Cleared Traditional

K912087 - ACL COAGULATION SYSTEMS

K912087 is the FDA 510(k) clearance for ACL COAGULATION SYSTEMS by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K912087 · Instrumentation Laboratory CO · Hematology device
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Sep 1991
Decision
129d
Days
Class 2
Risk

K912087 is an FDA 510(k) clearance for the ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS. 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 September 19, 1991 after a review of 129 days - within the typical 510(k) review window.

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 K912087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1991
Decision Date September 19, 1991
Days to Decision 129 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 113d · This submission: 129d
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 K912087.
BEHRING FIBRINTIMER A
K924124 · Behring Diagnostics, Inc. · Dec 1992
STANDARD HUMAN PLASMA
K924393 · Behring Diagnostics, Inc. · Nov 1992
KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM
K914188 · Ortho Diagnostic Systems, Inc. · Aug 1992
HEPARIN ADSORBENT
K912061 · Sigma Diagnostics, Inc. · Jul 1991
COAG-A-MATE - RA4
K900917 · Organon Teknika Corp. · Apr 1990
COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN
K900377 · Baxter Healthcare Corp · Mar 1990