The DIP | U.S. Urine Analysis Test System consists of a smartphone application, a proprietary Color-Board, and Urinalysis Reagent Strips. It is intended for the semi-quantitative detection of the following analytes in urine: Glucose. Specific Gravity, Blood, pH and Protein, as well as the qualitative detection of Nitrite,

The DIP | U.S. Urine Analysis Test System is intended for prescription home-use only, with results provided directly to the physician. The results can be used to guide patient management and care, and aid in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function and endocrine disorders. Physician interpretation of the results should be made in conjunction with the patient's other clinical information to determine if further confirmatory tests or consultations are necessary. Patients do not have access to the results at any point in the process.

Device Description

The DIP | U.S. Urine Analysis Test System consists of a smartphone application, a proprietary Color-Board, and Urinalysis Reagent Strips. It is intended for the semi-quantitative detection of the following analytes in urine: Glucose, Specific Gravity, Blood, pH and Protein, as well as the qualitative detection of Nitrite.

The software component of the DIP | U.S. Urine Analysis Test System consists of both an application and a back-end server. The App instructs the patient how to accurately administer the test and conducts a number of algorithm processes. Once analyzed, the DIP | U.S. Urine Analysis Test System's software securely transmits the clinical results directly to the patient's Electronic Medical Records for review by the physician. As stated above, the patients do not have access to the results at any point during the testing process.

AI/ML Overview

The provided text describes the acceptance criteria and study proving the device meets those criteria for the Healthy.io DIP | U.S. Urine Analysis Test System.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by the "percent exact match" and "±1 color block match" compared to the predicate device (ACON Mission U500 Urinalysis System). The exact numerical acceptance thresholds are not explicitly stated as strict percentages for all analytes, but the narrative implies "high-levels of accuracy" and specific target ranges are mentioned for certain analytes.

Analyte	Acceptance Criteria (Implied)	Reported Device Performance (±1 Color Block % Agreement)	Reported Device Performance (Exact Match %)
Glucose	High agreement with predicate (implied 100% for ±1 block)	100% (Study 2)	89.6% (Study 2)
Specific Gravity	High agreement with predicate (implied 100% for ±1 block)	>99% (Study 1)	63.4% (Study 1)
Blood	High agreement with predicate (implied 100% for ±1 block)	100% (Study 2)	91.4% (Study 2)
pH	High agreement with predicate (implied 100% for ±1 block)	>99% (Study 1)	75.7% (Study 1)
Protein	High agreement with predicate (implied 100% for ±1 block)	>99% (Study 1)	85% (Study 1)
Nitrite	High agreement with predicate (implied 100% for ±1 block)	>99% (Study 1)	99% (Study 1)

Additional Performance Metrics (from Analytical Performance Testing):

Repeatability: 99.3% exact match
Reproducibility: 98.5% exact match
Linearity: At least 89.4% exact match and 100% ±1 color block accuracy.
Illumination Study: 99.5% exact match
Boundary Study: 99.5% exact match

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

Two method comparison studies were conducted for the test set:

Study 1:
- Sample Size: 429 subjects, 500 total samples (including spiked samples). Only 284 results from LG Nexus 5 smartphones were used for performance data.
- Data Provenance: Two U.S. clinical sites. The studies involved lay-users in a simulated home-use environment. This indicates prospective data collection for the purpose of this validation.
Study 2:
- Sample Size: 250 subjects, 289 total samples (including spiked samples).
- Data Provenance: One U.S.-based clinic. Similar to Study 1, this appears to be prospective data collection in a simulated home-use setting.

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

The ground truth for the comparison studies was established by "a laboratory professional using the predicate (ACON Mission U500 Urinalysis System)" measuring aliquots of the same samples. The specific number of laboratory professionals or their detailed qualifications (e.g., years of experience, specific certifications) are not explicitly stated in the provided text.

4. Adjudication Method for the Test Set

The text describes comparing the DIP system's results to those from a laboratory professional using the predicate device. It does not mention any formal adjudication method (e.g., 2+1, 3+1 consensus) for discrepancies between the device and the predicate. The predicate device's readings appear to be treated as the reference standard (ground truth).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This was not a MRMC comparative effectiveness study in the typical sense of evaluating human reader improvement with AI assistance. The study evaluates the performance of the device itself as used by a lay-user, compared to a predicate device operated by a laboratory professional. There is no mention of human readers interpreting images with and without AI assistance to measure improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance data presented, particularly the "Method Comparison Study," represents the device's performance with a human-in-the-loop (lay-user) interacting with the smartphone application and Color-Board. The device itself (including its image recognition algorithm on the back-end) performs the analysis of the test strip after the user interacts with it. The usability results (e.g., 99% success rate for lay users completing the test) address the human-in-the-loop aspect.

