# K013482: Abuscreen Online Opiates 300 / 2000

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 21, 2001 after 63 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
Longest line of descent: 2 generations back to K935550 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974840: Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates Calibration Pack, Abuscreen Online Opiates Control, Roche Diagnostic Systems, Inc. (1998) Summary page 1.

## Indications for use
An in vitro diagnostic test for the qualitative and semi-quantitative detection of morphine and its metabolites in human urine on automated clinical chemistry analyzers at cutoff concentrations of 300 and 2000 ng/mL. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

Source page: https://510kreport.com/device/K013482
Methodology: https://510kreport.com/methodology