The AUTION MAX AX-4060 Urinalysis System (AUTION MAX) is comprised of the AUTION MAX AX-4060 automated urine analyzer and AUTION Sticks 9EB multi-parameter test strips.

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.

AUTION Sticks 9EB test strips are test strips for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, and leukocytes with the AUTION MAX AX-4060 urine analyzer. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders.

Special conditions for use statements: Prescription use only. AUTION Sticks 9EB test strips are not to be read visually.

Device Description

The AUTION MAX AX-4060 Urinalysis System is a fully automated urine analyzer that provides a semi-quantitative or qualitative measurement for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific gravity, turbidity, and color tone. The AUTION MAX AX-4060 Urinalysis System consists of AUTION MAX AX-4060 urine analyzer and AUTION Sticks 9EB test strips.

The AUTION Sticks 9EB test strips consist of a plastic strip containing 9 dry chemistry reagent pads impregnated with chemical substances for the determination of the above analytes in urine. These substances if present in urine leads to a chemical reaction that results in a color change, which is measured by the AUTION MAX AX-4060 urine analyzer based on spectrophotometry. In addition, three additional parameters, specific gravity, turbidity, and color tone are directly measured based on reflectance refractometry, transmitted and scattered light measurements.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary:

Device: AUTION MAX AX-4060 Urinalysis System
Predicate Device: AUTION MAX AX-4030 Fully Automated Urinalysis System

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets in the document. Instead, the study aims to demonstrate substantial equivalence to the predicate device. Therefore, the "acceptance criteria" are implicitly understood as matching or performing comparably to the predicate device's established performance, particularly in terms of agreement percentage. The reported device performance is presented as the agreement between the proposed device (AUTION MAX AX-4060) and the predicate device (AUTION MAX AX-4030).

Key Performance Metric: Percentage of Exact Match and Percentage within +/- 1 Color Block Match compared to the predicate device.

Analyte	Acceptance Criteria (Implicit: Substantial Equivalence to Predicate)	Reported Device Performance (Exact Match %)	Reported Device Performance (+/- 1 CB Match %)
GLU	High agreement (Exact and +/- 1 CB match)	98.1%	100.0%
PRO	High agreement (Exact and +/- 1 CB match)	94.5%	100.0%
BIL	High agreement (Exact and +/- 1 CB match)	99.5%	100.0%
URO	High agreement (Exact and +/- 1 CB match)	99.2%	100.0%
pH	High agreement (Exact and +/- 1 CB match)	92.9%	100.0%
BLD	High agreement (Exact and +/- 1 CB match)	95.8%	100.0%
KET	High agreement (Exact and +/- 1 CB match)	99.0%	100.0%
NIT	High agreement (Exact and +/- 1 CB match)	99.7%	100.0%
LEU	High agreement (Exact and +/- 1 CB match)	98.6%	100.0%
Turbidity	High agreement (Exact and +/- 1 CB match)	98.6%	100.0%
Color tone	High agreement (Exact and +/- 1 CB match)	82.7%	100.0%

(Note: The +/- 1 CB Match indicates results falling within one color block difference from the predicate, which is often considered acceptable for semi-quantitative tests.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set (Method Comparison): A total of 1374 samples were used. This included:
- 1333 natural patient samples
- 41 spiked samples
Data Provenance: The study was conducted at two (2) clinical laboratories. The document does not specify the country of origin, but given the FDA submission, it's likely conducted in or in accordance with standards for the U.S. and/or Japan (where the manufacturer is located). It is a prospective comparison study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This study does not involve human experts establishing a "ground truth" for each sample in the typical sense of diagnostic imaging or pathology. Instead, the "ground truth" for the method comparison study is the result obtained from the legally marketed predicate device (AUTION MAX AX-4030 Automated Urinalysis System). The study demonstrates the correlation and agreement of the new device's readings with the predicate device's readings. No information is provided about experts interpreting results aside from the automated systems.

