The ACR | LAB Urine Analysis Test System is comprised of a smartphone application, a proprietary Color-Board, and ACR Reagent Strips. It is intended for the semi-quantitative detection of albumin and creatinine in urine, as well as the presentation of their ratio. The ACR | LAB Urine Analysis Test System is intended for in-vitro diagnostic use by a healthcare professional in a point of care setting. These results may be used in conjunction with clinical evaluation as an aid in the diagnosis for kidney function.

Device Description

The ACR | LAB Urine Analysis Test System is comprised of a smartphone application, a proprietary Color-Board and ACR Reagent Strips. It is intended for the semi-quantitative detection of albumin and creatinine in urine, as well as the presentation of their ratio. The device is provided as a kit that is comprised of a canister of 100 FDA-cleared urine test strips (ACON Laboratories Inc. Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) K150330), 10 Color-Boards, and a User Manual. The ACR | LAB Urine Analysis Test System also consists of a smartphone application for use on iPhone 7 device (iOS 12), and an image recognition algorithm running on the Backend. The software component of the ACR | LAB consists of both an application (App) and a Backend server (Backend). The App instructs the professional user how to accurately perform the test. The App conducts a series of boundary condition analyses, and if the scan is approved, sends the information to the Backend for complete analysis and results classification. Once analyzed, the results are securely transmitted to a patient Electronic Medical Record for review by a healthcare professional. The patients do not have access to the results at any point during the testing process.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criteria are based on the agreement between the ACR | LAB Urine Analysis Test System and the predicate device (ACON Laboratories' Mission U120 Ultra Urine Analyzer). The study aimed for high percentages of exact match and ±1 color block match.

Note: The document explicitly states that the primary acceptance criteria for the method comparison study were the percent of exact match and ±1 color block match. While specific numerical targets for "high levels of accuracy" are not given as explicit "acceptance criteria," the reported performance exceeding predicate device agreement in these metrics is implicit evidence of meeting those criteria.

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

Sample Size:
- Native Urine Samples: 375 subjects
- Contrived Samples: 60 samples
- Total Samples for Clinical Performance: 435 samples (375 native + 60 contrived)
Data Provenance: The study evaluated native urine samples from 375 subjects as well as 60 contrived samples at three U.S. clinical sites. This indicates the data is prospective (newly collected for the study) and from the United States.

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

The document refers to the predicate device (ACON Laboratories' Mission U120 Ultra Urine Analyzer) as the "ground truth" or reference for comparison.

Number of "Experts" (for ground truth): The ground truth was established by readings from the predicate device (ACON Laboratories' Mission U120 Ultra Urine Analyzer). Two separate lab technicians measured each urine sample, one using the iPhone 7 device (ACR | LAB) and the second using the predicate device (U120 Ultra).
Qualifications of "Experts": The document states "Two separate lab technicians were responsible for measuring each urine sample." Their specific qualifications (e.g., years of experience, certifications) are not explicitly mentioned, but they are identified as "lab technicians."

4. Adjudication Method for the Test Set

The adjudication method appears to be none in the traditional sense of multiple human experts reviewing and deciding. Instead, the study directly compared the results of the ACR | LAB device against the results obtained from the predicate device (ACON Laboratories' Mission U120 Ultra Urine Analyzer). Each sample was tested once by the ACR | LAB and once by the predicate device, and the agreement between these two measurements was assessed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement

Was an MRMC study done? No, a traditional MRMC comparative effectiveness study was not done. This study is focused on the performance of a clinical diagnostic device, where consistency with a reference device is key, rather than an AI-assisted interpretation by multiple human readers.
Effect size of human readers improve with AI vs without AI assistance: This information is not applicable/not provided, as the study design was a direct comparison of the new device to a predicate device, not an assessment of human reader performance with and without AI assistance. The ACR | LAB system itself includes the smartphone app and image recognition algorithm as central components of its operation, so human interaction is inherent, but not a separate "with vs. without AI assistance" arm for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device description indicates that the "ACR | LAB Urine Analysis Test System is comprised of a smartphone application, a proprietary Color-Board, and ACR Reagent Strips." It also mentions that "The App instructs the professional user how to accurately perform the test. The App conducts a series of boundary condition analyses, and if the scan is approved, sends the information to the Backend for complete analysis and results classification."

