What is FDA product code OOI?

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.

Clinical Chemistry › Laboratory InstrumentsReal Time Nucleic Acid Amplification System

Aries® M1 System

Name: Aries® M1 System
Brand: Aries® M1 System

The ARIES® M1 System is a clinical multiplex test system that automates and integrates extraction of nucleic acid from a clinical sample, performs real -time PCR, and measuring and sorting…

Registry build 21.09.26

The ARIES® M1 System is a clinical multiplex test system that automates and integrates extraction of nucleic acid from a clinical sample, performs real -time PCR, and measuring and sorting multiple signals generated in an in vitro diagnostic assay.

15manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

6recalls on this code

Who Else Makes It

Concentrated in Jiangsu (4), Shandong (3), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OOI
Manufacturer	City	Province	Registered as	Device types
Zhejiang Orient Gene Biotech	Huzhou	Zhejiang	Contract manufacturer	86
Guangzhou Four E’s Scientific Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	61
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Biobase Biodustry(Shandong)Co., Ltd.	Jinan	Shandong	Manufacturer	70
Infitek Co., Ltd.	Shanghai	Shanghai	Manufacturer	49
Labpeak Co., Ltd.	Jinan	Shandong	Manufacturer	43
Scitek Global Co., Ltd.	Jinan	Shandong	Manufacturer	43
Bioteke Corporation (Wuxi) Co., Ltd.	Wuxi	Jiangsu	Manufacturer	21
Getein Biotech, Inc.	Nanjing	Jiangsu	Manufacturer	19
Xian Tianlong Science AND Technology Co., Ltd.	Xi’An	Shaanxi	Manufacturer	8
Hangzhou Bioer Technology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	6
Sansure Biotech Inc.	Changsha	Hunan	Manufacturer	4

Showing 12 of 15. All 15 manufacturers in China registered for Real Time Nucleic Acid Amplification System

Record

Regulatory record for Aries® M1 System
Listed by	Luminex Corporation, United States
FDA product code	OOI
Device type	Real Time Nucleic Acid Amplification System
Device class	Class 2
Regulation	21 CFR 862.2570
Establishment	Contract manufacturer, Remanufacturer, Complaint-file establishment, Manufacturer
Record published	2016-09-09
Record revised	2025-07-01 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Distribution end date	2025-04-29

Catalogue Numbers

Catalogue numbers for Aries® M1 System
Catalogue number	Size	Status
ARIES M6V1		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
GeneXpert Dx System	Cepheid	37
Alinity m	Abbott Molecular, Inc.	20
GeneXpert Infinity-80 System	Cepheid	13
Fluorescence Quantitative PCR Detection System	Anitoa Biotechnology(Hangzhou)Co., Ltd.	12
GeneXpert®	Cepheid	10
Certified Pre-Owned GeneXpert Dx System	Cepheid	10
Bioer GeneExplorer Thermal Cycler	Hangzhou Bioer Technology Co., Ltd.	7
m2000	Abbott Molecular, Inc.	5
GeneXpert Infinity-48s System	Cepheid	5
Panther Fusion®	Hologic, Inc.	4
Bioer LineGene 9600 Plus Fluorescent Quantitative Detection System	Hangzhou Bioer Technology Co., Ltd.	4
Bioer QuantGene 9600 Fluorescent Quantitative Detection System	Hangzhou Bioer Technology Co., Ltd.	3

Showing 12 of 188. All products under Real Time Nucleic Acid Amplification System

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K161495	2016-06-30
K160517	2016-04-12
K151917	2015-10-06

Recalls Naming This Product

2 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Aries® M1 System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Luminex Corporation	UDI-DI	2018-06-29	Class II	Process control	An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from other patients specimens) for a patient order.	153 (140 U.S. and 13 O.U.S.)	2021-04-28
Luminex Corporation	UDI-DI	2017-04-19	Class II	Nonconforming Material/Component	The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrum	15 units	2017-10-20

Recalls

4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2022-04-05	Class II	Under Investigation by firm	Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.	24 units
2021-11-17	Class II	Nonconforming Material/Component	Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid.	329	2024-07-08
2021-04-16	Class II	Equipment maintenance	Impacted lot may leak inside the ARIES instrument.	296 kits	2024-09-20
2019-02-20	Class II	Process control	Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.