(876 days)
The FINDER G6PD test is intended for semi-quantitative measurement of glucose-6-phosphate dehydrogenase in venous whole blood specimens collected in lithium heparin tubes, for the identification of G6PD deficient samples. The FINDER G6PD test is intended to be used with the FINDER Instrument in point of care or clinical laboratory settings.
The FINDER G6PD test system measures G6PD quantitatively from a 50uL venous whole blood specimen. The blood specimen should be collected in lithium heparin anticoagulant. The G6PD test system is suitable for use in both a point-of-care setting and a clinical laboratory. The time to result is around 16 minutes from sample introduction. The FINDER G6PD test system consists of the FINDER G6PD Test Cartridge and the FINDER Instrument. The cartridge uses electrowetting-based digital microfluidics to integrate and automate all the sample and reagent handling steps. The instrument contains all the hardware and software required to operate the cartridge, providing electrowetting control, thermal control and detection capability, a touch-screen user interface and software necessary to perform the test and report results.
FINDER G6PD Test: Acceptance Criteria and Performance Study
The FINDER G6PD Test is intended for semi-quantitative measurement of glucose-6-phosphate dehydrogenase in venous whole blood to identify G6PD deficient samples. The device is used with the FINDER Instrument in point-of-care or clinical laboratory settings.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a separate section with specific numerical targets. However, the performance data presented from precision, linearity, interference, sensitivity, and method comparison studies collectively demonstrate the device's acceptable performance in comparison to the predicate device and established guidelines. For the purpose of this analysis, key performance metrics from the non-clinical and clinical studies will be presented as the "reported device performance."
| Category | Specific Metric | Reported Device Performance |
|---|---|---|
| Precision | Single Site Precision (CV%) | |
| (Hemolysate Controls) | Low (1.4 U/gHb) | Repeatability: 4.1%, Reproducibility: 6.5% |
| Intermediate (7.0 U/gHb) | Repeatability: 3.6%, Reproducibility: 5.3% | |
| High (17.4 U/gHb) | Repeatability: 2.4%, Reproducibility: 5.2% | |
| Reproducibility Precision (CV%) | ||
| (Fresh Whole Blood) | Low (1.1 U/gHb) | Repeatability: 5.9%, Reproducibility: 6.0% |
| Intermediate (3.5 U/gHb) | Repeatability: 3.4%, Reproducibility: 4.4% | |
| High (11.2 U/gHb) | Repeatability: 6.6%, Reproducibility: 7.0% | |
| Linearity | Linear Range | 0.8 to 19.7 U/g Hb |
| Interference | Endogenous Substances | Non-interfering at maximum tested concentrations (e.g., Bilirubin 50 mg/dL, Hemoglobin 5 g/L) |
| Common Drugs | Non-interfering at maximum tested concentrations (e.g., Ampicillin 0.16 mM, Ibuprofen 2.5 mM) | |
| Hematocrit | Bias of -15.3% at 29% Hct (normal sample), -11.1% at 30% Hct (MDL sample) compared to 50% Hct. | |
| Sensitivity | Limit of Blank (LoB) | 0.2 U/g Hb |
| Limit of Detection (LoD) | 0.4 U/g Hb | |
| Limit of Quantitation (LoQ) | 1.1 U/g Hb | |
| Method Comparison | Slope (95% CI) | 0.92 (0.89, 0.95) |
| Intercept (95% CI) | 0.28 (0.12, 0.44) | |
| Correlation Coefficient | 0.9 | |
| Bias at 3.1 U/gHb (30% AMM) | 0.0 U/gHb (-0.1, 0.2) or 1.4% (-2.5%, 5.4%) | |
| Bias at 8.4 U/gHb (80% AMM) | -0.4 U/gHb (-0.5, 0.2) or -4.3% (-6.5%, -2.0%) | |
| **Categorical Agreement ( |
§ 864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay.
(a)
Identification. An erythrocytic glucose-6-phosphate dehydrogenase assay is a device used to measure the activity of the enzyme glucose-6-phosphate dehydrogenase or of glucose-6-phosphate dehydrogenase isoenzymes. The results of this assay are used in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a glucose-6-phosphate dehydrogenase deficiency. This generic device includes assays based on fluorescence, electrophoresis, methemoglobin reduction, catalase inhibition, and ultraviolet kinetics.(b)
Classification. Class II (performance standards).