K152800 is an FDA 510(k) clearance for the illumigene Mycoplasma DNA Amplification Assay. 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 October 23, 2015, 25 days after receiving the submission on September 28, 2015.
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 | K152800 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2015 |
| Decision Date | October 23, 2015 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| 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. |