Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard automated urinalysis system based on spectrophotometry and refractometry, with no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No
The device is an in vitro diagnostic (IVD) system used to measure analytes in urine for diagnostic purposes, not to treat or mitigate disease.

Diagnostic

Yes

The device is intended for the in vitro qualitative or semi-quantitative measurement of various analytes in urine, and the results can be used in the evaluation of kidney, urinary, liver, and other metabolic disorders, which are all diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description clearly states that the system is comprised of both a hardware component (the automated urine analyzer) and a consumable component (the test strips), in addition to any software that controls the analyzer.

IVD (In Vitro Diagnostic)

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 system is "intended for the in vitro qualitative or semi-quantitative measurement of the following analytes... in the evaluation of kidney, urinary, liver and other metabolic disorders." The term "in vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
Device Description: The description details how the system analyzes urine samples using test strips with chemical reagents, which react with substances in the urine. This process of analyzing a sample taken from the body to provide diagnostic information is the core function of an IVD.
Analytes Measured: The system measures various analytes in urine (glucose, protein, bilirubin, etc.) that are used to assess health conditions. This is a typical application for IVDs in clinical laboratories.
Care Setting and User: The system is intended for use by "trained operators in clinical laboratories," which is a common setting for IVD testing.
Performance Studies: The document describes performance studies like method comparison and precision studies, which are standard evaluations for IVD devices to demonstrate their accuracy and reliability.

The entire description aligns with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

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.

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.

Product codes (comma separated list FDA assigned to the subject device)

JIL, JIO, KQO, CDM, JIR, JMT, LJX, JJB, CEN, JIN

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.

Mentions image processing

Not Found

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

trained operators in clinical laboratories.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Precision Study:
Study Type: Repeatability and Reproducibility testing in accordance with CLSI standard EP5-A3.
Sample Size: Not explicitly stated for each level, but results obtained from 4 operators on 3 devices with 3 lots of reagents for a minimum of 20 days.
Key Results:

Level 1 (Negative/Normal) samples (N=120 for repeatability, N=240 for reproducibility): 99.2% to 100.0% exact match for pH, 100% exact match for all other analytes in repeatability; 99.6% to 100.0% exact match for pH, 100% exact match for all other analytes in reproducibility. All analytes showed 100% within +/- 1 CB match.
Level 2 (High) samples (N=120 for repeatability, N=240 for reproducibility): Exact match ranged from 90.8% (PRO) to 100% (GLU, BIL, URO, BLD, NIT, LEU, TURB, Color) for repeatability; exact match ranged from 94.6% (PRO) to 100% (GLU, BIL, BLD, NIT, LEU, TURB, Color) for reproducibility. All analytes showed 100% within +/- 1 BC match.
Level 3 (Mid) samples (N=120 for repeatability, N=240 for reproducibility): Exact match ranged from 99.2% (URO, KET) to 100% for other analytes in repeatability; exact match ranged from 99.2% (URO, KET, LEU) to 100% for other analytes in reproducibility. Most analytes showed 100% within +/- 1 BC match, with URO (99.6%) and KET (99.6%) being slightly lower for reproducibility.

Method Comparison Study:
Study Type: Agreement of results between the proposed device and the predicate device.
Sample Size: 1374 samples (1333 natural patient samples, 41 spiked samples).
Key Results:

Overall agreement percentage for exact match ranged from 82.7% (Color tone) to 99.7% (NIT).
Overall agreement percentage for within +/- 1 CB match was 100.0% for all analytes (GLU, PRO, BIL, URO, pH, BLD, KET, NIT, LEU, Turbidity, Color tone).

Interfering Substances Study:
Study Type: Evaluation of interfering substances influencing the accuracy of results.
Key Results:

Identifies specific substances (Ascorbic Acid, Urobilinogen, MESNA, Sodium Bicarbonate, Specific Gravity, Hemoglobin, Bilirubin, Urine pH, Methyl-dopa) and their concentrations that showed interference above certain limits.
Identifies therapeutic drugs and endogenous substances that showed no interference for the highest levels tested.

