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510(k) Data Aggregation
(59 days)
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
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). (5 mg/dL) | Sensitivity level is ≤5 mg/dL Salicylic Acid. |
| Endogenous Interference | Average recovery close to 100% compared to control samples. (>98.7% 104% 98.6% |
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