(541 days)
Not Found
Yes
The device description explicitly states that the software component includes "machine learning algorithmic components" for image analysis.
No.
The device is an in-vitro diagnostic system intended for the semi-quantitative measurement of albumin and creatinine in urine to aid in the assessment of kidney health. It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system."
No
The device description explicitly states that the system consists of a smartphone application, proprietary Color-Board, and an ACR Reagent Strip, and is provided as a kit that comprises a urine receptacle, an ACR Reagent Strip, an absorbing pad, a proprietary Color-Board and a user manual. These are physical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system..."
This statement directly identifies the device as an in-vitro diagnostic. The description of the device and its function (analyzing urine samples outside of the body to measure specific analytes) further supports this classification.
No
The letter does not mention that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The system consists of a smartphone application, proprietary Color-Board and an ACR Reagent Strip. The system is available for prescription-use only and is intended for people at risk of kidney disease. Results are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health.
Product codes (comma separated list FDA assigned to the subject device)
JFY, JIR, KQO
Device Description
The Minuteful - kidney test is comprised of a kit and a smartphone application. It is intended for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR).
The Minuteful - kidney test is intended for prescription-use only, as a home-use device to aid in the assessment of kidney health. The results can be used together with clinical evaluation to guide patient care.
The device is provided as a kit that comprises a urine receptacle, an ACR Reagent Strip, an absorbing (i.e. "blotting") pad, a proprietary Color-Board and a user manual. The device also consists of an easy-to-use smartphone application, image recognition algorithms, and a physician compendium.
The software component of the Minuteful - kidney test consists of both an application (app) and a backend server. Both components encompass different computer vision and machine learning algorithmic components, performing the image analysis activities. The app instructs the user how to accurately administer the test. The Image Validation Transfer System (IVTS) component of the Minuteful - kidney test enables its usage across a wide range of smartphone types and operating systems, essentially making the test platform agnostic.
Mentions image processing
image recognition algorithms
performing the image analysis activities
Mentions AI, DNN, or ML
machine learning algorithmic components
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home-use
prescription-use only
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance Testing: Precision (Repeatability, Reproducibility), Interference, Limit of Detection, Linearity, Stability.
Precision: Repeatability 100% exact match, Reproducibility 100% exact match.
Linearity: 100% exact match for albumin, creatinine, and ACR.
Stability: Kits passed all tests and were not impacted by exposure to different environmental conditions.
Clinical Performance Testing: Method Comparison studies were conducted in accordance with Good Clinical Practice (GCP), according to 21 CFR Part 50, 54, 56, 812, ISO 14155-1/2 and relevant local and national requlations (IRB committee). In addition, the Method Comparison studies complied with CLSI EP09c: Method Comparison and Bias Estimation Using Patient Samples; Approved Guidelines – Third Edition.
Sample size: More than 450 subjects.
Study Design: Each urine sample was tested by a lay user on the Minuteful - kidney test app, and then transferred to a professional user to conduct the test on the URiSCAN Optima Urine Analyzer. The professional user was blinded to the results of the lay user until after they had completed the test using the URiSCAN device.
Accuracy Results: Exact albumin-creatinine ratio agreement is 92.7%, with an overall ±1 color block of 100%. For albumin, exact agreement is 92.1%, and for creatinine, 88.2%, with both overall ±1 color block of 100%.
Usability Results: 100% of subjects were able to complete the study on the first attempt, with no usability issues.
Key results: The clinical and analytical performance study results demonstrate that the Minuteful - kidney test is substantially equivalent to the predicate device URiSCAN Optima Urine Analyzer (K141874).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Exact agreement for albumin-creatinine ratio: 92.7%
Overall ±1 color block for albumin-creatinine ratio: 100%
Exact agreement for albumin: 92.1%
Exact agreement for creatinine: 88.2%
Overall ±1 color block for albumin: 100%
Overall ±1 color block for creatinine: 100%
Usability completion rate: 100%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1645 Urinary protein or albumin (nonquantitative) test system.
(a)
Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 6, 2022
Healthy.io Ltd. Ron Zohar Chief Product Officer 8 Yitzhak Sadeh St. Tel Aviv. Israel 6777508
Re: K210069
Trade/Device Name: Minuteful - kidney test Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: JFY, JIR, KQO Dated: April 13, 2022 Received: April 14, 2022
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.
1
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) 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 (QS) 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 medical devices and radiation-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.
