510(k) K110786
K110786 is an FDA 510(k) premarket notification submitted by GenMark Diagnostics, Inc. for the device "ESENSOR WARFARIN SENSITIVITY SALIVA TEST". The FDA issued a decision of Substantially Equivalent on December 2, 2011. The device falls under product code NSU (Instrumentation For Clinical Multiplex Test Systems), a Class II device regulated under 21 CFR 862.2570.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 2011
- Date Received
- March 22, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrumentation For Clinical Multiplex Test Systems
- Device Class
- Class II
- Regulation Number
- 862.2570
- Review Panel
- CH
- Submission Type
Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature for de