Atlas FDA

OOI

14 FDA 510(k) clearances · Product code

88 daysmedian time to decision
249 days90th percentile
14clearances measured

FDA profile

Official device name
Real Time Nucleic Acid Amplification System
Device class
Class II (moderate risk)
Regulation
21 CFR 862.2570
Medical specialty
Clinical Chemistry
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.
Adverse events (MAUDE)
2021: 324 · 2022: 874 · 2023: 220 · 2024: 328 · 2025: 533 · 2026: 313
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Revogene (K243922)Meridian Bioscience, Inc.2025-03-20
Revogene (K222779)Meridian Bioscience, Inc.2023-01-26
Revogene (K220480)Meridian Bioscience, Inc.2022-07-11
revogene (K170558)Genepoc, Inc.2017-05-25
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) (K161495)Luminex Corporation2016-06-30
ARIES System (K160517)Luminex Corporation2016-04-12
ARIES System (K151917)Luminex Corporation2015-10-06
Alere i Instrument, Alere i Influenza A & B, Alere i Strep A (K151690)Alere Scarborough, Inc.2015-07-16
BD VIPER LT SYSTEM (K140447)Becton, Dickinson and Company2014-05-20
QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT (K123955)Life Technologies Corporation2013-03-08
ROTOR-GENE Q MDX (K113319)QIAGEN GmbH2012-02-06
3M INTEGRATED CYCLER (110V) & (220V) (K102314)Focus Diagnostics, Inc.2010-10-29
NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG (K093383)bioMerieux, Inc.2010-07-06
ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 (K092705)Abbott Molecular, Inc.2010-05-28

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Every clearance here is in the API, with alerts when new ones post.