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The ACON Urinalysis Reagent Strips (Urine) are for qualitative and semi-quantitative detection of one or more of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes and Ascorbic Acid.

The ACON Urinalysis Reagent Strips (Urine) are for single use in professional nearpatient (point-of-care) and centralized laboratory locations. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas:

• Kidney function .
• Urinary track infections .
• Carbohydrate metabolism (e.g. diabetes mellitus) .
• Liver function .
• Acid-base balance .
• Urine concentration ●

The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The test is to be read visually. It is intended for professional use only.

The ACON Urinalysis Reagent Strips are urine test strips of which Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, 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 professional use with human urine.

The provided text describes the ACON Urinalysis Reagent Strips, their intended use, and a comparison to predicate devices, but it does not contain specific acceptance criteria, detailed study results, or information about sample sizes for training/test sets, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, for aspects related to specific numerical acceptance criteria, detailed performance data, sample sizes, expert involvement, and comparative effectiveness studies, the information is not available in the provided document.

Here's an analysis of what information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document states that "performance characteristics... were verified by sensitivity study, reproducibility study, interference studies, temperature flex study, and stability studies," but it does not specify the quantitative acceptance criteria for these studies or present the detailed reported performance values against such criteria.

The submission focuses on establishing substantial equivalence based on intended use, target population, specimen type, materials, storage, test time, and methodologies used, which are listed as "Same" as the predicate devices.

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

Not available in the provided document. The document mentions "clinical studies were conducted at Beta sites" but does not specify the sample size for these studies or the country of origin. It also does not explicitly state whether the data was retrospective or prospective.

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

Not available in the provided document. The document states the "test is to be read visually" and "intended for professional use only," implying human interpretation. However, it does not detail how ground truth was established for the clinical studies, nor if experts were involved, their number, or their qualifications.

4. Adjudication Method for the Test Set

Not available in the provided document. There is no mention of any adjudication method (e.g., 2+1, 3+1) used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. The document discusses "clinical accuracy of results" and "comparable testing data" between the ACON strips and predicate devices, which suggests an equivalence study rather than a comparative effectiveness study involving human readers with and without AI assistance (which is not relevant for this type of manual test).

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

Partially applicable, but not in the context of an algorithm. The device is a manual urinalysis reagent strip intended for visual reading by a professional. Therefore, the concept of an "algorithm only" or "standalone" performance study in the context of AI is not applicable. The device is the standalone test, and its performance is inherently tied to human interpretation of the visual reaction. The document does state that the test is "to be read visually" and "intended for professional use only."

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not explicitly stated for clinical studies. While the document describes the chemical reactions for each analyte (e.g., glucose, bilirubin, ketone, etc.), forming the basis of the test, it does not specify how the "ground truth" was established for the clinical studies used to compare the ACON strips to the predicate devices. For urinalysis, ground truth often involves laboratory reference methods, but this is not detailed here.

8. The Sample Size for the Training Set

Not applicable. The ACON Urinalysis Reagent Strips are a chemical test, not an AI/machine learning algorithm. Therefore, there is no "training set" in the computational sense. The product development would involve chemical optimization and validation, not model training.

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

Not applicable. As stated above, this is not an AI/machine learning device, so the concept of a training set and its ground truth establishment is not relevant.

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URISTIK H Series Reagent Strips provide qualitative and semi-quantitative tests for ascorbic acid, pH, specific gravity, ketones (acetoacetic acid), blood, protein, nitrite, leukocytes, glucose, bilirubin, and urobilinogen in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

Dirui H Series Reagent Strips are for single use in professional near-patient (point-of-care) and centralized laboratory locations. The strips are intended for use in screening in the following areas:

• Kidney function
• Urinary tract infections
• Carbohydrate metabolism (e.g. diabetes mellitus)
• Liver function
• Acid-base balance
• Urine concentration

Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.

URISTIK H Series Reagent Strips For Urinalysis provide qualitative and semiquantitative tests for ascorbic acid, pH, specific gravity, ketones, blood, protein, nitrite, leukocytes, glucose, bilirubin and urobilinogen in urine. URISTIK H Series Reagent Strips For Urinalysis are firm plastic, dry reagent strips. The reagent areas are dipped into the urine sample and read visually according to a color chart or are read instrumentally with a Dirui H-50, H-100, or H-500 Urine Analyzer. The results are available within one minute. To obtain optimal results, it is necessary to use fresh, well-mixed and uncentrifuged urine.

The provided text describes the regulatory filing for the URISTIK H Series Reagent Strips but lacks specific quantitative acceptance criteria or detailed study results with exact performance metrics. However, it does provide a summary of the studies conducted and the conclusions reached regarding performance.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Specific quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or agreement percentages) are not explicitly stated in the provided document. Similarly, detailed quantitative performance data (like exact percentages of agreement or accuracy values) are not reported.

The document broadly states:

• "The studies demonstrated that professional users in centralized and point-of-care (POC) hospital, clinic, and doctor's office settings can obtain valid urinalysis test results."
• "Dirui studies showed that the URISTIK H Series Reagent Strips For Urinalysis provide test results consistent with laboratory methods and performance comparable to that of Bayer MULTISTIX 10 SG Reagent Strips in POC settings."

Therefore, a table with specific acceptance criteria and reported performance cannot be fully constructed from the given text.

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

• Sample Size: Not specified. The document only mentions "clinical laboratory settings."
• Data Provenance: The studies were conducted in "clinical laboratory settings by professional users." The product's manufacturer is Changchun Dirui Industrial Co., Ltd. (China), but the specific locations (e.g., countries) where these clinical studies were performed are not detailed. It is not explicitly stated whether the data was retrospective or prospective, but clinical laboratory studies often imply prospective collection.

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

• Number of Experts: Not specified.
• Qualifications: "Professional users" performed the tests and comparisons. Implicitly, these would be laboratory professionals or clinicians, but specific qualifications (e.g., "clinical pathologist with 5 years of experience") are not provided.

4. Adjudication Method for the Test Set

• The document states that "The results were compared to results obtained from Bayer MULTISTIX 10 SG Reagent Strips and from laboratory test methods." This implies a comparison against established methods. However, the specific adjudication method (e.g., whether multiple experts reviewed discrepant results, or if there was a predefined algorithm for determining a 'true' result) is not described.

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

• It is not explicitly stated that an MRMC comparative effectiveness study was done regarding human readers improving with or without AI assistance. The device is a reagent strip for urinalysis, which is typically read visually or by a dedicated analyzer; it's not an AI-assisted diagnostic imaging device for human interpretation. The study focused on the performance of the strips when read visually by professional users versus instrumentally, and in comparison to predicate devices and laboratory methods.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, performance was assessed both visually (implying human-in-the-loop) and "instrumentally using Dirui H Series Urine Analyzers." The instrumental reading can be considered a form of standalone performance for the combined strip-analyzer system, independent of visual human interpretation. However, the exact performance metrics for the instrumental reading versus visual reading are not provided.

7. Type of Ground Truth Used

• The ground truth was established by "laboratory test methods." These "laboratory test methods" are implied to be established, more definitive reference methods for the urinalysis parameters being assessed (e.g., chemical assays for glucose, microscopic examination for blood cells).

8. Sample Size for the Training Set

• The document does not mention a training set or its sample size. This is typical for reagent strip validation, which often focuses on clinical performance rather than machine-learning model training.

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

• As no training set is mentioned, the method for establishing its ground truth is also not described.

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