OOI — Real Time Nucleic Acid Amplification System Class II

FDA Device Classification

Classification Details

Product Code
OOI
Device Class
Class II
Regulation Number
862.2570
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243922meridian bioscienceRevogeneMarch 20, 2025
K222779meridian bioscienceRevogeneJanuary 26, 2023
K220480meridian bioscienceRevogeneJuly 11, 2022
K170558genepocrevogeneMay 25, 2017
K161495luminex corporationARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2June 30, 2016
K160517luminex corporationARIES SystemApril 12, 2016
K151917luminex corporationARIES SystemOctober 6, 2015
K151690alere scarboroughAlere i Instrument, Alere i Influenza A & B, Alere i Strep AJuly 16, 2015
K140447becton, dickinson andBD VIPER LT SYSTEMMay 20, 2014
K123955life technologies corporationQUANTSTUDIO DX REAL-TIME PCR INSTRUMENTMarch 8, 2013
K113319qiagenROTOR-GENE Q MDXFebruary 6, 2012
K102314focus diagnostics3M INTEGRATED CYCLER (110V) & (220V)October 29, 2010
K093383biomerieuxNUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQJuly 6, 2010
K092705abbott molecularABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES)May 28, 2010