The AUTION HYBRID™ AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (CHM) is an automated urine analyzer intended for the in vitro measurement of the following parameters: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The chemistry module is intended for use with the Uriflet™ S 9HA multi-parameter urine chemistry test strips. The flow cytometry module (FCM) is an automated urine particle analyzer intended to analyze the following parameters in urine samples: Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria and flags the presence of the following: Pathologic Casts, Crystals, Sperm, Small Round Cells, Yeast Like Cells, and Mucus. The AUTION HYBRID AU-4050 is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

Uriflet™ S 9HA is a urinalysis test strip with reagent pads for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, and Leukocytes. Uriflet S 9HA is for use with the AUTION HYBRID AU-4050 only.

The AUTION Control Solution is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry module.

Device Description

The AUTION HYBRID AU-4050 is a fully automated urine analysis system. The AU-4050 contains a test strip chemistry urine analyzer also called the chemistry module (CHM) and a flow cytometry urine particle analyzer also called the flow cytometry module (FCM) together in a single integrated device. The CHM module analyzes the following parameters in urine: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The FCM module measures the following parameters in urine utilizing flow cytometry technology: Red Blood Cells. White Blood Cells. Epithelial Cells, Casts, and Bacteria. The FCM module flags for the presence of the following: Pathologic Casts, Crystals, Sperm, Small Round Cells. Yeast Like Cells and Mucus.

AI/ML Overview

The provided document is a 510(k) summary for the ARKRAY AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analyzer System, Uriflet™ S 9HA Urine Test Strips, and AUTION Control Solution. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics in the way a novel device might.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not explicitly detailed in this 510(k) summary. The document emphasizes comparison to predicate devices and states that "Clinical and bench testing was used to verify the performance characteristics of this device. This testing showed acceptable device performance that is substantially equivalent to the performance of the predicate devices."

However, I can extract the available information and also highlight what is not present in the document.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or specific reported device performance metrics in a table format for the new device against predefined thresholds. Instead, it relies on demonstrating substantial equivalence to existing predicate devices (AUTION MAX AX-4030 Urinalysis System (K093098), SYSMEX UF1000i Automated Urine Particle Analyzer with Urinalysis WAM software (K080887), and Sysmex UF-II Control (K070910)).

The "performance" demonstration is primarily through comparison of technological characteristics, intended use, operating principles, and design features to the predicate devices. The assumption is that since the predicate devices are already cleared, demonstrating equivalence implies acceptable performance.

Here's a summary of the comparisons provided, which implicitly serve as performance benchmarks by virtue of their equivalence:

Category	AUTION MAX AX-4030 (Predicate Device - Chemistry Module)	AUTION HYBRID AU-4050 (Proposed Device - Chemistry Module)
Intended Use	Automated urine chemistry analyzer	Same
Sample Type	Human Urine	Same
Measurement Wavelength	430, 500, 565, 635, 760 nm	Same
Measurement Method	SpectrophotOMETRY Test Strip: Dual-wavelength reflectance measurement (Single wavelength for BLD) S.G.: Reflection refractometry Color Tone: Light-transmission measurement Turbidity: Light-scattering measurement	Same
Measurement Items	GLU, PRO, BIL, URO, PH, BLD, KET, NIT, LEU, S.G, turbidity, and color-tone	Same
Test Strip Reaction Time	Approx. 60 seconds	Same as AX-4030

Category	SYSMEX UF-1000i (Predicate Device - Flow Cytometry Module)	AUTION HYBRID AU-4050 (Proposed Device - Flow Cytometry Module)
Intended Use	Automated urine particle analyzer	Same
Sample Type	Human Urine	Same
Measurement Method	Sysmex flow cytometry using a red semiconductor laser	Same
Measurement Items	RBC, WBC, Epithelial Cells, Cast, and Bacteria (flags for Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell, and Mucus)	Same

Category	Sysmex UF-II Control (Predicate Device - Control Solution)	AUTION Control Solution (Proposed Device)
Intended Use	Quality control for urine particle analyzers	Same
Form	Liquid, ready to use	Same
Levels	2	Same
Storage Stability	2°C-10°C until expiration date	Same
Open Vial Stability	30 days at 2°C-10°C	Same
Matrix	Liquid matrix solution	Same
Analytes	Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria	Same

