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Synchron Systems Opiate Reagent

by Beckman Coulter, Inc.

510(k) K031002

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK031002 Date29 Apr 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1752-2020 FDA Class II initiated 4 Sep 2019

    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 patient test results.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DJG
Device Class
Class II
Regulation
21 CFR Part 862.3650
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Synchron Systems Opiate Reagent is an enzyme immunoassay intended for the qualitative determination of opiates in human urine at a cutoff value of 300 ng/mL (morphine). It is used in conjunction with the Synchron® System OP 300 Urine Calibrators on Synchron Systems.

This reagent is supplied for in vitro diagnostic use and is regulated under FDA 510(k) clearance (K031002) with product code DJG and regulation number 862.3650. It is intended for use in clinical laboratory settings and is not indicated as sterile, single-use, or reusable based on the provided data.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Synchron Systems Opiate Reagent intended for?

    The Synchron Systems Opiate Reagent is an enzyme immunoassay intended for the qualitative determination of opiates in human urine at a cutoff value of 300 ng/mL (morphine). It is used in conjunction with the Synchron® System OP 300 Urine Calibrators on Synchron Systems for in vitro diagnostic use in clinical laboratory settings.

  • How is the Synchron Systems Opiate Reagent supplied and what are its storage requirements?

    The reagent is supplied for in vitro diagnostic use, but the provided data does not specify its physical format, packaging, storage conditions, or whether it is sterile, single-use, or reusable. No details about supply form, storage temperature, or handling instructions are included in the device data.

  • What regulatory pathway was used for the Synchron Systems Opiate Reagent?

    The Synchron Systems Opiate Reagent received FDA 510(k) clearance under submission number K031002, with product code DJG and regulation number 862.3650. It was classified as a Class II device and found substantially equivalent to a predicate device, with a special 510(k) clearance type.