# K020716: Rapid Opiates Test Strip II, Rapid Opiates Test Card II and Doa Multiple Drug Test Cards (UP to Six Tests)

- Pathway: 510(k) (Traditional)
- Applicant: Rapid Diagnostics, Inc.
- Decided: May 6, 2002 after 62 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.
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. The FDA summary names its predicate without a number.
- (no number) Applied Biotech SureStep™ Drug Screen Test Morphine I: named in the summary without a submission number

## Indications for use
Rapid Opiates Test Card II is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Opiates and its metabolites in human urine specimens. The presence of Morphine in human urine above a cutoff level of 2,000ng/ml can be detected. The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.

Source page: https://510kreport.com/device/K020716
Methodology: https://510kreport.com/methodology