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ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)

by Instrumentation Laboratory (IL) Co.

510(k) K242127

Active European Union and United States

CE IVDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242127↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Special NumberK242127 Date16 Aug 2024ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
GKP
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 864.5400
Advisory Committee
Hematology
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 ACL TOP Family 50 Series is an automated coagulation instrument designed for laboratory use. It performs point-of-care and centralized testing of blood coagulation parameters, including prothrombin time (PT), activated partial thromboplastin time (aPTT), and other hemostasis assays to support diagnostic and monitoring applications in hematology.

The system is supplied as a reusable analyzer with single-use consumables, intended for use in clinical laboratories and point-of-care settings. It operates under FDA 510(k) clearance and IVDR compliance, featuring models differentiated by specific assay capabilities (e.g., CTS for coagulation tests, LAS for lupus anticoagulant screening). Storage and handling follow manufacturer guidelines to maintain performance, with no MRI safety restrictions noted.

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