Cleared Traditional

K073377 - ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)

K073377 is an FDA 510(k) clearance for ACL TOP (WITH SYSTEM SOFTWARE V3.0.0), manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code GKP cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K073377 · Instrumentation Laboratory CO · Hematology device
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Optimized for regulatory review, auditing and printing
May 2008
Decision
153d
Days
Class 2
Risk

K073377 is an FDA 510(k) clearance for the ACL TOP (WITH SYSTEM SOFTWARE V3.0.0). 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 May 4, 2008 after a review of 153 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5400 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K073377

510(k) Number K073377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2007
Decision Date May 04, 2008
Days to Decision 153 days
Submission Type Traditional
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
40d slower than avg
Panel avg: 113d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKP Device Classification - Class 2, Special Controls

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 44
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K073377.
ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
K160276 · Instrumentation Laboratory CO · Mar 2016
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS
K150877 · Instrumentation Laboratory CO · Dec 2015
ACL TOP 700 LAS
K091980 · Instrumentation Laboratory CO · Sep 2009
ACL TOP
K063679 · Instrumentation Laboratory CO · Jan 2007
ACL TOP MODEL, TOP
K033414 · Instrumentation Laboratory CO · Jan 2004
SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
K031377 · Dade Behring, Inc. · Sep 2003