Cleared Traditional

K951891 - ACL FUTURA COAGULATION SYSTEM

K951891 is the FDA 510(k) clearance for ACL FUTURA COAGULATION SYSTEM by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K951891 · Instrumentation Laboratory CO · Hematology device
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Nov 1995
Decision
193d
Days
Class 2
Risk

K951891 is an FDA 510(k) clearance for the ACL FUTURA COAGULATION SYSTEM. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on November 3, 1995 after a review of 193 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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.

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Submission Details

510(k) Number K951891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1995
Decision Date November 03, 1995
Days to Decision 193 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
80d slower than avg
Panel avg: 113d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 85
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K951891.
KC 1A COAGULATION ANALYZER/SET
K955724 · Sigma Diagnostics, Inc. · Mar 1996
KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM
K955735 · Sigma Diagnostics, Inc. · Mar 1996
COAGUCHEK SYSTEM
K952625 · Boehringer Mannheim Corp. · Nov 1995
CASCASE 480 SNSLYZER
K951497 · Helena Laboratories · Sep 1995
BEHRING FIBRINTIMER A
K926551 · Behring Diagnostics, Inc. · Apr 1995
ACT CONTROL SET
K940840 · Sigma Diagnostics, Inc. · Jul 1994