# K022355: Quicktox Multiple Drug Dipcard Coc/Met/THC/Amp/PCP/Bzo/Bar/MTD/Tca, Model QT61

- Pathway: 510(k) (Special)
- Applicant: Branan Medical Corp.
- Decided: Jul 30, 2002 after 11 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: 4 (0 Class I)
- 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.

## Recalls of this device
- Aug 18, 2020 · Class II · Z-3034-2020: Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
- Feb 15, 2019 · Class III · Z-0692-2020: Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere iScreen Drugs of Abuse Dip Test (P/N X11-IS10-22015-DX LOT #188744)
- Dec 15, 2017 · Class III · Z-1542-2018: The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box.
- Jun 26, 2017 · Class III · Z-3084-2017: The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly.

## Indications for use
The QuickToxTMMultiple Drug Dipcard is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine), morphine, methamphetamine, TKC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine. The cutoff concentrations are as follow: COC Benzoylecgonine 300 ng/ml MOR Morphine 2000 ng/ml MET Metham hetamine 1000 ng/mI THC 11-nor-A⁹-Tetrahydrocannabinol-9-carboxylicacid 50 ng/ml AMP Amphetamine 1000 ng/ml PCP Phencyclidine 25 ng/ml BZO Oxazepam 300 ng/ml BAR Secobarbital 300 ng/ml MTD Methadone 300 ng/ml TCA Nortriptyline 1000 ng/ml The QuickToxm Multiple 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/K022355
Methodology: https://510kreport.com/methodology