Search Results

The Healgen URS Test Strips are for the qualitative detection of Leukocytes (white blood cells) and nitrite in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use only.

Healgen URS Test Strips are in vitro diagnostic test devices for qualitative detection of leukocyte and nitrite in urine. The device is composed of two color pads aligned on a strip. One pad is employed for testing leukocyte and the other for nitrite by visually reading the color change of the pad and comparing with the corresponding blocks on a color chart.

The document describes the performance of the Healgen URS Test Strips for the qualitative detection of Leukocytes and Nitrite in urine to aid in UTI screening for over-the-counter home use.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for each performance characteristic in a formal table. However, it presents various study results that implicitly serve as an indication of meeting performance expectations for a Class I device intended for OTC use. The implied acceptance is based on the presented results demonstrating sufficient sensitivity, precision, and user-friendability.

Here's a table summarizing the reported device performance for key characteristics:

2. Sample size used for the test set and the data provenance

• Test Set Sample Sizes:
  • Sensitivity Study (LOD): 30 samples/tests per concentration for each analyte (Leukocyte and Nitrite). Each sample was tested in duplicates.
  • Precision/Reproducibility Study: 45 assays results for each of eight levels of control (total 3 lots x 3 sites x 2 operators x 5 days x 1 rep/day = 90 tests per control, though results are reported as N=45 for each control).
  • Analytical Specificity: Not explicitly stated as a single test set size, but multiple urine samples (negative urine spiked with interfering substances) were tested with three device lots by three different operators for each substance.
  • Lay-user Studies: 150 lay users with UTI symptoms.
• Data Provenance: The document does not explicitly state the country of origin for the data. However, for the precision study, it mentions "three clinical sites," implying clinical data from a real-world setting. The lay-user study involved recruitment of "150 lay users with UTI symptoms," suggesting prospective collection of real-world user data. The sensitivity and analytical specificity studies appear to be laboratory-based. It is not specified if any data was retrospective.

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

• LOD and Precision Studies: "Known concentrations" for spiked samples and "expected ranges/values" for controls are used as ground truth. The expertise involved in preparing these precisely calibrated samples and controls is implied but not explicitly detailed (e.g., analytical chemists, laboratory technicians). Operators are mentioned (5 for LOD, 2 at each of 3 sites for precision), but their role is to perform the tests, not establish ground truth.
• Analytical Specificity: Ground truth is established by "negative urine with different leukocyte and nitrite concentrations" which were likely precisely prepared laboratory samples.
• Lay-user Studies: The "comparison testing by healthcare professionals" served as the ground truth. The number and qualifications of these healthcare professionals are not specified beyond the general term "healthcare professionals."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• The document does not describe a formal adjudication method (like 2+1 or 3+1) for resolving discrepancies in the test results.
• For the lay-user study, the comparison is made between the layperson's results and the results obtained by healthcare professionals, implying the healthcare professional's result is the definitive ground truth for comparison.

5. 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

• No, an MRMC comparative effectiveness study was not done. This device is a test strip for visual interpretation by lay-users, not an AI-assisted diagnostic device evaluated by professional readers. The study focuses on direct comparison of lay-user performance to healthcare professional results for the test strip itself, not on the impact of AI assistance on human readers.

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

• No, this device is not an algorithm. It is a visual assay (colorimetric test strip) that requires human interpretation. Therefore, a standalone algorithm-only performance study is not applicable. The "standalone" performance here refers to the device's inherent chemical reaction and color development, which is then interpreted by a human.

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

• LOD, Precision, Analytical Specificity: Ground truth was established using known concentrations of spiked analytes in urine samples and control materials, presumably confirmed by established laboratory methods and validated reagents.
• Lay-user Study: Ground truth was established by results obtained by healthcare professionals using the same test strips. This implies the healthcare professionals' interpretation served as the 'expert' reference. It's not explicitly stated whether these healthcare professionals confirmed results with a gold standard like culture or microscopic analysis, or if their reading of the strip was considered the definitive truth for the purpose of the study.

8. The sample size for the training set

• The document describes performance studies for the Healgen URS Test Strips, which are a chemical assay (test strips) with visual interpretation. This is not a machine learning or AI-based device that typically requires a "training set." Therefore, the concept of a training set size is not applicable here.

