21 CFR § 862.1585 - Human placental lactogen test system.

---
identifier: "/us/cfr/t21/s862.1585"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1585 - Human placental lactogen test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1585"
section_name: "Human placental lactogen 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"
---


# 862.1585 Human placental lactogen test system.

(a) *Identification.* A human placental lactogen test system is a device intended to measure the hormone human placental lactogen (HPL), (also known as human chorionic somatomammotrophin (HCS)), in maternal serum and maternal plasma. Measurements of human placental lactogen are used in the diagnosis and clinical management of high-risk pregnancies involving fetal distress associated with placental insufficiency. Measurements of HPL are also used in pregnancies complicated by hypertension, proteinuria, edema, post-maturity, placental insufficiency, or possible miscarriage.

(b) *Classification.* Class II.