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510(k) Data Aggregation
(185 days)
The Healgen® Accurate Oral Fluid Drug Test COT/THC is a lateral flow chromatographic immunoassay for the qualitative detection of cotinine (COT) and/or marijuana (THC) in oral fluid at the following cut-off concentrations:
| Test | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Cotinine (COT) | (-) Cotinine | 30 |
| Marijuana (THC) | Delta-9-Tetrahydrocannabinol | 40 |
This test provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Liquid chromatography mass spectrometry (LC/MS) is the preferred method for the confirmation test.
The Healgen® Accurate Oral Fluid Drug Test is a competitive binding lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Marijuana (THC) and Cotinine in human oral fluid at the cutoff concentrations listed below and their metabolites:
| Test | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Cotinine (COT) | (-) Cotinine | 30 |
| Marijuana (THC) | Delta-9-Tetrahydrocannabinol | 40 |
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography mass spectrometry (GC/MS) and liquid chromatography mass spectrometry (LC/MS) are the preferred confirmatory methods.
The Healgen® Accurate Oral Fluid Drug Test COT/THC and Healgen® Accurate Oral Fluid Drug Test are immunochromatographic assays that uses a lateral flow system for the qualitative detection of cotinine and marijuana in human oral fluid. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
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