9. How the ground truth for the training set was established

• As stated above, this is not an AI/ML device, so there is no training set or ground truth establishment for a training set in the context of machine learning. The studies described are for analytical and lay-user performance of a diagnostic test strip.

Ask a specific question about this device

The ACON UTI Urinary Tract Infection Test Strips is for the qualitative detection of Leukocyte and Nitrite in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.

The ACON UTI Urinary Tract Infection Test Strips for Leukocytes and Nitrite are urine test strips of which Nitrite and Leukocyte reagent pads are affixed onto the plastic strips. The reagent pads react with the urine and provide a visible color reaction. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. The product is packaged with a drying agent in a plastic bottle. The entire reagent strip is disposable when the disposal directions are followed exactly. Laboratory instrumentation is not required. These tests are intended for over-the-counter home use with human urine.

Here's an analysis of the acceptance criteria and study information based on the provided text for the ACON UTI Urinary Tract Infection Test Strips:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or detailed reported device performance metrics (e.g., sensitivity, specificity, accuracy percentages) for the ACON UTI Urinary Tract Infection Test Strips. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device.

The "reported device performance" is broadly stated as:

• "The performance characteristics of the ACON UTI Urinary Tract Infection Test Strips were verified by sensitivity study, reproducibility study, interference studies, temperature flex study, read time flex study, and stability studies."
• "Testing results indicate that the ACON UTI Urinary Tract Infection Test Strips are robust and can perform satisfactorily when used according to the 'Directions for Use' statement specified in the package insert."
• "The laboratory testing results and clinical studies demonstrated a substantial equivalency on performance between the ACON UTI Urinary Tract Infection Test Strips and a legally marketed product, Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396), with similar product features and intended use."

Since specific numerical acceptance criteria are not provided, a table with quantitative metrics cannot be fully constructed. The primary "acceptance" was demonstrating substantial equivalence to the predicate device.

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

• Sample Size: The document does not specify the exact sample size (number of patients or urine samples) used for the clinical tests. It only states "clinical studies were conducted at Beta sites."
• Data Provenance: The data was collected from "Beta sites," indicating real-world clinical settings. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, and the submitter is based in San Diego, California, suggesting the studies were likely conducted in the USA (or at least within a regulatory framework acceptable to the FDA for a US market device). The studies were retrospective or prospective is not specified and cannot be determined from the provided text.

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

• The document states that "inexperienced lay users were able to obtain comparable testing data compared to those obtained by the professionals." This implies that "professionals" were involved in establishing a comparative benchmark.
• Number of Experts: Not specified.
• Qualifications of Experts: The experts are referred to as "professionals," but their specific qualifications (e.g., "radiologist with 10 years of experience" or medical technologists, lab technicians) are not detailed.

4. Adjudication Method for the Test Set

• The adjudication method is not explicitly described. The comparison involved "inexperienced lay users" versus "professionals" (presumably interpreting the test strips as well), but the process for resolving disagreements or establishing a definitive ground truth from these interpretations is not detailed.

5. 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

• No. This device is a manual urine test strip for home use, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and was not performed.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

• No. This device is a test strip that requires human visual interpretation. It is not an algorithm, and it does not operate in a standalone-algorithm-only manner.

7. The Type of Ground Truth Used

• The ground truth for the comparison was established by "professionals" using the "legally marketed Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396)." This implies a comparative ground truth against an established, legally marketed predicate device, rather than an independent gold standard like pathology or advanced imaging, given the nature of the test. For a UTI test strip, the "professional" interpretation of the predicate device's results would serve as the reference.

8. The Sample Size for the Training Set

• This information is not provided. The document discusses "clinical studies" and "laboratory testing results" but does not differentiate between "training" and "test" sets in the context of machine learning. As this is not an AI/ML device, a traditional "training set" as understood in that domain is likely not applicable. The "sensitivity study, reproducibility study, interference studies, temperature flex study, read time flex study, and stability studies" would involve various samples used for product development and validation, but these are not explicitly termed "training set."

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

• As a traditional diagnostic device (not AI/ML), the concept of a "training set" with ground truth in the AI sense is not directly applicable. If one considers the development and validation efforts as "training," then the establishment of ground truth for these internal studies would involve standard laboratory methods, reference materials, and controlled experimental conditions to determine the expected reactions and establish performance characteristics. However, these specific methods are not detailed in the provided summary.

