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510(k) Data Aggregation
(59 days)
The Emit® tox™ Salicylic Acid Assay is a homogenous enzyme immunoassay intended for use in the quantitative analysis of salicylic acid in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of salicylic acid overdose or in monitoring levels of salicylic acid to ensure appropriate therapy.
The Emit® tox™ Salicylic Acid Assay is a homogenous enzyme assay intended for use in quantitative analysis of Salicylic Acid in human serum or plasma.
The Emit® tox™ Salicylic Acid Assay is intended for the quantitative analysis of salicylic acid in human serum or plasma to diagnose and treat salicylic acid overdose or monitor therapeutic levels.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Specificity | No interference from tested compounds at specified levels. | Compounds with potential cross-reactivity did not interfere. |
| Comparative Analysis | Strong correlation to predicate device. (>0.993, slope 0.941) | Correlation of 0.993 with a slope of 0.941 to predicate (Abbott AxSYM® Salicylate Assay). |
| Precision (Within-Run) | Acceptable coefficient of variation (%CV). (<4.5%) | %CV ranging from 2.9% to 4.5%. |
| Precision (Total) | Acceptable coefficient of variation (%CV). (<5.8%) | %CV ranging from 3.9% to 5.8%. |
| Spike Recovery | Recovery within an acceptable range (e.g., 90-110%). | Recovery ranged from 91.8% to 104.7%. |
| Sensitivity | Lowest measurable concentration from 0 mg/dL with 95% confidence. (>5 mg/dL) | Sensitivity level is ≤5 mg/dL Salicylic Acid. |
| Endogenous Interference | Average recovery close to 100% compared to control samples. (>98.7% <102%) | Bilirubin: 98.7%, Hemoglobin: 99.4%, Triglycerides: 102%. No effect on accuracy. |
| High Sample Dilution | Recovery values within an acceptable range (e.g., 90-110%). (>104% <107%) | Recovery values ranged from 104% to 107%. No effect on accuracy. |
| Anticoagulants | Average recovery close to 100% compared to serum control. (>98.6% <106.3%) | Recovery ranged from 98.6% to 106.3%. |
Note: The document does not explicitly state the numerical acceptance criteria for each characteristic. The "Acceptance Criteria (Implied)" column is inferred from the reported performance, suggesting that the reported values met the internal acceptance criteria of the manufacturer.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample sizes used for the various tests (Specificity, Comparative Analysis, Precision, Spike Recovery, Sensitivity, Endogenous Interference, High Sample Dilution, Anticoagulants).
The document also does not directly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission to the FDA (a US regulatory body) by a US-based manufacturer (Syva Company - Dade Behring Inc., Cupertino, CA), it is highly probable that the data was generated in the United States and likely through prospective laboratory studies designed to evaluate device performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable to this type of device and study. The "Emit® tox™ Salicylic Acid Assay" is a diagnostic immunoassay that provides a quantitative measurement of a chemical substance (salicylic acid). The "ground truth" for such a system is typically established by reference methods or gravimetric preparation of known concentrations, not by expert consensus or interpretation of images/cases.
4. Adjudication Method
This section is not applicable for this type of quantitative immunoassay device. Adjudication methods (like 2+1, 3+1) are relevant for studies where human interpretation of results (e.g., medical images, pathology slides) is involved in establishing ground truth. For chemical assays, the "ground truth" is determined by the known concentration of the analyte or by a more accurate reference method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this is not relevant for a quantitative immunoassay device. MRMC studies are typically conducted for devices that involve human interpretation, such as imaging AI, to assess how AI assistance impacts human reader performance. This device provides a direct quantitative measurement.
6. Standalone Performance Study
Yes, a standalone performance study was performed. All the listed performance characteristics (Specificity, Comparative Analysis, Precision, Spike Recovery, Sensitivity, Endogenous Interference, High Sample Dilution, Anticoagulants) describe the performance of the Emit® tox™ Salicylic Acid Assay as a standalone algorithm/device. There is no human interpretation or human-in-the-loop component described for its intended use or performance evaluation.
7. Type of Ground Truth Used
The ground truth for the performance studies of the Emit® tox™ Salicylic Acid Assay was established using:
- Known concentrations of salicylic acid: For studies like Spike Recovery and Sensitivity, where samples are spiked with known amounts of salicylic acid.
- Reference method/Predicate Device: For Comparative Analysis, the Emit® tox™ Assay's results were compared against an established predicate device (Abbott AxSYM® Salicylate Assay), which serves as a clinical reference.
- Controlled samples: For interference studies (Endogenous Interference, Anticoagulants) and dilution studies, control samples with known compositions or prepared under controlled conditions were used.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for a training set. This is expected as the Emit® tox™ Salicylic Acid Assay is described as a "homogeneous enzyme immunoassay," indicating it is a chemical assay, not a machine learning or AI-based algorithm that typically requires a distinct training set. The performance statistics are based on analytical validation studies.
9. How Ground Truth for the Training Set Was Established
As noted above, since this is a chemical immunoassay and not an AI/ML algorithm, the concept of a "training set" with ground truth in the machine learning sense does not apply. The assay's fundamental chemical and enzymatic reactions form its operational basis, which is then validated through the detailed performance studies described.
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