Healgen 14 Panel Rapid Drug Test, CLIA Waived

Healgen 14 Panel Rapid Urine Drug Test Cup provides fast, professional point-of-care screening for 14 major drug classes in one convenient collection cup. Available in two configurations, this CLIA-waived, FDA 510(k)-cleared product delivers easy-to-read preliminary results in just 5 minutes for workplace, healthcare, rehabilitation, occupational-health, and pre-employment testing programs.

Product Specifications

Brand	Healgen Scientific
Available SKUs	HCDOAV-1145 and HCDOAV-1145A3
Test Format	14-panel rapid urine drug test cup
HCDOAV-1145 Panel	AMP1000-BAR300-BUP10-BZO300-COC300-MDMA500-MET1000-MOP300-MTD300-OXY100-PCP25-PPX300-TCA1000-THC50
HCDOAV-1145A3 Panel	AMP1000-BAR300-BUP10-BZO300-COC300-MDMA500-MET1000-MTD300-OPI2000-OXY100-PCP25-PPX300-TCA1000-THC50, plus AD (OX, SG, pH)
Specimen Type	Urine
Result Time	Read at 5 minutes
Temperature Check	90–100°F acceptable; observe temperature strip between 2 and 4 minutes after collection
Quantity	25 test cups per box
Result Display	Line-based
Test Method	Rapid diagnostic test (RDT); point-of-care test
Classification	FDA 510(k) Cleared and CLIA Waived
Intended Setting	Professional workplace, clinical, occupational-health, correctional, forensic, and point-of-care screening programs

Key Features

• Two 14-panel configurations: Select a standard 14-panel cup or a 14-panel cup with integrated adulterant checks.
• Rapid 5-minute results: Supports efficient, on-site preliminary drug screening without instrumentation.
• Integrated no-step cup design: Combines specimen collection and drug testing in one self-contained device.
• Leak-resistant Click Seal cap: Helps reduce spills and contamination risk during specimen collection and handling.
• Built-in temperature strip: Supports specimen-temperature verification shortly after collection.
• Adulterant-check option: Variant HCDOAV-1145A3 includes oxidants, specific gravity, and pH checks for added specimen-validity information.
• FDA 510(k) cleared and CLIA waived: Suitable for eligible professional point-of-care testing settings.
• Up to 99% accuracy: Validated against laboratory GC/MS methods for consistent screening performance.
• Long shelf life: Stable for up to 24 months to support inventory planning.
• SAMHSA-compliant cutoff levels: Supports standardized professional drug-screening practices.
• Confirmation-ready design: Supports secure specimen handling when laboratory confirmation is required.

Simple Test Procedure

• 1.
  Collect the urine specimen directly in the test cup, ensuring it reaches the minimum fill line.
• 2.
  Recap the cup securely and place it on a clean, flat surface.
• 3.
  Observe the integrated temperature strip between 2 and 4 minutes after collection. A temperature reading from 90–100°F is acceptable.
• 4.
  Peel back the result label to expose the test-result window.
• 5.
  Read and interpret the drug-screen results at 5 minutes.

How to Interpret Results

Important: No meaning is attributed to test-line color, intensity, or width. A faint test line is still interpreted as negative. This device provides preliminary screening results only; follow applicable program procedures for confirmatory laboratory testing when required. Adulterant checks apply only to variant HCDOAV-1145A3.

Frequently Asked Questions

What is the difference between HCDOAV-1145 and HCDOAV-1145A3?

HCDOAV-1145 is the standard 14-panel urine drug test cup and includes MOP300. HCDOAV-1145A3 includes OPI2000 instead and adds specimen-validity checks for oxidants, specific gravity, and pH.

What drugs do these 14-panel test cups screen for?

Both variants screen for amphetamine, barbiturates, buprenorphine, benzodiazepines, cocaine, MDMA, methamphetamine, methadone, oxycodone, phencyclidine, propoxyphene, tricyclic antidepressants, and marijuana/THC. HCDOAV-1145 includes morphine/opiates at MOP300, while HCDOAV-1145A3 includes opiates at OPI2000.

Which variant includes adulterant checks?

HCDOAV-1145A3 includes oxidants (OX), specific gravity (SG), and pH checks. HCDOAV-1145 does not include adulterant testing.

When should results be read?

Read and interpret the drug-screen results at 5 minutes after collecting the specimen and preparing the cup according to the instructions.

How many test cups are included per box?

Each variant is supplied in a box of 25 test cups.

Is this product CLIA waived?

Yes. Both variants are FDA 510(k) cleared and CLIA waived for eligible professional point-of-care testing settings.

What does a faint test line mean?

A faint test line is interpreted as a negative result. Test-line color, intensity, and width do not change the interpretation.