We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
    • Webinar Recordings
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Abbott's Pregnancy Blood Test Gets FDA Nod

Abbott's Pregnancy Blood Test Gets FDA Nod

April 30, 2015

Abbott’s i-Stat Total β-hCG pregnancy blood test has won FDA regulatory approval, the Abbott Park, Ill., devicemaker announced Thursday.

The first-of-its-kind blood test rapidly and accurately detects the human chorionic gonadotropin hormone commonly associated with pregnancy, the company says. By measuring very low levels of hCG in the blood stream using two to three droplets, the test can determine if a woman is in the early stages of pregnancy within 10 minutes.

Previously, medical professionals had to rely on urine-based testing, but this can pose a problem for a woman in an emergency setting. For example, she could be dehydrated, experiencing pain or unconscious. In these settings, the sooner a doctor can know a woman’s pregnancy status the better, since this factor must be taken into account during clinical decision-making, the devicemaker says.

The system can measure hCG in whole blood or plasma more quickly than urine tests. By displaying results that specify the amount of the hormone present, the i-Stat test could potentially cut down on false-negative readings.

The blood test also is available in Canada, Europe, the Middle East, South Africa, Australia and New Zealand. — Jason Scott

Devices Submissions and Approvals

    Upcoming Events

    • 07Dec

      Proactive Supplier Management Using Quality Agreements

    • 13Dec

      FDA Inspection Overhaul: How Things Have Changed in 2023

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    Featured Products

    • FDA, FTC and DOJ Enforcement of Medical Device Regulations

      FDA, FTC and DOJ Enforcement of Medical Device Regulations

    • Using Real-World Evidence in Drug and Device Submissions

      Using Real-World Evidence in Drug and Device Submissions

    Featured Stories

    • FDA Laboratory-Developed Tests Proposal Comments Pour In by Thousands

    • Healthcare Titans Expand Their Portfolios in Acquisition Deals

    • Ups and Downs of Gene Therapy Weighed by FDA’s Marks

    • Device Manufacturers Pressed by Europe’s MDCG to Get Certified ASAP

    The Revised ICH E8: A Guide to New Clinical Trial Requirements

    Learn More
    • Drug Products
      • Quality
      • Regulatory Affairs
      • GMPs
      • Inspections and Audits
      • Postmarket Safety
      • Submissions and Approvals
      • Research and Development
      • Commercial Operations
    • Device Products
      • Quality
      • Regulatory Affairs
      • QSR
      • Inspections and Audits
      • Postmarket Safety
      • Submissions and Approvals
      • Research and Development
      • Commercial Operations
    • Clinical Products
      • Trial Design
      • Data Integrity
      • GCP
      • Inspections and Audits
      • Transparency
    • Privacy Policy
    • Do Not Sell or Share My Data
    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing