# K993151: Radid Drug Screen 5-Panel Test

- Pathway: 510(k) (Traditional)
- Applicant: American Bio Medica Corp.
- Decided: Jan 10, 2000 after 111 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- 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 K990818 (1999). 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)
- K990820: Rapidone - Opiates Test, American Bio Medica Corp. (1999) Summary page 1.
- K990822: Rapidone - Cocaine Test, American Bio Medica Corp. (1999) Summary page 1.
- K990818: Rapidone - Marijuana Test, American Bio Medica Corp. (1999) Summary page 2.
- K992452: Rapidone-Amphetamine Test, American Bio Medica Corp. (1999). Cleared while this submission was under review Summary page 1.

## Cited in the summary but kept off the family tree
- K980084: ‘InstaCheck’ PCP Test. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
‘Rapid Drug Screen’ 5-Panel test is a one-step, lateral flow immunoassay for the simultaneous detection of 5 abused substances in urine (each assay occupies a separate channel). ‘Rapid Drug Screen’ 5-Panel test is intended for use in the qualitative detection of the following 5 drugs of abuse in human urine at the following levels: d-Amphetamine 1000 ng/ml Benzoyl ecgonine 300 ng/ml Cannabinoids 50 ng/ml Opiates 300 ng/ml Phencyclidine (PCP) 25 ng/ml ‘Rapid Drug Screen’ 5-Panel test is intended for professional use. It is not intended for over the counter sale to non-professionals. 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 (GC/MS). ‘Rapid Drug Screen’ 5-Panel test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K993151
Methodology: https://510kreport.com/methodology