# K981584: Abuscreen Online for Cannabinoids (100 Test Kit)

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: May 28, 1998 after 24 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 K913414 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913414: Abuscreen (R) Online (TM) for THC (50/100)(100TEST KT, Roche Diagnostic Systems, Inc. (1991) Summary page 2.

## Indications for use
The Abuscreen ONLINE for Cannabinoids (100 Test Kit) is an in vitro diagnostic test for the qualitative and semi-quantitative detection of cannabinoids in human urine at 50 and 100 ng/mL cutoffs and the qualitative detection at 20 ng/mL cutoff. 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/K981584
Methodology: https://510kreport.com/methodology