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210069
Device Name Minuteful - kidney test
Indications for Use (Describe)
The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The system consists of a smartphone application, proprietary Color-Board and an ACR Reagent Strip. The system is available for prescription-use only and is intended for people at risk of kidney disease. Results are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Healthy.io's Minuteful - kidney test K210069
Submitter:
Healthy.io Ltd. 8 Yitzhak Sadeh St. Tel Aviv, Israel 6777508
Phone: +972-54-445-4514 Facsimile: +972-77-470-4808
Contact Person: Ron Zohar
Date Prepared: April 13, 2022
Name of Device: Minuteful - kidney test
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 Urinary protein or albumin (nonquantitative) test system
- JFY Creatinine test system
- KQO Automated urinalysis system
Classification Panel: Clinical Chemistry
4
Predicate Device:
The Minuteful - kidney test is substantially equivalent to the following predicate device:
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| YD Diagnostics Corp. | URISCAN Optima urine chemistry test system | K141874 |
Device Description:
The Minuteful - kidney test is comprised of a kit and a smartphone application. It is intended for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR).
The Minuteful - kidney test is intended for prescription-use only, as a home-use device to aid in the assessment of kidney health. The results can be used together with clinical evaluation to guide patient care.
The device is provided as a kit that comprises a urine receptacle, an ACR Reagent Strip, an absorbing (i.e. "blotting") pad, a proprietary Color-Board and a user manual. The device also consists of an easy-to-use smartphone application, image recognition algorithms, and a physician compendium.
The software component of the Minuteful - kidney test consists of both an application (app) and a backend server. Both components encompass different computer vision and machine learning algorithmic components, performing the image analysis activities. The app instructs the user how to accurately administer the test. The Image Validation Transfer System (IVTS) component of the Minuteful - kidney test enables its usage across a wide range of smartphone types and operating systems, essentially making the test platform agnostic.
Intended Use/Indications for Use:
The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The system consists of a smartphone application, proprietary Color-Board and an ACR Reagent Strip. The system is available for prescription-use only and is intended for people at risk of kidney disease. Results are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health.
5
Table VIII.I: Comparison between Minuteful - kidney test and YD Diagnostics Corp. URiSCAN Optima urine chemistry test system
| Feature | Minuteful - kidney test | YD Diagnostics Corp. URISCAN
Optima (K141874) |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Minuteful – kidney test is an
in-vitro diagnostic, home-use
urine analysis test system for the
semi-quantitative measurement of
albumin and creatinine in urine,
as well as the presentation of
their ratio, the albumin-creatinine
ratio (ACR). The system consists
of a smartphone application,
proprietary Color-Board and an
ACR Reagent Strip. The system
is available for prescription-use
only and is intended for people at
risk of kidney disease. Results
are intended to be used in
conjunction with clinical
evaluation as an aid in the
assessment of kidney health. | The URISCAN Optima urine
chemistry test system consists of
URISCAN Optima Urine analyzer
and URISCAN 2 ACR Urine strips.
The intended use of the URISCAN
Optima Urine analyzer is to read the
color change on the test pads found
on the URISCAN 2ACR Urine strips
and to display and print the results.
The intended use of the URISCAN
2ACR Urine strips is for the in vitro
semi quantitative measurement of
the following parameters:
Albumin
Creatinine
ACR (Albumin Creatinine Ratio)
These measurements are useful in
the evaluation of renal, urinary and
metabolic disorders.
URISCAN Optima urine chemistry
test system is intended for
prescription use only, in clinical
laboratory and in point-of-care
setting. |
| Test Specimen | Urine | Urine |
| Detection
Methodology | Reflectance photometry | Reflectance photometry |
| Detection Device | Photosensitive diode | Photosensitive diode |
| Strips | URISCAN 2ACR urine strips
(K141874) | URISCAN 2ACR urine strips
(K141874) |
| Analytes | albumin, creatinine | albumin, creatinine |
| Power Source | Not Applicable | URISCAN Optima: DC 12V, 3.5A,
42VA
AC/DC Adaptor: AC 100-240 V,
50/60 Hz, 1.2 A |
| Data Transfer/
Capabilities | Via smartphone internet
connection from the backend
server to the lay user and a
healthcare professional.
