TABLE XI

Adequate Sensitivity Ramifications of the UF Adjustment to the AET Applied to a Medical Device. Is Method Sensitivity Adequate to Achieve the Adjusted AET?^{^a}

# of Devices Required per Day	AET (µg/mL)	LoD (µg/mL)^{^b}	Is the LoD ≤ the Adjusted AET?
# of Devices Required per Day	AET (µg/mL)	LoD (µg/mL)^{^b}	No UF	UF = 2	UF = 5	UF = 10
1	120	0.05	Yes	Yes	Yes	Yes
2	120	0.05	Yes	Yes	Yes	Yes
4	120	0.05	Yes	Yes	Yes	Yes
8	120	0.05	Yes	Yes	Yes	Yes
10	120	0.05	Yes	Yes	Yes	No

↵a Abbreviations: UF, uncertainty factor; AET, analytical evaluation threshold; LoD, limit of detection.
↵b Taken as 0.05 µg/mL, within the capability of many optimized chromatographic screening methods.