21 CFR § 862.1117 - B-type natriuretic peptide test system.

---
identifier: "/us/cfr/t21/s862.1117"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1117 - B-type natriuretic peptide test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1117"
section_name: "B-type natriuretic peptide 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"
---


# 862.1117 B-type natriuretic peptide test system.

(a) *Identification.* The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.

(b) *Classification.* Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”

[66 FR 12734, Feb. 28, 2001]