# K122633: Toxcup Drug Screen Cup

- Pathway: 510(k) (Traditional)
- Applicant: Branan Medical Corp.
- Decided: Feb 7, 2013 after 162 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K082898 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082898: Amedica Drug Screen Test Cup, Amedica Biotech, Inc. (2008) Summary page 2.

## Recalls of this device
- Aug 18, 2020 · Class II · Z-3032-2020: 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.
- Aug 18, 2020 · Class II · Z-3047-2020: 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.
- Aug 18, 2020 · Class II · Z-3033-2020: 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.
- Aug 18, 2020 · Class II · Z-3039-2020: 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.
- Aug 18, 2020 · Class II · Z-3031-2020: 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.
- Aug 18, 2020 · Class II · Z-3035-2020: 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.
- Aug 18, 2020 · Class II · Z-3040-2020: 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.
- Aug 18, 2020 · Class II · Z-3045-2020: 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.

## Indications for use
The ToxCup® Drug Screen Cup is an in vitro screening test for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration: AMP Amphetamine 500 ng/ml BAR Secobarbital 300 nglml BUPG Buprenorphine Glucuronide 10 ng/ml BZO Oxazepam 300 ng/ml COC Benzoylecgonine 150 nglml MDMA 3,4-methylenedioxymethamphetamine 500 ng/ml MET Methamphetamine 500 ng/ml MTD Methadone 300 ng/ml OPI Morphine 300 ng/ml OXY Oxycodone 100 ng/ml PCP Phencyclidine 25 ng/rnl PPX Propoxyphene 300 ng/ml TCA Nortriptyline 1000 ng/ml THC 11-nor-A9-Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml These tests provide visual qualitative results and are intended for in vitro diagnostic use only. The ToxCup® Drug Screen Cup is available in double drug analyte cassette dip format. It is intended for prescription point-of-care use and over-the-counter consumer use. These tests provide only a preliminary test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is confirming the results in a certified laboratory. For a quantitative result or to confirm preliminary positive results obtained by the ToxCup® Drug Screen Cup, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when a preliminary positive result is indicated.

Source page: https://510kreport.com/device/K122633
Methodology: https://510kreport.com/methodology