CLIA Waived 14 Panel Drug Test Cup with Fentanyl & EDDP

CLIA Waived 14 Panel Drug Test with Fentanyl and EDDP

This CLIA waived 14 panel drug test combines urine specimen collection and preliminary multi-drug screening in one integrated cup. The configuration includes dedicated panels for fentanyl, EDDP and tricyclic antidepressants, together with commonly requested opioid, stimulant, benzodiazepine and marijuana panels.

This product is intended for use according to its current labeling, instructions and CLIA classification. A CLIA-waived designation applies to the specific test system and documented analytes; the testing facility must still maintain the appropriate CLIA certificate and follow the manufacturer’s instructions.

Key product features

• Screens 14 drugs, drug classes and metabolites
• Includes fentanyl at FEN/1
• Includes methadone metabolite EDDP/300
• Includes both MTD/300 and EDDP/300 panels
• Includes TCA/1000
• CLIA-waived test configuration
• FDA 510(k)-cleared test system
• Preliminary results in approximately five minutes
• Integrated urine collection and screening cup
• Built-in specimen temperature strip
• Quantity-based pricing
• Free shipping on qualifying orders of 100 or more cups
• Clearance availability while remaining inventory lasts

What Does This CLIA Waived 14 Panel Drug Test Screen For?

This configuration screens for the following analytes at the listed preliminary screening cutoffs:

The listed cutoffs correspond with the current product configuration and the applicable test-system documentation. Always confirm the analytes and cutoffs against the current product pouch and instructions before use.

For a broader explanation of screening thresholds, review our guide to drug test cutoff levels.

Why Choose the Fentanyl and EDDP Configuration?

A general opiate panel should not be assumed to include fentanyl, methadone, EDDP, oxycodone or buprenorphine. This cup provides separate panels for these analytes.

Fentanyl – FEN/1

The dedicated fentanyl panel produces a qualitative preliminary result at a cutoff of 1 ng/mL. Fentanyl is screened separately from the general OPI/MOR panel.

A non-negative fentanyl result does not identify the amount used, determine impairment or establish when exposure occurred.

Methadone metabolite – EDDP/300

EDDP is a metabolite associated with methadone. This cup includes separate MTD/300 and EDDP/300 panels, allowing the preliminary screen to evaluate methadone and its metabolite independently.

An EDDP result does not by itself establish dosage, medication adherence or whether a medication was taken as prescribed.

Tricyclic antidepressants – TCA/1000

The TCA panel provides preliminary screening for the tricyclic-antidepressant drug class at 1,000 ng/mL. It should not be interpreted as identifying a particular medication without appropriate confirmation.

What Is Not Included in This Configuration?

This particular 14-panel configuration does not list:

• EtG alcohol-metabolite screening
• K2 or synthetic cannabinoids
• Gabapentin
• PCP
• Tramadol
• Norfentanyl
• pH, specific gravity or creatinine specimen-validity indicators

Panel combinations vary significantly between products. Buyers should compare all 14 panel drug test cup configurations instead of selecting a cup based only on the panel number.

CLIA-Waived and FDA 510(k)-Cleared Status

This product is sold as a CLIA-waived 14 panel drug test cup. FDA categorizes qualifying in vitro diagnostic tests according to their testing complexity. A waived test may be performed by an eligible laboratory operating under a CLIA Certificate of Waiver or another applicable CLIA certificate.

The Serenitu Cup  multi-drug urine test cup system was cleared under FDA 510(k) K243996, and the FDA CLIA database lists applicable Serenity Multi-Drug Urine Cup analytes as waived. Review FDA 510(k) K243996.

CLIA waiver does not mean that:

• The facility is exempt from CLIA requirements
• Manufacturer instructions can be modified
• A preliminary non-negative result is laboratory-confirmed
• The test determines impairment
• The result identifies the amount or exact time of drug use
• The same designation applies to a different SKU or configuration

Facilities should verify the current package insert, device identifier and documentation before adding the cup to their testing program. Buyers can also compare additional CLIA-waived drug testing products.

Who May Use This CLIA-Waived Test Cup?

Subject to the current product labeling and applicable requirements, CLIA-waived drug tests may be used by qualified testing sites operating under an appropriate CLIA certificate.