4. Adjudication Method for the Test Set

Since the "ground truth" is established by the predicate device's results and the comparison is between two automated systems, there was no human adjudication process (e.g., 2+1, 3+1 consensus) described for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study evaluates the performance of an automated urinalysis system against a predicate automated system, not the improvement of human readers with AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes. The primary study detailed, especially the Method Comparison (Section 14), assesses the standalone performance of the AUTION MAX AX-4060 Urinalysis System. It compares the results generated by the new automated system directly against those generated by the predicate automated system, without human intervention in the result interpretation or decision-making process during the comparison phase. The device itself is an automated system intended to be used by trained operators in clinical laboratories, but the performance data presented is for the automated analyzer's output.

7. Type of Ground Truth Used

The ground truth for the method comparison study was the results obtained from the legally marketed predicate device (AUTION MAX AX-4030 Automated Urinalysis System). For the initial precision study (Tables 3-5), the "Expected Result" for quality controls served as the reference.

8. Sample Size for the Training Set

The document is a 510(k) summary for a medical device (urinalysis system), not a typically "AI-driven" software device that undergoes explicit training. The device determines analytes based on chemical reactions and spectrophotometry (reflectance refractometry, transmitted and scattered light measurements). Therefore, there is no explicit "training set" in the context of machine learning algorithms usually discussed. The system is likely calibrated and validated during its development, but this is a different process than training an AI model.

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

As noted above, there is no explicit "training set" in the machine learning sense for this device. The chemical principles and measurement methods are well-established for urinalysis. Any calibration or internal development would have relied on known concentrations and reference methods for each analyte to ensure accurate colorimetric or other measurements. The basis of the technology relates to established chemical reactions on the test pads (e.g., Glucose oxidase reaction for glucose, Protein-error reaction for protein, etc.).

Summary

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April 13, 2023

ARKRAY Inc. Daya Ranamukhaarachchi VP/Scientific and Regulatory Affairs 5198 West 76th Street Minneapolis, MN 55439

Re: K193514

Trade/Device Name: AUTION MAX AX-4060 Urinalysis System Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: Class II Product Code: JIL, JIO, KQO, CDM, JIR, JMT, LJX, JJB, CEN, JIN Dated: October 19, 2022 Received: October 20, 2022

Dear Daya Ranamukhaarachchi:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Paula V. Caposino -S

Paula Caposino, Ph.D. Acting Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193514

Device Name AUTION MAX AX-4060 Urinalysis System

Indications for Use (Describe)

The AUTION MAX AX-4060 Urinalysis System (AUTION MAX) is comprised of the AUTION MAX AX-4060 automated urine analyzer and AUTION Sticks 9EB multi-parameter test strips.

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 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.

Special conditions for use statements: Prescription use only. AUTION Sticks 9EB test strips are not to be read visually.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(K) Summary

The 510(k) Summary is included on the following pages.

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510(k) Summarv

This 510(k) Summary of the AUTION MAX AX-4060 Urinalysis System is submitted in compliance with 21 CFR807.92 for the purposes of safety and effectiveness.

Date Prepared:	October 19, 2022
Establishment:	ARKRAY Factory Inc.1480 Koji, Konan-cho,Koka-shiShiga Japan, 520-3306
Submitter:	ARKRAY Inc.Yousuien-nai, 59 Gansuin-cho, Kamigyo-kuKyoto Japan, 602-0008Official US Agent: Daya RanamukhaarachchiARKRAY Factory USA Inc.VP/Scientific and Regulatory AffairsPhone (408) 234-0804Fax: (952) 646-3240Email: ranamukd@arkrayusa.com
Primary Contact:	Daya RanamukhaarachchiVP/Scientific and Regulatory AffairsPhone (408) 234-0804Fax: (952) 646-3240Email: ranamukd@arkrayusa.com
Secondary Contact:	Dhwani ThakkarRegulatory Affairs Project ManagerEmail: thakkard@arkrayusa.comPhone: 437-247-1628
Device Name:
Trade Name:	1. AUTION MAX AX-4060 Urinalysis System
Common Name:	1. Automated Urinalysis System2. Urinalysis Test Strip

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Predicate Device:

1. AUTION MAX AX-4030 Fully Automated Urinalysis System (K093098)
1. AUTION Sticks 9EB (K013783)

Regulatory Information:

Regulatory Classification for Urinalysis system and each of the tests are listed in Table 1.

