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URITEST 10 Urinalysis Reagent Strips provide qualitative and sem-quantitative tests for glucose, bilirubin, ketones (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrites, and leukocytes in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and bacteriuria.

ARJ Medical URITEST 10 Urinalysis Reagent Strips are for single use in professional near patient (point-of-care) facilities and centralized laboratory locations by medical technologists both read visually and on the Bayer Family of Clinitek Analyzers. The strips are intended of use in screening at-risk patients to assist diagnosis in the following areas:

Kidney Function Urinary Tract infections Carbohydrate metabolism 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.

URITEST 10 Urinalysis Reagent Strips provide qualitative and semi-quantitative for pH, specific gravity, ketones. blood, protein, nitrite, leukocytes, glucose, bilirubin, and urobilinogen in urine. URITEST 10 Urinalysis Reagent Strips 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 Bayer® Family of Clinitek Urine Analyzers. The results are available within 120 seconds. To obtain optimal results, it is necessary to use fresh, well-mixed and uncentrifuged urine.

The provided text describes the URITEST 10 Urinalysis Reagent Strips but lacks specific details regarding acceptance criteria and the comprehensive study methodologies typically found in a full submission. However, based on the available information, I can construct a response.

Acceptance Criteria and Device Performance Study

The document states that the performance of URITEST 10 Urinalysis Reagent Strips was compared to the legally marketed predicate device, Bayer MULTISTIX 10 SG Reagent Strips. The overarching acceptance criterion appears to be "performance comparable to that of Bayer MULTISTIX 10 SG Reagent Strips."

Since specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are not provided, I will infer that the reported performance implies a demonstration of equivalence or non-inferiority to the predicate device in terms of qualitative and semi-quantitative results for all ten analytes.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample size for the test set used in the clinical performance study. It only mentions "a clinical laboratory setting" for the study.
• Data Provenance: The data provenance is not explicitly stated in terms of country of origin. The study was conducted in a "clinical laboratory setting" and involved professional users in "centralized and point-of-care (POC) hospital clinical and doctor's office setting." It's reasonable to infer these settings are within the United States, given the FDA 510(k) submission. The study was prospective in nature as it involved collecting and testing urine samples using the URITEST 10 strips and comparing them to results from the predicate device.

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

• The document does not state the number of experts or their specific qualifications for establishing ground truth for the test set. Instead, the "ground truth" for comparison was established by the results obtained from the Bayer MULTISTIX 10 SG reagent strips, which served as the reference standard in this equivalence study. The tests were read both visually and instrumentally by "professional users" (medical technologists).

4. Adjudication Method for the Test Set

• The document does not mention any specific adjudication method (e.g., 2+1, 3+1). The "ground truth" was derived from the predicate device's results, with the URITEST 10 results being compared to them.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not conducted. This device is a traditional urinalysis reagent strip, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation in that context. The study did involve both visual and instrumental readings by professional users, but this is a standard practice for this type of device, not an AI assistance evaluation.

6. Standalone Performance Study (Algorithm Only)

• The concept of a "standalone (i.e., algorithm only without human-in-the-loop performance)" study is not applicable here. The device is a physical reagent strip that requires either visual interpretation by a human or instrumental reading (on Bayer Clinitek Urine Analyzers). It is not an algorithm that operates independently.

7. Type of Ground Truth Used

• The type of ground truth used was comparative performance against a legally marketed predicate device (Bayer MULTISTIX 10 SG Reagent Strips). This is a common approach for 510(k) submissions demonstrating substantial equivalence. The predicate device's results, obtained through standard laboratory methods and visual/instrumental readings by professionals, served as the reference.

8. Sample Size for the Training Set

• The document does not mention a "training set" in the context of device development. This terminology is typically associated with machine learning or AI algorithms, which are not described as part of this device's development or operation. The URITEST 10 is a chemical reagent-based test strip.

9. How Ground Truth for the Training Set Was Established

• As there is no mention of a "training set" for an algorithm, the question of how its ground truth was established is not applicable to this 510(k) summary.

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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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