Cleared Special

K260551 - HemosIL Factor V Leiden (APC Resistance V)

K260551 is an FDA 510(k) clearance for HemosIL Factor V Leiden (APC Resistance V), manufactured by Instrumentation Laboratory (IL) Co.. The device is a Class 2 Hematology device with product code GGW cleared through the Special 510(k) pathway after a 30-day FDA review.

K260551 · Instrumentation Laboratory (IL) Co. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
30d
Days
Class 2
Risk

K260551 is an FDA 510(k) clearance for the HemosIL Factor V Leiden (APC Resistance V). Classified as Test, Time, Partial Thromboplastin (product code GGW), Class II - Special Controls.

Submitted by Instrumentation Laboratory (IL) Co. (Bedford, US). The FDA issued a Cleared decision on March 20, 2026 after a review of 30 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.

FDA 510(k) Submission Details - K260551

510(k) Number K260551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2026
Decision Date March 20, 2026
Days to Decision 30 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
83d faster than avg
Panel avg: 113d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

GGW Device Classification - Class 2, Special Controls

Product Code GGW Test, Time, 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 - GGW Test, Time, Partial Thromboplastin

All 31
Devices cleared under the same product code (GGW) and FDA review panel - the closest regulatory comparables to K260551.
LUPOTEK KCT
K090105 · R2 Diagnostics, Inc. · Dec 2010
HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN
K083729 · Aniara Diagnostica, LLC · May 2009
CRYOCHECK CLOT APCR
K060284 · Precision Biologic, Inc. · May 2006
PEFAKIT APC-R FACTOR V LEIDEN
K042762 · Pentapharm , Ltd. · Dec 2004
PHOSPHOLIN ES AND CALCIUM CHLORIDE
K033471 · R2 Diagnostics, Inc. · Feb 2004
GRADILEIDEN V TEST
K992456 · Gradipore , Ltd. · Dec 1999
K260551 · HemosIL Factor V Leiden (APC Resistance V)
Download PDF FDA Summary Instrumentation Labor…