Note: Changes in operational characteristics like "Processing Speed," "Sample Volume," "Display," "Built-in Printer," "Dimensions," and "Weight" are noted but are not considered performance criteria in the context of substantial equivalence for accuracy or clinical efficacy. The critical aspect for this type of submission is that these changes do not raise new questions of safety or effectiveness.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "Clinical and bench testing was used to verify the performance characteristics of this device." However, it does not provide details on:

The specific sample sizes used for any test sets.
The provenance of the data (e.g., country of origin, retrospective or prospective nature of the studies).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the 510(k) summary. For in-vitro diagnostic devices like this, expert review for ground truth might involve clinical pathologists or laboratory professionals, but the document does not elaborate.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the 510(k) summary.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The device is an automated urine analyzer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance is not applicable and was not performed or referenced. The device performs the analysis automatically.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the device is inherently a standalone (algorithm only) device as it is a fully automated integrated urine analyzer system performing in vitro measurements. Its performance would be evaluated based on the accuracy and precision of its automated measurements against a reference method or predicate device, independent of direct real-time human interpretation assistance during the analysis. The "comparison to predicate devices" and "clinical and bench testing" mentioned constitute this standalone performance evaluation relative to known performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the specific type of ground truth used. For IVD devices, "clinical and bench testing" typically refers to studies where:

Bench testing might involve spiked samples, controls, or samples with known concentrations/particle counts verified by confirmatory lab methods.
Clinical testing would involve patient samples, likely compared against a reference method (e.g., manual microscopy for urine sediment, or established clinical chemistry methods for parameters like glucose, protein) which would effectively serve as the ground truth. Since the application is for "in vitro diagnostic use in screening patient populations," the ground truth would likely be established by clinical laboratory standards and reference methods.

8. The sample size for the training set

This information is not provided in the 510(k) summary. The document describes a traditional automated analyzer, not a machine learning/AI device that typically employs distinct "training" datasets in the computational sense. Performance verification for this device involved "clinical and bench testing."

9. How the ground truth for the training set was established

As the document does not describe a "training set" in the context of machine learning, this information is not applicable/provided. For traditional IVD analyzers, ground truth for sample data used in method comparison or verification studies (analogous to validation) would be established by reference laboratory methods, sometimes using spiked samples or certified reference materials for precision and accuracy assessments.

Summary

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K121456

arkray

FEB 0 1 2013

510(k) Summary
Date Prepared:	January 18th, 2013
Submitter:	ARKRAY Factory USA, Inc.5182 West 76th StreetMinneapolis, MN 55439Establishment Registration Number: 1832816
Contact Person:	Adam EttlAssociate Regulatory Affairs Project ManagerPhone: (952) 646-3142Fax: (952) 646-3110Email: ettla@arkrayusa.com
	Device Name and Regulatory Information
Trade Name:	1. ARKRAY AUTIONTM HYBRID AU-4050 Fully AutomatedIntegrated Urine Analyzer System

1. AUTION™ Control Solution
1. Uriflet™ S 9HA Urinalysis Test Strips
Common Name: 1. Automated Urinalysis System (Class I, Class II), Automated Urine Particle Analyzer (Class II)
- 2. Urinalysis Controls (Assayed and Unassayed) (Class 1, reserved)
- 1. Urinalysis Test Strip

. ·

Table 1: Regulatory Information

Regulation:21 CFRSection	ProductCode	Classification	Description
862.2900	KQO	Class I	Automated Urinalysis System
864.5200	LKM	Class II	Counter, Urine Particle
862.1660	JJW	Class I,reserved	Urinalysis Controls (Assayed andUnassayed)
862.1340	JIL	Class II	Glucose (Urinary, Non-Quantitative)
864.6550	JIO	Class II	Blood, Occult, Colormetric, In Urine
862.1785	CDM	Class I	Urobilinogen (Urinary Non-Quant.)
862.1550	CEN	Class I	Ph (Urinary, Non-Quant.)
862.1435	JIN	Class I	Ketones (Urinary, Non-Quant.)
862.1645	JIR	Class I	Protein or Albumin (Urinary, Non-Quant.)
862.1115	JJB	Class I	Urinary Bilirubin & Its Conjugates (Urinary,Non-Quant.)
862.1510	JMT	Class I	Nitrite (Urinary, Non-Quant.)
864.7675	LIX	Class I	Test, Urine Leukocyte