Potential settings may include:

• Physician offices
• Medical clinics
• Urgent-care facilities
• Treatment and rehabilitation programs
• Occupational-health programs
• Qualified laboratories
• Other properly certified point-of-care testing sites

Each organization is responsible for determining whether the device, CLIA classification and analyte configuration match its testing program.

How to Use the CLIA Waived 14 Panel Drug Test Cup

Always follow the instructions supplied with the current product.

1. Check the sealed package, expiration date and storage requirements.
2. Bring the test and urine specimen to the temperature required by the instructions.
3. Collect the required specimen volume directly in the cup.
4. Secure the lid immediately after collection.
5. Check the built-in temperature strip within the period stated in the instructions.
6. Place the cup on a flat surface and start the timer.
7. Read the drug-panel results at the manufacturer’s specified time—approximately five minutes for this product.
8. Do not interpret the results after the permitted reading window.
9. Record the results according to the facility’s testing procedures.

For illustrated guidance, review how to read a drug test cup.

Confirmation and Testing Limitations

This cup produces qualitative preliminary screening results. According to FDA documentation for the test system, a more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS or LC/MS may be used as appropriate for confirmation.

A rapid urine test cannot determine:

• Current impairment
• The amount of a substance consumed
• The exact time of exposure
• Whether a medication was taken as prescribed
• A quantitative drug concentration
• A laboratory-confirmed result

Screening cutoffs should not be confused with detection windows. Detection time varies according to the substance, cutoff, specimen, metabolism, frequency of use and other factors. General educational information is available in our drug detection times guide.

Compare Other 14 Panel Configurations

Select a test according to the panels and regulatory classification required by your program.

• Compare the complete selection of 14 panel drug test cups.
• Choose a 14 panel urine drug test with EtG, fentanyl and PCP when EtG and PCP are needed instead of EDDP and TCA.
• Consider a 14 panel drug test with EtG, fentanyl and tramadol when the testing program requires a dedicated tramadol panel.
• Review the 14 panel drug screen with GAB, K2, EtG and fentanyl when gabapentin and synthetic-cannabinoid screening are priorities.

The alternative products listed above are labeled Forensic Use Only. Do not substitute them when the testing environment specifically requires a CLIA-waived device.

Bulk Pricing and Clearance Availability

Quantity pricing is displayed above the Add to Cart button. Qualifying orders of 100 or more cups receive free shipping, and eligible in-stock orders placed before 3:00 PM EST can ship the same business day.

This product is sold as a clearance configuration, so price and availability can change as the remaining inventory is purchased. Buyers planning a large order should confirm the available quantity before ordering.

Organizations purchasing multiple configurations can also review our wholesale drug testing supplies.

Frequently Asked Questions

What does this CLIA waived 14 panel drug test screen for?

It screens for AMP, BAR, BUP, BZO, COC, EDDP, fentanyl, MDMA, methamphetamine, methadone, opiates/morphine, oxycodone, TCA and THC.

What is the fentanyl cutoff?

The dedicated fentanyl panel has a preliminary screening cutoff of 1 ng/mL. It is separate from the general opiate panel.

What is EDDP on a drug test?

EDDP is a metabolite associated with methadone. This cup includes separate EDDP/300 and MTD/300 panels.

Is this 14 panel drug test CLIA waived?

Yes. This product is sold as a CLIA-waived configuration. The testing facility must still maintain the appropriate CLIA certificate and follow the manufacturer’s instructions.

Is the test FDA approved?

The correct description is FDA 510(k) cleared, not FDA approved. The applicable multi-drug urine test cup system is listed under FDA 510(k) K243996. Confirm that the current product packaging identifies the same test system before publishing this claim.

How quickly are results available?

Preliminary results are available in approximately five minutes. Follow the exact reading time and interpretation window supplied with the current device.

Does a CLIA waiver eliminate confirmation testing?

No. CLIA classification does not make a preliminary non-negative result definitive. An appropriate confirmatory method should be used according to the facility’s procedures and product instructions.

Can this product be ordered in bulk?

Yes. Quantity pricing is displayed on the product page, and qualifying orders of 100 or more cups receive free shipping. Because this is a clearance product, large orders should be confirmed against current inventory.