# K023869: 'Rapidtec'-5M-Multiple Dip Test

- Pathway: 510(k) (Traditional)
- Applicant: American Bio Medica Corp.
- Decided: Apr 30, 2003 after 161 days
- Product code: DJR (Enzyme Immunoassay, Methadone)
- Device class: 2
- Regulation: 21 CFR 862.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K012159 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012159: Rapid Drug Screen, American Bio Medica Corp. (2001) Summary page 1.

## Most influential descendants
- K073078: Rapid Tox Cup (2008), 0 descendants of its own

## Indications for use
‘RapidTec’-SM-Mdtiple Dip Tes? is a om-step lateral flow immunoassay for the simultaneousqualitative detcction of inetharnphetamjnes, b e b y 1 ecgonine, cannabinoids, phencyclidine, and opiates in urine. ‘RapidTec’-SMrnultiple Dip Test Wiu dctect these &es #t the following concentrations: Methamphetamines: 1000 @ml Benzoyl ecgoninc 300 ng/ml Cannabinoids 50 ng/mI Phencylidine 25 @ml Opiates 2000 nghnl 300 ndmJ ‘Rapid Ted-5M-Multiple Dip Test is intended for professional use. It is not intended for over-thc-counter sale to nonprofessionals. The assay is casy to perform, but should not bc used without proper supervision. This immunoassay is a simplified, qualitative scrccnhg method that provides only a preliminary result for use in determining thc rmd for additional or confirmatory testing, i.e. gas chromatogaphy/mass spectromctry (GCIMS). ‘RapidTec’-SM-MultipleDip T e t provides onty a preliminary analytical result A more specific alternate cticmical method must be used in order to obtain. A more confirmed resuIt. G C M S is the preferred confirmatory method. Clinical and professional judgment should he apptied to any drug of abuse test result, particularly whcn pdiminary results are used.

Source page: https://510kreport.com/device/K023869
Methodology: https://510kreport.com/methodology