inui In-Home Urine Analysis Test System by Scanadu, Inc.

The inui In-Home Urine Analysis Test System consists of the inui In-Home Urine Analysis Device and the inui Urine Analysis Mobile Application. The inui In-Home Urine Analysis Test System is intended for detecting the following parameters in urine: Protein, Glucose, Leukocytes, Nitrites, and Ketones. The test results provide information regarding the status of Urinary Tract Infections (UT), proteinuria, glucosuria, and ketonuria. These results can be used as an aid for monitoring kidney functions and metabolic disorders (e.g. diabetes mellitus), and can be used in the screening for Urinary Tract Infections (UTI).

The inui In-Home Urine Analysis Device is intended for use as a prescription home use device.

Device Description

The inui In-Home Urine Analysis Test System consists of inui In-Home Urine Analysis Device and the inui Urine Analysis Mobile Application. It is an in vitro diagnostic device comprised of a disposable test paddle, a urine collection cup, a gray background sheet, and a mobile application ("inui App"). The plastic "paddle" contains multiple chemistry test pads (CTPs) and 1 quick response (QR) barcode. CTPs contain pre-dried chemicals that react to specific substances in a urine sample. A color reaction occurs on the CTP based on the amount of substance in the urine sample. The color reaction is captured as an image using the mobile device camera and should only be read using the inui App. The results are reported as specified by the measurement range for each test. The QR Code is used for quality control purposes to track lot number, expiration date, and paddle use.

The inui In-Home Urine Analysis System reports semi-quantitative or qualitative results for each test parameters.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the inui In-Home Urine Analysis Test System, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

General Acceptance Criteria from Analytical Performance:

Precision and Reproducibility: Proportion of agreement for each level and analyte tested to be above 95% to the expected values.
Limit of Detection (LOD) and Linearity: Established for each level and analyte.
Specificity and Interference Testing: Identification of interfering substances and their minimum concentration levels causing false positives/negatives. The device should produce an error message for substances introducing colors outside the analyte's normal range.

Clinical Performance Acceptance Criteria:

Clinical Accuracy (Method Comparison): Lay-user clinical test results should be comparable to those of professional users using the predicate device. Specific agreement percentages are implicitly set by the reported data in Table 5.
Usability: Lay users should be able to follow procedural steps to obtain successful test results with a specified performance percentage.
Lay-user Reproducibility: Lay-users should obtain the same results after repeated testing with a high reproducibility percentage.

