K143178 is an FDA 510(k) clearance for the FilmArray 2.0 System. This device is classified as a Instrumentation For Clinical Multiplex Test Systems (Class II - Special Controls, product code NSU).
Submitted by Biofire Diagnostics, LLC (Salt Lake City, US). The FDA issued a Cleared decision on January 30, 2015, 87 days after receiving the submission on November 4, 2014.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.2570. 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.
| 510(k) Number | K143178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2014 |
| Decision Date | January 30, 2015 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | NSU — Instrumentation For Clinical Multiplex Test Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.2570 |
| 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 |