510(k) K191352
K191352 is an FDA 510(k) premarket notification submitted by Binx Health, Inc. for the device "binx health io CT/NG Assay". The FDA issued a decision of Substantially Equivalent on August 8, 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. Binx Health, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2019
- Date Received
- May 20, 2019
- Clearance Type
- Traditional
- 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
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.