510(k) K170284
K170284 is an FDA 510(k) premarket notification submitted by Great Basin Scientific, Inc. for the device "Great Basin Bordetella Direct Test". The FDA issued a decision of Substantially Equivalent on March 31, 2017. The device falls under product code OZZ (Bordetella Pertussis Dna Assay System), a Class II device regulated under 21 CFR 866.3980. Great Basin Scientific, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2017
- Date Received
- January 30, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bordetella Pertussis Dna Assay System
- Device Class
- Class II
- Regulation Number
- 866.3980
- Review Panel
- MI
- Submission Type
A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.