# K983701: Modification to Abuscreen Online for Cannabinoids

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Dec 11, 1998 after 51 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- 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 K981585 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981585: Abuscreen Online for Cannabinoids (1000 Test Kit), Roche Diagnostic Systems, Inc. (1998) Summary page 2.

## Most influential descendants
- K030213: Online Dat II Cannabinoids II (2003), 0 descendants of its own

## Indications for use
Abuscreen ONLINE for Cannabinoids is an in vitro diagnostic test for the qualitative and semiquantitative detection of cannabinoids in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/mL, 50 ng/mL, and 100 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of cannabinoid use or abuse.

Source page: https://510kreport.com/device/K983701
Methodology: https://510kreport.com/methodology