Test Description	ProductCode	Device Class	Regulation	Device Panel
Automated urinalysissystem	KQO	Class I	21 CFR 862.2900	75 Chemistry
Glucose, urinary,nonquantitative	JIL	Class II	21 CFR 862.1340	75 Chemistry
Blood, occult,colorimetric, in urine	JIO	Class II	21 CFR 864.6550	81 Hematology
Urobilinogen, urinary,non-quantitative	CDM	Class I	21 CFR 862.1785	75 Chemistry
Protein or albumin,urinary, nonquantitative	JIR	Class I	21 CFR 862.1645	75 Chemistry
Nitrite, nonquantitative	JMT	Class I	21 CFR 862.1510	75 Chemistry
Leukocyte, peroxidasetest	LJX	Class I	21 CFR 864.7675	81 Hematology
Bilirubin and itsconjugates, urinary,non-quantitative	JJB	Class I	21 CFR 862.1115	75 Chemistry
pH, urinary,nonquantitative	CEN	Class I	21 CFR 862.1550	75 Chemistry
Ketones nonquantitative	JIN	Class I	21 CFR 862.1435	75 Chemistry

	Table 1. Regulatory Classification for AUTION MAX AX-4060 Urinalysis System
--	-----------------------------------------------------------------------------	--

Intended Use

The AUTION MAX AX-4060 Urinalysis System (AUTION MAX) is comprised of the AUTION MAX AX-4060 automated urine analyzer and AUTION Sticks 9EB multi-parameter test strips.

AUTION Sticks 9EB test strips are test strips for the in vitro qualitative or semi-quantitative

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measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, and leukocytes with the AUTION MAX AX-4060 urine analyzer. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders.

Special conditions for use statements: Prescription use only. AUTION Sticks 9EB test strips are not to be read visually.

Device Description

Substantial Equivalence

AUTION MAX AX-4060 Urinalysis System was developed as the successor to the predicate device AUTION MAX AX-4030 Urinalysis System. The device uses the same intendeduse claims as the predicate. The AX-4060 system utilizes the same principles and technology and shares the identical 9EB test strips for measuring the same urine analytes in a semiquantitative or qualitative manner similar to the predicate device. Some important device parts such as LED and Nozzle dispensing units were changed in the AX-4060 System due to a change in manufacturing source and the device was optimized to generate similar performance to the predicate device.

As described in the Performance Characteristics Section below, the verification and validation (bench and clinical) testing demonstrated substantial equivalence for the AX-4060 System with AUTION Sticks 9EB test strips to the predicate device. Bench testing supports that the AX-4060 System performs to meet specifications for precision, linearity, limits of detection (LOD), sensitivity, carryover and interference. Additionally, software testing, electrical safety testing and EMC testing also met performance criteria.

A list of similarities and differences between the proposed device and the predicate device is provided in Table 2.

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Table 2. Substantial Equivalence comparison between AUTION MAX AX-406
Urinalysis System and AUTION MAX AX-4030 Urinalysis System

