# K955677: Synchron Systems Cannabinoid 20 NG Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Apr 3, 1996 after 110 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943998 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940158: Emit Iic Cannabinoid Assay, Syva Co. (1995). 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”.
- K943998: Cannabinoid Eia Assay, Diagnostic Reagents, Inc. (1994) Summary page 1.
- K944701: Calibrators, Diagnostic Reagents, Inc. (1994) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K955677
Methodology: https://510kreport.com/methodology