(193 days)
System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on OLYMPUS analyzers
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.
Not Found
The provided text focuses on the FDA's 510(k) clearance of the Olympus Uric Acid Reagent, establishing its substantial equivalence to a predicate device. However, the document does not contain the detailed study information required to fully answer your request regarding acceptance criteria and performance studies.
Therefore, I cannot populate the table or provide specific answers to most of your questions based solely on the provided text. The document is a regulatory clearance letter, not a scientific study report.
Here's what I can extract and what is missing:
Information Present:
- Device Name: Olympus Uric Acid Reagent
- Intended Use: Quantitative determination of Uric Acid in human serum, heparinized plasma, and urine on OLYMPUS analyzers.
- Clinical Utility: Used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and patients receiving cytotoxic drugs.
- Regulatory Clearance: 510(k) clearance (K062862) issued on April 6, 2007.
Information NOT Present (and why it's typically in a study report, not a clearance letter):
- Acceptance Criteria and Reported Device Performance Table: The document doesn't list specific performance metrics (like accuracy, precision, linearity, limits of detection) or the thresholds for acceptable performance. It only states the device is substantially equivalent, implying its performance is comparable to an existing device.
- Sample Size for Test Set and Data Provenance: This information would be detailed in a validation study report.
- Number of Experts and Qualifications: Not relevant for a chemistry reagent validation; typically for image-based diagnostics where human interpretation is involved.
- Adjudication Method: Not relevant for a chemistry reagent.
- MRMC Comparative Effectiveness Study: Not relevant for a chemistry reagent. This applies to diagnostic tools where human interpretation is augmented by AI.
- Standalone Performance: While the "device" (reagent) performs standalone, the document doesn't provide the specific performance data.
- Type of Ground Truth Used: For a chemistry assay, the ground truth would typically be established using a reference method or certified reference materials with known uric acid concentrations. The document doesn't specify this.
- Sample Size for Training Set: Not applicable in the context of a chemical reagent validation in the same way it would be for a machine learning model.
- How Ground Truth for Training Set was Established: Again, not applicable as there's no "training set" in the machine learning sense for this type of device.
Conclusion:
The provided document is a regulatory approval letter. While it confirms the device's market readiness and intended use, it does not contain the detailed technical specifications or study results required to answer your specific questions about acceptance criteria and performance study design. This information would typically be found in the 510(k) submission summary or a separate validation study report, which is not included here.
§ 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.