# K981705: 'Rapid Drug Screen' 8 Panel-Low Volume

- Pathway: 510(k) (Traditional)
- Applicant: American Bio Medica Corp.
- Decided: Aug 27, 1998 after 105 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
“Rapid Drug Screen” $-Panel low volume test is a one-step, lateral flow immunoassay for the simultaneous detection of eight abused substances in urine (each assay occupies a separate channel). “Rapid Drug Screen” 8-Panel low volume test is intended for use in the qualitative detection of the following 8 drugs of abuse in human urine at the following levels: d-Amphetamine 750 ng/ml Barbiturates 300 ng/m! Benzodiazepines 300 ng/ml Benzoyl ecognine ) 225 ng/ml Cannabinoids (11-nor-9-carboxy-delta-9-THC) 50 ng/ml Methamphetamine 1000 ng/ml Opiates (codeine) 225 ng/ml (morphine-3-glucuronide) 225 ng/ml Phencyclidine (PCP) 19 ng/ml “Rapid Drug Screen” 8-Panel low volume test is intended for use by professional laboratories and physicians offices in a clinical setting. The assays are easy to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative screening method that provides only a preliminary analytical test result for use in determining the need for additional or confirmatory testing (i.e., gas chromatography/mass spectrometry (GC/MS)). “Rapid -Drug Screen” 8-Panel low volume 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/K981705
Methodology: https://510kreport.com/methodology