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The CLINITEK Advantus™ Urinalysis analyzer is a semi-automated, benchtop analyzer. It is designed to read Bayer® Reagent Strips for Urinalysis, such as, MULTISTIX® 10 SG and MULTISTIX PRO® Reagent Strips.

This analyzer is intended for the measurement of the following: Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH. Protein, Protein-to-Creatinine Ratio, Specific Gravity, and Urobilinogen. These measurements are used to assist diagnosis in the following areas:

• Kidney Function .
• Urinary tract infections .
• Metabolic disorders (e.g. diabetes mellitus) .
• . Liver Function

Tests performed using the CLINITEK Advantus™ are intended for in vitro diagnostic use.

The CLINITEK Advantus™ Urinalysis analyzer is a semi-automated, bench top analyzer. It is designed to read Bayer® Reagent Strips for Urinalysis, such as, MULTISTIX® 10 SG and Bayer MULTISTIX PRO® Reagent Strips.

The analyzer is a reflectance spectrophotometer that analyzes the color and intensity of the light reflected from the reagent area and reports the results in clinically meaningful units. The analyzer can determine and report the color of the urine.

All testing takes place on the fixed platform. The fixed platform consists of 3 sections: the strip loading station, the incubation/read station, and the waste bin. Strips are placed on the strip loading station. The push bar moves the strips to the incubation/read station, where they are tested. When testing is complete, the strips drop into the waste bin. When testing is complete, an internal thermal printer prints the test results.

The provided text describes the CLINITEK Advantus™ Urinalysis analyzer and its performance assessment for 510(k) submission. However, it does not explicitly provide a table of acceptance criteria with reported device performance or detailed information about the studies. Here's what can be extracted and inferred:

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

The document states, "Studies were conducted as internal laboratory setting and in clinical settings to demonstrate the performance of the CLINITEK Advantus™ analyzer and assess its substantial equivalence against the predicate devices and where applicable the referenced laboratory methods." It also highlights the device's ability to "preserve reagent algorithms and performance parameters."

While specific numerical acceptance criteria (e.g., accuracy percentages, sensitivity/specificity thresholds) and a direct performance comparison table are not provided in this summary, the core acceptance criterion is substantial equivalence to the predicate devices (CLINITEK 500 and CLINITEK 200+).

Inferred Table of Acceptance Criteria & Reported Performance:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not specified.
• Data Provenance: The studies were conducted in "internal laboratory setting and in clinical settings." This implies both controlled lab environments and real-world clinical usage. The country of origin is not explicitly stated, but the manufacturer is Bayer HealthCare, LLC, located in Norwood, MA, USA, suggesting the studies likely occurred in the US. The studies appear to be prospective to demonstrate device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document mentions "referenced laboratory methods" for comparison, which would imply the use of validated, possibly expert-performed, gold standard methods.

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

• Adjudication Method: Not specified. The comparison is against predicate devices and "referenced laboratory methods," suggesting a direct comparison rather than a human adjudication process for image interpretation.

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:

• MRMC Study: Not applicable. This device is an automated urinalysis analyzer, not an AI-assisted diagnostic tool for human readers interpreting complex images. Its function is to read reagent strips, and the comparison is largely against other automated or reference methods, not human interpretation improvement.

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

• Standalone Performance: Yes, the device itself is a standalone automated system. The performance assessment would inherently be of the "algorithm only" (the reflectance spectrophotometer and its interpretation logic) without continuous human intervention during the reading process. Humans load the strips and review results, but the reading itself is automated.

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

• Type of Ground Truth: The ground truth would have been established by the performance of the predicate devices (CLINITEK 500 and CLINITEK 200+) and "referenced laboratory methods." For urinalysis, these reference methods typically include established manual chemical tests, microscopy, or other validated laboratory analyzers. It implies a comparison to established, accepted diagnostic methods for each analyte.

8. The sample size for the training set:

• Sample Size for Training Set: Not specified. The document states "reagent algorithms and performance parameters" are preserved, suggesting a legacy of development, but details on specific training sets for new algorithms in this device are not provided.

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

• Ground Truth for Training Set: Not specified. Given the nature of a spectrophotometric reader, the "training" (calibration, algorithm development) would typically involve known concentrations of analytes and corresponding reflectance values to build the correlation between color intensity and analyte concentration. This would be established using highly accurate laboratory standards and methods.

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