COMPONENT/CHARACTERISTIC	PROPOSED	PREDICATE
510(k) Number	To Be Determined	K093098
Device	AUTION MAX AX-4060 UrinalysisSystem	AUTION MAX AX-4030Urinalysis System
	Similarities between Proposed and Predicate Devices
Device Type	Automated Urinalysis System	Same
FDA Product Code	KQO, JIL, JIO	Same
FDA Authorized Use	Prescription Use	Same
FDA Classification	Class II	Same
SpecimenType/Measurement Object	Urine	Same
Reagent(Chemical Test Strips)	AUTION Sticks 9EB	Same
Measurement Items	GLU (Glucose), PRO (Protein), BIL(Bilirubin), URO (Urobilinogen),PH (pH), BLD (Blood), KET(Ketones), NIT (Nitrite), LEU(Leukocytes), S.G. (Specificgravity), turbidity, and color tone.	Same
Sample Consumption	Max. 0.90 mL	Same
Required Sample Volume	Min. 2.0 mL	Same
Test Strip Reaction Time	Approx. 60 seconds	Same
Test Strip Storage	Two test strip storage compartments,each of which can contain differenttest strips	Same
Test Strip StorageCapacity	Maximum 200 test strips × twostorage compartments	Same
Max. Processing Speed	225 samples/hour	Same
Built-in Printer	58-mm width printer paper (24digits)	Same
COMPONENT/CHARACTERISTIC	PROPOSED	PREDICATE
Memory Capacity	Normal and STAT measurements:2500 testsControl measurement: 200 testsCheck measurement: 50 testsTrouble list: 100 tests	Same
Communication System	RS-232C compliant (Switchablebetween one-way and two-way)	Same
Power Requirements	100 - 240 V AC (Maximum powerline fluctuation of ±10%), 50/60 Hz	Same
Power Input	Max. 150 VA	Same
Intended UseEnvironment	For indoor use only	Same
Measurement environment	Temperature: 10 – 30°C (50 to86°F); Humidity: 30 – 60% RH(No condensation)	Same
Altitude	Up to 2000m (6560 feet)	Same
Differences between Proposed and Predicate Devices
Intended Use andIndications for Use	The AUTION MAX AX-4060Urinalysis System (AUTION MAX) iscomprised of the AUTION MAX AX-4060 automated urine analyzer andAUTION Sticks 9EB multi-parametertest strips.The AUTION MAX AX-4060 urineanalyzer, when used with AUTIONSticks 9EB test strips is a fullyautomated urinalysis system intendedfor the in vitro qualitative or semi-quantitative measurement of thefollowing analytes: glucose, protein,bilirubin, urobilinogen, pH, blood,ketones, nitrite, leukocytes, turbidity,and color. The test results of theseparameters can be used in the	The AUTION MAX AX-4030 Urinalysis System(AUTION MAX) is anautomated urine analyzerintended for the in vitromeasurement of the followinganalytes: glucose, protein,bilirubin, urobilinogen, pH,blood, ketones, nitrite,leukocytes, specific gravity,turbidity, and color. TheAUTION MAX is intendedfor use only with AUTIONSticks 9EB multi-parametertest strips.
	other metabolic disorders. This systemis intended to be used by trainedoperators in clinical laboratories.
	AUTION Sticks 9EB test strips aretest strips for the in vitro qualitative orsemi-quantitative measurement of thefollowing analytes: glucose, protein,bilirubin, urobilinogen, pH, blood,ketones, nitrite, and leukocytes withthe AUTION MAX AX-4060 urineanalyzer. The test results of theseparameters can be used in theevaluation of kidney, urinary, liver andother metabolic disorders.
	Special conditions for use statements:Prescription use only.AUTION Sticks 9EB test strips arenot to be read visually.
Configuration	Instrument, Sampler, Hand-heldbarcode reader and Accessories	Same, but the Hand-held barcode isoptional.

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COMPONENT/CHARACTERISTIC	PROPOSED	PREDICATE
LED Wavelength	5 LED wavelengths (450, 525,562, 635 and 760 nm)	5 LED wavelengths (430,500, 565, 635, 760 nm)
Warm-up Time	Max. 4 minutes	Max. 2 minutes
Display	Large color liquid crystal display (800× 480 dots) with touch panel	Large color liquid crystaldisplay (320 × 240 dots)No touch panel
External Output	1 port (Replaceable with theoptional Ethernet terminal)	2 ports (One of these ports canbe optionally used as anEthernet port)
Transmission Speed	RS-232C: Selectable from 300,600, 1200, 2400, 4800, 9600 and19200 bpsEthernet: 10BASE-T, 100BASE-TX	RS-232C: Selectable from300, 600, 1200, 2400, 4800,9600, and 19200 bpsEthernet: 10BASE-T
Dimensions	530 (W) × 530 (D) × 550 (H) mm(including the sampler)	530 (W) × 530 (D) ×530(H) mm(including the sampler)
Weight	Instrument: Approx. 40 kg (88 lb)Sampler: Approx. 4 kg (9 lb)	Instrument: approx. 37 kgSampler: approx. 4 kg
Storage Environment	Temperature: -10 – 50°C (14 to122°F); Humidity: 20 – 80% RH(No condensation)	Temperature: 1 – 30°C (34 to86°F);Humidity: 20 – 80% RH(No condensation)
Environment duringTransport	Temperature: -10 – 50°C (14 to122°F); Humidity: 20 – 80% RH(No condensation)	Temperature: -13 – 43°C (9 to109°F); Humidity: 20 – 80%RH (No condensation)

Test Principle:

The AUTION MAX AX-4060 urine analyzer measures analyte-specific test strips (AUTION Sticks 9EB) by dual-wavelength reflectance measurement (single wavelength for blood [BLD]). The AUTION MAX AX-4060 Urinalysis System detects urine analytes based on chemical reaction on each test pad relative to the concentration of measured analytes present in the urine sample. The chemical reaction leading to the color change that occurs on each chemical test pad is listed below.

