as a Mycoplasma Pneumoniae Dna Assay System (Class II - Special Controls, product code OZX).
Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on June 13, 2016, 80 days after receiving the submission on March 25, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3980. A Qualitative In Vitro Diagnostic Assay Intended To Detect Mycoplasma Pneumoniae Dna Extracted From Human Respiratory Specimens. Detection Of Mycoplasma Pneumoniae Dna Aids In The Diagnosis Of Mycoplasma Pneumoniae Respiratory Infection In Conjunction With Other Clinical And Laboratory Testing In Patients Exhibiting Signs And Symptoms Of Upper Respiratory Tract Infection..
| 510(k) Number | K160829 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2016 |
| Decision Date | June 13, 2016 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OZX — Mycoplasma Pneumoniae Dna Assay System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3980 |
| Definition | A Qualitative In Vitro Diagnostic Assay Intended To Detect Mycoplasma Pneumoniae Dna Extracted From Human Respiratory Specimens. Detection Of Mycoplasma Pneumoniae Dna Aids In The Diagnosis Of Mycoplasma Pneumoniae Respiratory Infection In Conjunction With Other Clinical And Laboratory Testing In Patients Exhibiting Signs And Symptoms Of Upper Respiratory Tract Infection. |