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Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode (Ise) Module

by Alfa Wassermann Diagnostic Technologies, Inc.

510(k) K123018

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 · Traditional NumberK123018 Date23 Apr 2013ClearedStatusActive

Recalls

0 recalls · FDA

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

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  • Withdrawn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
CFR
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE is a clinical chemistry system used for measuring analytes in serum and plasma. It includes a glucose reagent based on the hexokinase method and an ion selective electrode module for sodium, potassium, and chloride measurements.

The system is supplied for use in physician office laboratories, small hospitals, veterinary practices, and research facilities. It is a traditional 510(k) cleared device (K123018) with FDA authorization, classified as a class II medical device under regulation number 862.1345 for clinical chemistry.

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Questions

AI-generated answers, 6 Oct 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 ACE ALERA Clinical Chemistry System used for?

    The ACE ALERA Clinical Chemistry System is used for measuring analytes in serum and plasma, specifically glucose using the hexokinase method and sodium, potassium, and chloride using the ion selective electrode (ISE) module.

  • How is the ACE ALERA system supplied and where is it intended for use?

    The system is supplied for use in physician office laboratories, small hospitals, veterinary practices, and research facilities as a traditional 510(k) cleared device with FDA authorization under K123018.

  • What regulatory pathway and classification applies to the ACE ALERA system?

    The ACE ALERA system is a class II medical device cleared via the traditional 510(k) pathway (K123018) and is regulated under 21 CFR 862.1345 for clinical chemistry systems.