Quick answer: FDA-cleared urine drug test cups are CLIA-waived screening devices that detect drug metabolites at fixed cutoffs, such as THC at 50 ng/mL and cocaine metabolite at 150 ng/mL, for clinics, courts and employers. Every positive is preliminary; confirm by GC/MS or LC-MS/MS laboratory testing. American Screening Corp ships wholesale cups same-day nationwide.
- Buy only cups whose package insert lists the FDA 510(k) clearance and CLIA-waived status and states each cutoff in ng/mL.
- Match the panel and cutoffs to your program: federal-style cutoffs for regulated work, a broader panel for treatment and probation.
- Plan lab confirmation before you buy. A screen is never a final result on its own.
What does a wholesale buyer need to verify first?
Verify three documents: the FDA clearance listing, the CLIA-waived categorization, and the package insert. Together they show the device is cleared for its intended use and may be run in a waived-testing site. CLIA is the Clinical Laboratory Improvement Amendments program, administered with the CDC and CMS (CDC, "Clinical Laboratory Improvement Amendments (CLIA)", as of 2026).
Need drug tests for your clinic, program or workplace?
American Screening Corp has supplied FDA-cleared, CLIA-waived tests at wholesale pricing since 2004. Popular options:
Ordering 100+ tests? Request volume pricing.
Ask the supplier for lot numbers, expiration dating, and storage requirements. Reject any listing that cannot show these.
What do urine drug test cups detect, and at what cutoffs?
A urine cup is an immunoassay screen. It detects a drug or its metabolite when the concentration meets or exceeds a cutoff, measured in nanograms per milliliter (ng/mL). Federal workplace programs use the initial-test cutoffs in the HHS Mandatory Guidelines for Urine (SAMHSA, "Mandatory Guidelines for Federal Workplace Drug Testing Programs", as of 2026).
| Drug class | Initial cutoff (ng/mL) | Typical urine window |
|---|---|---|
| Marijuana metabolite (THCA) | 50 | 1-3 days occasional use; longer with heavy use |
| Cocaine metabolite (benzoylecgonine) | 150 | 2-4 days |
| Amphetamine / methamphetamine | 500 | 2-4 days |
| Opiates (codeine/morphine) | 2,000 | 1-3 days |
| Phencyclidine (PCP) | 25 | 3-8 days |
Windows vary with dose, frequency, metabolism and hydration. Always read the cutoffs printed on the specific cup you buy, because non-federal panels can use different values.
Which panel fits which buyer?
Clinics and treatment centers
Choose multi-drug panels that add benzodiazepines, buprenorphine, methadone and fentanyl where your protocols need them. Cups with built-in adulterant checks help document specimen validity.
Courts and probation
Choose panels aligned to the conditions of supervision. Document chain of custody and send every presumptive positive for laboratory confirmation.
Employers and staffing firms
Choose the panel named in your written policy. Regulated transportation testing follows DOT rules, which require specific collection and lab procedures (DOT, 49 CFR Part 40, "Procedures for Transportation Workplace Drug and Alcohol Testing Programs", as of 2026). A point-of-collection cup does not replace those procedures.
Cups or dip cards?
A cup is a closed container that holds the specimen, shows results in a window, and often includes a temperature strip. A dip card is a lower-cost strip format where the user dips the card into a collected specimen. Cups suit high-volume intake and supervised programs; wholesale drug test cups reduce handling steps and spill risk. Dip cards suit budget-driven bulk purchasing and low-volume sites.
Wholesale buyer checklist
- FDA 510(k) clearance and CLIA-waived status confirmed on the package insert
- Cutoffs listed in ng/mL for every analyte on the panel
- Lot number and expiration date on each case; at least several months of shelf life at delivery
- Temperature strip and adulterant checks if specimen validity matters to you
- Storage and operating temperature requirements met at your site
- Written instructions for reading results and a trained staff member
- A named laboratory for GC/MS or LC-MS/MS confirmation
- Shipping speed, return terms and a reachable account contact
- Private label or custom panel options if you resell
How do you read and act on a result?
- Check the temperature strip within the time stated in the insert.
- Wait the specified read time and do not read after the stated limit.
- Read each line: a visible line in the control region confirms the test ran, and for most cups a line in a drug region means negative.
- Treat any missing line in a drug region as a non-negative, preliminary result.
- Record the result and send the specimen for laboratory confirmation by GC/MS or LC-MS/MS.
A preliminary result is not proof of drug use. Prescription medications and some foods or products can cross-react, so decisions should wait for confirmation and, where applicable, review by a qualified professional.
Why buy wholesale from American Screening Corp?
American Screening Corp in Shreveport, Louisiana supplies drug and alcohol testing products to clinics, hospitals, treatment centers, courts, labs and staffing firms, with same-day shipping nationwide. We also offer lab confirmation, private label and DOT-compliant collection kits. Our support team regularly helps buyers match panels and cutoffs to a written policy; contact our wholesale team for a quote. Employers pairing testing with hiring can also use our sister division, Reveal Background, for employment background checks.
Frequently asked questions
Are all urine drug test cups FDA-cleared?
No. Confirm the 510(k) clearance and CLIA-waived status on the package insert and with the supplier before buying in bulk.
What cutoff should a wholesale buyer choose?
Use federal HHS initial cutoffs for regulated programs, such as 50 ng/mL for THCA. For other programs, follow your written policy and the cutoffs printed on the cup.
Does a positive cup result need confirmation?
Yes. Every positive screen is preliminary; confirm by GC/MS or LC-MS/MS laboratory testing before any action.
Can a cup replace DOT collection?
No. DOT-regulated tests must follow 49 CFR Part 40 collection, laboratory and review procedures.
Sources
- SAMHSA: Mandatory Guidelines for Federal Workplace Drug Testing Programs
- CDC: Clinical Laboratory Improvement Amendments (CLIA)
- U.S. DOT: 49 CFR Part 40
This is general information, not legal or medical advice.