1. Table of Acceptance Criteria and the Reported Device Performance

Parameter / Indication for Use	Acceptance Criteria (Implicit from Study Design)	Reported Device Performance
Analytical Performance
Precision & Reproducibility	>95% agreement to expected values for each level/analyte.	Achieved: "The proportion of agreement for each level and analyte tested met the established acceptance criteria and was found to be above 95% agreement to the expected values for both precision and reproducibility." (Page 7)
Limit of Detection (LOD)	Established for each level/analyte.	Achieved: LODs were determined, and a "Summary of the sensitivities are provided in Table 3." (Page 7)
Specificity / Interference	Identification of interfering substances, their levels, and a mechanism for handling abnormal urine colors (e.g., error message).	Achieved: "Thirty-nine potentially interfering exogenous and endogenous substances were evaluated." The device "produces an error message with no result (invalid) for any substance that introduces colors outside the range for that analyte." (Page 7-8) Acetoacetic Acid consistently produced an error message. Table 4 lists interfering substances and their levels. Other identified interferences include: - Protein: Albumin (>3000 mg/dL), Bilirubin (>10 mg/dL), Hemoglobin (>100 mg/dL), Chlorhexidine (>40 mg/dL), Riboflavin (>5 mg/dL), Hypochlorite (>375 mg/dL), Specific Gravity (>1.025). - Leukocyte: Human Leukocyte Esterase (>0.025 U/mL), Hemoglobin (>150 mg/dL), Albumin HSA (>3000 mg/dL), Bilirubin (>10 mg/dL), Sodium Chloride (>324 mg/dL), Hypochlorite (>375 mg/dL), Chlorhexidine (>60 mg/dL), Microbial Peroxidase (>0.65%), Riboflavin (>5 mg/dL), Sodium Acetate (>600 mg/dL), Sodium Bicarbonate (>630 mg/dL), Specific Gravity (>1.020), Urobilinogen (>4 mg/dL). - Nitrite: Sodium Nitrite (>5 mg/dL), Human Hemoglobin (>100 mg/dL), Hypochlorite (>375 mg/dL), Human Leukocyte (>0.0375 U/mL), Urobilinogen (>4 mg/dl), Sodium Bicarbonate (>945mg/dl), Sodium Acetate (>900 mg/dL), Hypochlorite (>375 mg/dL), Sodium Nitrite (>7.5 mg/dL). - Ketone: Lithium Acetoacetate (>40 mg/dL), Hypochlorite (>375 mg/dL), Sodium Nitrite (>7.5 mg/dL). - Glucose: D-(+)-Glucose (>500 mg/dL), Hypochlorite (>375 mg/dL), Bilirubin (invalid results at all conc), Lithium Acetoacetate (>80 mg/dL), Sodium Chloride (>486 mg/dL). (Pages 8-9)
Clinical Performance
Method Comparison (Lay User vs. Predicate)	Lay user results comparable to professional users with predicate device; high agreement percentages. An explicit threshold for each analyte/level is implied by the successful submission.	Achieved; "clinical test results that are comparable to those of a professional users". Protein: Negative (83% exact, 100% within 1 block), Trace (75% exact, 100% within 1 block), Moderate (90% exact, 100% within 1 block), Large (100% exact, 100% within 1 block). Glucose: Negative (100% exact, 100% within 1 block), Low (74% exact, 100% within 1 block), Moderate to Large (100% exact, 100% within 1 block). Leukocyte: Negative (100% exact), Positive (97% exact). Nitrite: Negative (96% exact), Positive (100% exact). Ketone: Negative/Trace (99% exact, 100% within 1 block), Small (67% exact, 100% within 1 block), Moderate to Large (100% exact, 100% within 1 block). (Table 5, Page 10)
Usability	Lay users can follow all procedural steps to obtain a successful test result, with a high overall performance percentage.	Achieved: Overall performance of 88.9% (1st paddle), 86.7% (2nd paddle), and 91.1% (3rd paddle). (Page 10)
Lay-user Reproducibility	High reproducibility (e.g., 100%) for lay-user repeated testing.	Achieved: "reproducibility of the inui Device in the hands of the lay user was 100%." (Page 10)

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

Test Set Sample Size:
- Clinical Accuracy (Method Comparison): Two studies were conducted using 190 and 91 lay users, respectively.
- Usability Study: 45 lay users.
- Lay-User Reproducibility Study: 10 lay users.
Data Provenance: The document does not explicitly state the country of origin. It indicates that the clinical evaluation followed an "Investigational Review Board approved clinical protocol," suggesting prospective data collection.

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

The ground truth for the clinical accuracy study was established by comparing lay-user results from the inui device to results obtained from the predicate device, Siemens Multistix® 10SG, "by professional users."
The document does not specify the exact number of professional users or their specific qualifications (e.g., "radiologist with 10 years of experience"). It just refers to them as "professional users."

4. Adjudication Method for the Test Set

The document describes a direct comparison method where lay-user results from the inui device are compared against results from the predicate device read by professional users.
It does not mention an explicit adjudication method like "2+1" or "3+1" to resolve discrepancies between multiple professional readers or to establish a consensus ground truth beyond the professional reading of the predicate device. The professional reading of the predicate device serves as the reference.

