The AUTION ELEVEN Semi-Automated Urinalysis System provides a qualitative and semi-quantitative measurements for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific gravity and color tone in urine specimens. The system is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The AUTION ELEVEN Semi-Automated Urinalysis System consists of the following:

· AUTION ELEVEN model AE-4022 Urine Analyzer (device component)
· AUTION Sticks 10EA Test Strips (reagent component)

Device Description

The AUTION ELEVEN Semi-Automated Urinalysis System provides a qualitative and semi-quantitative measurement for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific gravity and color tone. The system is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The AUTION ELEVEN Semi-Automated Urinalysis System consists of AUTION ELEVEN model AE-4022 urine analyzer and AUTION Sticks 10EA test strips.

The AUTION sticks 10EA consist of a plastic strip containing 10 pads impregnated with chemicals specific for the determination of a particular analyte. The chemical reaction with the urine results in a color change which is measured by the AUTION ELEVEN AE-4022 device, resulting in a display and print out indicating analyte concentration. The AUTION ELEVEN technology provides fast results that can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.

The semi-automated nature of the device requires the user to dip an AUTION Stick 10EA test strip into a patient urine specimen and place it on the instrument. The instrument processes the test strip, allowing 60 seconds for the chemical reactions to occur on the test strip reagent pads. After 60 seconds, the device measures the amount of reflectance generated from each reagent pad and converts the reflectance measurements to qualitative and semi-quantitative results for physician use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AUTION ELEVEN Semi-Automated Urinalysis System, extracted from the provided text:

Acceptance Criteria and Device Performance

Precision Results

Analyte	Acceptance Criteria (Exact match%)	Reported Device Performance (Exact match%)	Acceptance Criteria (+/- 1 Color Block%)	Reported Device Performance (+/- 1 Color Block%)
Glucose	Not explicitly stated	98% (Repeatability), 99% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)
Protein	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)
Bilirubin	Not explicitly stated	99% (Repeatability), 99% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)
Urobilinogen	Not explicitly stated	99% (Repeatability), 100% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)
pH	Not explicitly stated	98% (Repeatability), 99% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)
Specific Gravity	Not explicitly stated	96% (Repeatability), 97% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)
Blood	Not explicitly stated	99% (Repeatability), 100% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)
Ketones	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)
Nitrite	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)
Leukocytes	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)

Note: The document states that "results from bench testing met pre-determined acceptance criteria and support a determination of substantial equivalence." However, the specific numerical acceptance criteria for "Exact match %" and "+/- 1 Color Block %" were not explicitly listed in the tables provided for precision. The reported device performance values are the results obtained from the study.

Method Comparison Results (Accuracy)

Analyte	Acceptance Criteria (Exact Agreement with Predicate)	Reported Device Performance (Exact Agreement with Predicate)	Acceptance Criteria (Agreement within ± 1 color block)	Reported Device Performance (Agreement within ± 1 color block)
Glucose	Not explicitly stated	98%	Not explicitly stated	100%
Protein	Not explicitly stated	86%	Not explicitly stated	100%
Bilirubin	Not explicitly stated	100%	Not explicitly stated	100%
Urobilinogen	Not explicitly stated	98%	Not explicitly stated	100%
pH	Not explicitly stated	89%	Not explicitly stated	100%
Specific Gravity	Not explicitly stated	81%	Not explicitly stated	99%
Blood	Not explicitly stated	92%	Not explicitly stated	100%
Ketones	Not explicitly stated	96%	Not explicitly stated	100%
Nitrite	Not explicitly stated	99%	Not explicitly stated	100%
Leukocyte	Not explicitly stated	92%	Not explicitly stated	100%

Note: Similar to precision, the document states "The overall conclusion from the clinical evaluation is that the results are acceptable and support a determination of substantial equivalence," implying the reported accuracy rates met their internal acceptance criteria. However, the specific numerical acceptance thresholds were not provided in these tables.

Detection Limits/Sensitivity Results

The acceptance criteria here are that the "Actual Concentration" for a given semi-quantitative rank should result in the device reporting that rank (or a higher rank) at a certain "Percent in Rank." These are implicitly the acceptance criteria for sensitivity. The table shows the "Actual Concentration" and the "Percent in Rank" achieved. For instance, for Glucose, the acceptance criterion for the 4+ rank might be that at 750 mg/dL, it should be in the 4+ rank at least 50% of the time (reported 87%).