Limits of Detection and Sensitivity Study:
Study Type: Determination of limits of detection and minimum detection sensitivity.
Key Results: Provides minimum detection sensitivity for GLU (30 mg/dL), PRO (10 mg/dL), BIL (0.5 mg/dL), URO (2.0 mg/dL), BLD (0.023 mg/dL), KET (4.0 mg/dL), NIT (0.075 mg/dL), LEU (14 Leu/µL). Also provides detection sensitivity for each rank for all analytes.

Linearity Study:
Study Type: Evaluation of linearity for Non-strip based analytical parameters.
Key Results:

Color tone: 100% exact match for all tested colors (54/54).
Turbidity: 100% exact match for all ranks (60/60).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not directly reported in terms of sensitivity, specificity, PPV, NPV. Performance is reported as exact match and within +/- 1 Color Block match percentages.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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

2

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.

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.

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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3

5. 510(K) Summary

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

4

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-shi
Shiga Japan, 520-3306
Submitter:	ARKRAY Inc.
Yousuien-nai, 59 Gansuin-cho, Kamigyo-ku
Kyoto Japan, 602-0008
Official US Agent: Daya Ranamukhaarachchi
ARKRAY Factory USA Inc.
VP/Scientific and Regulatory Affairs
Phone (408) 234-0804
Fax: (952) 646-3240
Email: ranamukd@arkrayusa.com
Primary Contact:	Daya Ranamukhaarachchi
VP/Scientific and Regulatory Affairs
Phone (408) 234-0804
Fax: (952) 646-3240
Email: ranamukd@arkrayusa.com
Secondary Contact:	Dhwani Thakkar
Regulatory Affairs Project Manager
Email: thakkard@arkrayusa.com
Phone: 437-247-1628
Device Name:
Trade Name:	1. AUTION MAX AX-4060 Urinalysis System
Common Name:	1. Automated Urinalysis System

Urinalysis Test Strip |

5

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 | Product
Code | Device Class | Regulation | Device Panel |
|---------------------------------------------------------------|-----------------|--------------|-----------------|---------------|
| Automated urinalysis
system | 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, peroxidase
test | LJX | Class I | 21 CFR 864.7675 | 81 Hematology |
| Bilirubin and its
conjugates, 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.

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

6

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.

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.

7

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 Urinalysis
System	AUTION MAX AX-4030
Urinalysis 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
Specimen
Type/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. (Specific
gravity), 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 different
test strips	Same
Test Strip Storage
Capacity	Maximum 200 test strips × two
storage compartments	Same
Max. Processing Speed	225 samples/hour	Same
Built-in Printer	58-mm width printer paper (24
digits)	Same
COMPONENT/
CHARACTERISTIC	PROPOSED	PREDICATE
Memory Capacity	Normal and STAT measurements:
2500 tests
Control measurement: 200 tests
Check measurement: 50 tests
Trouble list: 100 tests	Same
Communication System	RS-232C compliant (Switchable
between one-way and two-way)	Same
Power Requirements	100 - 240 V AC (Maximum power
line fluctuation of ±10%), 50/60 Hz	Same
Power Input	Max. 150 VA	Same
Intended Use
Environment	For indoor use only	Same
Measurement environment	Temperature: 10 – 30°C (50 to
86°F); Humidity: 30 – 60% RH
(No condensation)	Same
Altitude	Up to 2000m (6560 feet)	Same
Differences between Proposed and Predicate Devices
Intended Use and
Indications for 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.

