Cleared Special

K060688 - HEMOSIL SYNTHASIL

K060688 is the FDA 510(k) clearance for HEMOSIL SYNTHASIL by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GFO) cleared through the Special 510(k) pathway after a 29-day FDA review.

K060688 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
29d
Days
Class 2
Risk

K060688 is an FDA 510(k) clearance for the HEMOSIL SYNTHASIL. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on April 13, 2006 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K060688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2006
Decision Date April 13, 2006
Days to Decision 29 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
84d faster than avg
Panel avg: 113d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GFO Activated Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 - GFO Activated Partial Thromboplastin

All 22
Devices cleared under the same product code (GFO) and FDA review panel - the closest regulatory comparables to K060688.
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HemosIL Silica Clotting Time
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HEMOSIL SILICA CLOTTING TIME
K050221 · Instrumentation Laboratory CO · Mar 2005
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
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K992712 · Sigma Diagnostics, Inc. · Dec 1999