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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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 Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
008171162
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00015482000011ARK Care®Version 2.5.3.2016-09-23
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00015482100032Assure® Slide Pill Swallowing Aid zero10000032018-12-28
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00015482102951ASSURE® ID Insulin 0.5cc Safety Syringe2102952016-09-23
00015482104658AUTION MAX™ AX-4060 Analyzer1005262025-11-07
00015482129743AUTION™ MAX AX-4022 Analyzer1029742017-02-03
00015482230296TechLITE PEN NEEDLES2301292016-09-23
00015482230326TechLITE Pen Needle 4mm x 32g Sample 10's2340322018-02-26
00015482230999TechLITE PEN NEEDLES2309292016-09-23
00015482232290TechLITE PEN NEEDLES2321292016-09-23
00015482232993TechLITE PEN NEEDLES2329292016-09-23
00015482234232TechLITE PLUS PEN NEEDLES2342322024-03-11
00015482234324TechLITE PEN NEEDLES2341322016-09-23
00015482234928TechLITE PEN NEEDLES2349322016-09-23
00015482235314TechLITE PEN NEEDLES2351312019-05-14
00015482235918TechLITE PEN NEEDLES2359312016-09-23
00015482236311TechLITE PEN NEEDLES2361312016-09-23
00015482236328TechLITE PEN NEEDLES2361322016-09-23
00015482238315TechLITE PEN NEEDLES2381312016-09-23

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