K093383 is an FDA 510(k) clearance for the NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG. This device is classified as a Real Time Nucleic Acid Amplification System (Class II - Special Controls, product code OOI).
Submitted by bioMerieux, Inc. (Durham, US). The FDA issued a Cleared decision on July 6, 2010, 249 days after receiving the submission on October 30, 2009.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.2570. The System Is A Clinical Multiplex Instrument Intended To Measure And Sort Multiple Signals Generated My Multiple Probes, Intercalating Dyes, Or Other Ligands In An Assay From A Clinical Sample. Signals May Be Generated By Fluorescence Or Other Phenomena And May Be Measured Using Filters On A Photodiode Or Other Detector. It May Integrate Sample And/or Reagent Handling, Amplification, Dedicated Instrument Control, Data Acquisition Software, Raw Data Storage Mechanisms And Other Essential Hardware Components Along With The Signal Reader Unit. The System Is Used With Specific Assays To Comprise An Assay Test System..
| 510(k) Number | K093383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2009 |
| Decision Date | July 06, 2010 |
| Days to Decision | 249 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OOI — Real Time Nucleic Acid Amplification System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.2570 |
| Definition | The System Is A Clinical Multiplex Instrument Intended To Measure And Sort Multiple Signals Generated My Multiple Probes, Intercalating Dyes, Or Other Ligands In An Assay From A Clinical Sample. Signals May Be Generated By Fluorescence Or Other Phenomena And May Be Measured Using Filters On A Photodiode Or Other Detector. It May Integrate Sample And/or Reagent Handling, Amplification, Dedicated Instrument Control, Data Acquisition Software, Raw Data Storage Mechanisms And Other Essential Hardware Components Along With The Signal Reader Unit. The System Is Used With Specific Assays To Comprise An Assay Test System. |