NSU · Instrumentation For Clinical Multiplex Test Systems
Clinical Chemistry · 21 CFR 862.2570 · Class 2
Overview
| Product Code | NSU |
|---|---|
| Device Name | Instrumentation For Clinical Multiplex Test Systems |
| Regulation | 21 CFR 862.2570 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.
The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems."
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K163652 | ePlex Instrument | Genmark Diagnostics, Incorporated | Jun 9, 2017 | SESE |
| K143178 | FilmArray 2.0 System | Biofire Diagnostics, LLC | Jan 30, 2015 | SESE |
| K133849 | VANTERA CLINICAL ANALYZER | Liposcience | Oct 22, 2014 | SESE |
| K141220 | APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE | Thermo Fisher Scientific (Life Technologies Holdin | May 22, 2014 | SESE |
| K133302 | FLEXMAP 3D | Luminex Corp. | Jan 10, 2014 | SESE |
| K121399 | LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P | Luminex Corp. | Jan 9, 2013 | SESE |
| K110786 | ESENSOR WARFARIN SENSITIVITY SALIVA TEST | GenMark Diagnostics, Inc. | Dec 2, 2011 | SESE |
| K093128 | ILLUMINA BEADXPRESS SYSTEM | Illumina, Inc. | Apr 28, 2010 | SESE |
| K082562 | APPLIED BIOSYSTEMS 7500 FAST DX | Applied Biosystems, Inc. | Sep 30, 2008 | SESE |
| K080995 | MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM | Affymetrix, Inc. | Jul 30, 2008 | SESE |
| K073506 | LUMINEX LX 100/200 INSTRUMENT | Luminex Corp. | Mar 7, 2008 | SESE |
| K070597 | VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST | Nanosphere, Inc. | Oct 11, 2007 | SESE |
| DEN040012 | AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM | Affymetrix, Inc. | Dec 23, 2004 | DENG |
Top Applicants
- Luminex Corp. — 3 clearances
- Affymetrix, Inc. — 2 clearances
- Applied Biosystems, Inc. — 1 clearance
- Biofire Diagnostics, LLC — 1 clearance
- GenMark Diagnostics, Inc. — 1 clearance
