Search Results
Found 1 results
510(k) Data Aggregation
(60 days)
ELECSYS ESTRADIOL ASSAY
Immunoassay for the in vitro quantitative determination of estradiol in human serum and plasma.
Competition principle. Total duration of assay: 18 minutes, 37 °C.
· 1st incubation (9 minutes): By incubating the sample (50 uL) with an estradiol-specific biotinylated antibody (65 uL), an immunocomplex is formed, the amount of which is dependent upon the analyte concentration in the sample.
·2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (35 µL) and an estradiol derivative labeled with a ruthenium complex* (65 uL), the still-vacant sites of the biotinylated antibodies become occupied, with the formation of an antibody-hapten complex. The entire complex becomes bound to the solid phase via interaction of biotin and streptavidin.
· The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame).
·Results are determined via a calibration curve which is instrumentspecifically generated by 2-point calibration and a master curve provided via the reagent bar code.
** Tris(2,2'-bipyridy))ruthenium(II) complex (Ru(bpy)" 3)
The provided text describes a 510(k) summary for the Boehringer Mannheim Elecsys® Estradiol Assay, comparing it to a predicate device, the Enzymun-Test® Estradiol Assay (K916132). This submission focuses on establishing substantial equivalence based on performance characteristics.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" with pass/fail thresholds. Instead, it presents performance characteristics of the new device (Elecsys® Estradiol) and directly compares them to the predicate device (Enzymun-Test® Estradiol). The implicit acceptance criterion is that the performance of the Elecsys® Estradiol Assay is comparable to or better than the predicate device.
Given this, I will construct a table comparing the performance of the Elecsys® Estradiol Assay with the Enzymun-Test® Estradiol Assay, as this constitutes the 'reported device performance' against an implicit 'acceptance' of being equivalent to the predicate.
| Feature | Elecsys® Estradiol Performance | Enzymun® Estradiol Performance (Predicate) | Implicit Acceptance Criteria (Comparison to Predicate) |
|---|---|---|---|
| Precision | Comparable precision (within-run and total) | ||
| Within-Run (Mean) | Low: 7.7, Mid: 44.0, High: 277.6, High: 1217.0 (pg/mL) | Low: 8.2, Mid: 53.3, High: 3021 (pg/mL) (Note: Different levels reported for Elecsys vs. Enzymun) | - |
| Within-Run (%CV) | Low: 3.0, Mid: 2.7, High: 3.3, High: 2.7 (Note: Different levels reported for Elecsys vs. Enzymun) | Low: 14.3, Mid: 16.1, High: 9.1 | - |
| Total (Mean) | Low: 9.0, Mid: 44.0, High: 277.6, High: 1217.0 (pg/mL) | Low: 10.3, Mid: 53.3, High: 3021 (pg/mL) | - |
| Total (%CV) | Low: 9.0, Mid: 9.0, High: 10.0, High: 10.0 (Note: Different levels reported for Elecsys vs. Enzymun) | Low: 16.1, Mid: 16.1, High: 10.3 | - |
| Lower Detection Limit | 10 pg/mL | 10 pg/mL | Equal or lower detection limit |
| Linearity | 10-4600 pg/mL (with a deviation from a linear line of ±10%) | 10-1300 pg/mL (with a deviation from a linear line of ±10%) | Comparable linearity range, potentially wider |
| Method Comparison (Vs Enzymun-Test Estradiol) | High correlation (r value > 0.97) and small bias | ||
| Least Squares | y = 1.027x + 6.32; r = 0.995; SEE = 31.03; N = 64 | y = 0.902x + 42.94; r = 0.976; SEE = 91.96; N = 74 | - |
| Passing/Bablok | - | y = 0.962x + 12.51; r = 0.976; SEE = 38.71; N = 74 | - |
| Interfering Substances (No interference at) | Bilirubin: 64.5 mg/dL; Hemoglobin: 1.0 g/dL; Lipemia: 1250 mg/dL; Biotin: 20 ng/mL | Bilirubin: 25 mg/dL; Hemoglobin: 200 mg/dL; Lipemia: 1500 mg/dL; Biotin: 24 ng/mL | Comparable or improved resistance to interference |
| Specificity (% Cross-reactivity) | Low cross-reactivity, comparable to predicate or better | ||
| 17 hydroxy-Progesterone |
Ask a specific question about this device
Page 1 of 1