(35 days)
The Uric Acid assay is used for the quantitation of uric acid in serum, plasma, or urine on the ALCYON 300/300i Analyzer. 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 yield a quinoneimine dye. The resulting change in absorbance at 550 nm is proportional to the uric acid concentration in the sample.
The Abbott Laboratories Uric Acid assay is an in vitro diagnostic device for the quantitative determination of uric acid in human serum, plasma, or urine. The study presented demonstrates its substantial equivalence to predicate devices, namely the Roche Cobas Mira Plus Automated Chemistry Uric Acid assay (for serum) and the Boehringer Mannheim Uric Acid assay on the Hitachi 717 Analyzer (for urine).
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (Abbott Uric Acid Assay) | Target Material/Application |
|---|---|---|---|
| Correlation Coefficient | "similar clinical results" (to Roche) | 0.9918 | Serum |
| "similar clinical results" (to B-M) | 0.9854 | Urine | |
| Slope | Not explicitly stated, but implied as close to 1 | 0.981 | Serum |
| 0.951 | Urine | ||
| Y-intercept | Not explicitly stated, but implied as close to 0 | 0.599 mg/dL | Serum |
| 0.435 mg/dL | Urine | ||
| Total %CV (Precision) | Not explicitly stated, but implied as acceptable for diagnostic assays | Level 1: 2.8% | |
| Level 2: 2.3% | Serum | ||
| Level 1: 4.4% | |||
| Level 2: 3.2% | Urine | ||
| Linearity | Not explicitly stated, but implied as relevant range | Up to 26 mg/dL | Not specified |
| Limit of Quantitation (Sensitivity) | Not explicitly stated, but implied as clinically relevant | 0.3 mg/dL | Not specified |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the exact sample sizes used for the method comparison studies. It mentions "Comparative performance studies were conducted" and "Precision studies were conducted using two levels of control material."
- Test Set Sample Size: Not explicitly stated for either method comparison or precision studies.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be retrospective in the sense that they are comparing the performance of the new device against existing, established predicate devices using collected samples. No information suggests it was a prospective trial with patient enrollment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the study design focuses on a method comparison against predicate devices, not on a human-read diagnostic interpretation. The "ground truth" for the test set is established by the measurements obtained from the predicate devices.
4. Adjudication Method for the Test Set:
This information is not applicable as the study design is a method comparison, not an expert-based adjudication of diagnostic findings. The results from the predicate devices serve as the reference.
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:
This information is not applicable. The device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, this study essentially represents a standalone performance evaluation of the Uric Acid assay on the ALCYON 300/300i Analyzer. The "algorithm" here refers to the chemical assay method implemented on the analyzer. Its performance is evaluated independently against predicate methods, without human interpretation in the diagnostic process beyond setting up the samples and reviewing the quantitative results.
7. The Type of Ground Truth Used:
The ground truth for the method comparison studies was established by the measurements provided by the predicate devices:
- Roche Cobas Mira Plus Automated Chemistry Uric Acid assay for serum samples.
- Boehringer Mannheim Uric Acid assay on the Hitachi 717 Analyzer for urine samples.
For precision studies, the ground truth would be inferred from the known values of the control materials used.
8. The Sample Size for the Training Set:
This information is not applicable. This is an in vitro diagnostic assay based on established chemical reactions, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" for such a device involves optimizing the biochemical reaction parameters and instrument settings during development.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the reasons stated in point 8. The development of such assays relies on biochemical principles rather than "ground truth" established from labeled data like in machine learning.
§ 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.