Cleared Abbreviated

K033414 - ACL TOP MODEL

K033414 is the FDA 510(k) clearance for ACL TOP MODEL by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GKP) cleared through the Abbreviated 510(k) pathway after a 77-day FDA review.

K033414 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
77d
Days
Class 2
Risk

K033414 is an FDA 510(k) clearance for the ACL TOP MODEL, TOP. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on January 12, 2004 after a review of 77 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K033414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2003
Decision Date January 12, 2004
Days to Decision 77 days
Submission Type Abbreviated
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
36d faster than avg
Panel avg: 113d · This submission: 77d
Pathway characteristics
Standards-based clearance path.

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.

Regulatory Peers - GKP Instrument, Coagulation, Automated

All 33
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K033414.
ACL TOP 700 LAS
K091980 · Instrumentation Laboratory CO · Sep 2009
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
K073377 · Instrumentation Laboratory CO · May 2008
ACL TOP
K063679 · Instrumentation Laboratory CO · Jan 2007
SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
K031377 · Dade Behring, Inc. · Sep 2003
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
K020979 · Dade Behring, Inc. · Jun 2002
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K001645 · Dade Behring, Inc. · Aug 2000