However, the "Analytical Performance Testing" (Precision, Interference, Limit of Detection, Linearity, Illumination, Boundary Studies) implicitly evaluates the algorithm's performance under controlled conditions with pre-determined reagent values or spiked samples, which can be seen as a form of standalone evaluation of the core analytical capability. For example, the Illumination Study and Boundary Study evaluate the device's (and thus the algorithm's) ability to measure accurately under varying external conditions. In these studies, the device measured against "predetermined reagent values," which serves as the ground truth for evaluating the algorithm's accuracy under those specific conditions.

7. The Type of Ground Truth Used

The primary ground truth used for the method comparison studies (clinical validation) was the readings obtained from the predicate device (ACON Mission U500 Urinalysis System) by a laboratory professional.

For the analytical performance studies (Precision, Interference, Limit of Detection, Linearity, Illumination, Boundary), the ground truth was based on validated spiked urine solutions at known concentrations or predetermined reagent values.

8. The Sample Size for the Training Set

The provided text does not explicitly state the sample size used for the training set for the image recognition algorithm. It focuses on the validation studies.

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

The text does not describe how the ground truth for the training set was established. It only mentions that the device includes an "image recognition algorithm running on the back-end." It is standard practice for such algorithms to be trained on large datasets with established ground truth, but the details of this process are not provided in this specific document.

Summary

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Image /page/0/Picture/0 description: The image shows 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

July 18, 2018

Healthy.io Ltd % John Smith, Partner Hogan Lovells US LLP 555 Thirteenth Street NW Washington, DC 20004

Re: K173327

Trade/Device Name: DIP/U.S. Urine Analysis Test System Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: Class II Product Code: JIL, JIO, CEN, JMT, JIR, JRE Dated: June 15, 2018 Received: June 15, 2018

Dear John Smith:

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 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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510(k) Number (if known) K173327 Device Name

DIP | U.S. Urine Analysis Test System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY

Healthy.io's DIP | U.S. Urine Analysis Test System

Submitter

Healthy.io 2 Ibn Gabirol 6407702 Tel Aviv, Israel Phone: +972-54-300-4884 Facsimile: +972-77-470-4808

Contact Person: Yonatan Adiri

Date Prepared: July 2018

Name of Device: DIP | U.S. Urine Analysis Test System

Common or Usual Name: Smartphone enabled urine analyzer

510(k): K173327

Requlation Section and Classification Name:

Class I: Urinary pH, Nitrite, Urinary Protein, Specific Gravity

Class II: Urinary Glucose and Occult Blood

21 CFR § 862.1340 Urinary Glucose (Non-Quantitative) Test System

21 CFR § 864.6550 Occult Blood Test

21 CFR § 862.1550 Urinary pH (Non-Quantitative) Test System

21 CFR § 862.1645 Urinary Protein or Albumin (Non-Quantitative) Test System

21 CFR § 862.1510 Nitrite (Non-Quantitative) Test System

21 CFR § 862.2800 Refractometer for clinical use

Product Code:

JIL	Urinary Glucose (non-quant.) test system
JIO	Blood, Occult, Colorimetric, in urine
CEN	Urinary, pH (non-quant.) test system
JMT	Nitrite (urinary, non-quant.) test system
JIR	Protein or Albumin (urinary, non-quant.) test system
JRE	Specific Gravity

Classification Panel: Chemistry, Hematology

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Predicate Device:

The DIP | U.S. Urine Analysis Test System is substantially equivalent to the following predicate device:

Manufacturer	Device	510(k) Number
ACON Laboratories Inc.	ACON Mission U500 UrinalysisSystem	K111221

Device Description

The DIP | U.S. Urine Analysis Test System consists of a smartphone application, a proprietary Color-Board, and Urinalysis Reagent Strips. It is intended for the semi-quantitative detection of the following analytes in urine: Glucose, Specific Gravity, Blood, pH and Protein, as well as the qualitative detection of Nitrite.