Interfering Substances

The acceptance criteria are implicitly that the identified interferents cause a specific shift in color blocks as described (e.g., False negative (-2 to -3 color block change) for Glucose with Ascorbic acid). The study identifies what interference occurs and its magnitude, implying these findings were deemed acceptable within the context of device labeling.

Study Details

Sample size used for the test set and the data provenance:
- Precision Study:
  - Sample Size: Not a direct patient sample size. Three (3) levels of quality controls were used for each analyte.
  - Data Provenance: Not specified, but likely controlled laboratory conditions given the use of commercial controls and specified dilutions/spiking.
- Method Comparison Study (Accuracy):
  - Sample Size: 8395 tests of individual analytes. The number of unique patient samples is not explicitly stated, but the note mentions "Each site collected urine patient samples from their clinical laboratory or obtained them from nearby hospitals."
  - Data Provenance: Clinical patient samples, collected and refrigerated within 2 hours of collection for up to 24 hours prior to testing. Country of origin is not specified, but the clinical sites suggest real-world data collection. The study is prospective in the sense that samples were collected for the purpose of this study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Precision Study: Not applicable. Ground truth was established by the known concentrations of the quality control materials.
- Method Comparison Study: Ground truth was established by comparison against "2 commercially available urinalysis predicates, 1 semi-automated urine analyzer was used for specific gravity comparison and one fully-automated urine analyzer was used to compare all the rest of the analytes." No human experts were explicitly mentioned for ground truth establishment for this comparison. The predicate devices served as the reference standard.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for either the precision or method comparison studies as ground truth was established either by known control concentrations or by predicate device performance, not by human expert consensus requiring adjudication.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an automated and semi-automated urinalysis system, and the studies focused on its analytical performance against predicate devices and known controls, not on human reader performance or AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance characteristics studies (Precision, Method Comparison, Detection Limits, Interfering Substances) represent standalone (algorithm only) performance of the AUTION ELEVEN Semi-Automated Urinalysis System. While a human dips the strip, the measurement and interpretation of the color change are performed by the automated device's optical unit and algorithms. The system then provides qualitative and semi-quantitative results automatically.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Precision Study: Known concentrations of quality control materials.
- Method Comparison Study: Comparison against established predicate urinalysis devices for each analyte.
The sample size for the training set:
- No information about a "training set" is provided in the document. This type of device (urinalysis analyzer) is typically developed and validated using analytical samples (spiked, diluted, known concentrations) and clinical samples, rather than a machine learning "training set" in the conventional sense. The "Performance Characteristics" section details the validation of the device's measurement accuracy and precision.
How the ground truth for the training set was established:
- Not applicable, as no training set was explicitly mentioned or described for this type of device validation.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 7, 2016

ARKRAY, INC. NAVEEN THURAMALLA VICE PRESIDENT, REGULATORY AFFAIRS 5182 76TH STREET EDINA MN 55439

Re: K160062

Trade/Device Name: AUTION ELEVEN Semi-Automated Urinalysis System Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: II Product Code: JIL, JIO, KQO, CDM, CEN, JIN, JJR, JJB, JMT, LJX, JRE Dated: August 29, 2016 Received: August 30, 2016

Dear Naveen Thuramalla:

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. 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 Parts 801 and 809); 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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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Courtney H. Lias -S

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 (if known) K160062

Device Name

AUTION ELEVEN Semi-Automated Urinalysis System

Indications for Use (Describe)

The AUTION ELEVEN Semi-Automated Urinalysis System consists of the following:

· AUTION ELEVEN model AE-4022 Urine Analyzer (device component)
· AUTION Sticks 10EA Test Strips (reagent component)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Research Use Only (21 CFR 201.3 Subject to Review)

Over-The-Counter Use Only (21 CFR 201.3 Subject to Review)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) Summary of the AUTION ELEVEN Semi-Automated Urinalysis System is submitted in compliance of 21 CFR 807.92 for the purposes of safety and effectiveness.

