Table 6 Cytotoxicity results
From: ISO 10993 biological evaluation of novel hemostatic powder – 4SEAL®
Material | Percent Viability [%] | System Suitability |
|---|---|---|
Positive control | 0.77 | Met criteria |
Negative control | 92.10 | Met criteria |
4SEAL® (1x) | 101.05 | No Cytotoxic Potential |
4SEAL® (2x) | 102.79 | No Cytotoxic Potential |
4SEAL® (3x) | 101.91 | No Cytotoxic Potential |
4SEAL® (4x) | 97.41 | No Cytotoxic Potential |
Quality check of assay | Result | System Suitability |
Absolute value of optical density (OD570) | 1.162 | Met criteria |
Systematic cell seeding errors | 3.36% | Met criteria |