Skip to content

Allegro Human Chorionic Gonadotropin IM System

by Nichols Institute Diagnostics 510(k)

Active United States

510(k) K872390

Overview

This is a Visual, Pregnancy Hcg, Prescription Use test system for human chorionic gonadotropin. It is classified under medical specialty Clinical Chemistry and regulation number 862.1155.

The device received FDA 510(k) clearance (K872390) on September 2, 1987, and is substantially equivalent to a legally marketed predicate. It is manufactured by Nichols Institute Diagnostics and supplied for prescription use.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK872390 Date2 Sep 1987ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Allegro(Tm) Human Chorionic Gonadotropin Im System
510(k) Number
FDA Product Code
JHI
Device Class
Class II
Regulation
21 CFR Part 862.1155
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Quest Diagnostics Nichols Institute

See all devices from Quest Diagnostics Nichols Institute →

Questions

  • What is the ALLEGRO(TM) Human Chorionic Gonadotropin IM System used for?

    The ALLEGRO(TM) Human Chorionic Gonadotropin IM System is a visual test system designed for the detection of human chorionic gonadotropin (hCG) in clinical chemistry applications. It is intended for prescription use and operates as a diagnostic aid in identifying pregnancy or monitoring hCG levels, based on its classification under regulation number 862.1155 and product code JHI.

  • How is the ALLEGRO(TM) Human Chorionic Gonadotropin IM System supplied and what is its intended use setting?

    The device is supplied for prescription use only, meaning it is intended to be used by or under the supervision of a licensed healthcare professional. It is not intended for over-the-counter or self-testing use, as indicated by its labeling and classification under the Clinical Chemistry specialty with FDA 510(k) clearance for professional diagnostic environments.

  • Is the ALLEGRO(TM) Human Chorionic Gonadotropin IM System a reusable or single-use test system?

    Based on the device description as a visual test system for hCG detection and its classification under Clinical Chemistry with product code JHI, the ALLEGRO(TM) system is designed for single-use application. Visual test systems of this type typically involve reagent strips or cassettes that are discarded after one use to prevent cross-contamination and ensure accurate results, consistent with standard in vitro diagnostic practices for such assays.