510(k) Number:	K160062
Date Prepared:	October 06, 2016
Establishment:	ARKRAY Inc.Yousuien-Nai59 Gansuin-Cho, Kamigyo-KuKyoto 602-0008, JapanEstablishment Registration Number: 9611444
Submitter:	ARKRAY, Inc.57 Nishiaketa-Cho, Higashi-Kujo, Minami-KuKyoto 601-8045, JapanTelephone: 81-75-968-9003Fax: 81-75-662-8977Official US Agent: Tom SpeikersARKRAY Factory USA, Inc.VP, Regulatory Affairs and Quality SystemsPhone: (952) 646-3168Fax: (952) 646-3110Email: SpeikersT@arkrayusa.com
Contact Person:	Naveen ThuramallaARKRAY Factory USA, Inc.Vice President, Regulatory AffairsPhone: (cell): 202-738-8303Email: ThuramallaN@arkrayusa.com

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Device Name

Trade Name:	AUTION ELEVEN Semi-Automated Urinalysis System
Common Name:	Automated Urinalysis System
510(k) Number:	K160062

Regulation:21 CFRSection	ProductCode	Classification	Description
862.1340	JIL	Class II	Glucose (Urinary, Non-Quantitative)
864.6550	JIO	Class II	Blood, Occult, Colorimetric, In Urine
862.2900	KQO	Class I	Automated Urinalysis System
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	LJX	Class I	Test, Urine Leukocyte
862.2800	JRE	Class I	Specific Gravity

Table 1: Regulatory Information

Predicate Devices

AUTION MAX AX-4030 Urinalysis System (K093098)

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Intended Use

The AUTION ELEVEN Semi-Automated Urinalysis System consists of the following:

AUTION ELEVEN model AE-4022 urine analyzer (device component) ●
AUTION Sticks 10EA test strips (reagent component) ●

