(347 days)
Yes
The device description explicitly states that the software component encompasses "machine learning algorithmic components, performing the image analysis activities."
No.
The device is described as an in-vitro diagnostic test system for measuring albumin and creatinine, used as an aid in assessing kidney health, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in-vitro diagnostic, home-use urine analysis test system" and that "Results are used in conjunction with clinical evaluation as an aid in the assessment of kidney health," which unequivocally identifies it as a diagnostic device.
No
The device description explicitly states that the system consists of a smartphone application, proprietary Color-Board, and an ACR Reagent Strip, and the kit includes physical components like a urine receptacle, reagent strip, blotting pad, and Color-Board. This indicates it is a system with both hardware and software components, not software-only.
Yes, the 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.
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 used in conjunction with clinical evaluation as an aid in the assessment of kidney health.
Product codes
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's kit includes 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
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription-use only, as a home-use device
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
Healthy.io conducted multiple validation studies including the Limit of Detection and the set of IVTS studies to ensure the modified device is substantially equivalent to the predicate device (Minuteful - kidney test K210069). The rest of the analytical performance studies are still relevant for the modified version of the Minuteful - kidney test, and their summary is available in the predicate device documentation (K210069).
Performance Testing: The performance characteristics of the Minuteful - kidney test were evaluated according to the following performance tests: Limit of Detection (LoD), Illumination Conditions (Multiple Illuminations and Extreme Illuminations), Physical Conditions, Multiple Shadow conditions, Blurriness, Misplaced Urine Stick, Dirty Color-Board. Precision, Interference, Linearity, Stability, and Clinical Performance Testing (Method Comparison) refer to the predicate device summary (K210069).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
September 8, 2023
Healthy.io Ltd. Ron Zohar Chief Product Officer 8 Yitzhak Sadeh St. Tel Aviv, Israel 6777508
Re: K222921
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: June 11, 2023 Received: June 12, 2023
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
1
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,
Paula V. Caposino -S
Paula Caposino, Ph.D. Acting Deputy Division 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
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Indications for Use
510(k) Number (if known) K222921
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 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) |
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Healthy.io's Minuteful - kidney test (K222921)
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: September 19, 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
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Predicate Device:
The Minuteful - kidney test is substantially equivalent to the following predicate device:
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| Healthy.io Ltd. | Minuteful - kidney test | K210069 |
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's kit includes 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.
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Table I Comparison between the Minuteful - kidney test (K222921) and Minuteful - kidney test (K210069) the predicate device.
| Feature | Minuteful - kidney test
(K210069) | Minuteful - kidney test
(K222921) |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| 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. | Same |
| Test Specimen | Urine | Same |
| Detection
Methodology | Reflectance photometry | Same |
| Detection Device | Photosensitive diode | Same |
| Strips | URiSCAN 2ACR urine strips
(K141874) | Same |
| Analytes | albumin, creatinine | Same |
| Power Source | Not Applicable | Same |
| 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 | Same |
| Feature | Minuteful - kidney test
(K210069) | Minuteful - kidney test
(K222921) |
| | with an EMR. | |
| Available
languages
on screen | English | English, Spanish |
| Measuring
Cycle/Incubation
Time | 75 seconds | Same |
| Throughput | Not Applicable | Same |
| 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. | Same |
| Dimensions | 106mm (W) x 143mm (D) x
30mm (H) | Same |
| Weight | 0.105kg | Same |
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Summary of Performance Data:
Healthy.io conducted multiple validation studies including the Limit of Detection and the set of IVTS studies to ensure the modified device is substantially equivalent to the predicate device (Minuteful - kidney test K210069). The rest of the analytical performance studies are still relevant for the modified version of the Minuteful - kidney test, and their summary is available in the predicate device documentation (K210069).
Performance Testing:
The performance characteristics of the Minuteful - kidney test were evaluated according to the following performance tests:
Limit of Detection (LoD):
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.
Illumination Conditions:
This study consisted of two separate studies; the Multiple Illuminations and Extreme Illuminations studies.
- . Multiple Illuminations: Testing was conducted under different lighting conditions of different color temperatures and intensities from different light sources representative of those that may be used in the home setting. The results of the study support that the performance is not impacted by lighting conditions that are likely to be found in the home use environment.
- Extreme Illuminations: Testing was conducted under different lighting conditions with . different saturation of the RGB spectrums as well as under different light intensities. Tested smartphones were evaluated at the edges of the device boundary conditions, under which the device allowed the smartphone to take an image of the urine test strip and Color-Board. The results of this testing support that the device performance is not impacted by different light color saturations.
Physical Conditions:
Testing was conducted under different distance conditions and different angle conditions. Tested smartphones were evaluated at the edges of the device boundary conditions, under which the device allowed the smartphone to take an image of the urine test strip and Color-Board. The performance of the device was not impacted within the supported conditions.
Multiple Shadow conditions:
Testing was conducted under different shadow configurations of different intensity and covering different portions of the Color-Board and urine test strip. Tested smartphones were evaluated at the edges of the device boundary conditions, under which the device allowed the smartphone to use the captured image of the urine test strip and Color-Board. The performance of the device was not impacted by the presence of shadows on the color-board and test strip within the supported conditions.
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Blurriness:
Testing was conducted under different conditions of blurred images consisting of different levels of focus and motion blur. Tested smartphones were evaluated at the edges of the device boundary conditions, under which the device allowed the smartphone to take an image of the urine test strip and Color-Board. The performance of the device was not impacted by the image blur within the supported conditions.
Misplaced Urine Stick:
Testing was conducted under different urine test strip placements. Tested smartphones were evaluated at the edges of the device boundary conditions, under which the device allowed the smartphone to use the captured image of the urine test strip and Color-Board. The performance of the device was not impacted by the test strip placement within the supported conditions.
Dirty Color-Board:
Testing was conducted under different dirty substances covering different parts of the Color-Board. consisting of different levels of focus and motion blur. Tested smartphones were evaluated at the edges of the device boundary conditions, under which the device allowed the smartphone to use the captured image of the urine test strip and Color-Board. The performance of the device was not impacted by the dirty substances within the supported conditions.
Precision: See Minuteful - kidney test summary (K210069).
Interference: See Minuteful - kidney test summary (K210069).
Linearity: See Minuteful - kidney test summary (K210069).
Stability: See Minuteful - kidney test summary (K210069).
Clinical Performance Testing:
Method Comparison: See Minuteful - kidney test summary (K210069).
Conclusion:
The modified Minuteful - kidney test is substantially equivalent to the predicate device Minuteful kidney test cleared in K210069.