You will see "CLIA waived" on many drug test cups and "forensic use only" on others. This guide explains what those labels mean and how to choose the right one for your program.
What is CLIA?
CLIA stands for the Clinical Laboratory Improvement Amendments of 1988, a federal law that sets quality standards for testing done on human samples to diagnose, prevent or treat disease, or to assess health. It is administered by the Centers for Medicare & Medicaid Services (CMS), and the FDA decides how complex each test is.
What does "CLIA waived" mean?
The FDA sorts tests into three groups: waived, moderate complexity and high complexity. A CLIA waived test is one the FDA has found simple enough, with a low enough risk of an incorrect result, to be used outside a full laboratory, for example in a clinic, physician's office or treatment program.
Facilities that run waived tests for health purposes must hold a CLIA Certificate of Waiver, follow the manufacturer's instructions exactly, and meet any state requirements. The application is made through CMS.
What does "forensic use only" mean?
Tests labeled forensic use only are not FDA cleared for clinical diagnosis. They are intended for non-clinical screening, such as workplace, legal or monitoring purposes. Many newer tests, including some strips for substances like kratom, K2 and gabapentin, are currently available only for forensic use.
Which one do you need?
| If you are... | Typical choice |
|---|---|
| A clinic, physician office or treatment program testing patients as part of their care | CLIA waived tests, used under a CLIA Certificate of Waiver |
| An employer screening applicants or employees (non-DOT) | CLIA waived or forensic use tests, depending on your policy and state law |
| A sober living home monitoring residents | Either, depending on your program, state rules and certifying organization |
| Testing for a newer substance with no CLIA waived option | A forensic use test, with lab confirmation of any positive |
Requirements vary by state and by why you are testing. If you are unsure, check with your state health department or your certifying organization.
Our CLIA waived drug test cups
10 Panel CLIA Waived Cup
Our most economical CLIA waived cup.
Shop 10 Panel12 Panel CLIA Waived Cup
Broader coverage, including BUP and MDMA.
Shop 12 Panel CLIA12 Panel CLIA Waived with PCP
For policies that include PCP.
Shop 12 Panel with PCPSee all CLIA waived drug test cups, or read what each panel detects.
Ordering for a house, program or company?
Volume pricing starts at 25 units and gets better at 50, 75 and 100. For standing orders or 500+ units, call (866) 407-2832 or email sales@drugtestsdirect.com for a quote.
Request a Bulk QuoteFrequently asked questions
Do I need a CLIA certificate to use drug test cups?
If you test patients for health purposes, such as diagnosis or treatment, you need a CLIA Certificate of Waiver to run waived tests. Other settings depend on why you are testing and on state law.
Is CLIA waived the same as FDA approved?
Not exactly. CLIA waived tests have been cleared by the FDA and categorized as waived, meaning they are simple enough to use outside a full laboratory.
Are forensic use only tests less accurate?
Not necessarily. The label reflects the intended use and regulatory status, not accuracy. Any preliminary positive should be confirmed by a lab.
Which of your cups are CLIA waived?
Our 10 panel CLIA waived cup and our two 12 panel CLIA waived cups, one with PCP.
Instant urine tests give preliminary results. Confirm any preliminary positive with a laboratory test (such as GC/MS) before taking action. Always follow the package insert.