Login / Register | 0 items - $ 0.00 CONTACT US

AlcoPro - Drug and Alcohol Testing Products & DOT Training

  • Products
  • Training
    • DOT Drug and Alcohol Training
    • Employer Substance Abuse Awareness Training
    • Hotels in Knoxville
    • Training Materials
    • DOT Regulations Knowledge Base
  • Knowledge Base
  • Repairs & Services
  • Resources
    • Catalogs
    • Knowledge Base
    • Buyer’s Guide
    • Product Document Library
    • Drug Test Finder
    • Drink Wheel
    • Window of Detection Tool
    • Breath Alcohol Instrument Mouthpiece Chart
  • News
    • News
    • AlcoPro Blog
    • Sign Up – AlcoPro Blog
  • Customer Service
    • Order & Return Policy
    • Shipping Information
    • Apply for Tax Exempt Status
    • Satisfaction & Warranty Policy
    • Repair Services and Technical Support
    • Privacy Policy
    • Customer Reviews
  • Contact Us
    • Contact Us
    • Quote Request
    • Catalog Request
    • Product Sample Request
    • BAC Wheel Request
    • Customer Reviews
  • About Us

800.227.9890

Follow Us on FacebookFollow Us on TwitterFollow Us on LinkedIn

CLIA Waived and FDA Clearance: What Does it Mean?

  • Home
  • /
  • Knowledge-base
  • /
  • Drug Testing Products
  • /
  • Product Questions
  • /
  • CLIA Waived and FDA Clearance: What Does it Mean?

CLIA Waived and FDA Clearance: What Does it Mean?

Clinical Laboratory Improvement Amendments (CLIA) is a Federal regulation that establishes quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results.  The FDA categorizes commercially marketed tests into one of three CLIA categories according to complexity and their potential for risk to public health:

  • Waived tests
  • Tests of moderate complexity
  • Tests of high complexity

CLIA Waived devices are the least complex.  In order to receive CLIA Waived status, a manufacturer must demonstrate that a device is simple to use, has low risk to public health, and that an untrained person can get accurate results by reading the instructions.

 The instruction sheet is what distinguishes a CLIA Waived device from an identical device that is not CLIA Waived.  Instruction sheets for CLIA Waived devices are written in simple to understand language and do not contain technical jargon.  There typically is no difference in the device itself from a CLIA Waived device and a device that does not have CLIA Waived status.

A device that is CLIA Waived does not require highly trained laboratory personnel to administer the test and does not require costly laboratory quality control testing.  Because non-professional staff is permitted to use CLIA Waived tests, the cost of testing is more economical and can be performed more timely by front-line staff.  Hospitals and laboratories that use devices that are not CLIA Waived typically must perform daily quality control testing on the devices to ensure they are giving accurate results.  This is typically not required of CLIA Waived devices.

FDA 510(k) Clearance:

Manufacturers must obtain FDA 510(k) clearance before selling their devices.  There are two types of FDA clearance for medical devices: Professional use and Over the Counter use.  Professional use is the typical FDA clearance, which means the device may be sold only to and used only by medical professionals.  A medical device manufacturer that wants to obtain CLIA Waived status for a device that already has FDA clearance for professional use must perform a number of additional studies to demonstrate the device can be safely used by untrained personnel.

FDA Over the Counter clearance means the device may be sold directly to and used by consumers.  By regulation, all devices that have FDA Over the Counter clearance are automatically CLIA Waived as well. 

ABOUT ALCOPRO

Since 1982, AlcoPro has supplied and manufactured the most accurate drug and alcohol testing instruments, kits, and supplies for professional use. We take pride in maintaining our industry-wide reputation for accuracy and quality as we help you—our top priority—perform alcohol and drug screenings and tests with greater precision and confidence.

Subscribe to Our Blog

  • This field is for validation purposes and should be left unchanged.

800.227.9890
Follow Us on FacebookFollow Us on TwitterFollow Us on LinkedInFollow Us on YouTube

Privacy Policy

© 2022 AlcoPro.
All Rights Reserved.

Custom Website Design & Development by VIEO Design