Ask a specific question about this device

Ask a specific question about this device

The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semi-quantitative urinalysis. DIASCREEN® Reagent Strips have been developed to allow health care professionals to test semi-quantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart.

DIASCREEN® Reagent Strips are plastic strips to which are affixed reagent test areas. Several product configurations are included with this submission, but all configurations are limited to one, some or all of the following tests: specific gravity, ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen.

The reagent test areas on the DIASCREEN® Reagent Strips are ready to use upon removal from the bottle and the entire reagent strip is disposable after use. The strips are to be read visually, requiring no additional laboratory equipment for testing.

The provided document describes the DIASCREEN® Reagent Strip System, focusing on the new leukocyte reagent area. The study aims to demonstrate substantial equivalence to previously approved devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are based on a clinical correlation study comparing the DIASCREEN® Leukocyte Reagent Strips to the Bayer Multistix 10 SG. The performance is reported as the percentage of responses falling within the same color block and within plus or minus one color block compared to the predicate device.

Note: The document implies "substantial equivalence" as the primary acceptance criterion, rather than specific numerical cutoffs. The reported performance demonstrates a strong agreement with the predicate device.

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

• Sample Size for Leucocyte Test (Comparison to Bayer Multistix):
  • Evaluation One: 39 fresh urine samples (for each of the two DIASCREEN® lots tested).
  • Evaluation Two: 279 fresh urine samples.
• Data Provenance: Prospective. Fresh urine samples were obtained at a medical facility for Evaluation One and at two clinical sites for Evaluation Two. The origin country is not explicitly stated, but the contact person and institutions (Wichita State University, Technovations Inc.) suggest the United States.

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

The ground truth for the test set was established by the results obtained from the "510(k) approved" marketed urinalysis strip system, specifically the Bayer Multistix 10 SG Reagent Strips. The readings of the DIASCREEN® strips were then visually compared to the DIASCREEN® color chart, which would presumably be interpreted by trained laboratory personnel.

• No specific "experts" were used to establish a separate ground truth. Instead, the predicate device (Bayer Multistix 10 SG) acted as the reference standard.
• For Evaluation One, the study was under the direction of James Jackson, MT(ASCP) CLS, Ph.D. at Wichita State University Department of Medical Technology. This individual possesses medical technology qualifications.
• For Evaluation Two, the study was conducted under the direction of Myron Rapkin, Technovations Inc. No specific qualifications are listed for this individual in the provided text.

4. Adjudication Method for the Test Set

The adjudication method was a direct comparison between the visual readings of the DIASCREEN® Reagent Strips using their own color chart and the results from the Bayer Multistix 10 SG Reagent Strips. There is no mention of an independent adjudication panel or consensus process.

5. 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a manual, visual dip-and-read test strip, not an AI-assisted system.

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

No, a standalone algorithm-only performance study was not done. The device is a visual dip-and-read test strip that requires human interpretation of color changes against a color chart.

7. The Type of Ground Truth Used

The ground truth used was the performance of a legally marketed and "510(k) approved" predicate device: the Bayer Multistix 10 SG Reagent Strips. This is a form of comparative ground truth against another validated diagnostic method rather than an absolute "expert consensus," "pathology," or "outcomes data" ground truth for the condition itself.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or "validation set" in the context of the clinical evaluation. The reported evaluations appear to be performance studies for verification rather than training a machine learning model. The strips were developed using established chemical reagents and principles.

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

Not applicable, as a discrete training set with explicitly established ground truth (in the AI context) is not described for this type of medical device submission. The device design and reagent compositions were likely developed based on known chemical reactions and prior experience with similar urinalysis strips.

Ask a specific question about this device

The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semi-quantitative urinalysis. DIASCREEN® Reagent Strips have been developed to allow health care professionals to test semi-quantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart.

The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip and is intended for use as an in vitro diagnostic aid using urine specimens. The strip contains solid phase reagent areas affixed to a plastic strip and is provided in a dry reagent format.

The strip provides qualitative and semi-quantitative tests for specific gravity, ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart for each concentration range. No additional reagents and laboratory equipment are required. The reagent strips are packaged in a plastic vial containing a desiccant. The test strips must be kept tightly capped in the vial to assure reagent reactivity. The directions must be followed exactly and it is necessary to use fresh, well-mixed, uncentrifuged urine for optimal results.

