# K974840: Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates Calibration Pack, Abuscreen Online Opiates Control

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Apr 24, 1998 after 121 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: 1 generation back to K935550 (1994). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951319: Roche Abuscreen Online for Opiates 1000 Test Kit-2000 NG/ML Cutoff Olympus AU800 Instrument Application, Roche Diagnostic Systems, Inc. (1995) Summary page 2.
- K935550: Abuscreen Online Negative Cal/Control Cal Pack and Mil Calibration Pack, Roche Diagnostic Systems, Inc. (1994) Summary page 2.
- K962280: Abuscreen Online Positive Control / 1.5X Calibrator, Roche Diagnostic Systems, Inc. (1996)

## Most influential descendants
- 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

## Indications for use
The Abuscreen OnLine II for Opiates 300/2000 Reagent is an in vitro diagnostic test for the qualitative (at 300 and 2000 ng/mL cutoff) and semi-quantitative (at 2000 ng/mL cutoff) detection of morphine and its metabolites in human urine. The Abuscreen ONLINE Opiates Calibration Pack is an in vitro diagnostic device designed for the calibration of the Roche reagent assays for opiates. The Roche Abuscreen ONLINE Opiates Control Pack is an assayed quality control sample for use with the Roche assays for opiates.

Source page: https://510kreport.com/device/K974840
Methodology: https://510kreport.com/methodology