The device is provided as a kit that comprises a urine receptacle, an FDA-cleared urine test strip (ACON Mission Urinalysis Reagent Strips, 510K number K061559), a Color-Board, and a User Manual. The DIP | U.S. Urine Analysis Test System also consists of a smartphone application for use with a LG Nexus 5 device (running operating system Lollipop 5.0), and an image recognition algorithm running on the back-end." Future iterations of the product will be available on additional phones and operating systems, but this submission is focused solely on the LG Nexus 5 and its respective operating system.

1 Back-end will henceforth refer to the system's cloud-based servers, which run the sever-side algorithms, and turn the algorithms analysis into clinical results. These are then securely transmitted to the patient's Electronic Medical Record. The DIP | U.S. Urine Analysis Test System back-end is HIPAA compliant and uses advanced security protocols for data handling and transmission.

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Device Components

The DIP | U.S. Urine Analysis Test System is comprised of the following components:

1. Urine Receptacle
1. A single, individually-wrapped Mission Urinalysis Reagent Strip U031-101 (ACON Laboratories Inc., K061559)
1. Color-Board
1. Smartphone App
1. Back-end, cloud-based server
1. User Manual
1. Physician compendium

Intended Use/Indication for Use

The DIP | U.S. Urine Analysis Test System consists of a smartphone application, a proprietary Color-Board, and Urinalysis Reagent Strips. It is intended for the semi-quantitative detection of the following analytes in urine: Glucose, Specific Gravity, Blood, pH and Protein, as well as the qualitative detection of Nitrite.

Feature	DIP U.S. Urine Analysis TestSystem	ACON Mission U500 UrinalysisSystem(K11221)
Intended Use	Prescription-only, in vitro diagnostichome-use	Prescription-only, in vitro diagnosticuse
Test Specimen	Urine	Urine
Detection Methodology	Reflectance Photometry	Reflectance Photometry
Detection device	Photosensitive Diode	Photosensitive Diode
Operating Conditions	0°-35°C [32°-95°F]10% to 90%. Relative humidity (non-condensing)	0°-40°C (32-104°F); <85% Humidity(non-condensing)
Strips to be used	Mission Urinalysis Reagent StripsU031-101 (K061559)	Mission Urinalysis Reagent StripsU031-101 (K061559)
Strip OperatingConditions	15°-30°C [59°-85°F]<85% Relative humidity (non-condensing)	15°-30°C [59°-85°F]<85% Relative humidity (non-condensing)

Table 3.1: Comparison Between DIP U.S. Urine Analysis Test System and the ACON Mission
U500 Urinalysis System

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Strip Incubation Time	1 minute	1 minute
Calibration	Automatic	Automatic
Power Source	Not Applicable	100-240 VAC, 50-60 Hz
Line Leakage Current	Not Applicable	<2.5mA (single fault)
Data Transfer	Via smartphone Internet connectionfrom the back-end server to thepatient Electronic Medical Records	Standard RS232C Port
Capabilities	Transmission to physician viaInternet connection	Internal Printer (included) 25 PinParallel External Printer PortConnector (included) Barcode Reader(optional)
Available languages onscreen	English (others as installed)	English (default), Spanish, French(Others as installed)
Measuring cycle	Approximately 1 minute per test	Approximately 1 minute per test
Smartphones	LG Nexus 5	Not Applicable
Operating Systems	Android Lollipop	Not Applicable
Dimensions	15.25 cm (H) x 8.5 cm (W) x 6.75 (L)	35.56 cm (L) x 27.43 cm (W) x 19.56cm (H)
Weight	115 g	4 kg

Summary of Performance Data

Healthy.io conducted both bench and clinical studies to test the accuracy of the DIP | U.S. Urine Analysis Test System and its agreement with the predicate device. Healthy.io conducted several studies to characterize the analytical and clinical performance of the DIP | U.S Urine Analysis Test System Two method comparison studies were conducted - one study included 429 subjects (500 samples including spiked sample) and a second study that included 250 subjects (289 samples including spiked samples). Analytical performance characteristic testing was also conducted for each analyte measured by the device. Software validation testing was also conducted. Performance of the DIP | U.S. Urine Analysis Test System based on this testing is summarized below.