This suggests that the device does not operate purely standalone (algorithm-only without human-in-the-loop). A healthcare professional is involved in:
* Performing the physical test (dipping the strip).
* Operating the smartphone application.
* Placing the strip on the Color-Board for scanning.

The algorithm on the Backend performs the complete analysis and classification, but this is initiated and guided by the human user through the app. Therefore, it's a human-in-the-loop system, and no standalone algorithm-only performance is documented separately.

7. The Type of Ground Truth Used

The ground truth for the clinical performance study was established by comparison to a legally marketed predicate device (ACON Laboratories' Mission U120 Ultra Urine Analyzer). The aim was to demonstrate substantial equivalence, meaning the new device's results should align closely with those of the established predicate.

8. The Sample Size for the Training Set

The document does not specify 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 document does not explicitly describe how the ground truth for the training set was established. It broadly mentions the software validation and hazard analysis but doesn't detail the data labeling process for the algorithm's training. It is common for such systems to be trained on a large dataset of images with corresponding known (e.g., laboratory-confirmed) values for albumin and creatinine, but this specific information is not provided here.

Summary

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July 26, 2019

Healthy.io Ltd Ron Zohar Chief Product Officer 2 Ibn Gabirol Street Tel Aviv, 6407702 Israel

Re: K182384

Trade/Device Name: ACR | LAB Urine Analysis Test System Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: JFY, JIR, KQO Dated: June 25, 2019 Received: June 25, 2019

Dear Ron Zohar:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182384

Device Name ACR | LAB Urine Analysis Test System

Indications for Use (Describe)

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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Attachment 3

510(K) SUMMARY

Healthy.io's ACR | LAB Urine Analysis Test System K182384

Submitter

Healthy.io Ltd. 2 Ibn Gabirol St. Tel Aviv, 6407702 Israel Phone: +972-54-445-4514 Fax: +972-77-470-4808 Contact Person: Ron Zohar

Date Prepared: July 2019

Name of Device: ACR | LAB Urine Analysis Test System

Common or Usual Name: Smartphone enabled albumin-creatinine ratio analyzer

Regulation Section and Classification Name:

Class I: Albumin Class II: Creatinine 21 CFR § 862.1645 Urinary protein or albumin (non-quantitative) test system 21 CFR § 862.1225 Creatinine test system 21 CFR § 862.2900 Automated urinalysis system

Product Code:

JIR JFY KQO

Classification Panel: Clinical Chemistry

Predicate Device:

The ACR | LAB is substantially equivalent to the following predicate device:

Manufacturer	Device	510(k) Number
ACON Laboratories Inc.	Mission U120 Ultra Urine Analyzerand Mission Urinalysis Reagent Strips(Microalbumin/Creatinine)	K142391

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Device Description:

The device is provided as a kit that is comprised of a canister of 100 FDA-cleared urine test strips (ACON Laboratories Inc. Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) K150330), 10 Color-Boards, and a User Manual. The ACR | LAB Urine Analysis Test System also consists of a smartphone application for use on iPhone 7 device (iOS 12), and an image recognition algorithm running on the Backend*.

The software component of the ACR | LAB consists of both an application (App) and a Backend server (Backend). The App instructs the professional user how to accurately perform the test. The App conducts a series of boundary condition analyses, and if the scan is approved, sends the information to the Backend for complete analysis and results classification. Once analyzed, the results are securely transmitted to a patient Electronic Medical Record for review by a healthcare professional. The patients do not have access to the results at any point during the testing process.

Device Components:

The ACR | LAB Urine Analysis Test System is comprised of the following components:

1. A canister of 100 Mission Urinalysis Reagent Strips U031-021 (ACON Laboratories Inc., K150330)
1. Ten individually wrapped Color-Boards
1. A smartphone App
1. A backend, cloud-based server
1. A user manual
1. iPhone 7 with iOS 12 (not provided)

Intended Use/Indication for Use:

Comparison of ACR | LAB and ACON Laboratories' Mission U120 Ultra Urine Analyzer:

Table 1 below summarizes similarities and variabilities between the ACR | LAB and its predicate device, ACON Laboratories' Mission U120 Ultra Urine Analyzer and Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) (K142391).

