# K984152: Synchron Systems Opiates 2000 NG (OP2) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jan 29, 1999 after 71 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K971596: Emit II Opiates 300/2000 Assay, Behring Diagnostics, Inc. (1997). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Recalls of this device
- Sep 4, 2019 · Class II · Z-1751-2020: Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative p

## Indications for use
The SYNCHRON® Systems Opiates 2000 ng (OP2) Reagent, in conjunction with the SYNCHRON System Drugs of Abuse (DAT) Urine Calibrators, is intended for use in the qualitative determination of Opiates in human urine at a cutoff value of 2000 ng/mL, on SYNCHRON Systems.

Source page: https://510kreport.com/device/K984152
Methodology: https://510kreport.com/methodology