# K951319: Roche Abuscreen Online for Opiates 1000 Test Kit-2000 NG/ML Cutoff Olympus AU800 Instrument Application

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Jun 1, 1995 after 70 days
- Product code: DOE (Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.)
- Device class: 2
- Regulation: 21 CFR 862.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K974840: Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates Calibration Pack, Abuscreen Online Opiates Control (1998), 3 descendants of its own
- K013482: Abuscreen Online Opiates 300 / 2000 (2001), 0 descendants of its own
- K992890: Roche Cobas Integra Opiates 300/2000 (1999), 0 descendants of its own
- K990399: Ontrak Testcup M2K, Model Cat. 11 1849 8 (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K951319
Methodology: https://510kreport.com/methodology