510(k) · Cleared
ClearedSynchron Systems Cannabinoid 20 NG Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Apr 3, 1996 as substantially equivalent to K940158 (Syva Co., 1995) and 2 other predicates after a 110-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Apr 3, 1996
- Review
- 110 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K943998 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK943998 Cannabinoid Eia AssayDiagnostic Reagents, Inc. · 1994
- This deviceK955677 Synchron Systems Cannabinoid 20 NG ReagentBeckman Instruments, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943998 | Cannabinoid Eia Assay | Diagnostic Reagents, Inc. | 1994 | — |
| 0 (this device) | K955677 | Synchron Systems Cannabinoid 20 NG Reagent | Beckman Instruments, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K940158 | Emit Iic Cannabinoid Assay Our OCR of the scanned summary read K840158, FDA’s number for Kosmedico GMBH Sunlamp Products (Kosmedico, Kosmetische & Medizinisch). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Emit II Cannabinoid 20 ng Assay”. | 1995 |
| * | K943998 | Cannabinoid Eia AssaySummary page 1…s Cannabinoid test system (21 CFR 862.3870) 4.0 Predicate Device(s) Emit || Cannabinoid 20 ng Assay, Syva Company, K840158 Cannabinoid Reagent, Diagnostic Reagents, Inc, K943998 THC Urine Calibrators and Controls, Diagnostic Reagents, Inc., K944701 50 Description The SYNCHRON Cannabinoid 20 ng Reagent is a… | 1994 |
| * | K944701 | CalibratorsSummary page 1…t || Cannabinoid 20 ng Assay, Syva Company, K840158 Cannabinoid Reagent, Diagnostic Reagents, Inc, K943998 THC Urine Calibrators and Controls, Diagnostic Reagents, Inc., K944701 50 Description The SYNCHRON Cannabinoid 20 ng Reagent is an enzyme immunoassay reagent test kit for the SYNCHRON Systems and prov… | 1994 |
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 3 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?
The SYNCHRON Systems Cannabinoid 20 ng Reagent, in conjunction with the SYNCHRON Systems THC Urine Calibrators, is intended for use in the qualitative determination of cannabinoids in human urine samples. This assay is designed for use with the family of SYNCHRON Systems, which include analyzers such as the SYNCHRON® CX4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.
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/K955677 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955677: Synchron Systems Cannabinoid 20 NG Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955677
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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