(58 days)
For in vitro diagnostic use with the CARESIDE™ Analyzer to quantitatively measure uric acid from whole blood, plasma or serum specimens to aid in the diagnosis and treatment of patients with numerous renal and metabolic disorders including renal failure, gout, leukemia, psoriasis, starvation or wasting conditions, and of patients receiving cytotoxic drugs. It is intended for professional laboratory use: not for point of care or physician office laboratory use.
CARESIDE™ Uric Acid cartridges are used with the CARESIDE™ Analyzer to quantitatively measure uric acid concentration in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE™ Uric Acid cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of uric acid concentration. The film cartridge (patent pending) contains all reagents necessary to measure uric acid concentration.
Here's an analysis of the provided text to extract the acceptance criteria and study information:
CARESIDE™ Uric Acid Device: Acceptance Criteria and Study Details
The provided 510(k) summary and FDA letter do not explicitly list formal "acceptance criteria" in a quantitative sense as might be found in a later clinical trial report (e.g., "sensitivity must be >X%, specificity >Y%"). Instead, the document focuses on demonstrating substantial equivalence to a predicate device, the Vitros URIC Slides for Johnson and Johnson's Vitros DT 60. The "acceptance criteria" are implicitly met by demonstrating comparable clinical performance.
The study described is an equivalence study aiming to show that the CARESIDE™ Uric Acid test is "substantially equivalent in principle, intended use, and clinical performance" to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
As stated, explicit quantitative acceptance criteria are not provided. The performance is assessed relative to the predicate device.
| Acceptance Criteria (Implicit) | Reported CARESIDE™ Uric Acid Device Performance (Clinical Performance Relative to Predicate) |
|---|---|
| Preamble: The CARESIDE™ Uric Acid test is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of uric acid on the Vitros DT 60 II. | Implied based on FDA clearance: The FDA has determined the device is substantially equivalent to the predicate device (Vitros URIC Slides, K912844/A), indicating that its clinical performance is considered comparable and acceptable for its intended use. |
| Specific Performance Aspects (Implicit): Accuracy, precision, linearity, and other performance characteristics expected of a uric acid test system, comparable to a legally marketed predicate device. This would include accurate quantification of uric acid concentration in the specified sample types (whole blood, plasma, serum). | The document describes the device's mechanism of action (uricase-peroxidase reaction leading to colorimetric measurement at 655 nm, calculated using a lot-specific standard curve). While specific numerical performance values are not given in this summary, the FDA clearance hinges on the submission containing sufficient data to support these aspects relative to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not explicitly stated in the provided text. The document is a 510(k) summary, which often provides an overview rather than a detailed data breakdown.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This information would typically be found in the detailed study report submitted with the 510(k).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/Not stated. For a quantitative in vitro diagnostic (IVD) device like a uric acid test, the "ground truth" is typically established by reference methods or comparison to a cleared predicate device, not by expert consensus interpreting images or clinical cases. The comparison would be against a known, accurate uric acid measurement.
- Qualifications of Experts: Not applicable/Not stated.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not stated. This concept (e.g., 2+1, 3+1) is typically relevant for studies involving human interpretation of data (e.g., radiology reads) where disagreements need resolution. For a quantitative IVD, the "adjudication" is inherent in the comparison of numerical results from the new device against the reference/predicate method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. MRMC studies are specific to evaluating how different human readers perform on multiple cases, often with and without AI assistance, and are common in image-based diagnostics. This device is a quantitative in vitro diagnostic, not an imaging AI diagnostic.
- Effect Size of Human Readers with/without AI: Not applicable, as it's not an AI-assisted diagnostic for human readers.
6. If a Standalone (Algorithm only without Human-in-the-Loop Performance) was done
- Standalone Performance: Yes, the study inherently evaluates the standalone performance of the device. As an in vitro diagnostic (IVD) test, the CARESIDE™ Uric Acid system (cartridge + analyzer) operates independently to produce a quantitative uric acid result. Its performance is measured as the accuracy and precision of these direct numerical outputs. The comparison is between the CARESIDE™ Analyzer's results and those of the predicate Vitros DT 60 II. Human intervention is limited to sample loading and initiating the test, not in interpreting the primary measurement.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this type of IVD device is typically established by:
- Comparison to a legally marketed predicate device: The text explicitly states "Substantial Equivalency Claim... to the currently marketed Vitros slides for the quantitative measurement of uric acid on the Vitros DT 60 II." This implies that the Vitros system serves as the primary comparator.
- Reference methods: While not explicitly mentioned in this summary, such studies often involve comparison to established laboratory reference methods for uric acid measurement, which are considered highly accurate.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not explicitly stated in the provided text. For IVDs, "training set" might refer to samples used for initial calibration, method development, or establishing lot-specific standard curves. The document mentions the analyzer uses "the lot-specific standard curve to calculate uric acid concentration," implying some form of calibration or training data is generated for each production lot, but the size is not given.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: Not explicitly stated. For the purpose of establishing a "lot-specific standard curve" (which functions similarly to a model training for IVDs), ground truth would be established through:
- Calibrator solutions: Using precisely known concentrations of uric acid, often traceable to international reference materials. These known concentrations are run on the device to generate the standard curve that relates measured signal (reflectance at 655 nm) to uric acid concentration.
- Internal reference materials: Using well-characterized control materials with established uric acid values.
§ 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.