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Synchron Systems Acetaminophen (ACTM) Reagent

by Beckman Coulter, Inc.

510(k) K000494

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 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK000494 Date14 Apr 2000ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2405-2008 FDA Unclassified (pre-2012) initiated 10 Jul 2008

    This recall was initiated after Beckman Coulter verified through testing that Acetaminophen reagents (lots #M702524 & M703276) manufactured with contaminated heparin has shown a negative bias in performance between the assay made with contaminated and uncontaminated heparin.

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  • Withdrawn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
LDP
Device class
Class II
Regulation
21 CFR Part 862.3030
Advisory committee
Clinical Toxicology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Acetaminophen (ACTM) Reagent is a colorimetric reagent used for the quantitative determination of acetaminophen concentration in human serum or plasma. It is designed to work with the Synchron LX®, UniCel® DxC 600/800 systems and the Synchron® Systems Drug Calibrator 2 set for clinical toxicology testing.

The reagent is supplied as a single-use kit and is cleared under FDA 510(k) (K000494) as a Class II device (product code LDP). It is intended for use in laboratory settings for the measurement of acetaminophen levels, and it is stored and shipped according to the manufacturer’s specifications.

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Questions

AI-generated answers, 26 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 clinical purpose does the ACTM Reagent serve?

    It is used in clinical toxicology laboratories to quantitatively determine acetaminophen concentrations in human serum or plasma, helping clinicians assess overdose severity and guide treatment decisions.

  • Is the reagent supplied as a single‑use kit or can it be reused?

    The ACTM Reagent is provided as a single‑use kit, ensuring consistent performance and preventing cross‑contamination between samples; each kit is intended for one testing session only.

  • Which analyzer platforms are compatible with this reagent?

    The reagent is designed for use with Beckman Coulter’s Synchron LX®, UniCel® DxC 600/800 systems, and the Synchron® Systems Drug Calibrator 2 set, allowing seamless integration into existing toxicology workflows.

  • How should the ACTM Reagent be stored and shipped?

    It must be stored and shipped according to Beckman Coulter’s specifications, typically under controlled temperature conditions to maintain reagent stability until use in the laboratory.