Medical Devices; Reclassification and Codification of Vitamin D Test System
fda-device · Food and Drug Administration · Rule · Published 1998-07-29 · Effective 1998-08-28 · 63 FR 40364
Document
Document number
98-20241
Federal Register citation
63 FR 40364
CFR reference
21 CFR 862
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1998-07-29
Effective date
1998-08-28
HHS docket
Docket No. 96P-0228
Abstract
The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to INCSTAR Corp. reclassifying INCSTAR 25-Hydroxyvitamin D <SUP>125</SUP>I Radioimmunoassay (RIA). This radioimmunoassay device is intended for use in clinical laboratories for the quantitative determination of 25- hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency. The device and substantially equivalent devices of this generic type were reclassified from class III (premarket approval) to class II (special controls). Accordingly, the order is being codified in the Code of Federal Regulations.