# K073078: Rapid Tox Cup

- Pathway: 510(k) (Traditional)
- Applicant: American Bio Medica Corp.
- Decided: May 30, 2008 after 212 days
- Product code: LAG (High Pressure Liquid Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K012159 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041712: 'Rapidtec 4' Test, American Bio Medica Corp. (2004) Summary page 1.
- K023869: 'Rapidtec'-5M-Multiple Dip Test, American Bio Medica Corp. (2003) Summary page 1.
- K053359: Rapidtox, American Bio Medica Corp. (2006) Summary page 1.

## Indications for use
Rapid Tox CupTM is a one-step, lateral flow immunoassay contained in a polypropylene cup for the simultaneous detection of abused drugs in urine. 'Rapid Tox Cup'- is intended for use in the qualitative detection of the following 14 drugs of abuse in human urine at the following levels: Amphetamine 1000 ng/mL Amphetamine 500 ng/mL Methamphetamine 1000 ng/mL Methamphetamine 500 ng/mL 3,4-methylenedioxymethamphetamine (MDMA) 1000 ng/mL 3,4-methylenedioxymethamphetamine (MDMA) 500 ng/mL Buprenorphine 12.5 ng/mL Benzodiazepines (Oxazepam) 300 ng/mL Barbiturates (Butalbital) 300 ng/mL Oxycodone 100 ng/mL Methadone 300 ng/mL Phencyclidine 25 ng/mL Propoxyphene 300 ng/mL Opiates 300 ng/mL Opiates 2000 ng/mL Cocaine (Benzoylecgonine) 300 ng/mL Cocaine (Benzoylecgonine) 150 ng/mL Tricyclic Antidepressants (Nortriptyiline) 1000 ng/mL THC/ Cannabinoids (11 norA9-THC-9-carboxylic acid) 50 ng/mL 'Rapid Tox Cup' is intended for professional use. It is not intended for over-the-counter sale to non-professionals. This assay is a simplified screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas-chromatography/mass spectrometry (GC/MS). The barbiturate BAR, benzodiazepine BZO and tricyclic antidepressant TCA will yield preliminary positive results when BAR, BZO, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, or tricyclic antidepressant in urine. Certain foods or medicines may interfere with tests for Barbiturates, Benzodiazepines, and Tricyclic Antidepressants and may cause positive results. There is no calibration necessary and therefore no calibrator needed for this device. 'Rapid Tox Cup' provides only a preliminary analytical result. A more specific alternate method must be used in order to obtain a more confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K073078
Methodology: https://510kreport.com/methodology