510(k) DEN200070
DEN200070 is an FDA 510(k) premarket notification submitted by Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) for the device "Simple 2 Test". The FDA issued a decision of De Novo Granted on November 15, 2023. The device falls under product code QYA (System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home), a Class II device regulated under 21 CFR 866.3385.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 15, 2023
- Date Received
- November 16, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
- Device Class
- Class II
- Regulation Number
- 866.3385
- Review Panel
- MI
- Submission Type
This device is an in vitro diagnostic system intended for self-collecting specimens in home settings or similar environments and testing in a clinical laboratory for detection of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections. The device is intended to aid in the diagnosis of sexually transmitted infections. The device is intended for prescription use or over-the-counter use.