FDA product code OUE: Micro Total Analysis Instrument System
OUE is the FDA product code for micro total analysis instrument system. It is a Class II device, regulated under 21 CFR 862.2570 and reviewed by the Immunology panel. Devices under OUE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for OUE devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Micro Total Analysis Instrument System |
| Device class | Class II |
| Regulation | 21 CFR 862.2570 |
| Review panel | IM — Immunology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for OUE devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-09-11.
Frequently asked questions
What is FDA product code OUE?
OUE is the FDA product code for micro total analysis instrument system. It is a Class II device, regulated under 21 CFR 862.2570 and reviewed by the Immunology panel.
What device class is OUE?
Class II, regulation 21 CFR 862.2570. Typical premarket route: 510(k) exempt.
Have OUE devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2013-09-11.
Next steps
- Run an FDA pathway report with predicate devices for product code OUE
- Run a recall and safety report across every OUE manufacturer
- Watch product code OUE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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