510(k) · Cleared
ClearedImmulite Cannabinoids
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Apr 28, 1997 as substantially equivalent to K961620 (Roche Diagnostic Systems, Inc., 1996) and 1 other predicate after a 210-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Apr 28, 1997
- Review
- 210 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K930007 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK930007 Immulite TSH Third Generation ControlDiagnostic Products Corp. · 1993
- This deviceK963916 Immulite CannabinoidsDiagnostic Products Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930007 | Immulite TSH Third Generation Control | Diagnostic Products Corp. | 1993 | — |
| 0 (this device) | K963916 | Immulite Cannabinoids | Diagnostic Products Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K961620 | Abiscreen Online for Cannabinoids - ES 50/100Summary page 2…(DPC) 3700 West 96th Strect Los Angeles. CA 90043-3597 Establishment Registration #: DPC: 2017183 Substantial Equivalent Predicate Device: Roche Abuscreen Online THC (K961620) Abbott AxSYM Cannabinoids (K95128&) and DPC's Third Generation TSH Control Module (K930007) Description and Intended Use of De… | 1996 |
| Kept off the family tree | K951288 | FDA’s K951288 is Axsym Cannabinoids Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1995 |
| * | K930007 | Immulite TSH Third Generation ControlSummary page 2…017183 Substantial Equivalent Predicate Device: Roche Abuscreen Online THC (K961620) Abbott AxSYM Cannabinoids (K95128&) and DPC's Third Generation TSH Control Module (K930007) Description and Intended Use of Device: IMMULITE® Cannabinoids is a solid-phase. chemiluminescent enzyme immunoassay designed… | 1993 |
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?
- 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?
IMMULITE® Cannabinoids is a solid-phase. chemiluminescent enzyme immunoassay designed for use with the IMMULITE" Automated Analyzer for the semiquantitative and qualitative measurement for cannabinoids and metabolites in urine. It is intended strictly for in vitro diagnostic use in the context of a program involving an established confirmatory test for tetrahydrocannabinol (THC. cannabis. marijuana) and its metabolites
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/K963916 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963916: Immulite Cannabinoids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963916
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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