Device Description

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Substantial Equivalence

#	Element ofComparison	AUTION MAX AX-4030(Predicate)	ClaimedSubstantialEquivalentDevice, AUTIONELEVENSemi-AutomatedUrinalysis System	AUTIONELEVENComparison
1	ProprietaryName	AUTION MAX	AUTIONELEVEN	N/A
2	510(k) Number	K093098 (2009)	K160062	N/A
3	Class	Class II (Blood and Glucoseanalytes raise system toClass II / 510(k) required)	Class II (Bloodand Glucoseanalytes raisesystem to Class II /510(k) required)	SAME
4	Data Type	Qualitative, Semi-Quantitative	Qualitative, Semi-Quantitative	SAME
5	Location	Clinical Laboratory	ClinicalLaboratory	SAME
6	MedicalDevice/IVD	Medical Device/IVD	MedicalDevice/IVD	SAME
7	Specimen	Human Urine	Human Urine	SAME
8	Analytes	GlucoseProteinBilirubinUrobilinogenpHBloodKetonesNitriteLeukocyteSpecific Gravity	GlucoseProteinBilirubinUrobilinogenpHBloodKetonesNitriteLeukocyteSpecific Gravity	SAME
9	Color ToneDetection	23 color tones using 3wavelengths (red, green andblue); executed by a colortone unit with a differentcalculation	23 color tonesusing 4wavelengths (red,green, blue,infrared); executedby the optical unit	Testingdemonstratescolor tonedetection.
#	Element ofComparison	AUTION MAX AX-4030(Predicate)	ClaimedSubstantialEquivalentDevice, AUTIONELEVENSemi-AutomatedUrinalysis System	AUTIONELEVENComparison
10	Color Tonecorrection	Calculation to mitigate urinecolor interference	Calculation tomitigate urinecolor interference	Testing showscolor does notinhibit results.
11	AbnormalColor Marker(!)(ketone,urobilinogen,bilirubin)	Calculations based onwavelengths 430nm, 500nm,565nm, and 635nm	Calculations basedon wavelengths430nm, 500nm,565nm, and 635nm	Same formulacomparing theanalyte padreflectanceratio of 2colors dividedby thereference padreflectanceratio of thesame 2 colors.
12	Turbidity/Clarity	Determines turbidity	Does notdetermineturbidity. Optionavailable for userto enter level ofclarity perlaboratoryprofessionaleducation.	Device doesnot determinethis optionalparameter.
#	Element ofComparison	AUTION MAX AX-4030(Predicate)	ClaimedSubstantialEquivalentDevice, AUTIONELEVENSemi-AutomatedUrinalysis System	AUTIONELEVENComparison
13	Reagent TestStrips	AUTION Sticks 9EB:(1) No specific gravityreagent pad (usesRefractometer);(2) Uses blank pad forcorrection due to urinecolor; different calculation(3) Has black marker formodel distinction by device	AUTIONSticks10EA:(1) Has specificgravity reagentpad;(2) Uses blank padfor correction dueto urine color;(3) Has blackmarker for modeldistinction bydevice	SAME asAUTIONMAX for allreagent padsexceptspecificgravity.SAMEchemicalreactions, asAUTIONMAX.AUTIONELEVEN wascompared toAUTIONMAX for 9analytes, asthe morerecentpredicate, andwas comparedto AUTIONJET(K030600) forspecificgravity only.
14	Quality ControlSolution	Commercial urine analyzerControl Solution	Commercial urineanalyzer ControlSolution	SAME
#	Element ofComparison	AUTION MAX AX-4030(Predicate)	ClaimedSubstantialEquivalentDevice, AUTIONELEVENSemi-AutomatedUrinalysis System	AUTIONELEVENComparison
15	Check Strips –for qualitycontrol ofdevice opticalunit's lightintensity	AUTION Check Strips(provided with device)	AUTION CheckStrips (providedwith device)	SAME
16	Method ofdevicechemistrydetermination	Colorimetric Reflectometryof reagent chemical reactionwith analyte for all analytes*except Refractometry forspecific gravity	ColorimetricReflectometry ofreagent chemicalreaction withanalyte for allanalytes	SAME asAUTIONMAX for allreagent padsexceptspecificgravity.SAME asAUTION JET(K030600) forspecificgravity.
17	BarcodeReaderPossible/NotRequired	Yes	Yes	SAME
18	Urine mixedforhomogeneity	By hand and aspirator	By hand	ClinicalTesting showsthat AUTION
19	Urine appliedto reagent pad	Automatic pipette-applied	Hand-dipped for 2seconds	MAX andAUTION
#	Element ofComparison	AUTION MAX AX-4030(Predicate)	ClaimedSubstantialEquivalentDevice, AUTIONELEVENSemi-AutomatedUrinalysis System	AUTIONELEVENComparison
20	Timingbetween urineapplication anddetermination	Automatic	Controlled byHumancount/soundalarms +automation	ELEVENdevicesperformsimilarly andthere is noadditionaleffect onsafety andeffectiveness.
21	Timing ofreagentreaction	Approximately 60 seconds	Approximately 60seconds	SAME
22	Resultdetermination	Automatic	Automatic	SAME
23	Rank Table	Includes Qualitative andSemi-Quantitative Ranks	IncludesQualitative andSemi-QuantitativeRanks; Semi-Quantitative ranksmatch Qualitativeranks in number	SAME; AllSemi-Quantitativeranks withinthe respectiveQualitativerank arecombined.The ranksalign withpredicateQualitativeranks andtheirrespectiveSemi-Quantitativeconcentrationlimitsalthough only1 Semi-
#	Element ofComparison	AUTION MAX AX-4030(Predicate)	ClaimedSubstantialEquivalentDevice, AUTIONELEVENSemi-AutomatedUrinalysis System	AUTIONELEVENComparison
				Quantitativeconcentrationreference isprovidedwhere therefor apredicateSemi-Quantitativerank.
24	Software-Controlled	Yes	Yes	SAME
25	Printed DataReport	Yes	Yes	SAME
26	MeasurementWavelengthsfor Analytes	Dual wavelengthmeasurement using 565,635, 760 nm (Except blood,which uses only 635 nm)	Dual wavelengthmeasurementusing 565, 635,760 nm (Exceptblood, which usesonly 635 nm)	SAME
27	ProcessingSpeed	225 samples/hr	514 samples/hr	Resultdeterminationtime remainsthe same, sono differencein technologyor chemistry– justthroughput.
28	MemoryCapacity	2500 tests	520 tests	Testing forelectronicsafety andcompatibility.
29	Crystal (LC)Display	Yes	Yes
30	Built-in printer	Yes	Yes
31	External output	RS-232C/Ethernet	RS-232C/Ethernet
#	Element ofComparison	AUTION MAX AX-4030(Predicate)	ClaimedSubstantialEquivalentDevice, AUTIONELEVENSemi-AutomatedUrinalysis System	AUTIONELEVENComparison
32	BarcodeSpecifications	NW-7, CODE39, code 128,ITF;On unit	NW-7, CODE39,code 128, ITF;hand held type
33	Voltage Supply	100-240 VAC, 50/60 Hz	100-240 VAC,50/60 Hz; useadapter 12 VDC3A
34	Dimensions(mm)	530 (w) x 530(d) x 530 (h)	210 (w) x 328 (d)x 164 (h)	N/A
35	Linearity	Yes	Yes	SAME
36	Sensitivity	Yes	Yes	SAME
37	InterferingSubstances	Yes	Yes	SAME
38	DetectionLimit/Specificity	Yes	Yes	SAME
39	Accuracy byComparison	Yes	Yes	SAME
40	Precision	Yes	Yes	SAME
41	Color ToneDetection	Yes	Yes	SAME
42	Color ToneCorrection	Yes	Yes	SAME
43	ElectricalSafety	Yes	Yes	Slightdifferences
44	Radiofrequency	Yes	Yes	per
45	ElectricalCompatibility	Yes	Yes	specifications.Testing
46	DeviceSoftware	Yes	Yes	ensures safetyand efficacy.
47	Stability-Closed Bottle	Yes	Yes	SAME
48	Stability-OpenBottle	Yes	Yes	SAME

