# K991883: Redi-Test Opiates

- Pathway: 510(k) (Traditional)
- Applicant: Advantage Diagnostics Corp.
- Decided: Sep 15, 1999 after 105 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) DRI, Opiate Enzyme Immunoassay: named in the summary without a submission number

## Indications for use
The Redi-Test Opiates is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of opiates at a cut off concentration of 300ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.

Source page: https://510kreport.com/device/K991883
Methodology: https://510kreport.com/methodology