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PRINCIPLE
-----------

Glucose: Glucose oxidase reaction.
------------------------------------

Glucose	GOD Gluconic acid + H2O2
H 2 O 2 + 4-AAP + 1-Naphthol-3,6-disulfonic acid	POD Quinone imine dye (purple color) oxidation

Protein: Protein-error reaction.
----------------------------------

Protein + pH indicator	acid pH indicator changes to a cyan color
------------------------	-------------------------------------------------------------------------------------------------------------------------------

Bilirubin: Azo-coupling reaction.
-----------------------------------

2-Methyl-5-nitroaniline + Sodium nitrite	acid Diazonium salt diazo reaction
Bilirubin + Diazonium salt	acid Azo dye (reddish brown color) coupling reaction

Urobilinogen: Azo-coupling reaction.
--------------------------------------

Urobilinogen + Diazonium salt	acid Azo dye (reddish brown color) coupling reaction
-------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

pH: pH indicator.
-------------------

H + + mixed pH indicator	mixed pH indicator shows range of colors covering the urinary pH range (yellow - cyan color)
-------------------------------------	----------------------------------------------------------------------------------------------

Blood: Activity measurement of pseudoperoxidase in hemoglobin.
----------------------------------------------------------------

CHP + TMBZ	hemoglobin H2O + Cumene + Oxidation dye (cyan color) pseudoperoxidase action
------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Ketones: Legal reaction.
--------------------------

Ketones + Sodium nitroprusside	alkaline Ketones complex (purple color)
--------------------------------	-----------------------------------------------------------------------------------------------------------------------------

Nitrite: Griess reaction.
---------------------------

Nitrite + Sulfanilamide	acid Diazo-compound + NEDA-2HCI
	acid Azo dye (pink color) coupling reaction

Leukocytes: Measurement of leukocyte esterase activity.
---------------------------------------------------------

TAI	esterase from leukocytes Indoxyl + MMB Azo dye (purple color)
	hydrolysis coupling reaction

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Performance Characteristics

Precision

Precision study included repeatability and reproducibility testing in accordance with the CLSI standard EP5-A3. Three (3) levels of quality controls were used to attain results at negative, mid-level positive and high-positive analyte ranges. Two (2) levels of commercial controls were used to obtain the 3 levels by mixing as needed to obtain the highest and midlevel controls for testing of all the analyte ranks. Each analyte was tested using 4 operators on 3 devices combined with 3 lots of reagents for a minimum of 20 days. Results for each level are presented in Table 3, Table 4 and Table 5.

Table 3. Repeatability and Reproducibility of AUTION MAX AX-4060 Urinalysis System Combined results for Level 1 (Negative/Normal) samples

		Results of all combinations
		Repeatability(N=120)		Reproducibility(N=240)
Analyte	Expected Result	Exactmatch	Within+/- 1 CB	Exactmatch	Within+/- 1 CB
GLU	Normal	100.0%	100.0%	100.0%	100.0%
PRO	Negative	100.0%	100.0%	100.0%	100.0%
BIL	Negative	100.0%	100.0%	100.0%	100.0%
URO	Normal	100.0%	100.0%	100.0%	100.0%
pH	5.0	99.2%	100.0%	99.6%	100.0%
BLD	Negative	100.0%	100.0%	100.0%	100.0%
KET	Negative	100.0%	100.0%	100.0%	100.0%
NIT	Negative	100.0%	100.0%	100.0%	100.0%
LEU	Negative	100.0%	100.0%	100.0%	100.0%
TURB	Negative	100.0%	100.0%	100.0%	100.0%
Color	Colorless	100.0%	100.0%	100.0%	100.0%