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

No, an MRMC comparative effectiveness study involving AI assistance for human readers was not explicitly described.
The study focuses on the standalone performance of the inui system (which incorporates an app for image capture and analysis) when used by lay-users, against a predicate device read by professional users.
The system itself is the "AI assistance" in the sense that the mobile app performs the color analysis traditionally done visually. The comparison is between the inui system's performance by lay users and the predicate device's performance by professional users, not human readers with vs. without AI assistance.

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

Yes, in spirit, the core of the inui device's performance is essentially standalone algorithm performance within the context of a "lay-user-in-the-loop" setting.
The "inui App" performs the electronic color analysis via the mobile phone camera. The "lay user reproducibility study" and the "clinical accuracy study" demonstrate the device's (including the algorithm's) performance when operated by lay users. The comparison in the clinical accuracy study is effectively between the inui device's algorithm output (managed by lay users) and a predicate device's visual interpretation by professionals.

7. The Type of Ground Truth Used

The ground truth for the clinical accuracy (method comparison) study was established by comparison to a legally marketed predicate device (Siemens Multistix® 10SG device) assessed by professional users. This is a form of "reference method" ground truth.
For the analytical performance studies (Precision, LOD, Specificity), the ground truth was based on expected values and established protocols in accordance with CLSI guidelines.

8. The Sample Size for the Training Set

The document is a 510(k) summary, which focuses on validation data. It does not provide information on the sample size for the training set used to develop the inui device's mobile application algorithm.

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

The document does not provide details on how the ground truth for the training set was established, as it pertains to the development process of the device which is typically not included in a 510(k) summary.

Summary

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May 25, 2018

Scanadu Inc. Daya Ranamukhaarachchi VP Regulatory & Clinical Affairs 1196 Borregas Ave., Ste 200 Sunnyvale, CA 94089

Re: K180356

Trade/Device Name: inui In-Home Urine Analysis Test System Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: Class II Product Code: JIL, JIR, LJX, JMT, JIN Dated: April 19, 2018 Received: April 19, 2018

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. 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

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Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Kellie B. Kelm -S

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 (if known) K180356

Device Name

inui In-Home Urine Analysis Test System

Indications for Use (Describe)

The inui In-Home Urine Analysis Device is intended for use as a prescription home use device.

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)

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510(k) Summary K180356

The following 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

1.	Preparation date:	May 23, 2018
2.	Owner/Submitter Information:	Scanadu, Inc.1196 Borregas Ave., Suite 200Sunnyvale, CA 94089
		Daya Ranamukhaarachchi, PhDVP Regulatory & Clinical Affairs

VP Regulatory & Clinical Affairs daya.ranamukhaarachchi@scanadu.com

Phone: (650) 919-8861

1. Device Information

a.	Proprietary Name:	inui In-Home Urine Analysis Device
b.	Common name:	Urinalysis Test
c.	Classification Number:	See Regulatory Classification below
d.	Classification Panel:	Clinical Chemistry

1. Predicate Device Information

Device Name	Multistix® 10 SG Test Strips
Manufacturer	Siemens Inc.
510(k) number	# K992257

1. Regulatory Classification
  The regulatory information for the Inui In-Home Urine Analysis Device is listed below:

Medical Device Panel:	Clinical Chemistry
Regulatory Classification:	The regulatory classification information for the specific analytes tested in the Inui In-Home Urine Analysis Device is listed in Table 1.

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Test Description	Product Code	Deviceclass*	Regulation
Leukocyte peroxidase test	LJX	Class I	21 CFR §864.7675
Urinary protein or albumin (non-quantitative) test system	JIR	Class I	21 CFR §862.1645
Nitrite (non-quantitative) test system	JMT	Class I	21 CFR §862.1510
Ketones (non-quantitative) test system	JIN	Class I	21 CFR §862.1435
Urinary Glucose (non-quantitative) test system	JIL	Class II	21 CFR §862.1340

Table 1. Regulatory Classification for Scanadu Urinalysis Device

6. Device Description

The inui In-Home Urine Analysis System reports semi-quantitative or qualitative results for each test parameters. Table 2 provides reported levels for each parameter tested in inui Device.