Backend will henceforth refer to the system's cloud-based servers, which run the server-side algorithms, and turn the algorithms' analysis into clinical results. These are then securely transmitted to a patient Electronic Medical Record. The ACR | LAB Backend is HIPAA compliant and uses advanced security protocols for data handling and transmission.

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Table 1: Comparison between ACR LAB Urine Analysis Test System and the ACON Laboratories' Mission
U120 Ultra Urine Analyzer (K142391)

Feature	Healthy.io's ACR LAB Urine Analysis Test System (K182384)	ACON Laboratories' Mission U120 Ultra Urine Analyzer and strips (K142391)
Intended Use	The ACR LAB Urine Analysis TestSystem is comprised of asmartphone application, aproprietary Color-Board, and ACRReagent Strips. It is intended for thesemi-quantitative detection ofalbumin and creatinine in urine, aswell as the presentation of theirratio. The ACR LAB Urine AnalysisTest System is intended for in-vitrodiagnostic use by a healthcareprofessional in a point of caresetting. These results may be usedin conjunction with clinicalevaluation as an aid in the diagnosisfor kidney function.	The Mission® U120 Ultra UrineAnalyzer is a uranalysis instrumentintended for in vitro diagnostic use. Itis intended for professional use only atpoint-of-care locations. The MissionU120 Ultra Urine Analyzer is intendedto read Mission® Urinalysis ReagentStrips (Microalbumin/Creatinine) forthe semi-quantitative measurementof albumin and creatinine. Thesemeasurements are used to assistdiagnosis for kidney function.
Test Specimen	Urine	Urine
DetectionMethodology	Reflectance Photometry	Reflectance Photometry
Detection device	Photosensitive Diode	Photosensitive Diode
Operating Conditions	0-35°C (32-95°F); ≤93% Humidity(non-condensing)	0-40°C (32-104ºF); ≤85% Humidity(non-condensing)
Strips to be used	Mission Urinalysis Reagent StripsU031-021 (K150330)	Mission Urinalysis Reagent StripsU031-021
Strip OperatingConditions	15-30°C [59°-86°F]20%-80% Relative humidity (non-condensing)	15-30°C [59°-86°F]20%-80% Relative humidity (non-condensing)
Strip Incubation Time	1 minute	1 minute
Calibration	Automatic	Automatic
Power Source	Not Applicable	6 AA batteries 100- 240 VAC(adapter), (46-65 Hz± 1HZ)
Line Leakage Current	Not Applicable	<2.5mA
Data Transfer	Via internet connection from theBackend to the dedicatedsmartphone as well as to a patientElectronic Medical Record (EMR)	USB port (data communications);Standard RS232C port for barcodereader or data transfer or externalprinter
Capabilities	Transmission to EMR via internetconnection	Internal printer (included) 25 pinparallel external printer port
Feature	Healthy.io's ACR LAB Urine Analysis Test System (K182384)	ACON Laboratories' Mission U120 Ultra Urine Analyzer and strips (K142391)
		connector (included) barcode reader (optional)RS232C barcode readerBluetooth adapterEthernet via USB to RJ45 adapterUSB wireless net-card (optional)SD card or USB flash drive for software update
Available languages on screen	English (others as installed)	English (default) and additional languages
Measuring cycle	Approximately 1 minute per test	Approximately 1 minute per test
Smartphones	iPhone 7	Not Applicable
Operating Systems	iOS 12	Not Applicable
Dimensions	5.0 cm (H) x 23.2 cm (W) x 18.5 (L)	260 mm (L) x 150 mm (W) x 175 mm (W)
Weight	<380 g (not including the dedicated smartphone)	< 1.66 kg without batteries or power supply

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Summary of Equivalence Discussion:

ACR | LAB and its predicate device, ACON Laboratories' Mission U120 Ultra Urine Analyzer (K142391), both are intended for prescription, in vitro diagnostic use by a healthcare professional in a point of care setting, with test results reviewed by a clinician for further care. The Method Comparison study results and bench test results demonstrate substantial equivalence and provide evidence for the safety and effectiveness of the ACR | LAB Urine Analysis Test System in comparison to the ACON Laboratories' Mission U120 Ultra Urine Analyzer and Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) (K142391).