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			Results of all combinations
		Expected Result		ReproducibilityRepeatability(N=120)(N=240)
Analyte	Qualitative	Semi-quantitative(mg/dL)	Exactmatch	Within+/- 1 BC	Exactmatch	Within+/- 1 BC
GLU	+3	300-500	100.0%	100.0%	100.0%	100.0%
PRO	+3	300-600	90.8%	100.0%	94.6%	100.0%
BIL	+3	6-10	100.0%	100.0%	100.0%	100.0%
URO	+4	>12	100.0%	100.0%	95.8%	100.0%
pH	8.0	8.0	99.2%	100.0%	99.6%	100.0%
BLD	+2	0.2-0.5	100.0%	100.0%	100.0%	100.0%
KET	+3	80-100	98.3%	100.0%	99.2%	100.0%
NIT	+2		100.0%	100.0%	100.0%	100.0%
LEU		>500 (Leu/μL)	100.0%	100.0%	100.0%	100.0%
TURB	+2		100.0%	100.0%	100.0%	100.0%
Color		dark yellow	100.0%	100.0%	100.0%	100.0%

Table 4. Repeatability and Reproducibility of AUTION MAX AX-4060 Urinalysis System Combined results for Level 2 (High) samples

Table 5. Repeatability and Reproducibility of AUTION MAX AX-4060 Urinalysis System Combined results for Level 3 (Mid) samples

					Results of all combinations
	Expected Result		Repeatability(N=120)		Reproducibility(N=240)
Analyte	Qualitative	Semi-quantitative(mg/dL)	Exactmatch	Within+/- 1 BC	Exactmatch	Within+/- 1 BC
GLU	+1	70-100	100.0%	100.0%	100.0%	100.0%
PRO	+1	30-70	100.0%	100.0%	100.0%	100.0%
BIL	+2	2-4	100.0%	100.0%	100.0%	100.0%
URO	+2	4-6	99.2%	100.0%	99.2%	99.6%
pH	6.5	6.5	100.0%	100.0%	100.0%	100.0%
BLD	+1	0.06-0.1	100.0%	100.0%	100.0%	100.0%
KET	+1	10-20	99.2%	99.2%	99.2%	99.6%
NIT	+1		100.0%	100.0%	100.0%	100.0%
LEU		250 (Leu/μL)	100.0%	100.0%	99.2%	100.0%
TURB	+1		100.0%	100.0%	100.0%	100.0%
Color	yellow		100.0%	100.0%	100.0%	100.0%

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Method Comparison

A method comparison study was conducted to evaluate the agreement of results from AUTION MAX AX-4060 Urinalysis System to the FDA-cleared predicate device AUTION MAX AX-4030 Automated Urinalysis System. Testing was performed at two (2) clinical laboratories by using two (2) instruments and two (2) different lots of test strips. A total of 1374 samples, consisting of 1333 natural patient samples and 41 spiked samples, were tested across the sites.

The data from each site was combined and are presented in Table 6 showing percentages of Exact Match and within +/- 1 Color Block Match for all analytes on test strips. Non-test strip items for turbidity and color tone are in the same templates of Table 7 and Table 8 as the test strip analytes.

Analyte	AllSamples(n)	ExactMatch(n)	%ExactMatch	95% CI	% +/- 1CB Match
GLU	1044	1024	98.1%	97.2% - 98.8%	100.0%
PRO	1048	990	94.5%	93.0% - 95.8%	100.0%
BIL	1338	1331	99.5%	99.0% - 99.8%	100.0%
URO	1341	1330	99.2%	98.6% - 99.6%	100.0%
pH	1063	987	92.9%	91.2% - 94.3%	100.0%
BLD	1044	1000	95.8%	94.5% - 96.9%	100.0%
KET	1336	1322	99.0%	98.3% - 99.4%	100.0%
NIT	1046	1043	99.7%	99.3% - 99.9%	100.0%
LEU	1044	1029	98.6%	97.8% - 99.2%	100.0%

Table 6. Overall agreement of results for all test analytes between proposed and predicate device

Table 7. Summary table for turbidity

Analyte	AllSamples(n)	Exact Match(n)	% ExactMatch	95% CI	% +/- 1 CBMatch
Turbidity	1044	1029	98.6%	97.8%-99.2%	100%

Table 8. Summary table for color tone

Analyte	All Samples (n)	Exact Match (n)	% Exact Match	95% CI	% +/- 1 CB Match
Color tone	1044	863	82.7%	80.3% - 84.9%	100.0%

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Interfering Substances

Evaluation of interfering substances influencing the accuracy of results on AUTION MAX AX-4060 Urinalysis System was conducted with AUTION Sticks 9EB.

