510(k) · Cleared
ClearedCannabinoids
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Mar 13, 2002 as substantially equivalent to K904571 (Syva Co., 1990) after a 166-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Mar 13, 2002
- Review
- 166 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904571 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK904571 Emit (R) II Cannabinoid 50 NG AssaySyva Co. · 1990
- This deviceK013247 CannabinoidsAbbott Laboratories · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904571 | Emit (R) II Cannabinoid 50 NG Assay | Syva Co. | 1990 | — |
| 0 (this device) | K013247 | Cannabinoids | Abbott Laboratories | 2002 | — |
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 |
|---|---|---|---|
| * | K904571 | Emit (R) II Cannabinoid 50 NG AssaySummary page 2…can be measured spectrophotometrically. Substantial Equivalence: The Cannabinoids assay is substantially equivalent to the Emit® Il Cannabinoid assay (K904571) on the SYVA®-30R Analyzer. Borh assays yield similar Performance Characteristics. Similarities: « Both assays are in vitro im… | 1990 |
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?
- Its one ancestor has no 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?
The Cannabinoids assay is used for the qualitative analysis of cannabinoids in human urine with a cutoff of 50 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoids use or overdose. The Cannabinoids assay is calibrated with 11-nor-A°-THC-9-COOH and will detect a variety of —A’-THC metabolites. The Cannabinoids assay provides only a preliminary analytical test result. A more…
Read the full statement (115 words)
The Cannabinoids assay is used for the qualitative analysis of cannabinoids in human urine with
a cutoff of 50 ng/mL for use in clinical laboratories. Measurements obtained by this device are
used in the diagnosis and treatment of cannabinoids use or overdose.
The Cannabinoids assay is calibrated with 11-nor-A°-THC-9-COOH and will detect a variety of
—A’-THC metabolites.
The Cannabinoids assay provides only a preliminary analytical test result. A more specific
alternate chemical method must be used in order to obtain a confirmed analytical result. Gas
chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical
consideration and professional judgment should be applied to any drug of abuse test result,
particularly when preliminary positive results are used.
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/K013247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013247: Cannabinoids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013247
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026