(321 days)
The URISCAN Optima urine chemistry test system consists of URiSCAN Optima Urine analyzer and URISCAN 2ACR Urine strips. The intended use of the URiSCAN Optima Urine analyzer is to read the color change on the test pads found on the URiSCAN 2ACR Urine strips and to display and print the results.
The intended use of the URiSCAN 2ACR Urine strips is for the in vitro semi quantitative measurement of the following parameters;
Albumin Creatinine ACR (Albumin Creatinine Ratio)
These measurements are useful in the evaluation of renal, urinary and metabolic disorders. URiSCAN Optima urine chemistry test system is intended for prescription use only, in clinical laboratory and in point-of-care setting.
URiSCAN Optima - the semi-quantitative urine analyzer is used with the aim of helping examine patients in a professional setting through early detection of disease before they get a thorough checkup, by using chemical components contained in urine; and it is a device to measure the amounts of components in urine, including albumin, creatinine and ACR (albumin creatinine ratio). The results appear on a liquid crystal display and can be printed on the analyzer's internal printer and transferred to a host computer, if desired.
Here's a breakdown of the acceptance criteria and study information for the URiSCAN Optima Urine analyzer and URiSCAN 2ACR Urine strips, extracted from the provided text:
Acceptance Criteria and Device Performance
| Parameter | Acceptance Criteria (Target/Threshold) | Reported Device Performance (Exact agreement with predicate device) |
|---|---|---|
| Microalbumin | Not explicitly stated as a single numeric threshold for exact agreement, but implied to be high agreement with predicate. | 95.7% (Overall) |
| 100.0% (Positive Agreement) | ||
| 100.0% (Negative Agreement) | ||
| Creatinine | Not explicitly stated as a single numeric threshold for exact agreement, but implied to be high agreement with predicate. | 96.6% (Overall) |
| ACR | Not explicitly stated as a single numeric threshold for exact agreement, but implied to be high agreement with predicate. | 98.0% (Overall) |
| 97.8% (Positive Agreement) | ||
| 98.3% (Negative Agreement) |
Note on "Acceptance Criteria": The document does not explicitly state pre-defined numeric acceptance criteria for the outcome percentages of the comparison studies (e.g., "must be >95% exact agreement"). Instead, the comparison study results are the performance claims being used to demonstrate substantial equivalence. However, for precision, there are implicit criteria for "Level 1 - Negative Control" and "Level 2 - Positive Control" for Microalbumin and Creatinine in the precision tests.
| Test Item | Level 1 - Negative Control | Level 2 - Positive Control |
|---|---|---|
| Microalbumin | ≤10mg/L | 80-≥150mg/L |
| Creatinine | 10-50mg/dL | 100 - ≥300mg/dL |
For precision, the reported performance was 100% for all sites (A, B, C) and both levels for both Microalbumin and Creatinine.
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size: 351 random urine specimens.
- Data Provenance: Fresh urine specimens collected in a clean, dry container at three different Point-of-Care (POC) sites (157 samples at the first, 99 at the second, and 95 at the third). This indicates prospective collection at multiple sites. The country of origin is not explicitly stated, but given the manufacturer is based in Korea and the submission is to the FDA, it could be either U.S. or international data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Does not apply. The ground truth in this comparison study was established by another device (predicate device: Clinitek Status with Clinitek Microalbumin 2 reagent strips), not human experts.
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Adjudication method for the test set:
- Does not apply. Ground truth was established by a predicate device, so no human adjudication was performed.
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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 was a method comparison study comparing the performance of two automated devices (URISCAN Optima vs. Clinitek Status) on urine chemistry analysis. It was not an MRMC study and did not involve human readers or AI assistance in that context.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes. The method comparison study directly evaluated the performance of the URiSCAN Optima Urine analyzer (an algorithm-driven device) against a predicate device. This is a standalone performance assessment of the device's ability to read and interpret the urine strips.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by comparison with a legally marketed predicate device: "Clinitek Status with Clinitek Microalbumin 2 reagent strips".
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The sample size for the training set:
- The document does not provide details on the sample size for a "training set." This type of device (a urine chemistry analyzer) typically operates based on calibrated spectrophotometric readings of test pads rather than machine learning algorithms trained on large datasets in the way an AI-driven imaging diagnostic device would. Calibration and control samples are used, but a "training set" in the context of deep learning is not applicable here.
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How the ground truth for the training set was established:
- Does not apply in the context of a machine learning training set. For calibration and control solutions, the "ground truth" (target values) were established through an internal procedure using commercially available stock of albumin and creatinine in buffered solutions, and re-checked using a commercial calibrator set.
§ 862.2900 Automated urinalysis system.
(a)
Identification. An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.