Summary of Performance Data:

Healthy.io conducted both bench and clinical studies to test the accuracy of the ACR | LAB Analysis Test System and its agreement with its predicate device. These analytical and clinical performance studies (conducted in three independent point of care clinical sites in the United States) as well as the software validation testing are summarized below.

Analytical Performance Testing:

The performance characteristics of the ACR | LAB 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 provided by Clinical and Laboratory Standards Institute document EP05-A3 – Evaluation of Precision of Quantitutive Measurement Procedures; Approved Guideline – Third Edition.

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The Repeatability study was conducted at three sites over the course of one day. Each operator tested three spiked levels of urine using twenty ACR Reagent Strips (Strips) from three lots on a dedicated iPhone 7 device. For each analyte, 189 total tests were performed during the Repeatability study (189 = 3 sites X 3 solutions X 3 lots X 7 strips X 1 phones). The ACR | LAB device recorded an exact match of 100% during the study.
I 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 every run, each operator used a dedicated iPhone 7 device to test three spiked levels of urine. To do this, the operator used three Strips per sample, one Strip each from three separate lots. Five devices were used throughout course of the study. These were rotated, with three phones used on any given day. For each analyte, 1,080 total tests were taken during the Reproducibility study (3 sites x 3 solutions X 3 lots x 20 days x 1 device). The ACR | LAB device recorded an exact match of 99.8% during the course of the study.

Interference. Testing of potential interfering substances with the ACR | LAB Urine Analysis Test System was designed and executed in accordance with guidance provided by Clinical and Laboratory Standards Institute document EP07 – Interference Testing in Clinical Chemistry – Third Edition; and EP37 -Supplemental Tables for Interference Testing in Clinical Chemistry, 1st Edition.

. Interference was defined as a change in output of ≥ 1 color block between spiked and unspiked (control) samples. Once interference was detected, a dose-response study was carried out at three decreasing intervals to determine the lowest concentration level that causes interfering substances and their lowest concentrations causing interference were identified and listed in the accompanying User Manual.
Limit of Detection. Testing of the ACR | LAB Urine Analysis Test System Limits of Detection 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.
. The Limit of Detection study was based on validated spiked or diluted urine solutions at known concentrations for each analyte. The samples were adjusted to concentrations that were divided into four equivalent intervals between the stated cut-off blocs. The cut-off for each block is defined as the lowest concentration at which >55% of the results were positive.
Linearity. The linearity study of the ACR | LAB Urine Analysis Test System was designed in accordance with guidance 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 ACR | LAB Urine Analysis Test System to provide results that are directly proportional to the concentrations of analytes within each test sample. The study tested the entire range of values that the ACR | LAB Urine Analysis Test System is designed to measure. These expected values were presented against actual device results. Both of the analytes demonstrated a linear relationship between variables, with no biases disrupting the overall pattern of linearity.

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Timing Flex Study. This experiment essentially consists of four different studies: 1. carry-over; 2. dipping; 3. wetting (blotting); and 4. assay-time; and was designed to evaluate how the timing of dipping, wetting, and blotting, as well as carry-over of the Strips impacts the ability of the ACR | LAB Urine Analysis Test System to accurately measure the levels of albumin and creatinine in a urine sample. The framework of this study is based primarily on similar studies of devices with similar indications for use.

