(27 days)
Intended for measure uric acid in serum, plasma and are used in the obtain and urine. Measurements and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
The Wako L-Type UA F Test is an in vivo assay for the quantitative determination of uric acid in serum and plasma. The Wako L-Type UA F is a method utilizing uricase, N-ethyl-N-(2-hydroxy-3sulfopropyl)-3,5-dimethoxy-4-fluoroaniline (F-DAOS) and 4-aminoantipyrine.
Here's a breakdown of the acceptance criteria and study information for the Wako L-Type UA F Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Method Comparison | Correlation Coefficient (vs. predicate) | High correlation (e.g., >0.9) | 0.970 |
| Regression Equation (vs. predicate) | Close to y = x | y = 1.028x - 0.34 | |
| Precision | Reproducibility/Consistency | Acceptable values | Acceptable values can be obtained on a day-to-day basis |
| Sensitivity | Minimum Detectable Level (LOD) | Undefined | 0.2 mg/dL |
Note: The document explicitly states "The safety and effectiveness of the Wako L-Type UA F Test is demonstrated by its substantial equivalency to the Wako UA 30R Uric Acid product." Therefore, the predicate device's performance serves as the de facto acceptance criteria for comparing method performance. The acceptance criteria for precision and minimum detectable level are not explicitly stated as numerical targets in this summary, but rather implied by the statement of "acceptable values" and the reporting of the LOD.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for the method comparison study. The document only mentions "In comparison studies against the predicate assay."
- Data Provenance: Not specified. It does not mention the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. This device is an in vitro diagnostic (IVD) assay for quantitative measurement of a biomarker. The ground truth would typically be established by the reference method (the predicate device in this case), not by expert human graders.
4. Adjudication Method for the Test Set:
- Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is an IVD device measuring a biochemical parameter, not an imaging or diagnostic device that involves human reader interpretation. Therefore, an MRMC study is not relevant to this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The "comparison studies against the predicate assay" represent a standalone performance evaluation of the Wako L-Type UA F Test. It measures the device's output (uric acid concentration) and compares it directly to the output of the predicate device.
7. The Type of Ground Truth Used:
- Predicate device's measurements. The ground truth for evaluating the Wako L-Type UA F Test's performance in the comparison study was the results obtained from the "Wako UA 30R Uric Acid product." This is a common approach for establishing substantial equivalence for new IVD assays.
8. The Sample Size for the Training Set:
- Not applicable / Not stated. For an in vitro diagnostic assay like this, there isn't typically a "training set" in the sense of machine learning. The development of the assay's reagents and methodology would involve internal R&D, but the document does not describe a separate "training set" with associated ground truth as one would for an AI/ML diagnostic.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As noted above, the concept of a training set for an AI/ML algorithm doesn't directly apply here. The fundamental principles of the assay rely on established biochemical reactions (enzymatic oxidation, colorimetric measurement) rather than a trained algorithm. The "ground truth" for developing such a test is the accurate biochemical quantification of uric acid.
§ 862.1775 Uric acid test system.
(a)
Identification. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.(b)
Classification. Class I (general controls). The device, when it is solely intended for use as an acid reduction of ferric ion test, a phosphotungstate reduction test, a gasometric uricase test, an ultraviolet uricase test, or an oxygen rate uricase test, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.