510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OOIClass II

Real Time Nucleic Acid Amplification System

21 CFR 862.2570 / Clinical Chemistry
FDA source (opens on fda.gov)

OOI is the FDA product code for Real Time Nucleic Acid Amplification System, a class II device type, regulated under 21 CFR 862.2570. FDA's definition for this code reads: "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...". As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 30 recalls.

Classification record

Product code
OOI
Device name
Real Time Nucleic Acid Amplification System
FDA 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.
Regulation
21 CFR 862.2570
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
14
Ingested recalls
30

Clearances, product code OOI

By decision year
14 clearances under product code OOI with a decision year between 2010 and 2025, 2010 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code OOI by decision year
YearClearances
20103
20121
20131
20141
20152
20162
20171
20221
20231
20251

Applicants with the most clearances

Product code OOI
Applicants holding the most 510(k) clearances under product code OOI
ApplicantClearances
Luminex Corporation3
Meridian Bioscience Inc3
Abbott Molecular, Inc.1
Alere Scarborough, Inc.1
Becton Dickinson & Co1
DiaSorin Molecular LLC1
Genepoc, Inc.1
Life Technologies Corporation1
Qiagen1
bioMerieux, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 73 companies shown, in name order