For occupational exposure to lead, OSHA requires ZPP whole blood concentration to be reported in units of µ
g/dL. For adults, conversion of ZPP to units of µ
g/dL assumes a hematocrit of 45%.
Compliance Statement B
: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations.
This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.