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 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.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the AUTION MAX AX-4030 Urinalysis System, extracted from the provided text.

The provided document is a 510(k) summary for the AUTION MAX AX-4030 Urinalysis System. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results and acceptance criteria in the same way a typical medical device study report might. Therefore, some of the requested information (like specific acceptance criteria values, detailed study designs, and expert qualifications/adjudication) is not explicitly present in this regulatory filing.

However, based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Specific numerical acceptance criteria for each analyte are not explicitly detailed in this 510(k) summary. The document states "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." This indicates that detailed performance data exists, but it is not included in the publicly available summary provided.

For a device like this, acceptance criteria would typically be defined for parameters such as:

Accuracy/Correlation: Comparison of results to a reference method or predicate device results (e.g., % agreement, correlation coefficient).
Precision/Reproducibility: Repeatability and intermediate precision (e.g., coefficient of variation within acceptable limits).
Limit of Detection (LoD) / Limit of Quantitation (LoQ): The lowest concentration at which an analyte can be reliably detected/quantified.
Interference: Performance in the presence of common interferents in urine.
Carryover: Ensuring no significant contamination between samples.

Since these specific values are not in the provided text, a table cannot be fully constructed. The summary states that the results of non-clinical testing "appear in Section 18," indicating that the device met whatever acceptance criteria were established for those tests to support its substantial equivalence claim.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in the provided 510(k) summary. The document mentions "Non-clinical verification and validation testing," but does not detail the sample sizes used for this testing.
Data Provenance: Not specified in terms of country of origin for the test data, nor whether it was retrospective or prospective. It is implied to be internal verification and validation conducted by ARKRAY, Inc., likely involving various urine samples.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable/provided. For an automated urinalysis system measuring defined analytes, "ground truth" is typically established by reference methods or validated laboratory techniques, not by human expert interpretation in the same way an imaging study would.

4. Adjudication Method for the Test Set

Not applicable/provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the primary mode of operation for this automated system.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for an automated urinalysis system like the AX-4030, which performs objective measurements of chemical analytes. This type of study is typically used for imaging diagnostics where human readers interpret images, often with and without AI assistance, to assess diagnostic performance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, implicitly. The "Non-clinical verification and validation testing" described in the document as appearing in "Section 18" would constitute standalone performance testing of the device (its algorithms and hardware) without human intervention in the analysis process itself. The device is described as an "automated urine analyzer."

7. The Type of Ground Truth Used

The ground truth for an automated urinalysis system is typically established by:

Reference Laboratory Methods: Gold standard chemical assays for each analyte (e.g., enzymatic methods for glucose, turbidimetric methods for protein).
Gravimetric methods for specific gravity, etc.
Microscopic examination for correlation with certain parameters (e.g., blood, leukocytes, though the AX-4030 measures these chemically).
Predicate Device Comparison: Often, a key component of a 510(k) submission is demonstrating performance equivalent to a legally marketed predicate device.

The specific ground truth methods are not detailed in this summary but would be found in Section 18 of the original submission.

8. The Sample Size for the Training Set

Not specified. The 510(k) summary does not provide details about a training set, as this document focuses on the performance validation rather than the development of the algorithm itself. For a device that measures analytes using test strips, the "training" would primarily relate to calibration and ensuring the spectrophotometric readings accurately correlate with analyte concentrations, rather than machine learning training in the contemporary sense.

9. How the Ground Truth for the Training Set Was Established

Not specified. As mentioned above, the concept of a "training set" with established ground truth is less directly applicable in the sense of a machine learning model for image interpretation. For a chemical analyzer, ground truth for calibration and initial validation would involve using precisely prepared calibrators, controls, and known concentration samples analyzed by reference methods.

Summary

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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 +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:
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:

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: 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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Page 2

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.

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:

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

Regulation Number and Section

§ 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.