NSU — Instrumentation For Clinical Multiplex Test Systems Class II
Classification Details
- Product Code
- NSU
- Device Class
- Class II
- Regulation Number
- 862.2570
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K163652 | genmark diagnostics, incorporated | ePlex Instrument | June 9, 2017 |
| K143178 | biofire diagnostics | FilmArray 2.0 System | January 30, 2015 |
| K133849 | liposcience | VANTERA CLINICAL ANALYZER | October 22, 2014 |
| K141220 | thermo fisher scientific (life technologies holdin | APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE | May 22, 2014 |
| K133302 | luminex | FLEXMAP 3D | January 10, 2014 |
| K121399 | luminex | LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP | January 9, 2013 |
| K110786 | genmark diagnostics | ESENSOR WARFARIN SENSITIVITY SALIVA TEST | December 2, 2011 |
| K093128 | illumina | ILLUMINA BEADXPRESS SYSTEM | April 28, 2010 |
| K082562 | applied biosystems | APPLIED BIOSYSTEMS 7500 FAST DX | September 30, 2008 |
| K080995 | affymetrix | MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM | July 30, 2008 |
| K073506 | luminex | LUMINEX LX 100/200 INSTRUMENT | March 7, 2008 |
| K070597 | nanosphere | VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC A | October 11, 2007 |
| DEN040012 | affymetrix | AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM | December 23, 2004 |