510(k) · Cleared
ClearedOnline Dat II Cannabinoids II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Apr 11, 2003 as substantially equivalent to K983701 (Roche Diagnostic Systems, Inc., 1998) after an 80-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Apr 11, 2003
- Review
- 80 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981585 (1998). No later device cites it as a predicate yet.
- Root · 2 generations backK981585 Abuscreen Online for Cannabinoids (1000 Test Kit)Roche Diagnostic Systems, Inc. · 1998
- 1 generation backK983701 Modification to Abuscreen Online for CannabinoidsRoche Diagnostic Systems, Inc. · 1998
- This deviceK030213 Online Dat II Cannabinoids IIRoche Diagnostics Corp. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981585 | Abuscreen Online for Cannabinoids (1000 Test Kit) | Roche Diagnostic Systems, Inc. | 1998 | — |
| −1 | K983701 | Modification to Abuscreen Online for Cannabinoids | Roche Diagnostic Systems, Inc. | 1998 | — |
| 0 (this device) | K030213 | Online Dat II Cannabinoids II | Roche Diagnostics Corp. | 2003 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LDJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LDJ device
- #1 K232732 Rapid Marijuana (THC) Test Strip 20, Rapid…score 9.4 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K983701 | Modification to Abuscreen Online for CannabinoidsSummary page 1…me: Enzyme immunoassay, cannabinoids 3) Predicate We claim substantial equivalence to the currently marketed Abuscreen device OnLine Cannabinoids assay (K98370 1). Continued on nextpage… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All LDJ devicesLDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDJ
48in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDJ
1in 2015
MAUDE reports naming product code LDJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 4 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 219 | 0 | 0 |
| 2012 | 4 | 193 | 0 | 0 |
| 2013 | 3 | 162 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 48 | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030213: Online Dat II Cannabinoids II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030213
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026