Table 2: Substantial Equivalence

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Standards Referenced

Clinical and Laboratory Standards Institute. (2014). EP05-A3 Vol 34 No.13 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline-Third Ed.

Clinical and Laboratory Standards Institute. (2003). EP06-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline.

Clinical and Laboratory Standards Institute. (2005). EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition.

Clinical and Laboratory Standards Institute. (2010). EP09-A2-IR Vol. 30 No. 17 Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline – Second Edition.

Clinical and Laboratory Standards Institute. (2009). GP-16-A2 21 No.19 Urinalysis: Approved Guideline - Third Edition.

Clinical and Laboratory Standards Institute. (2012). EP17-A2 Vol 32 No.8 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline- Second Edition.

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Test Principle

The AUTION ELEVEN Semi-Automated Urinalysis System device model AE-4022 uses 4 LED wavelengths to accurately read AUTION 10EA Stick test strips which are impregnated with chemicals to induce the reactions shown below upon contact with particular analytes in urine. Three (3) of the wavelengths read the analyte interaction while the fourth wavelength is used for color tone detection and correction.

Glucose: Glucose oxidase reaction. GOD → Gluconic acid + H₂O₂ Glucose POD H2O2 + 4-AAP + 1-Naphthol-3,6-disulfonic acid > 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. acid 2-Methyl-5-nitroaniline + Sodium nitrite Diazonium salt diazo reaction acid Bilirubin + Diazonium salt Azo dye (reddish brown color) coupling reaction Urobilinogen: Azo-coupling reaction. acid Urobilinogen + Diazonium salt > Azo dye (reddish brown color) coupling reaction pH: pH indicator. ► ► mixed pH indicator shows range of colors H+ + mixed pH indicator covering the urinary pH range (yellow - cyan color) Specific Gravity: Cation extraction. cation extraction Cation + D-2-EHPA + pH indicator color reaction of pH indicator (cyan - yellow color) Blood: Activity measurement of pseudoperoxidase in hemoglobin. hemoglobin > H2O + Cumene + Oxidation dye (cyan color) CHP + TMBZ pseudoperoxidase action Ketones: Legal reaction. alkaline Ketones + Sodium nitroprusside > Ketones complex (purple color) Nitrite: Griess reaction. acid Nitrite + Sulfanilamide -> Diazo-compound + NEDA-2HCl acid Azo dye (pink color) coupling reaction Leukocytes: Measurement of leukocyte esterase activity. TAI esterase from leukocytes - Indoxyl + MMB -______________________________________________________________________________________________________________________________________________________________________________ hydrolysis

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Performance Characteristics

Bench testing and clinical testing were done in order to verify that the above differences are minor in nature and do not affect the overall performance, safety, or effectiveness of the proposed device compared to the predicate device.

