inui In-Home Urine Analysis Test System

K180356 · Scanadu, Inc. · JIL · May 25, 2018 · Clinical Chemistry

Device Facts

• Record ID: K180356
• Device Name: inui In-Home Urine Analysis Test System
• Applicant: Scanadu, Inc.
• Product Code: JIL · Clinical Chemistry
• Decision Date: May 25, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1340
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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 (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.

Device Story

System comprises disposable test paddle with chemistry test pads (CTPs), urine collection cup, gray background sheet, and mobile application. User collects urine, applies to paddle; mobile device camera captures image of color reaction on CTPs. App performs electronic color analysis to determine semi-quantitative or qualitative results. Used in home setting by lay users under prescription. Results aid monitoring of kidney function, metabolic disorders, and UTI screening. QR code on paddle ensures quality control (lot/expiration). System provides invalid error messages for interfering substances or colors outside expected ranges.

Clinical Evidence

Clinical accuracy established via two-method comparison (n=190, n=91) between lay-user inui device results and professional-user predicate device results. Usability study (n=45) confirmed lay-user ability to follow procedural steps (86.7%-91.1% success). Reproducibility study (n=10) showed 100% reproducibility. Agreement metrics provided for all analytes; exact match agreement ranged from 67% to 100%, with 100% agreement within one color block for semi-quantitative analytes.

Technological Characteristics

Disposable plastic paddle with chemistry test pads (CTPs) and QR barcode. Colorimetric detection via mobile device camera and app. Storage: 15-30°C. Connectivity: Mobile application-based analysis. Software-based image processing for color analysis.

Indications for Use

Indicated for prescription home use by individuals to detect protein, glucose, leukocytes, nitrites, and ketones in urine as an aid in monitoring kidney function, metabolic disorders (e.g., diabetes), and screening for urinary tract infections (UTI).

Regulatory Classification

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.

Predicate Devices

• Siemens Multistix 10 SG Test Strips (k992257)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

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 ([e-mail]) or phone [phone] 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 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.

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

| <span> <span style="font-size: 14px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|---------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 14px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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.<br>1196 Borregas Ave., Suite 200<br>Sunnyvale, CA 94089 |
| | | Daya Ranamukhaarachchi, PhD<br>VP Regulatory & Clinical Affairs |

VP Regulatory & Clinical Affairs [e-mail]

Phone: [phone]

- 3. 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 |

- 4. Predicate Device Information

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

- 5. 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 | Device<br>class* | 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 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. 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.

