Cleared Special

K242127 - ACL TOP Family 50 Series (ACL TOP 750 (FDA 510(k) Clearance)

Also includes:
ACL TOP 750 CTS ACL TOP 750 LAS ACL TOP 550 CTS ACL TOP 350 CTS)

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K242127 · Instrumentation Laboratory (IL) Co. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
28d
Days
Class 2
Risk

K242127 is an FDA 510(k) clearance for the ACL TOP Family 50 Series (ACL TOP 750. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Instrumentation Laboratory (IL) Co. (Bedford, US). The FDA issued a Cleared decision on August 16, 2024 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5400 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Instrumentation Laboratory (IL) Co. devices

Submission Details

510(k) Number K242127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2024
Decision Date August 16, 2024
Days to Decision 28 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 113d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GKP Instrument, Coagulation, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.