Cleared Traditional

K000053 - ACL 9000 SYSTEM

K000053 is the FDA 510(k) clearance for ACL 9000 SYSTEM by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K000053 · Instrumentation Laboratory CO · Hematology device
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Mar 2000
Decision
68d
Days
Class 2
Risk

K000053 is an FDA 510(k) clearance for the ACL 9000 SYSTEM. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on March 15, 2000 after a review of 68 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K000053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2000
Decision Date March 15, 2000
Days to Decision 68 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
45d faster than avg
Panel avg: 113d · This submission: 68d
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 K000053.
BEHRING COAGULATION TIMER ANALYZER (BCT)
K001064 · Dade Behring, Inc. · Jun 2000
DADE BEHRING COAGULATION ANALYZER (BCT)
K001067 · Dade Behring, Inc. · Jun 2000
BEHRING COAGULATION SYSTEM (BCS)
K000973 · Dade Behring, Inc. · May 2000
BEHRING COAGULATION SYSTEM (BCS)
K992959 · Dade Behring, Inc. · Jan 2000
DADE BEHRING BFTII
K984501 · Dade Behring, Inc. · Jul 1999
STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
K983460 · American Bioproducts Co. · Nov 1998