# K021114: 'Rapidtec' 5A Multiple Dip Test

- Pathway: 510(k) (Traditional)
- Applicant: American Bio Medica Corp.
- Decided: Jul 23, 2002 after 109 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- 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 K002447 (2000). 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)
- K002447: Modification to Rapid Drug Screen 9-Panel, American Bio Medica Corp. (2000) Summary page 1.

## Indications for use
‘RapidTec’-SA-Multiple Dip Test is a one-step lateral flow immunoassay for the simultaneous qualitative detection of amphetamines, benzoyl ecgonine, cannabinoids, phencyclidine, and opiates in urine. ‘RapidTec’-SA-Multiple Dip Test is intended for professional use. It is not intended for over-the-counter sales to nonprofessionals. The assay is easy to perform, but should not be used without proper supervision. This immunoassay is a simplified, qualitative 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 (GCMS.) ‘RapidTec’-SA-Multiple Dip Test provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a more confirmed result. GCMS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.

Source page: https://510kreport.com/device/K021114
Methodology: https://510kreport.com/methodology