# K990820: Rapidone - Opiates Test

- Pathway: 510(k) (Traditional)
- Applicant: American Bio Medica Corp.
- Decided: Jul 15, 1999 after 126 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K971961: Forefront Diagnostics, Inc. ‘Instacheck’ Drug Screen - Morphine 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.

## Most influential descendants
- K993151: Radid Drug Screen 5-Panel Test (2000), 0 descendants of its own

## Indications for use
‘RapidOne’ - Opiates Test is a one-step, lateral flow immunoassay for the detection of morphine in urine. ‘RapidOne’ - Opiates Test is intended for use in the qualitative detection of morphine in human urine at 300 ng/ml. ‘RapidOne’ - Opiates 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) or HPLC. ‘RapidOne’ - Opiates 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/K990820
Methodology: https://510kreport.com/methodology