Cleared Traditional

K113211 - HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL

K113211 is an FDA 510(k) clearance for HEMOSIL LA POSITIVE CONTROL & HEMOSIL L..., manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K113211 · Instrumentation Laboratory CO · Hematology device
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Jan 2012
Decision
65d
Days
Class 2
Risk

K113211 is an FDA 510(k) clearance for the HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on January 4, 2012 after a review of 65 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

FDA 510(k) Submission Details - K113211

510(k) Number K113211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2011
Decision Date January 04, 2012
Days to Decision 65 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
48d faster than avg
Panel avg: 113d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGN Device Classification - Class 2, Special Controls

Product Code GGN Plasma, Coagulation Control
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 - GGN Plasma, Coagulation Control

All 79
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