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Analytical Performance Testing:

The performance characteristics of the DIP | U.S. Urine Analysis Test System were evaluated by the following analytical performance tests:

Precision. This study was comprised of two separate sub-studies, including: 1) Repeatability; and 2) Reproducibility. The precision studies were designed and executed in accordance with guidance provided by Clinical and Laboratory Standards Institute document EP05-A3 – Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition.

I The Repeatability study was conducted at three sites over the course of one day. Each operator tested two spiked levels of urine using twenty sticks from three lots on a Nexus phone. For each analyte, 360 total tests were taken during the Repeatability study (360 = 3 sites X 2 solutions X 3 lots X 20 sticks). The DIP | U.S. Urine Analysis Test System recorded an exact match of 99.3% during the course of the study.
트 The Reproducibility study was conducted at three sites over the course of 20 days, with test operators switching locations every six-to-seven days. For each run, every operator tested three spiked levels of urine using one stick from three lots respectively on a Nexus device. For each analyte, 1,080 total tests were taken during the Reproducibility study (3 sites x 3 solutions X 3 lots x 2 runs x 20 days). The DIP | U.S. Urine Analysis Test System recorded an exact match of 98.5% during the course of the study.

Interference. Testing of potential interfering substances with the DIP | U.S. Urine Analysis Test System was designed and executed in accordance with guidance provided by Clinical and Laboratory Standards Institute document EP7-A2 - Interference Testing in Clinical Chemistry: Approved Guideline - Second Edition.

" Interference was defined as a change in output of ±2 color block between spiked and unspiked (control) samples. Once interference was detected at one or more analytes, a dose-response study was carried out at three decreasing intervals to determine the lowest concentration level that causes interference. Both the DIP | U.S. Urine Analysis Test System and the predicate device recorded similar results during their respective interference testing.
Limit of Detection. Testing of the DIP | U.S. Urine Analysis Test System detection limits was designed and executed in accordance with guidance provided by Clinical and Laboratory Standards Institute (CLSI) document EP17-A2 – Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition.
트 The Detection of Limit study was based on validated spiked urine solutions at known concentrations for each analyte. The samples were divided into four separate and equal intervals between the theoretical cut-off points between each semi-quantitative level. The sponsor tested each of these solution, with the cut-off point defined as the lowest concentration at which at least 55% of the results tested positive for the desired color block. The study demonstrated the ability of the DIP | U.S. Urine Analysis Test System to

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accurately detect the limits concentration of every analyte measured by the DIP | U.S. Urine Analysis Test System

Linearity. The linearity study of the DIP | U.S. Urine Analysis Test System was designed and executed in accordance with quidance provided by the Clinical and Laboratory Standards Institute (CLSI) document EP6-A - Evaluation of Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline.

The Linearity study tested the ability of the DIP | U.S. Urine Analysis Test System to provide . results that were directly proportional to the concentrations of analytes within each test sample. The study tested the entire range of values that the DIP | U.S. Urine Analysis Test System is designed to measure. For every value of analyte, the DIP | U.S. measured at least an 89.4% exact match and a 100% +-1 color block accuracy. There were no detectable biases disrupting the overall pattern of linearity for any of the analytes. This study successfully demonstrates linearity for the DIP | U.S Urine Analysis Test System's device.

Stability:

The stability study was designed:

To provide evidence of the DIP | U.S. Urine Analysis Test System's performance over time under the influence of environmental factors such as temperature and humidity.
To establish DIP | U.S. Urine Analysis Test System's shelf life and recommended storage conditions, under which it maintains stable performance.

The DIP | U.S. Urine Analysis Test System was tested according to International Electrotechnical Commission standards, IEC TR 60721-4-1:2001+A1:03, Class 1K2 and IEC TR 60721-4-1:2001+A1:03, Class 1M2). The DIP | U.S. Urine Analysis Test System successfully passed these examinations at 6-, 12-, and 14- month time intervals.

