# K982211: Profile-II Model 600582

- Pathway: 510(k) (Traditional)
- Applicant: Medtox Diagnostics, Inc.
- Decided: Jul 29, 1998 after 36 days
- Product code: DKE (Reagents, Test, Tetrahydrocannabinol)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
PROFILE-II is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids (THC), cocaine, opiates, amphetamines and phencyclidine (PCP) in human urine. The test detects the major metabolites of these drugs at the following cut-off concentrations: THC Tetrahydrocannabinol 50 ng/mL COoC Cocaine (Benzoylecgonine) 300 ng/mL OPS Opiates (Codeine/Morphine) 300 ng/mL AMP Amphetamine 1000 ng/mL PCP Phencyclidine 25 ng/mL This product is intended for use under medical supervision in hospitals, physician offices, health clinics and drug treatment/counseling centers. It is not for over-the-counter sale. PROFILE-II 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) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K982211
Methodology: https://510kreport.com/methodology