Cleared Traditional

K961991 - ACL 6000 SYSTEM (ACL 6000)

K961991 is the FDA 510(k) clearance for ACL 6000 SYSTEM (ACL 6000) by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GKP) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K961991 · Instrumentation Laboratory CO · Hematology device
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Sep 1996
Decision
106d
Days
Class 2
Risk

K961991 is an FDA 510(k) clearance for the ACL 6000 SYSTEM (ACL 6000). Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on September 4, 1996 after a review of 106 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K961991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1996
Decision Date September 04, 1996
Days to Decision 106 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
7d faster than avg
Panel avg: 113d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 31
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K961991.
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K992321 · Dade Behring, Inc. · Sep 1999
COAG-A-MATE MAX
K991101 · Organon Teknika Corp. · Jun 1999
COAG-A-MATE MTX
K962857 · Organon Teknika Corp. · Jan 1997
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
K961579 · American Bioproducts Co. · Jul 1996
STA AUTOMATED MULTI-PARAMETRIC ANALYZER
K942117 · American Bioproducts Co. · Feb 1995
CASCADE M, CAT. NO. 1710
K931956 · Helena Laboratories · Aug 1993