Cleared Traditional

K150877 - ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS

Also marketed or referenced as:
ACL TOP 550 CTS ACL TOP 750 ACL TOP 750 CTS ACL TOP 750 LAS

K150877 is an FDA 510(k) clearance for ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS, 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 256-day FDA review.

K150877 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
256d
Days
Class 2
Risk

K150877 is an FDA 510(k) clearance for the ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS. 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 December 13, 2015 after a review of 256 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 - K150877

510(k) Number K150877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2015
Decision Date December 13, 2015
Days to Decision 256 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
143d slower than avg
Panel avg: 113d · This submission: 256d
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 45
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K150877.
ACL TOP Family 50 Series (ACL TOP 750
K242127 · Instrumentation Laboratory (IL) Co. · Aug 2024
ACL TOP Family 70 Series
K231031 · Instrumentation Laboratory Company · Jun 2023
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 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