Cleared Special

K043184 - HEMOSIL RECOMBIPLASTIN

K043184 is an FDA 510(k) clearance for HEMOSIL RECOMBIPLASTIN, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code GJS cleared through the Special 510(k) pathway after a 35-day FDA review.

K043184 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
35d
Days
Class 2
Risk

K043184 is an FDA 510(k) clearance for the HEMOSIL RECOMBIPLASTIN. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on December 22, 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 864.7750 - 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 - K043184

510(k) Number K043184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2004
Decision Date December 22, 2004
Days to Decision 35 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
78d faster than avg
Panel avg: 113d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

GJS Device Classification - Class 2, Special Controls

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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 - GJS Test, Time, Prothrombin

All 124
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K043184.
COAGUCHEK XS SYSTEM
K060978 · Roche Diagnostics · Aug 2006
HEMOSIL PT-FIBRINOGEN HS PLUS
K060931 · Instrumentation Laboratory CO · May 2006
ACTICLOT, MODEL 824
K052124 · American Diagnostica, Inc. · Oct 2005
PHOSPHOPLASTIN RL
K040296 · R2 Diagnostics, Inc. · May 2004
COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
K030845 · Roche Diagnostics Corp. · May 2003
PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
K021190 · Roche Diagnostics Corp. · Oct 2002
K043184 · HEMOSIL RECOMBIPLASTIN
Download PDF FDA Summary Instrumentation Labor…