510(k) DEN190025
DEN190025 is an FDA 510(k) premarket notification submitted by OraSure Technologies, Inc. for the device "OraQuick Ebola Rapid Antigen Test". The FDA issued a decision of De Novo Granted on October 10, 2019. The device falls under product code QID (Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens), a Class II device regulated under 21 CFR 866.4002. OraSure Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 10, 2019
- Date Received
- May 13, 2019
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
- Device Class
- Class II
- Regulation Number
- 866.4002
- Review Panel
- MI
- Submission Type
A device to detect antigens of biothreat microbial agents in human clinical specimens is identified as an in vitro diagnostic device intended for the detection of antigens of microbial agents in specimens collected from patients with signs and symptoms of infection with biothreat microbial agents and who have been exposed to these agents or are suspected or at risk of exposure. Devices to detect antigens of biothreat microbial agents in human clinical specimens may be used for cadaver testing if the cadaver constitutes a source of human-to-human transmission and if testing is performed to prevent human disease.