(99 days)
The ChemTrak AccuMeter® Theophylline Test provides a rapid, noninstrumented enzyme immunochromatographic method for in vitro quantitative measurement of Theophylline concentrations in ambulatory patients using fingerstick whole blood, heparinized venous whole blood or serum. This test has not been validated for use with blood from neonates.
The AccuMeter Theophylline Test is a rapid immunoassay for the quantitative detection of theophylline, using HRP labeled anti-theophylline antibodies and immobilized monoclonal anti-theophylline antibodies. The immunospecific signal is measured by the height of the enzyme label along the test strip.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy (Correlation to Predicate) | Correlation Coefficient (R) for AccuMeter Fingerstick vs. TDx | 0.943 (from Table 1, "AccuMeter Compared to TDx Theophylline" for 102 observations) and 0.937 (from Table 2, "AccuMeter Fingerstick vs TDx" for 40 observations). |
| Correlation Coefficient (R) for AccuMeter Serum vs. TDx | 0.959 (from Table 2, "AccuMeter Serum vs TDx" for 39 observations) | |
| Correlation Coefficient (R) for AccuMeter Whole Blood vs. TDx | 0.963 (from Table 2, "AccuMeter Whole Blood vs TDx" for 39 observations) | |
| Precision | Within-Run % CV (Coefficient of Variation) | Level 1: 5.9% (Study 1), 7.7% (Study 2), 7.5% (Study 3) |
| Level 2: 6.0% (Study 1), 6.0% (Study 2), 4.7% (Study 3) | ||
| Total % CV (Coefficient of Variation) | Level 1: 7.6% (Study 1), 7.8% (Study 2), 10.7% (Study 3) | |
| Level 2: 6.7% (Study 1), 7.6% (Study 2), 8.4% (Study 3) | ||
| Sensitivity | Lower Limit of Detection | 5 ug/mL (The assay is sensitive enough to detect down to 5 ug/mL. Results |
§ 862.3880 Theophylline test system.
(a)
Identification. A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.(b)
Classification. Class II.