AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM

K093098 · Arkray, Inc. · KQO · Dec 23, 2009 · Clinical Chemistry

Device Facts

• Record ID: K093098
• Device Name: AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM
• Applicant: Arkray, Inc.
• Product Code: KQO · Clinical Chemistry
• Decision Date: Dec 23, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.2900
• Device Class: Class 1

Intended 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.

Device Story

Automated urine analyzer; processes urine samples using AUTION Sticks 9EB multi-parameter test strips. Device features loading/unloading sides for samples, LCD display, operator panel, and built-in printer. Operates on 100-240VAC. Used in clinical settings by healthcare professionals to measure analytes including glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. Provides automated analysis to assist clinicians in diagnostic decision-making regarding patient health status.

Clinical Evidence

Bench testing only; no clinical data provided. Verification and validation activities performed per design control requirements to confirm modifications met predetermined acceptance criteria.

Technological Characteristics

Automated urine analyzer; 100-240VAC power; LCD display; built-in printer. Complies with UL 61010-1, IEC 61010-1/2-101/2-081, EN 61326, and FCC Part 15. Uses AUTION Sticks 9EB multi-parameter test strips.

Indications for Use

Indicated for in vitro measurement of urine analytes (glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, color) in clinical settings using AUTION Sticks 9EB test strips.

Regulatory Classification

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.

Predicate Devices

• AUTION MAX AX-4280 Urinalysis System (K013783)

Submission Summary (Full Text)

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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 [phone] FAX [phone]
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: [phone] FAX: [phone]

AUTION MAX AX-4030 Urinalysis System

Contact Name:

KENNETH L. BLOCK, RAC

Data Prepared:

August 20, 2009

KQO, JIL, JIO Urinalysis System

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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),

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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: [phone] FAX: [phone] Email: [e-mail]

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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 [phone]. 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 [phone]. 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 [phone] 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