Urine Analytes	Results
Protein	Negative
	Trace [15 mg/dL]
	Moderate [30(+) mg/dL]
	Large [100(++) -2000(++++) mg/dL]
Glucose	Negative
	Low [100 mg/dL]
	Moderate to Large [250(+) -2000(++++) mg/dL]
Leukocytes	Negative
	Positive

Table 1. Reported Levels for parameters tested in inui Device

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Urine Analytes	Results
Nitrites	Negative
	Positive
Ketones	Negative [0-5 mg/dL]
	Small [15 mg/dL]
	Moderate to Large [40-160 mg/dL]

7. Indications and Intended Use

The inui In-Home Urine Analysis Test System consists of inui In-Home Urine Analysis Device and the inui Urine Analysis Mobile Application. The inui In-Home Urine Analysis Test System is intended for detecting the following parameters in urine: Protein, Glucose, Leukocytes, Nitrites, and Ketones. The test results provide information regarding the status of Urinary Tract Infections (UTI), proteinuria, glucosuria, and ketonuria. These results can be used as an aid for monitoring kidney functions, metabolic disorders (e.g. diabetes mellitus), and can be used in the screening for urinary tract infections (UTI).

The inui In-Home Urine Analysis Device is intended for use as a Prescription Home use device.

1. Substantial Equivalence
  Substantial equivalence has been established using the predicate device Multistix 10SG Reagent Test Strips (K992257). As with the predicate device, the proposed device is intended for detecting specific urine analytes using the colorimetry methods that are used in other urinalysis devices. The specific differences to the indications include (1) Prescription Home-use vs. Prescription use, (2) use of the device with a mobile application supported by a mobile device, and (3) only a subset of substances (Protein, Glucose, Leukocytes, Nitrites, and Ketones) tested in the predicate devices are tested in inui Device.

Summary of the similarities and differences between the predicate device and Inui In-Home Urine Analysis Device is provided in Table below:

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Area ofComparison	inui In-Home Urine AnalysisDevice (K180356)	Multistix® 10 SG Test Strips(K992257)
Indications forUse	The inui In-Home Urine AnalysisDevice is intended for detectingthe following parameters in urine:Protein, Glucose, Leukocytes,Nitrites, and Ketones. The testregarding the status of UrinaryTract Infections (UTI), proteinuria,glucosuria, and ketonuria. Theseresults can be used as an aid formonitoring kidney functions,metabolic disorders (e.g. diabetesmellitus), and can be used in thescreening for urinary tractinfections (UTI).The inui In-Home Urine AnalysisDevice is intended for use as aPrescription Home use device.The inui In-Home Urine AnalysisDevice is intended for use withthe inui Urine Analysis MobileApplication supported by mobilephone devices.	Intended for use in at-riskpatient groups to assistdiagnosis in the followingareas: kidney function,carbohydrate metabolism(e.g., diabetes mellitus),urinary tract infections andliver function. The reagentstrips also measure physicalcharacteristics, including acid-base balance and urineconcentration. The test resultscan be used along with otherdiagnostic information to ruleout certain disease states.
Device users	Prescription home use by lay users	In near-patient (point-of-care)and centralized laboratorylocations.
ChemicalSubstancesDetected	Protein, Glucose, Leukocyte,Nitrite, and Ketone	Leukocytes, Protein, Nitrites,Blood, Ketones and Glucose,Creatinine, Specific Gravity,pH, Bilirubin, Urobilinogen
TargetPopulation	Adults	Same
Intendedspecimen	Urine	Same
MaterialsProvided	Chemical Test Pads affix to aplastic paddle; Urine collectioncup; Mobile phone App; Graybackground sheet	Chemical Test Pads affixed to afirm plastic strip
Test Time	All analytes are read at once in 1minute	Analytes are read at differenttimes up to 2 minutes
Detection	Image capture by mobile phonedigital camera	Visual read by trainedprofessionals
Resultsdetermination	Electronic color analysis via Mobilephone App	Visual comparison to colorchart or machine read
Urine analytedetectionmethodology	Based on color change resultingfrom the reaction of urine analyteson test pads	Same
Storage	56-86°F (15 - 30°C)	Same