DIASCREEN® Reagent Strips are plastic strips to which are affixed reagent test areas. Several product configurations are included with this submission, but all configurations are limited to one, some or all of the following tests: specific gravity, ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen.

The reagent test areas on the DIASCREEN® Reagent Strips are ready to use upon removal from the bottle and the entire reagent strip is disposable after use. The strips are to be read visually, requiring no additional laboratory equipment for testing.

This document describes the DIASCREEN® Reagent Strip System for urinalysis, a dip-and-read test strip for semi-quantitative urinalysis.

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are not explicitly stated as numerical targets the device must meet in the provided text. Instead, the study aims to demonstrate substantial equivalence by showing high agreement (within the same color block or within one color block) between the DIASCREEN® Reagent Strips and a legally marketed predicate device (Bayer Multistix 10 SG). The reported device performance is presented as the percentage of agreement.

Here's a table summarizing the performance data, with the understanding that the "acceptance criteria" are implied by the observed high percentages of agreement with the predicate device.

Note: The document also reports cross-lot consistency for DIASCREEN® (Lot 1 vs. Lot 2), showing high agreement (91-100% within the same color block and 100% within 1 color block).

2. Sample Size and Data Provenance:

• Test Set Sample Size: 53 fresh urine samples.
• Data Provenance: The urine samples were obtained from a "mixed patient population" at a "medical facility." The study was conducted in the US at Wichita State University (Kansas), though the manufacturer is based in Korea. The study appears to be prospective, as fresh urine samples were obtained and tested for the evaluation.

3. Number of Experts and Qualifications for Ground Truth:

The document does not explicitly state the number of experts used for establishing ground truth, nor their specific qualifications beyond the study director, James Jackson MT(ASCP) CLS, Ph.D. While the study director is qualified, it's not indicated if he acted as the sole expert for all ground truth determinations or if additional, similarly qualified personnel were involved in reading the strips and/or performing confirmation tests.

4. Adjudication Method for the Test Set:

The study involved a comparison between the DIASCREEN® Reagent Strips and the Bayer Multistix 10 SG. When data between the two products did not agree within one color block, an "alternate procedure" (confirmation test) was used. This implies an adjudication process where a third, more definitive method resolved discrepancies between the initial two readings.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the performance of the DIASCREEN® strips to a predicate device and to confirmative tests, not the improvement of human readers with vs. without AI assistance. The device is a visual dip-and-read strip, not an AI-assisted diagnostic tool in the sense of image analysis software.

6. Standalone Performance Study:

Yes, a standalone performance study was done in the sense that the performance of the DIASCREEN® Reagent Strips themselves was evaluated independently against comparator methods and against a predicate device. The results are based on visual comparison with a color chart, which is the intended standalone use of the device. The study evaluates the algorithm of the test strip (i.e., its chemical reactions and color development) and the visual interpretation of results.

7. Type of Ground Truth Used:

The ground truth for the test set was established using a combination of:

• Predicate Device Comparison: Bayer Multistix 10 SG was used as a primary comparator.
• Confirmatory (Reference) Tests: For discrepancies (data not agreeing within one color block between DIASCREEN® and Bayer), specific confirmation tests were employed for each analyte:
  • Specific Gravity: Refractometer
  • Leukocyte: Microscopic Evaluation, CHEMSTRIP (Boehringer Mannheim)
  • pH: pH Meter
  • Blood: Microscopic Evaluation, CHEMSTRIP (Boehringer Mannheim), Ascorbic Acid Test/Urispec (Henry Schein)
  • Nitrite: Microscopic Evaluation, CHEMSTRIP (Boehringer Mannheim)

8. Sample Size for the Training Set:

The document does not provide information about a "training set" or its sample size. This type of device (visual reagent strip) does not typically involve machine learning or AI models that require specific training sets in the computational sense. The "development" of the strips would involve chemical formulation and calibration, rather than algorithmic training on a dataset.

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

As no "training set" in the context of AI/machine learning is described, there is no information on how its ground truth was established. The "ground truth" for the performance evaluation in this document refers to the established values obtained from the predicate device and the confirmatory reference methods on the test set of urine samples.

Ask a specific question about this device