# K023489: Quicktox Multiple Drug Dipcard

- Pathway: 510(k) (Special)
- Applicant: Branan Medical Corp.
- Decided: Dec 16, 2002 after 60 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- 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 QuickToxTM Multiple Drug Dipcard is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine). morphine, methamphetamine, THC, amphetamines, phencyclidine., benzodiazepinc (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine. The cutoff concentrations are as follow: COC Benzoylecgon ine 300 ng/ml MOR2000 Morphine 2000 2000 ng/ml MOR300 Morphine 300 300 ng/ml MET1000 Methamphetamine 1000 1000 ng/ml MET500 Methamphetamine 500 500 ng/ml THC 11-nor-A9-Tetrahydrocannabinol-9-carboxylicacid 50 ng/ml AMP Amphetamine 1000 ng/ml PCP Phencyclidine 25 ng/ml BZO 0xazep a m 300 ng/ml BAR Secobarbital 300 ng/ml MTD Mettiadone 300 ng/ml TCA Nortriptyline 1000 ng/ml The QuickToxTMMultiple Drug Dipcard is used to obtain visual, qualitative results for multiple drugs-of-abused in humane urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.

Source page: https://510kreport.com/device/K023489
Methodology: https://510kreport.com/methodology