Healgen Scientific is proud to announce the FDA 510(k) clearance of the Healgen® Accurate® Oral Fluid Drug Test, a multi-analyte oral fluid screening device that strengthens our growing portfolio of rapid toxicology solutions. This non-invasive, easy-to-administer test is designed to support confident, on-the-spot decisions in workplace and clinical testing environments.
Built on competitive binding, lateral flow immunochromatographic technology, the test delivers qualitative, preliminary results for eight drugs of abuse from a single oral fluid specimen. Simultaneous detection of the drugs and/or their metabolites, at the defined cutoff concentrations listed below, is achieved. These drugs are detected in a single testing step, helping streamline oral fluid screening programs while maintaining clearly defined analytical cutoffs
| Test | Calibrator | Cutoff (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 50 |
| Cocaine (COC) | Benzoylecgonine | 20 |
| Marijuana (THC) | Delta-9-Tetrahydrocannabinol | 40 |
| Methadone (MTD) | Methadone | 30 |
| Methamphetamine (MET) | d-Methamphetamine | 50 |
| Opiates (OPI) | Morphine | 40 |
| Oxycodone (OXY) | Oxycodone | 20 |
| Phencyclidine (PCP) | Phencyclidine | 10 |
How The Test Works
The Healgen® Accurate® Oral Fluid Drug Test uses an immunoassay based on competitive binding, where any drug present in the oral fluid specimen competes with immobilized drug conjugates for antibody binding sites. When a drug is present below its cutoff concentration, a visible colored line appears in the test line region; when present above the cutoff, the test line does not form, indicating a preliminary positive result for that analyte. A control line is built into each strip to confirm adequate specimen volume and proper membrane wicking, supporting reliable test performance at the point of care.
Robust Performance Backed by Analytical Studies
Extensive analytical performance and precision studies were conducted across multiple device lots spanning a range of concentrations from well below to well above the cutoff values for each analyte. Reproducibility data demonstrate consistent negative results at concentrations below cutoff and high agreement for positive results at and above the cutoff, supporting the reliability of the test across the full panel. Additional analytical studies, including agreement with LCMS/MS results, further support the test’s performance.
A Powerful Addition to Healgen’s Toxicology Portfolio
By adding a 510(k) cleared, eight drug oral fluid test to the toxicology portfolio, Healgen Scientific offers customers more flexibility in choosing specimen types and formats that align with their testing protocols. The Accurate® Oral Fluid Drug Test complements our existing toxicology solutions and reflects our commitment to developing accessible, reliable tools that support health, safety, and compliance initiatives across a range of settings.
To explore more of Healgen Scientific’s testing options, visit the Healgen Human Health page.