FDA.reportPublic FDA data

AUTION EYE™ AI-4510 Analyzer

Primary DI
00015482188627
Brand
AUTION EYE™ AI-4510 Analyzer
Company
ARKRAY USA, INC.
Model
108861
Device description
The AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use. AUTION EYE AI-4510 is intended for the quantitative measurement of red blood cells (RBC), white blood cells (WBC) and squamous epithilial cells (SQEC), the semi-quantitative measurement of bacteria (BACT) and crystals (CRYS) and the qualitative measurement of white blood cell clumps (WBCC), non-squamous epithilial cells (NSE), hyaline casts (HYAL), non-hyaline casts (NHC), yeast (YST), mucus (MUCS) and sperm (SPRM) in urine samples.
Published
2024-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKMCounter, Urine Particle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKMCounter, Urine ParticleHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232416000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232416000AUTION EYE AI-4510 Urine Particle Analysis SystemArkray, Inc.2024-05-03LKM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00015482188627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00015482188627000154821886270154821886270015482188627

GMDN Terms#

Term, Definition table
TermDefinition
Urine analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-646-3108xxx@xxx.xxx

Regulatory Flags#

DUNS number
008171162
Device count
1
Serial number
true

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Primary DI, Brand, Model table
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00015482510046Assure® Control - Control Solution Level 15100042019-04-01
00015482510053Assure® Control - Control Solution Level 25100052019-04-01
00015482510077Assure® Control - Control Solution Level 35100072019-04-01
00015482102913ASSURE® ID Insulin 1cc Safety Syringe2102912016-09-23
00015482102951ASSURE® ID Insulin 0.5cc Safety Syringe2102952016-09-23
00015482511104GLUCOCARD® W Blood Glucose Monitoring System 5111002019-04-01
00015482512057GLUCOCARD® W Blood Glucose Test Strips5120502019-04-01
10015482102910ASSURE® ID Insulin 1cc Safety Syringe2102912016-09-23
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04987562440139Fully Automated Urine Particle Analyzer UF-5000SYSMEX CORPORATIONLKM2018-05-31
10837461001256iQ200BECKMAN COULTER IRELAND INC.LKM2016-09-07
10837461001300iQ200BECKMAN COULTER IRELAND INC.LKM2016-09-07
10837461001317iQ200BECKMAN COULTER IRELAND INC.LKM2016-09-07
10837461001355iQ200BECKMAN COULTER IRELAND INC.LKM2016-09-07
10837461002192iQ®200 IRIS INTERNATIONAL, INC.LKM2016-09-07
04987562408542Fully Automated Urine Particle Analyzer UF-1000iSYSMEX CORPORATIONLKM2016-08-04
00664369000639Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM SoftwareSysmex America, Inc.LKM2016-08-04