Synchron Systems OP 300 Low and High Urine Calibrators

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

SYNCHRON Systems OP 300 Low Urine Calibrator EUDAMED

Synchron GUDID

Generic Name

Opiate/opiate metabolite IVD, calibrator

Model / Ref / Catalog

474982

Primary DI / UDI-DI

D-474982RV EUDAMED

15099590223304 GUDID

Basic UDI-DI

B-474982RV

510(k) Number

K993022 ↗

FDA Product Code

DLJ

EMDN Code

W0102152209 Drugs of abuse / toxicology standards and calibrators

GMDN Term

Opiate/opiate metabolite IVD, calibrator

Device Class

Class IVD General EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 862.3200

EU market of registration

Ireland

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• Access Testosterone

  Class B

  CE/IVDR

• Access IL-6

  Class C

  CE/IVDR

• Access Ultrasensitive hGH

  Class B

  CE/IVDR

• Access Thyroglobulin

  Class C

  CE/IVDR

• Access HBs Ag

  IVD Annex II List A

  CE/IVDD

• Access Ultrasensitive Insulin

  Class C

  CE/IVDR

See all devices from Beckman Coulter, Inc. →

• Are the Synchron Systems OP 300 Low and High Urine Calibrators intended for single-use or can they be reused in a clinical setting?

  The Synchron Systems OP 300 Low and High Urine Calibrators are explicitly designed as single-use, non-sterile reagents for in vitro use in clinical laboratories. Reuse is not recommended or supported, as this could compromise the accuracy and reliability of urine sample calibration for toxicology assays.

• What types of toxicology assays are these calibrators authorized for, and how do I confirm compatibility with my lab’s testing?

  These calibrators are drug-specific and authorized under FDA 510(k) clearance (K993022) for clinical toxicology applications, particularly for assays requiring standardized reference materials. While the device is classified under product code DLJ and medical specialty Clinical Toxicology, compatibility should always be verified with your lab’s specific assay protocols or manufacturer guidelines, as drug-specific calibrators may vary by analyte.

• How should I store the Synchron Systems OP 300 Low and High Urine Calibrators, and what are the expected shelf-life considerations?

  Storage follows standard laboratory protocols for drug calibrators, though exact shelf-life details are not specified in the data. Generally, these should be stored according to manufacturer instructions (likely refrigerated or at room temperature, as with most calibrators) and used within the labeled expiration date. Always check the packaging for specific storage conditions and avoid exposure to extreme temperatures or light.

• What regulatory pathway was followed for FDA clearance of these calibrators, and how does this affect their use in clinical settings?

  The Synchron Systems OP 300 Low and High Urine Calibrators received FDA 510(k) clearance (K993022) under a Traditional review pathway, determined to be substantially equivalent to a predicate device. This clearance confirms their safety and effectiveness for clinical toxicology assays in laboratories, ensuring they meet regulatory standards for accuracy and reliability in urine sample calibration. The Class II designation also indicates they undergo additional post-market surveillance.

• Are these calibrators compatible with multiple drug assays, or are they limited to specific substances?

  While the calibrators are drug-specific, the data does not specify exact substances covered. They are designed to support clinical toxicology assays broadly, meaning they are likely intended for calibration of tests detecting a range of drugs or toxins in urine. For precise compatibility, refer to the manufacturer’s documentation or consult Beckman Coulter’s technical support, as the calibrators may vary by analyte type (e.g., opioids, benzodiazepines, etc.).