eCFR Reference Browser

---

title: "21 CFR §862.2860"

source: "https://www.ecfr.gov/current/title-21/section-862.2860"

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: "C"

subpart_subject: "Clinical Laboratory Instruments"

section_number: "862.2860"

section_subject: "Mass spectrometer for clinical use."

cfr_reference: "21 CFR 862.2860"

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 mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

§862.2860 - Mass spectrometer for clinical use.