eCFR Reference Browser

---

title: "21 CFR §862.1825"

source: "https://www.ecfr.gov/current/title-21/section-862.1825"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "862"

part_subject: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"

subpart_code: "B"

subpart_subject: "Clinical Chemistry Test Systems"

section_number: "862.1825"

section_subject: "Vitamin D test system."

cfr_reference: "21 CFR 862.1825"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(a)Identification. A vitamin D test system is a device 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.

(b)Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:

(1)Labeling in conformance with 21 CFR 809.10 and

(2)Compliance with existing standards of the National Committee on Clinical Laboratory Standards.

§862.1825 - Vitamin D test system.