(31 days)
The Uric Acid assay is used for the quantitation of uric acid in serum, plasma, or urine. Measurements of uric acid 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.
Uric Acid is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma, or urine. The Uric Acid assay is a clinical chemistry assay in which uric acid is oxidized to allantoin by uricase with the production of hydrogen peroxide. The peroxide reacts with 4-aminoantipyrine and TBHB in the presence of peroxidase to vield a quinoneimine dye. The resulting change in absorbance at 548 nm is proportional to the uric acid concentration in the sample.
The provided text describes a 510(k) submission for the Abbott Laboratories Uric Acid assay. This submission focuses on establishing substantial equivalence to a predicate device rather than a new technology proving clinical effectiveness. Therefore, the information typically requested for AI/ML devices regarding acceptance criteria, study design, and ground truth for clinical performance is not directly applicable or available in this document.
However, I can extract information related to the performance characteristics that were used to demonstrate substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate table, but it describes the performance characteristics that indicate substantial equivalence. The comparative performance is assessed against the Boehringer Mannheim® Uric Acid assay (K873363) on the Hitachi® 717 Analyzer.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Abbott Uric Acid assay) |
|---|---|---|
| Serum Application | ||
| Correlation Coefficient (vs. predicate) | High correlation (e.g., >0.99) | 0.9990 |
| Slope (vs. predicate) | Close to 1.0 (e.g., 0.95 - 1.05) | 1.074 |
| Y-intercept (mg/dL) (vs. predicate) | Close to 0.0 | 0.134 mg/dL |
| Precision (Total %CV Level 1/Panel 101) | Low %CV | 2.3% |
| Precision (Total %CV Level 2/Panel 102) | Low %CV | 1.3% |
| Linearity (up to) | Suitable for clinical range | 33.1 mg/dL |
| Limit of Quantitation (Sensitivity) | Clinically relevant | 0.2 mg/dL |
| Urine Application | ||
| Correlation Coefficient (vs. predicate) | High correlation (e.g., >0.99) | 0.9973 |
| Slope (vs. predicate) | Close to 1.0 (e.g., 0.95 - 1.05) | 0.999 |
| Y-intercept (mg/dL) (vs. predicate) | Close to 0.0 | 0.184 mg/dL |
| Precision (Total %CV Level 1/Panel 201) | Low %CV | 3.1% |
| Precision (Total %CV Level 2/Panel 202) | Low %CV | 1.8% |
| Linearity (up to) | Suitable for clinical range | 433.8 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size (number of patients or samples) used for the comparative performance studies. It states "Comparative performance studies were conducted" and "Precision studies were conducted using the Uric Acid assay" with "two levels of control material."
- Sample Size: Not specified.
- Data Provenance: Not specified. Based on the context of an in-vitro diagnostic device submission, the data would typically be from laboratory testing using human serum, plasma, or urine samples, likely collected retrospectively or prospectively for method validation purposes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable to this type of device and submission. The "ground truth" for a Uric Acid assay is the actual concentration of uric acid in a sample, typically determined by a reference method or the predicate device itself. Expert consensus is not a method for establishing the concentration of a chemical analyte.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation (e.g., imaging devices) where multiple human readers assess a case and discrepancies need resolution. For a quantitative chemical assay, the comparison is directly between numerical results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers perform with and without AI assistance, which is irrelevant for a simple quantitative chemical assay.
6. Standalone (Algorithm Only) Performance:
Yes, the studies described are essentially a standalone performance assessment of the Abbott Uric Acid assay (the "algorithm" or measurement method in this context) compared to a predicate device. The performance characteristics reported (correlation, slope, intercept, precision, linearity, sensitivity) are all measures of the device's inherent analytical performance. There is no "human-in-the-loop" aspect to these measurements.
7. Type of Ground Truth Used:
The ground truth used for the comparative studies was the results obtained from the predicate device, the Boehringer Mannheim Uric Acid assay on the Hitachi 717 Analyzer. For precision studies, the ground truth would be considered the true concentration of uric acid in the control materials.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a "training set" in the conventional sense. The device is a chemical assay, and its performance is based on the chemical reactions and optical measurement principles, not on a trained algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this type of device.
§ 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.