Code of Federal Regulations Title 21. Food and Drugs § 21.862.1840 Total 25–hydroxyvitamin D mass spectrometry test system

(i) Performance testing of device precision must, at a minimum, use intended sample type with Vitamin D concentrations at medically relevant decision points. At least one sample in the precision studies must be an unmodified patient sample. This testing must evaluate repeatability and reproducibility using a protocol from an FDA–recognized standard.

(ii) Performance testing of device accuracy must include a minimum of 115 serum or plasma samples that span the measuring interval of the device and compare results of the new device to results of a reference method or a legally marketed standardized mass spectrometry based vitamin D assay. The results must be described in the 21 CFR 809.10(b)(12) compliant labeling of the device.

(iii) Interference from vitamin D analogs and metabolites including vitamin D2, vitamin D3, 1–hydroxyvitamin D2, 1–hydroxyvitamin D3, 3–Epi–25–Hydroxyvitamin D2, 3–Epi–25–Hydroxyvitamin D3, 1,25–Dihydroxyvitamin D2, 1,25–Dihydroxyvitamin D3, 3–Epi–1,25–Dihydroxyvitamin D2, and 3–Epi–1,25–Dihydroxyvitamin D3, 25, 26–Dihydroxyvitamin–D3, 24 (R), 25–dihydroxyvitamin–D3, 23 (R), 25–dihydroxyvitamin–D3 must be described in the 21 CFR 809.10(b)(7) compliant labeling of the device.