Saliva Screen 1 Panel Healgen Drug Test Kit for Cotinine, FDA 510(k), CLIA Waived

Healgen Saliva Screen 1 Panel Cotinine Drug Test Kit provides a fast, non-invasive oral-fluid screening option for recent nicotine and tobacco use. This single-use saliva test detects cotinine, a primary metabolite of nicotine, at a 30 ng/mL cutoff and delivers clear, line-based results in 10 minutes—without urine collection or handling. Each box contains 25 FDA 510(k)-cleared, CLIA-waived test devices for workplace, clinical, insurance, smoking-cessation, and drug-free program screening.

Product Specifications

Key Features

• Single-panel cotinine screen: Detects cotinine, a primary nicotine metabolite, in oral fluid at a 30 ng/mL cutoff level.
• Supports tobacco-use screening: Provides screening information related to recent use of cigarettes, cigars, pipe tobacco, smokeless tobacco, and other nicotine-containing products.
• Non-invasive saliva collection: Provides an alternative to urine-based testing with no urine collection or handling required.
• Rapid results: Delivers preliminary, line-based screening results at 10 minutes.
• Simple, single-use format: Designed for convenient professional oral-fluid screening workflows.
• FDA 510(k)-cleared and CLIA-waived: Designed for eligible professional point-of-care testing settings.
• 12–18 month shelf life: Supports inventory planning for ongoing screening programs.
• 25 tests per box: Suitable for workplaces, clinics, smoking-cessation programs, insurance evaluations, and drug-free program testing.

Simple Test Procedure

1. Open the sealed test device and follow the package instructions before collection.
2. Collect oral fluid with the device according to the manufacturer’s directions.
3. Place the device as directed and allow the test to develop.
4. Read and interpret the cotinine screening result at 10 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 a negative result. This device provides preliminary screening results; follow applicable program procedures for confirmation of presumptive positive results.

Frequently Asked Questions

What does this saliva test detect?

This Healgen oral-fluid screening test detects cotinine, a primary metabolite of nicotine, at a 30 ng/mL cutoff level.

What types of nicotine use can cotinine screening help identify?

Cotinine screening can provide information related to recent nicotine or tobacco use, including cigarettes, cigars, pipe tobacco, smokeless tobacco, and other nicotine-containing products.

How long does it take to get results?

Read and interpret the test result at 10 minutes after following the collection procedure.

Does this test require a urine sample?

No. This test uses oral fluid/saliva, providing a non-invasive alternative to urine-based screening.

How many tests are included per box?

Each box contains 25 individual Healgen cotinine saliva test devices.

Is this product CLIA waived?

Yes. This product is 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 result interpretation.