FDA.reportPublic FDA data

AUTION EYE™ Calibrator Focus/Calibrator

Primary DI
00015482181598
Brand
AUTION EYE™ Calibrator Focus/Calibrator
Company
ARKRAY USA, INC.
Model
108159
Device description
AUTION EYE Calibrator is intended for in vitro diagnostic use only for focusing and calibrating the AUTION EYE AI-4510.
Published
2024-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KQOAutomated Urinalysis System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQOAutomated Urinalysis SystemClinical Chemistry1

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
00015482181598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00015482181598000154821815980154821815980015482181598

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 Temperature2 Degrees Celsius8 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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987486009801AUTION Check Plus Controls1024782020-02-26
04987486001959S.G. Calibrator H1006722017-04-12
04987486053002S.G. Calibrator H111581N/A2025-12-19
00015482104658AUTION MAX™ AX-4060 Analyzer1005262025-11-07
00015482510060Assure® Control - Control Solution Level 2 & Level 35100062025-09-26
00015482600501Assure® Titanium Blood Glucose Test Strips6000502025-09-15
00015482601003Assure® Titanium Blood Glucose Test Strips6001002025-09-15
00015482600013Assure® Titanium Blood Glucose Meter6000012025-09-15
10015482600508Assure® Titanium Blood Glucose Test Strips6000502025-09-15
10015482601000Assure® Titanium Blood Glucose Test Strips6001002025-09-15
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
10015482102958ASSURE® ID Insulin 0.5cc Safety Syringe2102952016-09-23
30015482501779Assure® Platinum Blood Glucose Meter5011772022-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.KQO2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.KQO2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.KQO2026-04-16
00854080008612SciteckSciteck Diagnostics, Inc.KQO2026-04-07
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.KQO2025-09-18
04987486005292Concentrated Washing Solution 3ARKRAY USA, INC.KQO2024-12-02
00015482117344AUTION™ Sticks 9EB - Test StripsARKRAY USA, INC.KQO2024-12-02
00015482181550AUTION EYE™ Sheath Solution - 10L BottleARKRAY USA, INC.KQO2024-12-02
00015482181574AUTION EYE™ Control Solution H/LARKRAY USA, INC.KQO2024-12-02
14987486005299Concentrated Washing Solution 3ARKRAY USA, INC.KQO2024-12-02
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.KQO2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSKQO2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSKQO2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSKQO2024-06-04
20682607200508MISSION U500 URINE ANALYZERAcon Laboratories, Inc.KQO2024-03-08