Precision Results

Each analyte was tested at 3 clinical sites using 3 operators on 3 devices for a minimum of 20 days. Three (3) levels of quality controls were used to attain results at negative, midlevel positive and high-positive analyte ranges. Two (2) levels of commercial controls were used to obtain the 3 levels, using dilutions and spiking materials as needed to obtain the highest and mid-level controls for testing of all the analyte ranks.

	Table 3: Precision Results

	Repeatability		Reproducibility
Analyte	Exact match%	+/- 1Color Block%	Exact match%	+/- 1Color Block%
Glucose	98%	100%	99%	100%
Protein	100%	100%	100%	100%
Bilirubin	99%	100%	99%	100%
Urobilinogen	99%	100%	100%	100%
pH	98%	100%	99%	100%
Specificgravity	96%	100%	97%	100%
Blood	99%	100%	100%	100%
Ketones	100%	100%	100%	100%
Nitrite	100%	100%	100%	100%
Leukocytes	100%	100%	100%	100%

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Comparison Study Results

A Method Comparison study was performed at 3 sites to compare the AUTION ELEVEN Semi-Automated Urinalysis System against 2 commercially available urinalysis predicates, 1 semi-automated urine analyzer was used for specific gravity comparison and one fully-automated urine analyzer was used to compare all the rest of the analytes.

Each site collected urine patient samples from their clinical laboratory or obtained them from nearby hospitals. Urine samples were collected and refrigerated within 2 hours of collection, for up to 24 hours of refrigeration prior to clinical study testing. For inclusion into the study, the samples collected had to be positive for at least one of the chemistry analytes present on the AUTION Stick 10EA urinalysis strip

Data from each site was combined for the analysis. Accuracy (percent agreement) results are shown below.

Analyte	Number ofsamples	PercentPositiveSamples	ExactAgreementwith Predicate	95% CI	Agreementwithin ± 1color block
Glucose	2199	16%	98%	97.5 - 98.6	100%
Protein	563	56%	86%	83.2 - 89.1	100%
Bilirubin	2323	8%	100%	99.1 - 99.7	100%
Urobilinogen	2308	12%	98%	94.7 - 96.4	100%
pH	2307	100%	89%	88.3 - 90.9	100%
Specific Gravity	548	100%	81%	77.9 - 84.6	99%
Blood	548	45%	92%	89.2 - 94	100%
Ketones	2221	28%	96%	95.1 - 96.8	100%
Nitrite	2209	6%	99%	99.6 - 98.8	100%
Leukocyte	548	40%	92%	89 - 93.8	100%

Table 4: Method Comparison Results

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Interfering Substances

Table 5: Interferent Results

Analyte	Interferent	Concentration	Result
Glucose	Ascorbic acid	>50 mg/dL	False negative(-2 to -3 color block change)
Glucose	pH	<pH4	False positive(+2 color block change)
Protein	Hemoglobin	>20 mg/dL	False positive(+2 color block change)
Bilirubin	Urobilinogen	>8 mg/dL	False positive(+1 color block change)
Urobilinogen	Bilirubin	>3 mg/dL	False positive(+1 color block change)
pH		N/A
Specific Gravity	pH	<pH4	Elevated(+2 color block change)
	Albumin	>300 mg/dL	Elevated(+2 color block change)
	Ammonium chloride	>200 mg/dL	Elevated(+2 color block change)
Blood	Substances such asMESNA that contain	>50 mg/dL	False negative(-3 color block change)
Ketones	Substances such asMESNA that contain	>5 mg/dL	False positive(+2 to +5 color block change)
Nitrite		N/A
Leukocytes	Glucose	>200 mg/dL	False negative(-2 color block change)
	Albumin	>300 mg/dL	False negative(-2 color block change)
	pH	<pH4	False negative(-2 color block change)

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Detection Limits/Sensitivity Results

Listed below are thresholds by which the analyte concentration/level is met for the higher rank at least 50% of the time.

