FDA.reportPublic FDA data

AUTION MAX™ AX-4060 Analyzer

Primary DI
00015482104658
Brand
AUTION MAX™ AX-4060 Analyzer
Company
ARKRAY USA, INC.
Model
100526
Device description
The AUTION MAX AX-4060 urine analyzer, when used with AUTION Sticks 9EB test strips is a fully automated urinalysis system intended for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, turbidity, and color. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders. This system is intended to be used by trained operators in clinical laboratories.
Published
2025-11-07
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
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)Clinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193514000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193514000AUTION MAX AX-4060 Urinalysis SystemArkray, Inc.2023-04-13JIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00015482104658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00015482104658000154821046580154821046580015482104658

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
Handling Environment Humidity30 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Handling Environment Temperature50 Degrees Fahrenheit86 Degrees Fahrenheit
Special Storage Condition, Specify00Humidity non-condensing. Sampler storage 33.8 to 86°F, Humidity: 20 to 80% R.H. (non-condensing)
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature14 Degrees Fahrenheit122 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
008171162
Device count
1
Serial number
true

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Primary DI, Brand, Company table
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