A list of interfering substances for a given analyte is provided in Table 9 below. The interfering substances and their highest concentrations tested with no interference are listed in Table 10 below.

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Analyte	Substance	Concentration limit with nosignificant interference	Effect when above the concentration limit
	Ascorbic Acid	20 mg/dL	At 50 mg/dL decreased from +2 to +1
Glucose	Urobilinogen	4 mg/dL	At 8 mg/dL decreased from +2 to +1
	MESNA	100 mg/dL	At 150 mg/dL increased from NORMAL to +/-
	Sodium Bicarbonate	200 mg/dL	At 250 mg/dL increased from +3 to +4
Protein	Specific Gravity	1.02	At 1.025 decreased from +3 to +2
	Hemoglobin	10 mg/dL	At 12 mg/dL increased from - to +/-
Urobilinogen	Bilirubin	3.5 mg/dL	At 7 mg/dL increased from NORMAL to +1
Blood	Ascorbic Acid	50 mg/dL	At 100 mg/dL decreased from +2 to +1
	MESNA	50 mg/dL	At 100 mg/dL decreased from +2 to +1
	Urine pH	pH 8.5	At pH 9 decreased from +2 to +/-
	Methyl-dopa	50 mg/dL	At 67 mg/dL increased from - to +/-
Ketones	MESNA	1.5 mg/dL	At 3 mg/dL increased from - to +/-
	Ascorbic Acid	50 mg/dL	At 100 mg/dL decreased from +2 to +1
Nitrite	MESNA	150 mg/dL	At 200 mg/dL decreased from +2 to +1
	Urobilinogen	5 mg/dL	At 8 mg/dL decreased from +2 to +1
Leukocytes	Bilirubin	7 mg/dL	At 10.5 mg/dL increased from negative to 25
	Hemoglobin	3 mg/dL	At 6.25 mg/dL decreased from 250 to 75
	MESNA	370 mg/dL	At 660 mg/dL decreased from 250 to 75

Table 9. Substances interfering with test analytes

Based on the interference testing, following limitations have been included in the labeling:

1. Elevated hematuria (6.25 mg/dL Hb, approximately 2,156 RBC/uL) has been shown to cause falsely lowered Leukocyte readings and should be considered when interpreting Leukocyte results.
1. Samples from patients taking methyl dopa may be falsely elevated for blood, negative to trace at 67 mg/dL and negative to +1 at 225 mg/dL. Patients taking the maximum daily dose of methyl dopa may have approximately 210 mg/dL methyl dopa excreted in the urine.
Patients taking SGLT2 or similar inhibitors may have extremely high urinary glucose values. Due to a 3. hook effect on the glucose pad, if a patient's urine glucose level is greater than 20,000 mg/dL, then falsely decreased glucose results may be obtained with the test.
When acidic or alkaline compounds, such as ascorbic acid and sodium bicarbonate are taken internally 4. for treatment or as supplements, they may affect urine pH.

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Interfering Substances	Highest Concentration Tested with No Interference**
Therapeutic drugs
Acetaminophen	40 mg/dL
Acetoacetic Acid Lithium	150 mg/dL
Ammonium Chloride	400 mg/dL
Amoxicillin	360 mg/dL
Calcium Chloride	300 mg/dL
Citric Acid Monohydrate	75 mg/dL
Oxalic Acid Dihydrate	70 mg/dL
Potassium Chloride	1000 mg/dL
Sodium Chloride	2000 mg/dL
Sodium Dihydrogen Phosphate	1000 mg/dL
Sodium Nitrate	10 mg/dL
Sodium Nitrite	2 mg/dL
Endogenous substances
Albumin	1000 mg/dL
Creatinine	600 mg/dL
Fructose	100 mg/dL
Galactose	100 mg/dL
Glucose	2000 mg/dL
Glycine	450 mg/dL
Lactose	108 mg/dL
Low Urine pH	pH 5
Riboflavin	10 mg/dL
Urea	3000 mg/dL

Table 10. Substances with no interference for the highest levels tested

** Not all of the substances tested for interference demonstrated no significant interference for all analytes. For those substances that on initial screening were found to interfere with certain analytes, dose-response testing was conducted to establish the concentration limit below which no significant interference is expected. The results are given in Table 10 above.