Table 6: Detection Limits

Analyte	QualitativeRank	Semi-QuantitativeRank	ActualConcentration	Percent inRank	Units
Glucose	-	NEG	0	100%	mg/dL
	±	30	30	100%	mg/dL
	1+	70	60	100%	mg/dL
	2+	150	125	100%	mg/dL
	3+	300	250	100%	mg/dL
	4+	1000	750	87%	mg/dL
Protein	-	NEG	0	100%	mg/dL
	±	10	10	100%	mg/dL
	1+	30	25	63%	mg/dL
	2+	100	85	100%	mg/dL
	3+	300	250	100%	mg/dL
	4+	1000	800	97%	mg/dL
Bilirubin	-	NEG	0	100%	mg/dL
	1+	0.5	0.5	50%	mg/dL
	2+	2	1.9	53%	mg/dL
	3+	6	5.3	87%	mg/dL
4+	14	12	100%	mg/dL
Urobilinogen	NORM	NORM	0	100%	mg/dL
	1+	2	2.0	100%	mg/dL
	2+	4	3.5	50%	mg/dL
	3+	8	6.5	100%	mg/dL
4+	16	14	100%	mg/dL
pH	N/A	5.0	5.0	100%	N/A
		5.5	5.3	100%
		6.0	5.8	100%
		6.5	6.3	87%
		7.0	6.8	100%
		7.5	7.3	87%
		8.0	7.8	97%
		8.5	8.3	50%
		9.0	8.9	50%

