# K033334: Profile -ER

- Pathway: 510(k) (Special)
- Applicant: Medtox Diagnostics, Inc.
- Decided: Nov 10, 2003 after 25 days
- Product code: DIS (Enzyme Immunoassay, Barbiturate)
- Device class: 2
- Regulation: 21 CFR 862.3150
- 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
The 3 Panel TCA/BAR/BZO is a one-step immunochromatographic test for the rapid, qualitative detection of tricyclic antidepressants, barbiturates and benzodiazepines and their metabolites. The test detects the major metabolites of these drugs at the following cutoff concentrations: Tricyclis antidepressants (Desipramine) - 50 n g / d Barbiturates (Phenobarbital)-200 ng/ml Benzodiazepines (Nordiazepam)-300 n g / d This product is not for over-the-counter-sale The 3 Panel 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 (GCMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result

Source page: https://510kreport.com/device/K033334
Methodology: https://510kreport.com/methodology