- 8. 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 of<br>Comparison | inui In-Home Urine Analysis<br>Device (K180356) | Multistix® 10 SG Test Strips<br>(K992257) |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The inui In-Home Urine Analysis<br>Device is intended for detecting<br>the following parameters in urine:<br>Protein, Glucose, Leukocytes,<br>Nitrites, and Ketones. The testregarding the status of Urinary<br>Tract Infections (UTI), proteinuria,<br>glucosuria, and ketonuria. These<br>results can be used as an aid for<br>monitoring kidney functions,<br>metabolic disorders (e.g. diabetes<br>mellitus), and can be used in the<br>screening for urinary tract<br>infections (UTI).<br><br>The inui In-Home Urine Analysis<br>Device is intended for use as a<br>Prescription Home use device.<br><br>The inui In-Home Urine Analysis<br>Device is intended for use with<br>the inui Urine Analysis Mobile<br>Application supported by mobile<br>phone devices. | Intended for use in at-risk<br>patient groups to assist<br>diagnosis in the following<br>areas: kidney function,<br>carbohydrate metabolism<br>(e.g., diabetes mellitus),<br>urinary tract infections and<br>liver function. The reagent<br>strips also measure physical<br>characteristics, including acid-<br>base balance and urine<br>concentration. The test results<br>can be used along with other<br>diagnostic information to rule<br>out certain disease states. |
| Device users | Prescription home use by lay users | In near-patient (point-of-care)<br>and centralized laboratory<br>locations. |
| Chemical<br>Substances<br>Detected | Protein, Glucose, Leukocyte,<br>Nitrite, and Ketone | Leukocytes, Protein, Nitrites,<br>Blood, Ketones and Glucose,<br>Creatinine, Specific Gravity,<br>pH, Bilirubin, Urobilinogen |
| Target<br>Population | Adults | Same |
| Intended<br>specimen | Urine | Same |
| Materials<br>Provided | Chemical Test Pads affix to a<br>plastic paddle; Urine collection<br>cup; Mobile phone App; Gray<br>background sheet | Chemical Test Pads affixed to a<br>firm plastic strip |
| Test Time | All analytes are read at once in 1<br>minute | Analytes are read at different<br>times up to 2 minutes |
| Detection | Image capture by mobile phone<br>digital camera | Visual read by trained<br>professionals |
| Results<br>determination | Electronic color analysis via Mobile<br>phone App | Visual comparison to color<br>chart or machine read |
| Urine analyte<br>detection<br>methodology | Based on color change resulting<br>from the reaction of urine analytes<br>on 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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- 9. 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<br>(Negative) | 10 mg/dL to<br>below 23 mg/dL<br>(Trace) | 23 mg/dL to<br>below 60 mg/dL<br>(Moderate) | 60 mg/dL and<br>above<br>(Large) |
| Glucose | Below 50 mg/dL<br>(Negative) | 50 mg/dL and<br>below 175 mg/dL*<br>(Low) | 175 mg/dL and<br>above<br>(Moderate-Large) | NA |
| Leukocyte | Below 0.0023<br>U/ml<br>(Negative-Trace) | 0.0023 U/ml and<br>above<br>(Small-Large) | NA | NA |
| Nitrite | Below 0.025<br>mg/dL<br>(Negative) | 0.025 mg/dL and<br>above<br>(Positive) | NA | NA |
| Ketone | Below 10 mg/dL<br>(Negative-Trace) | 10 mg/dL and<br>below 28 mg/dL<br>(Small) | 28 mg/dL and<br>above<br>(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<br>(Positive Bias/Increase in Response) | Positive Control<br>(Negative Bias/Decrease in<br>Response) |
|-----------|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Albumin HSA (>3000 mg/dL) (Expected<br>Interferent) | Acetoacetic Acid (invalid results at<br>all 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)<br>Bilirubin (>10 mg/dL)<br>Sodium Chloride (>324 mg/dL)<br>Hypochlorite (>375 mg/dL)<br>Chlorhexidine (>60 mg/dL)<br>Microbial Peroxidase (>0.65%)<br>Riboflavin (>5 mg/dL)<br>Sodium Acetate (>600 mg/dL)<br>Sodium Bicarbonate (>630 mg/dL)<br>Specific Gravity (>1.020)<br>Urobilinogen (>4 mg/dL) |
| Nitrite | Sodium Nitrite (>5 mg/dL) (Expected Interferrent) | Sodium Bicarbonate (>945mg/dl)<br>Sodium Acetate (>900 mg/dL)<br>Hypochlorite (>375 mg/dL)<br>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<br>(Exact Match) | % Agreement<br>(within one Color Block) |
| Protein | Negative | 83 | 100 |
| | Trace 15 mg/dL | 75 | 100 |
| | Moderate<br>30(+) mg/dL | 90 | 100 |
| | Large<br>100(++)-2000(++++)<br>mg/dL | 100 | 100 |
| Glucose | Negative | 100 | 100 |
| | Low<br>100 mg/dL | 74 | 100 |
| | Moderate to Large<br>250(+)-2000(++++) | 100 | 100 |
| | | | |
| Leukocyte | Negative | 100 | N/A |
| | Positive | 97 | N/A |
| Nitrite | Negative | 96 | N/A |
| | Positive | 100 | N/A |
| Ketone | Negative/ Trace<br>0-5 mg/dL | 99 | 100 |
| | Small 15mg/dL | 67 | 100 |
| | Moderate to Large<br>40-160 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).