# K031002: Synchron Systems Opiate Reagent

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Apr 29, 2003 after 29 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
Longest line of descent: 1 generation back to K944606 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944606: CX Opiate Reagent for Synchron CX Systems, Beckman-Diagnostic Systems Group (1994) Summary page 1.

## Recalls of this device
- Sep 4, 2019 · Class II · Z-1752-2020: Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative pati

## Indications for use
Opiate 300 ng (OP) Reagent, in conjunction with the SYNCHRON@System OP 300 Urine Calibrators, is intended for the qualitative determination of opiates in human urine, at a cutoff value of 300 ng/mL (morphine), on SYNCHRON Systems. The Opiate assay provides a rapid screening procedure for determining the presence of opiates in urine. This test provides only a preliminary analytical result: a positive result by this assay should be confirmed by another generally accepted non-immunological method, such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K031002
Methodology: https://510kreport.com/methodology