(137 days)
Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
The Wako L-Type UN test is an in vitro assay for the quantitative determination of urea nitrogen in serum and plasma. The Wako L-Type UN is a method based on enzymatic assay utilizing urease and glutamate dehydrogenase.
The Wako L-Type UN test is an in vitro assay designed for the quantitative determination of urea nitrogen in serum and plasma. The provided document is a 510(k) summary demonstrating its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance (Wako L-Type UN) |
|---|---|---|
| Accuracy / Correlation | Substantial equivalency to predicate device. Implied correlation coefficient and regression equation demonstrating strong agreement. | Correlation coefficient of [Value Missing]; Regression equation of y = x + [Values Missing] when compared against the predicate assay. |
| Precision / Reproducibility | Acceptable values on a day-to-day basis. | "Precision studies indicate acceptable values can be obtained on a day to day basis." (Specific quantitative values are not provided). |
| Analytical Sensitivity (Minimum Detectable Level) | A specified minimum detectable level. | 0.6 mg/dL |
Note: The exact numerical values for the correlation coefficient and the regression equation are missing from the provided text in the section: "In comparison studies against the predicate assay, a correlation coefficient of and a regression equation of y = x + was obtained."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "comparison studies" but does not provide the number of samples used in these studies.
- Data Provenance: Not explicitly stated. Given that Wako Diagnostics is located in Richmond, VA, U.S.A., and the FDA approval process, it is highly likely that the comparison studies, particularly for clinical samples, were conducted in the U.S. The studies are by nature retrospective as they compare results of the new device against an existing predicate device using collected samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is an in vitro diagnostic (IVD) assay for a quantitative biochemical marker (urea nitrogen). The "ground truth" for such assays is typically established by certified reference methods or established predicate devices, not by expert interpretation of images or clinical cases. The comparison is against another analytical method.
4. Adjudication Method for the Test Set
Not applicable. As described above, the comparison is between analytical methods, not subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an in vitro diagnostic device, not an imaging device or a diagnostic aid that involves human readers interpreting cases.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance
Yes, the study describes two types of standalone performance:
- Comparison Study: This study directly compares the Wako L-Type UN test (algorithm/method only) against a predicate assay (another algorithm/method only) to demonstrate substantial equivalence. This is a standalone comparison of device performance.
- Precision Study: This study assesses the consistency of the Wako L-Type UN test's results over time, which is also a standalone performance characteristic of the device itself.
- Minimum Detectable Level: This is an intrinsic standalone performance characteristic of the assay.
7. Type of Ground Truth Used
The "ground truth" for the test set was the results obtained from the legally marketed predicate device. The study aims to show substantial equivalence, meaning the new device provides results that are comparable and consistent with an already accepted method for measuring urea nitrogen.
8. Sample Size for the Training Set
Not applicable. This is an in vitro diagnostic assay and generally does not involve a "training set" in the same way machine learning algorithms do. The development of such assays involves method optimization and validation, but the concept of a distinct training set for an algorithm is not directly relevant here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention or implication of a distinct "training set" for an algorithm in this context. The development process would rely on established biochemical principles and analytical chemistry methodologies.
§ 862.1770 Urea nitrogen test system.
(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.