Cleared Special

K002400 - MODIFICATION OF ACL ADVANCE

K002400 is an FDA 510(k) clearance for MODIFICATION OF ACL ADVANCE, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code JPA cleared through the Special 510(k) pathway after a 26-day FDA review.

K002400 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
26d
Days
Class 2
Risk

K002400 is an FDA 510(k) clearance for the MODIFICATION OF ACL ADVANCE. 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 August 30, 2000 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K002400

510(k) Number K002400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2000
Decision Date August 30, 2000
Days to Decision 26 days
Submission Type Special
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
87d faster than avg
Panel avg: 113d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

JPA Device Classification - Class 2, Special Controls

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 173
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K002400.
BEHRING COAGULATION SYSTEM, MODEL BCS
K002080 · Dade Behring, Inc. · Nov 2000
THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
K002177 · Haemoscope Corp. · Sep 2000
COAGUCHEK S SYSTEM, MODEL 2138280
K994349 · Roche Diagnostics Corp. · Sep 2000
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
K002400 · MODIFICATION OF ACL ADVANCE
Download PDF FDA Summary Instrumentation Labor…