Identify Diagnostics USA 12 Panel Fentanyl Drug Test Cup with BUP - CLIA Waived

USA Made 12 Panel Urine Drug Test Cup with Fentanyl and Buprenorphine

The Identify Diagnostics USA 12 Panel Drug Test Cup provides rapid preliminary screening for 12 drugs and drug classes using one integrated urine collection device. This USA made configuration includes a fentanyl test panel with a 1 ng/mL cutoff and a buprenorphine panel with a 10 ng/mL cutoff.

The cup uses competitive lateral flow immunoassay technology to produce qualitative screening results. The specimen is collected directly inside the device, eliminating the need to transfer urine to a separate test. A secure threaded lid, concealed result area, internal control lines and an attached temperature strip support a straightforward collection and interpretation process.

Results are read at 5 minutes. Fresh urine specimens do not require special preparation or pretreatment before testing. The device is intended for single use with human urine only.

Drug Panels and Cutoff Concentrations

AMP Amphetamine 500 ng/mL
BAR Barbiturates 300 ng/mL
BZO Benzodiazepines 300 ng/mL
BUP Buprenorphine 10 ng/mL
COC Cocaine 150 ng/mL
MDMA Ecstasy 500 ng/mL
FEN Fentanyl 1 ng/mL
THC Marijuana 50 ng/mL
MTD Methadone 300 ng/mL
MET Methamphetamine 500 ng/mL
MOR Morphine 300 ng/mL
OXY Oxycodone 100 ng/mL

Click the icon below the view the product insert:

Designed for Efficient Urine Drug Screening

The all-in-one format combines specimen collection and rapid testing within the same cup. After the specimen has been collected, the lid is secured and the device is placed on a flat surface while the test develops. The peel-away label keeps the result panels covered until they are ready to be interpreted.

The built-in temperature strip should be checked shortly after collection. A green indicator within the acceptable temperature range helps confirm that the specimen was recently collected. The separate control line on each test strip functions as an internal procedural control by confirming adequate specimen volume, membrane wicking and proper test performance.

How to Perform the Test

Open the sealed pouch only when ready to begin testing. Remove the lid and collect the urine specimen directly in the cup. Replace and securely tighten the lid, set the cup on a flat surface and start a timer. Peel back the result label and interpret the control and test lines at 5 minutes according to the package insert.

Understanding the Results

Negative: A control line and a test line appear for the applicable panel. Any visible test line, including a faint test line, is interpreted as a negative result because the drug concentration is below the panel cutoff.

Preliminary positive: The control line appears but no test line appears for the applicable panel. This indicates that the drug or drug metabolite may be present at or above the stated cutoff concentration.

Invalid: No control line appears. An invalid result may be caused by insufficient specimen volume or an incorrect testing procedure. The test should be repeated with a new device.

Rapid Lateral Flow Immunoassay Technology

Each panel operates as a competitive lateral flow immunoassay. When a target drug is absent or present below the cutoff concentration, a visible test line forms. When the drug or drug metabolite is present at or above the cutoff, it competes for the available antibody binding sites and the corresponding test line does not form.

Preliminary Screening and Result Confirmation

This product provides a qualitative preliminary urine drug screening result. A positive result does not determine the amount of drug present, the route of administration or the level of impairment. A negative result means the concentration is below the applicable cutoff and does not necessarily establish that the specimen is completely drug-free.

When a confirmed analytical result is required, a more specific alternate method should be used. Gas chromatography mass spectrometry or liquid chromatography mass spectrometry may be used for confirmation in accordance with the applicable testing program and procedures.

Product Details

Made in the United States
CLIA Waived
FDA 510(k) cleared
12 drug screening panels
Fentanyl cutoff of 1 ng/mL
Buprenorphine cutoff of 10 ng/mL
Results read at 5 minutes
Built-in specimen temperature strip
Integrated urine collection and testing cup
Protected results beneath a peel-away label
Internal procedural control lines
Fresh urine requires no pretreatment
Designed for human urine specimens
Single-use testing device