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	862.2900	JRE	Class .	Refractometer for Clinical Use------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
--	----------	-----	---------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Predicate Devices

AUTION MAX AX-4030 Urinalysis System (K093098)

SYSMEX UF1000i Automated Urine Particle Analyzer with Urinalysis WAM software (K080887)

Sysmex UF-II Control (K070910)

Device Description

Indications for Use

AUTION HYBRID™ AU-4050 Fully Automated Integrated Urine Analyzer System

The AUTION HYBRID™ AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (CHM) is an automated urine analyzer intended for the in vitro measurement of the following parameters: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The chemistry module is intended for use with the Uriflet™ S 9HA multi-parameter urine chemistry test strips. The flow cytometry module (FCM) is an automated urine particle analyzer intended to analyze the following parameters in urine samples: Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria and flags the presence of the following: Pathologic Casts, Crystals. Sperm. Small Round Cells. Yeast Like Cells. and Mucus. The AUTION HYBRID AU-4050 is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

AUTION™ Control Solution

The AUTION Control Solution is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry module.

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Uriflet S 9HA Urinalysis Test Strips

Comparison to Predicate Devices

A comparison of the ARKRAY AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analyzer System to the predicate devices indicates the following similarities:

Same intended use .
. Same technological characteristics
Same operating principle �
. Same design features

The comparison matrices presented below clearly demonstrate that the proposed AU-4050 device is substantially equivalent to the AX-4030 and UF-1000i devices; and the AUTION Control Solution is substantially equivalent to the UF-II Control with regard to the following important aspects:

. Intended Use
. Fundamental Technology
. Performance Specifications

TABLE 1 below is a comparison between the AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analzer System and the AUTION MAX AX-4030 Urinalysis System (K093098) used for urine chemistry analysis.

TABLE 2 below is a comparison between the AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analzer System and the Sysmex UF-1000i Urine Particle Analyzer with Urinalysis WAM software (K080887) used for urine sediment analysis.

TABLE 3 below is a comparison between the AUTION Control Solution and the Sysmex UF-II Control solutions used for quality control purposes on the FCM unit of the AUTION HYBRID AU-4050.

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Category	Substantial Equivalence Comparison TableAX-4030 (Predicate device-K093098)	AU-4050 (proposeddevice)
Intended Use	Automated urine chemistry analyzer forthe in vitro measurement of urinechemistry analytes.	Same
Sample Type	Human Urine	Same
Sample Volume	2 mL	5 mL
MeasurementWavelength	430,500,565,635,760 nm	Same
Measurement Method	Operating Principle:Spectrophotometery Test Strip: Dual-wavelength reflectance measurement(Single wavelength for BLD) S.G .:Reflection refractometry Color Tone:Light-transmission measurementTurbidity: Light-scattering measurement	Same
Measurement Items	GLU, PRO, BIL, URO, PH, BLD, KET,NIT, LEU, S.G, turbidity and color-tone	Same
Test Strip Reaction Time	Approx. 60 seconds	Same as AX-4030
Processing Speed	225 samples/hr	200 samples/hr (CHMmode); 100 samples/hr(CHM + FCM mode)
Display	Large color liquid crystal display(320 x 240 dots)	IPU computer screen
Built-in Printer	Yes	Yes
External Output	RS-232C/Ethernet	Same
Supply Voltage	100-240 VAC, 50/60 Hz	Same
Site Location	For indoor use only	Same
Dimensions (mm)	530 (W) x 530 (D) x 530(H)	800 (W) x 720 (D) x720(H)
Physical Layout	-Analyzer-Sampler	Same
Weight	Approx. 41 kg	Approx. 120 kg
	TABLE 2
Substantial Equivalence Comparison Table
Category	UF-1000i (Predicate device-K080887)	AU-4050 (proposeddevice)
Intended Use	Automated urine particle analyzer forthe in vitro measurement of urinesediments.	Same
Sample Type	Human Urine	Same
Sample Volume	3 mL	5 mL
Measurement Wavelength	N/A	Same
Measurement Method	The device utilizesSysmex flow cytometry using a redsemiconductor laser for analyzingorganized elements or urine. Particlecharacterization and identification isbased on detection of forward scatter,fluorescence, and adaptive clusteranalysis. The UF-1000i uses theaddition of a new bacteria channel andside scatter light signal.	Same
Measurement Items	RBC, WBC, Epithelial Cells, Cast, andBacteria and flags the presence of thefollowing: Pathologic Cast, Crystal,Sperm, Small Round Cell, Yeast likecell and Mucus.	Same
Test Strip Reaction Time	N/A	Same as AX-4030
Processing Speed	100 samples/hr	200 samples/hr (CHMmode); 100 samples/hr(CHM + FCM mode)
Display	IPU computer screen	IPU computer screen
Built-in Printer	No	Yes
External Output	RS-232C/Ethernet	Same
Supply Voltage	100-240 VAC, 50/60 Hz	Same
Site Location	For indoor use only	Same
Dimensions (mm)	580 (W) x 710 (D) x 615(H)	800 (W) x 720 (D) x720(H)
Physical Layout	-Analyzer-Sampler	Same
Weight	Approx. 75.5 kg	Approx. 120 kg

