OOI · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.2570
Classification
FDA Product Code
OOI
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 862.2570
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.