510(k) DEN180047
DEN180047 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "Aptima Mycoplasma genitalium Assay". The FDA issued a decision of De Novo granted on Jan 23, 2019. The device falls under product code QEP (Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections), a Class II device regulated under 21 CFR 866.3393. Hologic, Inc. has 119 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo granted)
- Decision Date
- Jan 23, 2019
- Date Received
- Aug 31, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
- Device Class
- Class II
- Regulation Number
- 866.3393
- Review Panel
- MI
- Submission Type
- 510(k)
A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data.