. Carry-Over. In this study, strips were held in both the "up" (with the creatinine on top) and "down" (with the albumin on top) positions for different time intervals after being dipped in spiked solutions. None of the carry-over time durations, in both "up" and "down" configurations had any impact on the ACR | LAB's ability to measure accurate results. The study used the most extreme cases, testing for high-positive "run-off" into low-positive patches.
Wetting (Blotting) Time: This experiment tested six different "blotting" times, i.e. the tester dipped the Strip and then waited a specific amount of time (0-, 5-, 10-, 20-, 40- and 60-seconds) before blotting the Strip and scanning it with the ACR | LAB device. For creatinine, none of the various dipping times impacted the accuracy of the device. For albumin, waiting 60-seconds to blot the strip resulted in False Positive results. The User Manual and in-app instructions direct the professional user to dip, blot, and place the strip on the Color-Board in quick succession.
Dipping Time. Strips were dipped in spiked solutions for four different time durations (1-, 2-, 5-, and 10-seconds) to test the impact of various dipping times on the ACR | LAB's ability to perform accurate measurements. For creatinine, none of the various dipping times impacted the accuracy of the device. For albumin, at times 5- and 10-seconds there was an increase in False Positive results. The User Manual and in-app instructions direct the professional user to dip the ACR Reagent Strip for 1-second.
Assay Time: This experiment tested how different assay times impacted the ACR | LAB's ability to measure accurate results. Strips were dipped and then immediately blotted, per the device's instructions. The user then waited a predetermined amount of time (60-, 80-, 100-, or 120- seconds) before scanning the strip. None of the assay time durations had any impact on the ACR | LAB's ability to accurately measure albumin or creatinine. The User Manual and the in-app instructions direct the professional user to scan the Strip and Color-Board once the in-app timer has indicated that 60-seconds have elapsed.

Stability. This stability experiment was designed to test the ACR | LAB ability to provide accurate measurements after subjecting the device kit to both real time and accelerated aging timeframes and conditions that could arise during transportation (e.g. temperature, humidity and vibration). In addition, an open vial experiment was also conducted. After exposure to these transportation conditions and timeframes, the performance of the kits was evaluated through a number of functional tests. The ACR | LAB device was not affected by any of these parameters and its stability was therefore confirmed.

Clinical Performance Testing:

Method Comparison. The objective of the Method Comparison study was to test the ACR | LAB's degree of agreement with its predicate device, when operated by a professional user at a point-of-care location

The primary acceptance criteria for the study were the percent of exact match and ±1 color block match between the ACR | LAB Urine Analysis Test System and the predicate. Throughout the testing, the ACR |

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LAB Urine Analysis Test System demonstrated high levels of accuracy as demonstrated by its percent of agreement with the predicate device.

Study Design

The study evaluated native urine samples from 375 subjects as well as 60 contrived samples at three U.S. clinical sites. The ACR | LAB device was provided to the study coordinators. All subjects were asked to provide a urine sample. Two separate lab technicians were responsible for measuring each urine sample. The first lab technician measured the urine sample using the iPhone 7 device; the second technician measured the urine sample using the predicate device, the ACON Laboratories' Mission U120 Ultra Urine Analyzer (U120 Ultra). Each urine sample was tested twice in total; once with the iPhone 7 device and then subsequently with the predicate device (U120 Ultra). The results of the ACR | LAB device and results measured by the predicate (U120 Ultra) were compared.

Study Results – Accuracy

The overall agreement (% exact match) between the ACR | LAB Urine Analysis Test System and the predicate device was 89% for albumin and 84% for creatinine. The overall agreement between the ACR | LAB Urine Analysis Test System and the predicate device when measuring the albumin-creatinine ratio was 93%. The ± 1 color block % agreement between the ACR | LAB Urine Analysis Test System and the predicate device was 100% for albumin, 100% for creatinine, and 100% for the albumin-creatinine ratio.

The high rates with which the ACR | LAB measured the same results as the predicate ACON Laboratories' Mission U120 Ultra Urine Analyzer demonstrate substantial equivalence between the two devices.

Software Validation:

Validation of the ACR | LAB device software was performed according to 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 devices, the OCR's HIPAA regulation and ISO 27001:2013, 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 ACR | LAB Urine Analysis Test System is substantially equivalent to the predicate device Mission® U120 Ultra Urine Analyzer and Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) (FDA 510(k): K142391).

Regulation Number and Section

§ 862.1225 Creatinine test system.

(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.