Results are available for secure
sharing with an EMR. | Bi-directional RS 232C interface
High-speed thermal printer (203 dpi),
barcode reader |
| Available
languages on
screen | English | English, German, Italian, Russian,
Spanish, Portuguese, Korean, and
Chinese |
| Measuring
Cycle/Incubation
Time | 75 seconds | Routine test mode - 100 seconds
Quick test mode - 6 seconds |
| Throughput | Not Applicable | 36 tests/hour |
| Smartphones/
Operating
Systems | The product supports a wide variety
of currently available smartphones
and operating systems. Newly
introduced smartphone-hardware
and new operating systems will
be validated by the company on a
regular basis. | Not Applicable |
6
7
| Dimensions | 187mm (W) x 143.6mm (L) x
24.6mm (H) | 210mm (W) x 240mm (L) x 90mm
(H) |
|------------|-----------------------------------------|-------------------------------------|
| Weight | 0.125 kg | 0.97kg |
8
Summary of Performance Data:
Healthy.io conducted both bench and clinical studies to test the accuracy of the Minuteful kidney test and its agreement with its predicate device. These analytical and clinical performance studies are summarized below.
Analytical Performance Testing:
The performance characteristics of the Minuteful - kidney test were evaluated according to the following analytical performance tests:
Precision. This study consisted of two separate studies: 1) Repeatability and 2) Reproducibility. The precision studies were designed and executed in accordance with guidance provided by the Clinical and Laboratory Standards Institute (CLSI) document EP05-A3 - Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition.
- . Repeatability. The Minuteful - kidney test recorded an exact match of 100% during the course of the study.
- Reproducibility. The Minuteful kidney test recorded an exact match of 100% during . the course of the study. .
Interference. Testing of potential interfering substances with the Minuteful - kidney test was designed and executed in accordance with guidance provided by the Clinical and Laboratory Standards Institute (CLSI) document EP07: Interference Testing in Clinical Chemistry; Approved Guideline - Third Edition and CLSI EP37: Supplemental Tables for Interference Testing in Clinical Chemistry - First Edition.
Limit of Detection. Testing of the Minuteful - kidney test detection limits was designed and executed in accordance with guidance provided by the Clinical and Laboratory Standards Institute (CLSI) document EP17-A2 - Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guidelines - Second Edition.
Linearity. The linearity study of the Minuteful - kidney test was designed and executed 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 Minuteful - kidney test measured every level of albumin, creatinine and ACR at an exact match of 100%.
Stability. The stability experiment was designed to evaluate the ability of the Minuteful - kidney test to provide accurate measurements after exposure to environmental conditions (e.g.
9
temperature, humidity and vibration), which are designed to simulate aging and transportation conditions. This experiment was designed according to multiple International Electrotechnical Commission standards, IEC TR 60721-4-1:2001+A1:-3, Class 2K2 and IEC TR 60721-4-1:2001+A1:-3, Class 2M3. The Minuteful - kidney test kits passed all tests and were not impacted by exposure to the different environmental conditions, demonstrating stability.
Clinical Performance Testing:
Method Comparison. The Method Comparison studies were conducted in accordance with Good Clinical Practice (GCP), according to 21 CFR Part 50, 54, 56, 812, ISO 14155-1/2 and relevant local and national requlations (IRB committee). In addition, the Method Comparison studies complied with CLSI EP09c: Method Comparison and Bias Estimation Using Patient Samples; Approved Guidelines – Third Edition. The objective of the Method Comparison studies was to evaluate the accuracy and usability performance of the Minuteful - kidney test in the hands of the lay user.
Study Design
More than 450 subjects were recruited to the clinical trials based on their ability to provide a urine sample and comfortably complete tasks using a smartphone. Each urine sample was tested by a lay user on the Minuteful - kidney test app, and then transferred to a professional user to conduct the test on the URiSCAN Optima Urine Analyzer. The professional user was blinded to the results of the lay user until after they had completed the test using the URiSCAN device.
Study Results - Accuracy
Results from subjects in the clinical trials were analyzed to show an exact agreement when compared to the comparator device. The exact albumin-creatinine ratio agreement is 92.7%, with an overall ±1 color block of 100%. Per analyte, the exact agreement for albumin is 92.1% and for creatinine 88.2%, with both overall ±1 color block of 100%. The results show that the Minuteful - kidney test measurements are substantially equivalent to the measurements taken by the comparator device.
Study Results - Usability
100% of subjects were able to complete the study on the first attempt, with no usability issues.
Conclusions:
The clinical and analytical performance study results demonstrate that the Minuteful - kidney test is substantially equivalent to the predicate device URiSCAN Optima Urine Analyzer (K141874).