Cleared Traditional

K082859 - HEMOSIL ROUTINE CONTROL LEVEL 1

K082859 is the FDA 510(k) clearance for HEMOSIL ROUTINE CONTROL LEVEL 1 by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K082859 · Instrumentation Laboratory CO · Hematology device
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Dec 2008
Decision
81d
Days
Class 2
Risk

K082859 is an FDA 510(k) clearance for the HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED. 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 December 19, 2008 after a review of 81 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

Submission Details

510(k) Number K082859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2008
Decision Date December 19, 2008
Days to Decision 81 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
32d faster than avg
Panel avg: 113d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 52
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K082859.
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TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
K062840 · Biosite Incorporated · Mar 2007
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K063823 · Roche Diagnostics Corp. · Jan 2007
TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS
K050799 · Biosite Incorporated · Jun 2005