Search Results

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 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.

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.

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

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Additional Performance Metrics (from Analytical Performance Testing):

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

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

Two method comparison studies were conducted for the test set:

• Study 1:

  • Sample Size: 429 subjects, 500 total samples (including spiked samples). Only 284 results from LG Nexus 5 smartphones were used for performance data.
  • Data Provenance: Two U.S. clinical sites. The studies involved lay-users in a simulated home-use environment. This indicates prospective data collection for the purpose of this validation.

• Study 2:

  • Sample Size: 250 subjects, 289 total samples (including spiked samples).
  • Data Provenance: One U.S.-based clinic. Similar to Study 1, this appears to be prospective data collection in a simulated home-use setting.

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

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

7. The Type of Ground Truth Used

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

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

8. The Sample Size for the Training Set

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

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

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

Ask a specific question about this device

The Healthy Me™ Ketone Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative detection of Ketone (Acetoacetic acid) in urine. The identification of ketones is used in the diagnosis of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets.

The Healthy Me™ Ketone Reagent strips are intended for Over the Counter use by lay people with Diabetes and/or people on low carb diets at home to check for the ketones in urine. This product is not intended for the management of diabetes.

The On Call Ketone Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative detection of Ketone (Acetoacetic acid) in urine. The identification of ketones is used in the diagnosis of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets.

The On Call Ketone Reagent strips are intended for Over the Counter use by lay people with Diabetes and/or people on low carb diets at home to check for the ketones in urine. This product is not intended for the management of diabetes.

On Call® & Healthy Me" Ketone Reagent Strips for Urinalysis consists of a Plastic Strip to which a regent pad is affixed. The reagent pad reacts with the urine and provides a visible color reaction. On Call® & Healthy Me™ Ketone Reagent Strips for Urinalysis are packaged along with a drying agent in a Canister bottle. Each strip is stable and ready to use upon removal from the Canister. The entire reagent strip is disposable. Results are obtained by direct comparison to the test strip with a color blocks printed on the bottle label. Accurate timing is essential to provide optimal results. No calculations or laboratory instruments are needed.

Here's an analysis of the provided text regarding the acceptance criteria and study for the On Call/Healthy Me Ketone Reagent Strips for Urinalysis:

Introduction to the Device
The device, On Call® & Healthy Me™ Ketone Reagent Strips for Urinalysis, is intended for the qualitative and semi-quantitative detection of acetoacetic acid (ketones) in urine. It's designed for over-the-counter use by laypersons, including those with diabetes or on low-carb diets, to monitor for ketones at home. The test is based on a color change reaction with nitroprusside and acetoacetic acid, ranging from light pink (negative) to darker pink/purple (positive).

Acceptance Criteria and Device Performance

• Same block agreement: High agreement across all color blocks.
• Agreement within +/- one block: Very high agreement across all color blocks. | 1. Results of ACON Ketone by Layperson vs Bayer Ketostix by Technician at 3 Sites with solution concentrations matching color blocks:
• Same block agreement: 99.4% (ranging from 55/56 for 15 mg/dL to 60/60 for Neg, 5mg/dL, 40mg/dL, and 61/61 for 160mg/dL, and 60/61 for 80mg/dL).
• Agreement within +/- one block: 100.0%. |
  | User Performance Agreement | Accuracy against Predicate Device (Technician read) using Participant Midstream Urine:
• Same block agreement: High agreement across all color blocks where predicate showed results.
• Agreement within +/- one block: Very high agreement across all color blocks where predicate showed results. | 2. Participants' Midstream Urine with ACON Ketone Reagent Strips by Layperson vs Urine Collected in Cup with Bayer Ketostix by Technician at 2 sites:
• Same block agreement: 100% for observable results where data is provided (Neg, 5 mg/dL, 15 mg/dL, 40 mg/dL). Note: No results reported for 80 mg/dL or 160 mg/dL when read by layperson with ACON, while technician with Bayer showed 0 for these too. This suggests either these levels were not present in midstream urine or were not detected by either device/method. |
  | Substantial Equivalence | Demonstrate substantial equivalence to the predicate device (Bayer Ketostix reagent strips K801270) in terms of intended use, principle, reagents, specimen, methodology, and performance. | The conclusion explicitly states: "The above mentioned results demonstrate that the On Call and Healthy Me Ketone reagent strips for urinalysis are substantially equivalent to legally marketed predicate device currently sold on the U.S. market." |
  | Analytical Performance | Reference to prior 510(k) (K061559) for ACON Urinalysis Reagent Strips. | "The performance of Ketone reagent strips has been evaluated and present in 510k- K061559-ACON Urinalysis Reagent Strips." (The specific acceptance criteria from K061559 are not detailed here, but the statement implies they were met). |
  | Clinical Sensitivity/Specificity | Not applicable; assumed to be covered by the method comparison and substantial equivalence to a predicate for which these were established. | Not Applicable. |

Study Details

1. Sample Size used for the test set and the data provenance:

   • Study 1 (Solutions): 347 samples. These were solution concentrations designed to match the color blocks. The provenance is not explicitly stated beyond being conducted at "3 Sites." It's likely a controlled laboratory study rather than patient samples.
   • Study 2 (Midstream Urine): 71 samples. These were "Participants' Midstream Urine." The provenance is not explicitly stated beyond being conducted at "2 sites." It's likely prospective collection for the purpose of the study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Ground truth was established by a "Technician" reading the predicate device (Bayer Ketostix).
   • The number of technicians is not specified.
   • Their qualifications are not specified (e.g., years of experience, specific certifications), other than being identified as "Technician."