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Analyte	QualitativeRank	Semi-QuantitativeRank	ActualConcentration	Percent inRank	Units
SpecificGravity	N/A	< 1.005	1.005	100%	N/A
		1.010	1.008	60%
		1.015	1.013	90%
		1.020	1.019	100%
		1.025	1.023	97%
		>1.030	1.028	83%
Blood	-	NEG	0	100%	mg/dL
	±	0.03	0.023	100%	mg/dL
	1+	0.06	0.05	97%	mg/dL
	2+	0.20	0.18	87%	mg/dL
	3+	1.00	0.9	50%	mg/dL
Ketone	-	NEG	0	100%	mg/dL
	±	5	4	100%	mg/dL
	1+	10	7.5	100%	mg/dL
	2+	40	30	100%	mg/dL
	3+	80	70	73%	mg/dL
	4+	150	130	63%	mg/dL
Nitrite	-	N/A	0	100%	N/A
	1+	N/A	0.075	50%
	2+	N/A	0.3	100%
Leukocytes	N/A	NEG	0	100%	Leu/µL
		25	25	100%	Leu/µL
		75	50	77%	Leu/µL
		250	180	97%	Leu/µL
		500	390	83%	Leu/µL
Analyte	QualitativeRank	Semi-QuantitativeRank	Concentration/Level Tested	Exact Match	± 1 ColorBlock
Glucose	-	NEG	0 mg/dL	100% (21/21)	100% (21/21)
	±	30	45 mg/dL	90.5% (19/21)	100% (21/21)
	1+	70	85 mg/dL	100% (21/21)	100% (21/21)
	2+	150	170 mg/dL	100% (21/21)	100% (21/21)
	3+	300	340 mg/dL	100% (21/21)	100% (21/21)
	4+	1000	2700 mg/dL	100% (21/21)	100% (21/21)
Protein	-	NEG	0 mg/dL	100% (21/21)	100% (21/21)
	±	10	15 mg/dL	100% (21/21)	100% (21/21)
	1+	30	30 mg/dL	100% (21/21)	100% (21/21)
	2+	100	120 mg/dL	100% (21/21)	100% (21/21)
	3+	300	480 mg/dL	100% (21/21)	100% (21/21)
	4+	1000	1000 mg/dL	100% (21/21)	100% (21/21)
Bilirubin	-	NEG	0 mg/dL	100% (21/21)	100% (21/21)
	1+	0.5	1.5 mg/dL	100% (21/21)	100% (21/21)
	2+	2	3 mg/dL	100% (21/21)	100% (21/21)
	3+	6	6 mg/dL	100% (21/21)	100% (21/21)
	4+	14	14 mg/dL	100% (21/21)	100% (21/21)
Urobilinogen	NORM	NORM	normal	100% (21/21)	100% (21/21)
	1+	2	3 mg/dL	100% (21/21)	100% (21/21)
	2+	4	5 mg/dL	100% (21/21)	100% (21/21)
	3+	8	10 mg/dL	95.2% (20/21)	100% (21/21)
4+	16	20 mg/dL	100% (21/21)	100% (21/21)
pH	N/A	5	5.0	100% (21/21)	100% (21/21)
		5.5	5.5	100% (21/21)	100% (21/21)
		6	6.0	100% (21/21)	100% (21/21)
		6.5	6.5	100% (21/21)	100% (21/21)
		7	7.0	95.2% (20/21)	100% (21/21)
		7.5	7.5	100% (21/21)	100% (21/21)
		8	8.0	100% (21/21)	100% (21/21)
		8.5	8.4	95.2% (20/21)	100% (21/21)
		9	9.0	100% (21/21)	100% (21/21)
SpecificGravity	N/A	< 1.005	1.000	100% (21/21)	100% (21/21)
		1.010	1.010	100% (21/21)	100% (21/21)
		1.015	1.015	95.2% (20/21)	100% (21/21)
		1.020	1.020	90.5% (19/21)	100% (21/21)
		1.025	1.025	100% (21/21)	100% (21/21)
		>1.030	1.035	100% (21/21)	100% (21/21)
Analyte	QualitativeRank	Semi-QuantitativeRank	Concentration/Level Tested	Exact Match	± 1 ColorBlock
Blood	-	NEG	0 mg/dL	100% (21/21)	100% (21/21)
	±	0.03	0.03 mg/dL	100% (21/21)	100% (21/21)
	1+	0.06	0.08 mg/dL	100% (21/21)	100% (21/21)
	2+	0.20	0.6 mg/dL	95.2% (20/21)	100% (21/21)
	3+	1.00	1.3 mg/dL	100% (21/21)	100% (21/21)
Ketone	-	NEG	0 mg/dL	100% (21/21)	100% (21/21)
	±	5	5 mg/dL	100% (21/21)	100% (21/21)
	1+	10	15 mg/dL	100% (21/21)	100% (21/21)
	2+	40	60 mg/dL	100% (21/21)	100% (21/21)
	3+	80	120 mg/dL	90.5% (19/21)	100% (21/21)
	4+	150	240 mg/dL	100% (21/21)	100% (21/21)
Nitrite	-	N/A	0 mg/dL	100% (21/21)	100% (21/21)
	1+		0.1 mg/dL	100% (21/21)	100% (21/21)
	2+		0.8 mg/dL	100% (21/21)	100% (21/21)
Leukocytes	N/A	NEG	0 Leu/µL	100% (21/21)	100% (21/21)
		25	25 Leu/µL	100% (21/21)	100% (21/21)
		75	75 Leu/µL	95.2% (20/21)	100% (21/21)
		250	250 Leu/µL	100% (21/21)	100% (21/21)
		500	520 Leu/µL	100% (21/21)	100% (21/21)

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Linearity Results

Table 7: Linearity

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Proposed Labeling

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

Conclusion

Bench Testing

Bench testing evaluations were used to verify performance characteristics of the AUTION ELEVEN Semi-Automated Urinalysis System. Bench testing evaluations included: linearity, sensitivity, interfering substances, detection limit/specificity, electrical compatibility and safety, radiofrequency compatibility, device software validation, and test strip shelf life and stability. In all instances, results from bench testing met pre-determined acceptance criteria and support a determination of substantial equivalence.

Clinical Testing

A precision study was performed on each analyte across 3 sites with 3 operators (1 per site) and 3 devices using 3 levels of quality control solutions per analyte to evaluate repeatability and reproducibility. A Method Comparison study was performed at a predetermined number of sites with 8395 tests of individual analytes including both natural and spiked samples. The overall conclusion from the clinical evaluation is that the results are

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acceptable and support a determination of substantial equivalence without additional risk to safety and efficacy.

Based upon the intended use, comparison with the previously cleared predicate devices, technology similarities, and bench and clinical data, the AUTION ELEVEN Semi-Automated Urinalysis System is substantially equivalent to the predicate devices, 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.