Additional Studies: Healthy.io designed and conducted two additional studies concerning the effects of: 1) light (Illumination Study); and 2) physical boundaries (Boundary Study) on the DIP | U.S. Urine Analysis Test System. Both of these studies demonstrated the device's ability to measure accurate levels of analytes under different lighting settings and boundary conditions as described below:

. Illumination Study: Healthy.io designed a study to test the DIP | U.S. Urine Analysis Test System under ten common lighting conditions (spectral properties were measured with standard devices). The device measured multiple levels of all six analytes under different lighting conditions. The device measured a total exact match of 99.5% when compared to the predetermined reagent values.
I Boundary Study: Healthy.io designed a study to evaluate the physical boundary conditions (angle, distance, lighting) that guide a user when scanning the dipstick – while still receiving accurate results. The DIP | U.S. Urine Analysis Test System measured all six analytes at the angular, distance, and lighting limits of the device. At these boundaries, the DIP | U.S. Urine Analysis Test System measured a total exact match of 99.5% when compared to the predetermined reagent values.

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Method Comparison Study:

Two method comparison studies were conducted to demonstrate the DIP | U.S. Urine Analysis Test System's degree of agreement with its predicate device, when operated by a lay-user in a simulated home-use environment. These studies were both designed and executed in accordance with the Clinical and Laboratory Standards Institute (CLSI) document EP9-A2 - Method Comparison and Bias Using Estimation Samples, Approved Guideline, Second Edition.

The primary acceptance criteria for the study were the percent exact match and ±1 color block match between DIP | U.S. Urine Analysis Test System and the predicate. Throughout the testing, the DIP | U.S. Urine Analysis Test System demonstrated high-levels of accuracy as measured by its percent of agreement with the predicate device.

The first study enrolled 429 subjects and collected 500 total samples from two U.S. clinical sites. Subjects were able to choose which device to use, based on their level of familiarity with either phone. Samples were analyzed comparing subject results using the DIP | U.S. Urine Analysis Test System and results of aliquots of the same samples measured by a laboratory professional using the predicate (ACON Mission U500 Urinalysis System).

트 Study Results - Usability

Of the 429 tests conducted, 424 tests were successfully completed, meaning that the user completed the test and results were sent to the physician, demonstrating a very high success rate (>99%) for the product usability among lay users. Subjects also filled out usability evaluation surveys to rank different aspects of the product's usability. The average result from these surveys was 4.9 out of 5 demonstrating overall positive feedback from subjects using the product.

. Study Results - Accuracy

The overall ± 1 color block % agreement between the DIP | U.S. Urine Analysis Test System and the ACON Mission U500 Urinalysis System was above 99% across the board for all analytes during the initial Method Comparison study. Exact match levels for Nitrites and Protein were 99% and 85%, respectively. The pH and SG analyte exact match levels are 75.7% and 63.4%, respectively. (The performance data in this submission only uses the 284 results from the LG Nexus 5 smartphones used in the experiment.)

The second study enrolled 250 subjects and collected 289 total samples from a U.S. based clinic. Samples were analyzed comparing subject results using the DIP | U.S. Urine Analysis Test System and results of aliquots of the same samples measured by a laboratory professional using the predicate (ACON Mission U500 Urinalysis System).

" Study Results - Usability

249 patients, out of the 250 enrolled were able to successfully complete the test with the DIP | U.S. Urine Analysis Test System device.

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Study Results – Accuracy .

The exact match for Blood was 91.4% (100% +/-1 color block) and 89.6% for Glucose (100% +/-1 color block). Moreover, there were zero instances of False Negative measurements for Blood and Glucose during this study.

In conclusion, the DIP | U.S. Urine Analysis Test System, when used by a lay person, demonstrated a high degree of agreement with the predicate device for every parameter.

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Software Validation:

Validation of the Dip.io device software was performed according to the clause 14 of IEC 60601-1 (third edition) Software requirements, IEC 62304:2004 to IEC 62304 - 2006/AC 2008, Medical device, and Software life-cycle processes standards. The software related documents were composed according to the specific IEEE standards and the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The Software Validation documents summarize the validation assessment and demonstrate that the software meets the design requirements and all potential risks have been mitigated.

In accordance with the FDA's guidance for management of cyber-security in medical device, the OCR's HIPAA requlation and ISO 27001. Healthy.io conducted a comprehensive hazard analysis. The cyber security analysis report, together with the cyber security validation test report summarizes the assessment process for cyber security and demonstrates that the software meets the required level of cyber security protection.

Conclusions:

The clinical and analytical performance study results demonstrate that the DIP | U.S. Urine Analysis Test System is substantially equivalent to the predicate device ACON Mission U500 Urinalysis System (FDA 510(k): K111221).

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.