Cleared Traditional

K050221 - HEMOSIL SILICA CLOTTING TIME

K050221 is the FDA 510(k) clearance for HEMOSIL SILICA CLOTTING TIME by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GFO) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K050221 · Instrumentation Laboratory CO · Hematology device
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Optimized for regulatory review, auditing and printing
Mar 2005
Decision
58d
Days
Class 2
Risk

K050221 is an FDA 510(k) clearance for the HEMOSIL SILICA CLOTTING TIME. 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 March 30, 2005 after a review of 58 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. 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 K050221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2005
Decision Date March 30, 2005
Days to Decision 58 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
55d faster than avg
Panel avg: 113d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K050221.
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SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
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K992712 · Sigma Diagnostics, Inc. · Dec 1999
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