6 Panel Cup Detecting AMP, COC, MET, OPI, PCP, & THC, CLIA Waived and FDA Approved As low as $0.89

Why Choose an FDA Cleared & CLIA Waived Drug Test Cup?

When selecting a rapid drug test, it’s important to understand the difference between FDA Cleared and CLIA Waived. While these designations are often mentioned together, they serve different purposes and both help ensure you’re purchasing a professional-quality drug testing device.

At 12 Panel Now, we manufacture the Serenity® Drug Test Cup to meet strict quality and regulatory standards, giving employers, healthcare providers, laboratories, rehabilitation centers, and occupational health professionals confidence in every test.

What Is a CLIA Waived Drug Test?

The Clinical Laboratory Improvement Amendments (CLIA) are federal regulations administered by the Centers for Medicare & Medicaid Services (CMS). A drug test that is CLIA Waived has been evaluated as simple to perform and carries a low risk of inaccurate results when used according to the manufacturer’s instructions.

Benefits of a CLIA Waived Drug Test Cup

• Simple one-step testing procedure
• Fast results in approximately 5 minutes
• Designed for use outside of traditional laboratories
• Minimal operator training required
• Reliable performance for point-of-care drug testing
• Ideal for professional workplace and clinical screening programs

Common Uses for CLIA Waived Drug Test Cups

CLIA Waived drug testing devices are commonly used by:

• Employers and workplace drug testing programs
• Occupational health clinics
• Physician offices and medical practices
• Drug testing collection facilities
• Rehabilitation and treatment centers
• Schools and universities
• Government agencies
• Correctional facilities

Note: Facilities performing testing for medical diagnosis or submitting claims to insurance providers generally require an appropriate CLIA Certificate of Waiver (or another applicable CLIA certification) before using waived testing devices.

What Does FDA Cleared Mean?

Most professional rapid drug test cups are FDA Cleared through the FDA’s 510(k) review process. This clearance demonstrates that the device has been evaluated for its intended use and has been shown to be substantially equivalent to a legally marketed medical device.

An FDA Cleared drug test cup provides confidence that the product:

• Meets federal medical device requirements
• Has been evaluated for safety and intended performance
• Is manufactured under established quality system standards
• Delivers reliable, consistent screening results when used as directed

Although many people use the phrase “FDA Approved,” the correct regulatory term for most rapid drug test cups is FDA Cleared.

Why FDA Cleared and CLIA Waived Matter

A drug test cup that is both FDA Cleared and CLIA Waived combines regulatory confidence with ease of use, making it an excellent choice for professional on-site drug testing.

Key Advantages

✔ Meets recognized federal quality and performance standards

✔ Suitable for point-of-care drug testing

✔ Simple, one-step testing process

✔ Fast, easy-to-read results

✔ Trusted by employers, healthcare providers, and collection professionals

✔ Ideal for workplace, occupational health, rehabilitation, and clinical environments

Understanding the Difference

Questions About CLIA Waived or FDA Cleared Drug Tests?

The team at 12 Panel Now is committed to helping customers select the right drug testing solution for their workplace, healthcare facility, rehabilitation program, or collection site. If you have questions about Serenity® Drug Test Cups, regulatory requirements, private labeling, or product selection, contact us at [email protected]. We’re happy to help you choose the best testing solution for your needs.