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Synchron Systems Vancomycin Reagent; Synchron Systems Vancomycin Calibrator

by Beckman Coulter, Inc.

510(k) K013076

Active European Union and United States

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K013076↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK013076 Date12 Dec 2001ClearedStatusActive
European UnionCE/IVDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K013076 decided 12 Dec 2001 Active
  • EUDAMED Active

Recalls

1 recall · FDA

    • Terminated Z-0886-06 FDA Unclassified (pre-2012) initiated 30 Mar 2006

    Beckman Coulter has received reports of patient samples and quality control recovery shifting low when using Vancomycin reagent lots M507219 and M511327. Internal QC recovery was as much as 15% lower than the assigned target value.

Timeline

2 dated events

  1. Cleared FDA 510(k) K013076
  2. Recall initiated FDA recalls Z-0886-06

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
LEH
Models / Variants
Device class
Class II
Regulation
21 CFR Part 862.3950
Advisory committee
Clinical Toxicology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Vancomycin Reagent and Calibrator are in vitro diagnostic (IVD) devices designed for use in radioimmunoassay (RIA) to quantitatively determine vancomycin levels in patient samples. These reagents enable precise measurement of the antibiotic concentration, supporting clinical monitoring for therapeutic drug management and toxicity prevention in patients receiving vancomycin therapy.

The device is supplied as a reagent kit and calibrator set, intended for single-use in clinical laboratory settings. It is regulated under the In Vitro Diagnostic Device Directive (IVDD) and has received FDA 510(k) clearance as substantially equivalent to a predicate device. Sterility and performance are critical, and proper storage conditions must be maintained as specified in the accompanying instructions. The product is categorized under Clinical Toxicology and adheres to regulatory requirements for diagnostic accuracy and safety.

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