Table 2. Substantial Equivalence between Inui In-Home Urine Analysis Device and Multistix 10SG Reagent Strips Predicate device

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1. Assessment of Analytical Performance
  This Section details the Precision and Reproducibility, Limit of Detection, and Specificity (Interference testing) studies conducted in accordance with the applicable Clinical Laboratory Standards Institute (CLSI) standards.
a. Precision and Reproducibility
The precision and reproducibility testing was conducted in accordance with CLSI guidelines as applicable for qualitative and semi-quantitative assays. The precision and reproducibility was evaluated with two studies: repeatability (within run) and reproducibility (between run).

The proportion of agreement for each level and analyte tested met the established acceptance criteria and was found to be above 95% agreement to the expected values for both precision and reproducibility.

Limit of Detection and Linearity b.
The purpose of this study was to establish the Limit of Detection (LOD) and Linearity of inui In-Home Urine Analysis device. The test measurements are considered either semi-quantitative or qualitative depending on the analyte. The LOD for each level and analyte were determined based on the established protocol and the results generated separately for each analyte. Summary of the sensitivities are provided in Table 3.
Specificity and Interference Testing ﻥ
The study design was developed in accordance with CLSI guidelines as applicable for qualitative and semi-quantitative assays. Thirty-nine potentially interfering exogenous and endogenous substances were evaluated. Substances that cause abnormal urine color may affect the readability of the chemistry test pads by the App. The inui device has built-in additional precautions: it produces an error message with no result (invalid) for any substance that introduces colors outside the range for that analyte. Extreme concentrations of substance such as Acetoacetic

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Acid at all tested concentrations consistently produced an error message.

The results with the interfering substances and the minimum concentration level tested that produced false positives and false negatives are provided in Table 4 for each analyte and level.

Analyte	Tested Levels
Protein	Below 10 mg/dL(Negative)	10 mg/dL tobelow 23 mg/dL(Trace)	23 mg/dL tobelow 60 mg/dL(Moderate)	60 mg/dL andabove(Large)
Glucose	Below 50 mg/dL(Negative)	50 mg/dL andbelow 175 mg/dL*(Low)	175 mg/dL andabove(Moderate-Large)	NA
Leukocyte	Below 0.0023U/ml(Negative-Trace)	0.0023 U/ml andabove(Small-Large)	NA	NA
Nitrite	Below 0.025mg/dL(Negative)	0.025 mg/dL andabove(Positive)	NA	NA
Ketone	Below 10 mg/dL(Negative-Trace)	10 mg/dL andbelow 28 mg/dL(Small)	28 mg/dL andabove(Moderate-large)	NA

Table 3. Summary of sensitivities for five urine analytes

Table 4. Summary Table depicting Interfering substances and their levels for each analyte

Definitions:

Positive interference: A test result, which incorrectly indicates that a particular condition or attribute is present.

Negative interference: A test result, which incorrectly indicates that a particular condition or attribute is absent.