3. Adjudication method for the test set:

   • The document implies that the technician's reading of the predicate device was taken as the reference standard (ground truth). There is no mention of a
     multi-reader adjudication method (e.g., 2+1, 3+1) for establishing this ground truth.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This was not an MRMC study comparing human readers with and without AI assistance. This study compared a layperson reading the investigational device against a technician reading a predicate device.
   • Therefore, no effect size related to AI assistance for human readers is applicable or provided.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • No, this device is a manual reagent strip read by a human (layperson). It does not involve an algorithm or AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth was established by a "Technician" reading the predicate device (Bayer Ketostix) and comparing the color change to the color blocks. This is a form of reference standard comparison to a legally marketed predicate device, where the predicate read by a trained professional serves as the benchmark. For the first study, it was confirmed against known solution concentrations.

7. The sample size for the training set:

   • The document does not explicitly state a separate "training set" for the current device. The performance evaluation presented is for the validation/test set. It mentions that "The performance of Ketone reagent strips has been evaluated and present in 510k- K061559-ACON Urinalysis Reagent Strips," implying a prior validation for a professional version of the device, which would have had its own training/test data.

8. How the ground truth for the training set was established:

   • Since a training set for this specific submission is not specified, how its ground truth was established is not detailed in this document. For the predicate device (Bayer Ketostix) and the previously cleared professional device (K061559), the ground truth would have likely been established through reference laboratory methods (e.g., spectrophotometry, enzymatic assays) for quantitative ketone levels, which are then correlated with the semi-quantitative color scale.

Ask a specific question about this device

The Mission® U500 Urine Analyzer is intended for use in conjunction with the Mission® Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Billirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection Nitrite. The instrument is intended for prescription, for in vitro diagnostic use only. Mission Urinalysis Reagent Strips are available in different test configurations and the measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract.

The Mission® U500 Urine Analyzer is a semi-automated reflectance photometer in conjunction with Mission Urinalysis Reagent Strips (originally cleared under K061559) that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip. The analyzer throughput is 500 tests per hour and the measuring cycle is 7 seconds per test. The analyzer stores up to 2,000 patient records and prints the results in Conventional, SI, or Arbitrary units using an integrated internal or external printer.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Mission® U500 Urine Analyzer:

Acceptance Criteria and Device Performance for Mission® U500 Urine Analyzer

The provided document describes the Mission® U500 Urine Analyzer and its substantial equivalence to a predicate device (ACON U120 Urine Analyzer). While explicit "acceptance criteria" are not presented as a standalone table with numerical targets, the document implicitly defines acceptance based on demonstrating substantial equivalence to the predicate device through analytical and clinical performance.

The "reported device performance" is primarily articulated through the comparison to the predicate device and the conclusion that the new device is "substantially equivalent."

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided text. The document mentions "Clinical study data are presented for the percent positive agreement, percent negative agreement, and percent agreement on and between color blocks," which implies a set of clinical samples were used.
• Data Provenance: The studies were conducted "in-house and in a clinical setting." The document does not specify the country of origin for the clinical data. It also doesn't explicitly state whether the data was retrospective or prospective, though "clinical performance testing" typically implies prospective collection for such comparison studies.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • For this type of device (urine chemistry analyzer reading reagent strips), the "ground truth" would typically refer to a consensus reading by trained, certified clinical laboratory personnel or medical professionals, or possibly reference methods of laboratory analysis, rather than "experts" in the sense of radiologists.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the context of human readers improving with or without AI assistance. This device is an automated analyzer, not an AI-assisted diagnostic tool for human readers. The clinical study compares the device's performance to a predicate device's performance.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance: Yes, the entire study effectively serves as a standalone performance evaluation of the "algorithm" (the automated reflectance photometer) as it compares the new device's readings to those of a predicate automated device. The device itself is the algorithm, interpreting the color changes on reagent strips. The "Analytical Performance Testing" and "Clinical Performance Testing" sections describe this.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical comparison was based on comparison to the predicate device (ACON U120 Urine Analyzer). The document states: "Clinical performance of the Mission® U500 Urine Analyzer was evaluated in a method comparison study between the Mission® U500 Urine Analyzer and ACON U120 Urine Analyzer predicate device." For the analytical performance, it would involve known concentrations/values of analytes in controlled samples.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable in the context of this device. This device is a reflectance photometer, which relies on a fixed optical and chemical-reaction principle, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its calibration is "Automatic," implying an internal, fixed calibration procedure rather than a learning algorithm.

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

• Ground Truth for Training Set: Not applicable for the reasons stated above (not an AI/ML algorithm requiring a training set). The calibration of such a device would be established using certified reference materials or standardized solutions with known analyte concentrations.

Ask a specific question about this device