Cleared Traditional

K040359 - HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2

K040359 is the FDA 510(k) clearance for HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2 by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K040359 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
35d
Days
Class 2
Risk

K040359 is an FDA 510(k) clearance for the HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2. 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 19, 2004 after a review of 35 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.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K040359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2004
Decision Date March 19, 2004
Days to Decision 35 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
78d faster than avg
Panel avg: 113d · This submission: 35d
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 84
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K040359.
COAG-A-MATE MTX III
K051030 · bioMerieux, Inc. · Dec 2005
HEMORAM/AGGRAM ANALYZER
K050053 · Helena Laboratories · Jul 2005
MDA B.30
K050513 · bioMerieux, Inc. · Apr 2005
MODIFICATION TO STANDARD HUMAN PLASMA
K023141 · Dade Behring, Inc. · Jan 2003
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
K021162 · Sigma Diagnostics, Inc. · Aug 2002
BCS SYSTEM
K013114 · Dade Behring, Inc. · Nov 2001