Analyte	Negative Control(Positive Bias/Increase in Response)	Positive Control(Negative Bias/Decrease inResponse)
	Albumin HSA (>3000 mg/dL) (ExpectedInterferent)	Acetoacetic Acid (invalid results atall conc)
Protein	Bilirubin (>10 mg/dL)
	Hemoglobin (>100 mg/dL)	Hypochlorite (>375 mg/dL)
	Chlorhexidine (>40 mg/dL)
	Riboflavin (>5 mg/dL)	Specific Gravity (>1.025)
Leukocyte	Human Leukocyte Esterase (>0.025 U/mL) (Expected Interferent)	Acetoacetic Acid (invalid results at all conc)
	Hemoglobin (>150 mg/dL)	Albumin HSA (>3000 mg/dL)Bilirubin (>10 mg/dL)Sodium Chloride (>324 mg/dL)Hypochlorite (>375 mg/dL)Chlorhexidine (>60 mg/dL)Microbial Peroxidase (>0.65%)Riboflavin (>5 mg/dL)Sodium Acetate (>600 mg/dL)Sodium Bicarbonate (>630 mg/dL)Specific Gravity (>1.020)Urobilinogen (>4 mg/dL)
Nitrite	Sodium Nitrite (>5 mg/dL) (Expected Interferrent)	Sodium Bicarbonate (>945mg/dl)Sodium Acetate (>900 mg/dL)Hypochlorite (>375 mg/dL)Sodium Nitrite (>7.5 mg/dL)
	Human Hemoglobin (>100 mg/dL)
	Hypochlorite (>375 mg/dL)
	Human Leukocyte (>0.0375 U/mL)
	Urobilinogen (>4 mg/dl)
Ketone	Lithium Acetoacetate (>40 mg/dL) (Expected Interferrent)	Acetoacetic Acid (invalid results at all conc)
		Hypochlorite (>375 mg/dL)
		Sodium Nitrite (>7.5 mg/dL)
Glucose	D-(+)-Glucose (>500 mg/dL) (Expected Interferrent)	Acetoacetic Acid (invalid results at all conc)
	Hypochlorite (>375 mg/dL)	Lithium Acetoacetate (>80 mg/dL)
	Bilirubin (Invalid results at all conc)	Sodium Chloride (>486 mg/dL)

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10. Assessment of Clinical Performance

A clinical accuracy (i.e. method comparison) was established based on the agreement between the results obtained from the inui Device in the hands of the lay-users and the results from the predicate device, Siemens Multistix® 10SG device (K992257), by professional users. Two-method comparison studies were conducted using 190 and 91 lay users following an Investigational Review Board approved clinical protocol. Testing performed via clinical evaluation demonstrated that typical lay users between the ages of 18 and 71 can obtain clinical test results that are comparable to those of a professional users using a visual read method, as shown in the table 5.

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Additionally, a usability study with 45 lay users was conducted to evaluate their ability to perform urine testing with instructions given in the inui App and the instructions for use provided with the inui Device. Each lay user tested three paddles provided in the device kit. The usability testing produced an overall performance of 88.9%, 86.7%, and 91.1% for the first, second and third paddle, respectively, confirming that the lay users can follow the entire procedural steps (from sign-in and, test set-up to understanding the results) to obtain a successful test result.

In addition, a lay-user reproducibility study with 10 lay users was conducted to evaluate the ability of the lay-user to perform urine testing and obtain the same result after repeated testing. User reproducibility testing demonstrated that the reproducibility of the inui Device in the hands of the lay user was 100%.

Analyte	Level	Lay User vs Predicate Device
		% Agreement(Exact Match)	% Agreement(within one Color Block)
Protein	Negative	83	100
	Trace 15 mg/dL	75	100
	Moderate30(+) mg/dL	90	100
	Large100(++)-2000(++++)mg/dL	100	100
Glucose	Negative	100	100
	Low100 mg/dL	74	100
	Moderate to Large250(+)-2000(++++)	100	100

Leukocyte	Negative	100	N/A
	Positive	97	N/A
Nitrite	Negative	96	N/A
	Positive	100	N/A
Ketone	Negative/ Trace0-5 mg/dL	99	100
	Small 15mg/dL	67	100
	Moderate to Large40-160 mg/dL	100	100

Table 5. Agreement of lay user test results with the predicate device and professional user testing

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11. Conclusion

Analytical performance testing and clinical studies, including lay user testing, usability testing, and reproducibility testing demonstrated that the Inui In-Home Urine Analysis Device is safe and effective, and lay users can use the device. Based on these data, the Inui In-Home Urine Analysis Device is substantially equivalent to the Siemen's Multistix device (K992257).

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.