# Medical Devices; Reclassification and Codification of Vitamin D Test System
> **Food and Drug Administration** · Final rule. · Published 1998-07-29 · Effective 1998-08-28 · 63 FR 40364
## Document
- **Document number:** 98-20241
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 40364
- **CFR reference:** 21 CFR 862
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/07/29/98-20241/medical-devices-reclassification-and-codification-of-vitamin-d-test-system)
---
*AI Analytics · CC0 1.0*