510(k) · Cleared
ClearedModification to Abuscreen Online for Cannabinoids
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Dec 11, 1998 as substantially equivalent to K981585 (Roche Diagnostic Systems, Inc., 1998) after a 51-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Dec 11, 1998
- Review
- 51 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981585 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK981585 Abuscreen Online for Cannabinoids (1000 Test Kit)Roche Diagnostic Systems, Inc. · 1998
- This deviceK983701 Modification to Abuscreen Online for CannabinoidsRoche Diagnostic Systems, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK030213 Online Dat II Cannabinoids IIRoche Diagnostics Corp. · 2003
Most influential descendants
Showing 1 of 1 · See all- K030213Online Dat II Cannabinoids IIRoche Diagnostics Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981585 | Abuscreen Online for Cannabinoids (1000 Test Kit) | Roche Diagnostic Systems, Inc. | 1998 | — |
| 0 (this device) | K983701 | Modification to Abuscreen Online for Cannabinoids | Roche Diagnostic Systems, Inc. | 1998 | — |
| +1 | K030213 | Online Dat II Cannabinoids II | Roche Diagnostics Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
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 |
|---|---|---|---|
| * | K981585 | Abuscreen Online for Cannabinoids (1000 Test Kit)Summary page 2…gnostic Systems, Inc. claims equivalence. Table 2 Product Name Predicate Product 510(k) Number and Date Name Predicate Cleared Abuscreen ONLINE for Abuscreen ONLINE for K981585 6/28/98 Cannabinoids Cannabinoids 029 Roche Diagnostic Systems. Inc. Abuscreen ONLINE® Cannabinoids somerville.… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030213 | Online Dat II Cannabinoids II | 2003 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K030213 (Roche Diagnostics Corp., 2003) has gone furthest, with 0 descendants of its own.
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?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983701 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983701: Modification to Abuscreen Online for Cannabinoids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983701
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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