21 CFR § 862.3880 - Theophylline test system.

---
identifier: "/us/cfr/t21/s862.3880"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.3880 - Theophylline test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.3880"
section_name: "Theophylline test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 862.3880 Theophylline test system.

(a) *Identification.* A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.

(b) *Classification.* Class II.