(83 days)
Not Found
No
The document describes a standard automated urinalysis system that measures analytes using test strips and does not mention any AI or ML components.
No
The device is an automated urine analyzer intended for in vitro measurement of various analytes, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as an automated urine analyzer that performs "in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color." This measurement of analytes for diagnostic purposes, without directly treating a condition, indicates it's a diagnostic device.
No
The device description explicitly details hardware components such as a main unit, power cord, LCD display, operator panel, loading/unloading sides, and a built-in printer. This indicates it is a physical device with integrated software, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is intended for the in vitro measurement of various analytes in urine. "In vitro" means "in glass" or "outside of the body," which is a key characteristic of IVD devices.
- Measurement of Analytes: The device measures specific substances (analytes) in a biological sample (urine) to provide information about a person's health. This is the core function of an IVD.
- Use with Test Strips: The device is intended for use with "AUTION Sticks 9EB multi-parameter test strips." These test strips are also IVD components, designed to react with the urine sample to produce a measurable signal.
The description of the device itself (hardware components, power, display, printer) supports its function as an automated analyzer for performing these in vitro tests.
N/A
Intended Use / Indications for Use
The AX-4030 is an automated urine analyzer that is designed to measure and analyze urine samples using measurements that include but are not limited to; Normal, STAT, Control and Check. These measurements are used to examine the following analytes; glucose(GLU), protein(PRO), bilirubin(BIL), urobilinogen (URO), pH (PH), blood (BLD), ketones (KET), nitrite (NIT) leukocytes (LEU) and specific gravity (S.G.). In addition, this device is used only with AUTION Sticks 9EB multi-parameter test strips.
The AUTION MAX AX-4030 Urinalysis System (AUTION MAX) is an automated urine analyzer intended for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The AUTION MAX is intended for use only with AUTION Sticks 9EB multi-parameter test strips.
Product codes
JIL, KQO, CDM, CEN, JIN, JIO, JIR, JJB, JMT, JRE, LJX
Device Description
The AX-4030 device is composed of one main unit. A power cord provides the necessary electricity to run both the device and all of its components. The device is powered by the power cord which, itself, provides 100-200/200-240VAC with a frequency of 50-60Hz. The front of the main unit includes the LCD display screen and operator panel (top-center). In addition, there are several other features located along the bottom of the device including loading and u unloading sides for urine samples. One of the best features that the AX-4030 includes is a builtin printer that is located on top of the device.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical verification and validation testing was conducted on the AX-4030 device and the results of such testing appear in Section 18 of this submission.
AX-4030 software was validated in accordance with the appropriate FDA guidance documents and the required documents regarding all software design, development, risk analysis, and validation activities appear in Section 16 of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.2900 Automated urinalysis system.
(a)
Identification. An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
L093098
RKRAY Inc
Image /page/0/Picture/1 description: The image shows the word "ARKRAY" in bold, black letters. To the right of the word is a black diamond shape with three curved lines inside. The lines are not solid, but rather made up of small dots or specks, giving them a textured appearance. The overall image has a clean, minimalist design.
57 NISHI AKETA-CHO, HIGASHI-KUJO,
MINAMI-KU, KYOTO 601-8045, JAPAN
TEL +81-75-672-5311 FAX +81-75-662-8950
URL http://www.arkray.co.jp
510(k) Summary AUTION MAX AX-4030 Urinalysis System Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
DEC 2 8 2009
Submitter Name:
ARKRAY, Inc. 57 Nishiaketa-Cho, Higashi-Kujo, Minami-Ku Kyoto, JAPAN 601-8045 TEL: (+81) 75-672-5311 FAX: (+81) 75-661-9435
AUTION MAX AX-4030 Urinalysis System
Contact Name:
KENNETH L. BLOCK, RAC
Data Prepared:
August 20, 2009
KQO, JIL, JIO Urinalysis System
I、II
| Proprietary Name: |
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| Primary Product Code: |
| Common Name: |
| Class: |
| CFR Section: |
Predicate Devices:
21 CFR 862.2900, 21 CFR 862.1340, 21 CFR 864-6650 K013783 AUTION MAX AX-4280 Urinalysis System (ARKRAY, Inc.)
Device Description:
The AX-4030 device is composed of one main unit. A power cord provides the necessary electricity to run both the device and all of its components. The device is powered by the power cord which, itself, provides 100-200/200-240VAC with a frequency of 50-60Hz. The front of the main unit includes the LCD display screen and operator panel (top-center). In addition, there are several other features located along the bottom of the device including loading and u unloading sides for urine samples. One of the best features that the AX-4030 includes is a builtin printer that is located on top of the device.
Indication for Use:
The AX-4030 is an automated urine analyzer that is designed to measure and analyze urine samples using measurements that include but are not limited to; Normal, STAT, Control and Check. These measurements are used to examine the following analytes; glucose(GLU), protein(PRO), bilirubin(BIL), urobilinogen (URO), pH (PH), blood (BLD), ketones (KET),
1
nitrite (NIT) leukocytes (LEU) and specific gravity (S.G.). In addition, this device is used only with AUTION Sticks 9EB multi-parameter test strips.
Cited Standards to Determine Substantial Equivalence:
AZ-4030 complies with UL 61010-1, CSA C22.2 No. 61010-1, IEC61010-1, IEC61010-2-101, IEC61010-2-081, EN61010-1, EN61010-2-101, EN61010-2-081, EN 61326, EN61000-3-2, EN 61000-3-3, JIS C 1806-1, JIS C 61000-3-2, and FCC Part 15 Subpart B.
Non-Clinical Testing:
Non-clinical verification and validation testing was conducted on the AX-4030 device and the results of such testing appear in Section 18 of this submission.
Software Validation:
AX-4030 software was validated in accordance with the appropriate FDA guidance documents and the required documents regarding all software design, development, risk analysis, and validation activities appear in Section 16 of this submission.
Truthful and Accuracy Statement:
Signed by a corporate management representative of the submitter, the required statement attesting to the truthfulness and accuracy of the information contained in Section 6 of this submission.
Further Information:
Please contact the following individual to request any further information regarding this submission:
Kenneth L. Block, RAC Consultant Ken Block Consulting 1201 Richardson Dr. Suite 140 Richardson, TX 75080 TEL: 972-480-9554 FAX: 972-767-4325 Email: ken@kenblockconsulting.com
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
DEC 2 3 2009
ARKRAY, Inc. C/O Mr. Kenneth L. Block Ken Block Consulting 1201 Richardson Drive, Suite 140 Richardson, Texas 75080
Re: K093098
Trade/Device Name: AUTION MAX AX-4030 Urinalysis System Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: Class II Product Code: JIL, KQO, CDM, CEN, JIN, JIO, JIR, JJB, JMT, JRE, LJX Dated: December 1, 2009 Received: December 2, 2009
Dear Mr. Block:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. .
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K093098
Device Name: AUTION MAX AX-4030 Urinalysis System
Indications for Use:
The AUTION MAX AX-4030 Urinalysis System (AUTION MAX) is an automated urine analyzer intended for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The AUTION MAX is intended for use only with AUTION Sticks 9EB multi-parameter test strips.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 489.309Y
AUTION MAX AX-4030 Urinalysis System Additional Information - K093098
December 22, 2009 Page 1 of 1