# K030213: Online Dat II Cannabinoids II

- Pathway: 510(k) (Abbreviated)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 11, 2003 after 80 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: 2 generations back to K981585 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983701: Modification to Abuscreen Online for Cannabinoids, Roche Diagnostic Systems, Inc. (1998) Summary page 1.

## Indications for use
Cannabinoids II (THC 11) 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. 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/K030213
Methodology: https://510kreport.com/methodology