and the contraction of the comments of the comments of the comments of

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TABLE 3Substantial Equivalence Comparison Table
Category	Sysmex UF-II Control (Predicatedevice-K070910)	AUTION ControlSolution (Proposeddevice)
Intended Use	UF II Control contains control particlesfor use in quality control mode of theSysmex Fully Automated Urine ParticleAnalyzer (UF-1000i and UF-500i) andFully Automated Integrated UrineAnalyzer (UX-2000)	The AUTION ControlSolution is intended forin vitro diagnostic useonly for perfromingquality controlprocedures with theAUTION HYBRIDAU-4050 flowcytometry module.
Form	Liquid, ready to use	Same
Levels	2	Same
Storage Stability	2°C-10°C until expiration date	Same
Open Vial Stability	30 days at 2°C-10°C	Same
Matrix	Liquid matrix solution	Same
Analytes	Red Blood Cells, White Blood Cells,Epithelial Cells, Casts, and Bacteria	Same

Summary of Performance Data

Clinical and bench testing was used to verify the performance characteristics of this device. This testing showed acceptable device performance that is substantially equivalent to the performance of the predicate devices.

Conclusion

Based upon the indications for use, comparison with the previously cleared predicate devices, technology and verification testing, ARKRAY has determined that the AUTION HYBRID AU-4050 described in this submission has been shown to be substantially equivalent to the predicate devices.

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Image /page/6/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present. The image is likely a header or title for a document or website related to the Department of Health & Human Services.

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three abstract human figures, represented by flowing lines, suggesting unity and collaboration.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

February 1, 2013

ARKRAY, Inc. c/o Adam Ettl 5182 West 76th Street Edina, Minnesota 55439

Re: K121456

Trade/Device Name: AUTION HYBRID™ AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet™ S 9HA Urine Test Strips; AUTION Control Solution Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Product Code: JIO, KQO, LKM, JJW, JIL, CDM, JJB, JIN, JJR JMT, LJX, CEN, JRE Dated: December 18, 2012 Received: December 19, 2012

Dear Mr. Ettl,

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Adam Ettl

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket s 1561 Yiers Part 807.97). 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benson for

Courtney H. Lias, Ph.D.

Director

Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K121456

Device Name: AUTION HYBRID™ AU-4050 Fully Automated Integrated Urine Analyzer System

Uriflet™ S 9HA Urine Test Strips

AUTION™ Control Solution

Indications for Use:

AUTION HYBRID™ AU-4050 Fully Automated Integrated Urine Analyzer System

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Ruth A. Chesler

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health (OIR)

510(k) K121456

Page 1 of 2

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Indications for Use

510(k) Number: K121456

Uriflet™ S 9HA Urine Test Strips

AUTION™ Control Solution

The AUTION Control Solution is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry module.

× Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR

· Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Ruth A. Chesler

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health (OIR)

510(k) K121456

Page 2 of 2

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.