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 | 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. |
| | 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. | |
| Configuration | Instrument, Sampler, Hand-held
barcode reader and Accessories | Same, but the Hand-
held barcode is
optional. |

8

9

10

| 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 crystal
display (320 × 240 dots)
No touch panel
External Output	1 port (Replaceable with the
optional Ethernet terminal)	2 ports (One of these ports can
be optionally used as an
Ethernet port)
Transmission Speed	RS-232C: Selectable from 300,
600, 1200, 2400, 4800, 9600 and
19200 bps
Ethernet: 10BASE-T, 100BASE-
TX	RS-232C: Selectable from
300, 600, 1200, 2400, 4800,
9600, and 19200 bps
Ethernet: 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 kg
Sampler: approx. 4 kg
Storage Environment	Temperature: -10 – 50°C (14 to
122°F); Humidity: 20 – 80% RH
(No condensation)	Temperature: 1 – 30°C (34 to
86°F);
Humidity: 20 – 80% RH
(No condensation)
Environment during
Transport	Temperature: -10 – 50°C (14 to
122°F); Humidity: 20 – 80% RH
(No condensation)	Temperature: -13 – 43°C (9 to
109°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	Exact
match	Within
+/- 1 CB	Exact
match	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		Reproducibility
Repeatability
(N=120)
(N=240)
Analyte	Qualitative	Semi-
quantitative
(mg/dL)	Exact
match	Within
+/- 1 BC	Exact
match	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)	Exact
match	Within
+/- 1 BC	Exact
match	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 | All
Samples
(n) | Exact
Match
(n) | %
Exact
Match | 95% CI | % +/- 1
CB 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 | All
Samples
(n) | Exact Match
(n) | % Exact
Match | 95% CI | % +/- 1 CB
Match |
|-----------|-----------------------|--------------------|------------------|-------------|---------------------|
| 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%

15

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.

16

| Analyte | Substance significant interference |--------------|----------- | | Ascorbic Acid | Glucose | Urobilinogen | | MESNA | | Sodium | Protein | Specific Gravity | | Hemoglobin | Urobilinogen | Bilirubin | Blood | Ascorbic Acid | | MESNA | | Urine pH | | Methyl-dopa | Ketones | MESNA | | Ascorbic Acid | Nitrite | MESNA | | Urobilinogen | Leukocytes | Bilirubin | | Hemoglobin | | MESNA | Concentration limit with no
| Effect when above the concentration limit |
---------|---------------------------------------------------------|---------------------------------------------|
| 20 mg/dL | At 50 mg/dL decreased from +2 to +1 |
| 4 mg/dL | At 8 mg/dL decreased from +2 to +1 |
| 100 mg/dL | At 150 mg/dL increased from NORMAL to +/- |
Bicarbonate | 200 mg/dL | At 250 mg/dL increased from +3 to +4 |
| 1.02 | At 1.025 decreased from +3 to +2 |
| 10 mg/dL | At 12 mg/dL increased from - to +/- |
| 3.5 mg/dL | At 7 mg/dL increased from NORMAL to +1 |
| 50 mg/dL | At 100 mg/dL decreased from +2 to +1 |
| 50 mg/dL | At 100 mg/dL decreased from +2 to +1 |
| pH 8.5 | At pH 9 decreased from +2 to +/- |
| 50 mg/dL | At 67 mg/dL increased from - to +/- |
| 1.5 mg/dL | At 3 mg/dL increased from - to +/- |
| 50 mg/dL | At 100 mg/dL decreased from +2 to +1 |
| 150 mg/dL | At 200 mg/dL decreased from +2 to +1 |
| 5 mg/dL | At 8 mg/dL decreased from +2 to +1 |
| 7 mg/dL | At 10.5 mg/dL increased from negative to 25 |
| 3 mg/dL | At 6.25 mg/dL decreased from 250 to 75 |
| 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.

17

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

| | Block
output | Semi-quantitative
rank | Evaluation
Conc.(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

| | Block
output | Semi-
quantitative
rank | Evaluation
pH | %
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% |

20

| | Block
output | Semi-
quantitative
rank | Evaluation
Conc. | %
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.