# K992033: Modification to 'Rapid Drug Screen' 9-Panel

- Pathway: 510(k) (Traditional)
- Applicant: American Bio Medica Corp.
- Decided: Jun 30, 1999 after 14 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 K955935 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983770: 'Rapid Drug Screen' 9-Panel, American Bio Medica Corp. (1998) Summary page 1.
- K955935: Triage Panel for Drugs of Abuse/Tricyclic Antidepressants, Biosite Incorporated (1996) Summary page 1.

## Indications for use
‘Rapid Drug Screen’ 9-Panel is a one-step, lateral flow immunoassay for the simultaneous detection of 8 abused substances and tricyclic antidepressants in urine. The “Rapid Drug Screen” 9-Panel test is intended for use in the qualitative detection of thé following 9 drugs in human urine at the following levels: d-Amphetamine 750 ng/ml Barbiturates 300 ng/ml 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 Tricyclic Antidepressants 1000 ng/ml ‘Rapid Drug Screen’ 9-Panel is intended for use by professional laboratories. 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 »reliminary result for use in determining the need for additional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS). ‘Rapid Drug Screen’ 9-Panel provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a more confirmed ahalytical 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/K992033
Methodology: https://510kreport.com/methodology