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Limits of Detection and Sensitivity

Limits of detection and Minimum detection sensitivity were determined based on three instruments, and three reagent lots. Listed below in Table 11-14 are the quantitative values indicating the lower limit of the rank in which 50% or more of the results are falling into the specific rank.

Analyte	Minimum detection sensitivity
GLU	30 mg/dL (+/-)
PRO	10 mg/dL (+/-)
BIL	0.5 mg/dL (+1)
URO	2.0 mg/dL (+1)
BLD	0.023 mg/dL (+/-)
KET	4.0 mg/dL (+/-)
NIT	0.075 mg/dL (+1)
LEU	14 Leu/µL

Table 11. Minimum detection sensitivity

Table 12. Detection sensitivity for each Rank

	Blockoutput	Semi-quantitativerank	EvaluationConc.(mg/dL)	%Positive
GLU	+/-	30,50	30	100%
	+1	70, 100	60	93%
	+2	150,200	125	97%
	+3	300,500	250	100%
	+4	1000,over	750	100%
PRO	+/-	10, 20	10	67%
	+1	30, 70	30	77%
	+2	100, 200	85	53%
	+3	300, 600	250	73%
	+4	over	800	93%
BIL	+1	0.5, 1.0	0.5	53%
	+2	2.0, 4.0	1.5	93%
	+3	6.0, 10.0	5	93%
	+4	over	12	93%
URO	+1	2.0, 3.0	2	60%

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AUTION MAX AX-4060 Urinalysis System K193514

	+2	4.0, 6.0	4	80%
	+3	8.0, 12.0	7	100%
	+4	over	14	100%
BLD	+/-	0.03	0.023	100%
	+1	0.06, 0.10	0.045	100%
	+2	0.20, 0.50	0.15	97%
	+3	1.00, over	0.75	73%
KET	+/-		4	97%
	+1	10, 20	7.5	100%
	+2	40, 60	30	100%
	+3	80, 100	70	63%
	+4	150, over	150	100%
NIT	+1		0.075	57%
	+2		0.3	100%

Table 13. Detection sensitivity for each Rank of pH

	Blockoutput	Semi-quantitativerank	EvaluationpH	%Positive
pH	5.5	5.5	5.3	100%
	6	6	5.8	100%
	6.5	6.5	6.2	100%
	7	7	6.8	93%
	7.5	7.5	7.3	80%
	8	8	8	100%
	8.5	8.5	8.5	100%
	9	9	8.8	87%

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	Blockoutput	Semi-quantitativerank	EvaluationConc.	%Positive
LEU	25	25	14 cells/ μ L	100%
	75	75	48 cells/ μ L	70%
	250	250	172 cells/ μ L	60%
	500	500	396 cells/ μ L	90%

Linearity

Linearity was evaluated for Non-strip based analytical parameters. Tables 15 and 16 below respectively show the linearity for Color tone and Turbidity.

Color	Exact match
COLORLESS	100% (54/54)
BROWN	100% (54/54)
ORANGE	100% (54/54)
YELLOW	100% (54/54)
GREEN	100% (54/54)
BLUE	100% (54/54)
VIOLET	100% (54/54)
RED	100% (54/54)

Table 15. Linearity for Color tone

Table 16. Linearity for Turbidity
-----------------------------------

Analyte	Rank	Exact match
Turbidity	-	100% (60/60)
	+1	100% (60/60)
	+2	100% (60/60)

Proposed Labeling

Labeling adequately communicates the device's intended use, safety precautions and directions for use. It satisfies 21 CFR Part 809.10 for in vitro diagnostic devices.

Conclusion

The information provided in this 510(k) premarket notification supports that the AUTION MAX AX-4060 Urinalysis System is substantially equivalent to the AUTION MAX AX-4030 Fully-Automated Urinalysis System.

Regulation Number and Section

§ 862.1340 Urinary glucose (nonquantitative) test system.

(a)
Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.(b)
Classification. Class II.