OUE — Micro Total Analysis Instrument System Class II
FDA product code OUE covers "Micro Total Analysis Instrument System", a Class II medical device regulated under 21 CFR 862.2570. Submissions are reviewed by the Clinical Chemistry panel.
Classification Details
- Product Code
- OUE
- Device Class
- Class II
- Regulation Number
- 862.2570
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
A micro total analysis instrument system is a clinical multiplex instrument intended to measure and sort signals generated by fluorescently-labeled immune complexes from a clinical sample on a microcapillary chip. Signals may be quantified using laser-induced-fluorescence detection using filters on a photodiode or other detector. It may integrate microfluidic chips with discrete zones for clinical sample and assay reagents; capillary electrophoresis; reagent handling system; dedicated instrument control; data acquisition software; raw data storage mechanisms; and other essential hardware components and signal reader unit. It is used with specific assays to comprise an assay test system.