(271 days)
Yes
The device description explicitly mentions an "image recognition algorithm running on the back-end" which is a common application of AI/ML in medical imaging analysis.
No
The device is described as a diagnostic tool for detecting analytes in urine to aid in diagnosis and monitoring of diseases, not for providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system's results can be used to "aid in the diagnosis and monitoring of metabolic or systemic diseases."
No
The device description explicitly states it includes hardware components: a proprietary Color-Board, Urinalysis Reagent Strips, a urine receptacle, and a User Manual, in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the "semi-quantitative detection" and "qualitative detection" of specific analytes in urine. This directly aligns with the definition of an in vitro diagnostic product, which is used to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease.
- Specimen Type: It analyzes urine, which is a specimen derived from the human body.
- Purpose: The results are 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." This is a clear diagnostic and monitoring purpose.
- Components: The system includes urinalysis reagent strips, which are a common component of IVD tests.
- Comparison to Predicate: The submission references a predicate device (K111221; ACON Mission U500 Urinalysis System) which is also an IVD.
While the system incorporates a smartphone application and image processing, its core function is the in vitro analysis of a human specimen to provide diagnostic information. The technology used to read and interpret the results doesn't change its fundamental classification as an IVD.
No
The input letter does not contain any explicit statement 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 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.
Product codes
JIL, JIO, CEN, JMT, JIR, JRE
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 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.
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found. The text mentions "image recognition algorithm" but not AI, DNN, or ML specifically.
Input Imaging Modality
Reflectance Photometry
Anatomical Site
Urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription home-use only, with results provided directly to the physician.
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
Method Comparison Study 1:
Sample size: 500 total samples from 429 subjects
Data source: two U.S. clinical sites
Annotation protocol: 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).
Method Comparison Study 2:
Sample size: 289 total samples from 250 subjects
Data source: U.S. based clinic
Annotation protocol: 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).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench and Clinical Studies to test accuracy and agreement with predicate device.
Analytical Performance Testing:
Precision (Repeatability and Reproducibility):
- Repeatability: 3 sites, 2 spiked levels of urine, 20 sticks from 3 lots, Nexus phone. 360 total tests. Exact match of 99.3%.
- Reproducibility: 3 sites, 20 days, 3 spiked levels of urine, 1 stick from 3 lots, Nexus device. 1,080 total tests. Exact match of 98.5%.
Interference:
- Interference defined as change in output of ±2 color block between spiked and unspiked samples.
- Both DIP | U.S. Urine Analysis Test System and predicate device recorded similar results.
Limit of Detection:
- Based on validated spiked urine solutions at known concentrations for each analyte.
- Demonstrated ability to accurately detect the limits concentration of every analyte.
Linearity:
- Tested ability to provide results directly proportional to concentrations of analytes.
- Measured at least 89.4% exact match and 100% ±1 color block accuracy.
- No detectable biases.
Stability:
- Tested over time under environmental factors (temperature, humidity).
- Established shelf life and recommended storage conditions.
- Passed examinations at 6-, 12-, and 14-month intervals.
Additional Studies:
Illumination Study:
- Tested under ten common lighting conditions.
- Measured a total exact match of 99.5% compared to predetermined reagent values.
Boundary Study:
- Evaluated physical boundary conditions (angle, distance, lighting).
- Measured a total exact match of 99.5% compared to predetermined reagent values.
Method Comparison Study 1 (simulated home-use by lay-user):
- Sample size: 429 subjects, 500 total samples.
- Primary acceptance criteria: percent exact match and ±1 color block match with predicate.
- Usability: 424 out of 429 tests successfully completed (>99% success rate). Average usability survey score of 4.9 out of 5.
- Accuracy: Overall ±1 color block % agreement >99%. Exact match levels: Nitrites 99%, Protein 85%, pH 75.7%, SG 63.4% (based on 284 LG Nexus 5 results).
Method Comparison Study 2 (simulated home-use by lay-user):
- Sample size: 250 subjects, 289 total samples.
- Usability: 249 out of 250 patients successfully completed the test.
- Accuracy: Exact match for Blood 91.4% (100% +/-1 color block), Glucose 89.6% (100% +/-1 color block). Zero instances of False Negative measurements for Blood and Glucose.
Software Validation:
- Performed according to IEC 60601-1 (clause 14), IEC 62304:2004 to IEC 62304 - 2006/AC 2008, IEEE standards, and FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- Comprehensive hazard analysis and cyber security analysis conducted according to FDA's guidance, OCR's HIPAA regulation, and ISO 27001.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Performance Testing:
- Precision (Repeatability): Exact match of 99.3%.
- Precision (Reproducibility): Exact match of 98.5%.
- Linearity: At least 89.4% exact match and 100% ±1 color block accuracy.
- Illumination Study: Total exact match of 99.5%.
- Boundary Study: Total exact match of 99.5%.
Method Comparison Study 1:
- Usability: >99% success rate.
- Accuracy: Overall ±1 color block % agreement >99%.
- Exact match %: Nitrites 99%, Protein 85%, pH 75.7%, SG 63.4%.
Method Comparison Study 2:
- Exact match %: Blood 91.4% (100% +/-1 color block), Glucose 89.6% (100% +/-1 color block).
- False Negative: Zero instances for Blood and Glucose.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
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 Urinalysis | |
| System | 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 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.
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.
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.
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:
-
- Urine Receptacle
-
- A single, individually-wrapped Mission Urinalysis Reagent Strip U031-101 (ACON Laboratories Inc., K061559)
-
- Color-Board
-
- Smartphone App
-
- Back-end, cloud-based server
-
- User Manual
-
- 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.
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.
| Feature | DIP U.S. Urine Analysis Test
System | ACON Mission U500 Urinalysis
System
(K11221) |
|-------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------|
| Intended Use | Prescription-only, in vitro diagnostic
home-use | Prescription-only, in vitro diagnostic
use |
| 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); 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).