6 Panel Urine Drug Test Cup 90ML: AMP, COC, BZO, MET, OPI, THC, PH/SG, As low as $1.49

FDA-Approved & CLIA-Waived Product

This device is intended for FDA-Approved & CLIA-Waived only and is specifically designed for drugs of abuse testing in law enforcement settings.

What Does CLIA Waived Mean?

CLIA stands for Clinical Laboratory Improvement Amendments. It is a federal regulation overseen by CMS (Centers for Medicare & Medicaid Services).

When a drug test cup is labeled CLIA Waived, it means:

• The test is considered simple to perform

• It has a low risk of incorrect results

• It can be used in non-laboratory settings

• It does not require a certified laboratory

• Staff do not need advanced laboratory training

Who Can Use CLIA Waived Drug Tests?

• Doctor’s Office
• Occupational health clinics
• Drug testing collection sites
• Rehab facilities
• Some employer-based testing programs

If a facility performs testing for clinical/medical purposes and bills insurance, they must have a CLIA Certificate of Waiver to use these tests legally.

What Does FDA Approved (or Cleared) Mean?

For drug test cups, the correct term is usually FDA Cleared, not technically “approved.”

When a drug test cup is FDA cleared:

• The manufacturer submitted data to the FDA
• The FDA determined the test is safe and effective for its intended use
• It meets federal standards for accuracy, reliability, and manufacturing quality

Most rapid drug test cups are cleared through the FDA’s 510(k) process, meaning they are substantially equivalent to an already legally marketed device.

CLIA Waived + FDA Cleared Together

When a drug test cup is both:

(FDA Cleared or CLIA Waived)

It Means:

• ✔ The test meets federal safety and performance standards
• ✔ It is simple enough for on-site use
• ✔ It can legally be used in waived settings (with proper certification if required)
• ✔ It is appropriate for point-of-care testing

Important Distinction

FDA Cleared = Product meets federal medical device standards

CLIA Waived = Allowed to be used outside of a complex lab

They are related but separate designations.

If you are unsure about the intended use or appropriate setting for any rapid screening device, we strongly recommend contacting us at [email protected] for guidance.

FAQ’s

1. What drugs does this 6 panel urine test cup detect?

This test detects THC (Marijuana), Benzodiazepines (BZO), Cocaine (COC), Amphetamines (AMP), Methamphetamine (MET), and Opiates (OPI) at SAMHSA-approved cutoff levels.

2. Does this cup detect adulterated or tampered urine samples?

Yes. It includes adulteration testing for pH, Specific Gravity (SG), and Creatinine (CR) to identify dilution or sample manipulation.

3. How accurate is the 6 panel drug test cup?

The cup offers 99% accuracy when used correctly and complies with SAMHSA cutoff standards, making it reliable for professional and FDA-approved and CLIA-waived screening.

4. How quickly can results be read?

Results are available within 5 minutes. Do not interpret results after 8 minutes, as accuracy may be affected.

5. Is this test cup FDA approved and CLIA waived?

Yes. It is FDA-approved and CLIA-waived, suitable for use in labs, clinics, probation offices, correctional facilities, and law enforcement settings.