Cleared Traditional

K021022 - HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED)

Also marketed or referenced as:
HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)

K021022 is the FDA 510(k) clearance for HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED) by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K021022 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
46d
Days
Class 2
Risk

K021022 is an FDA 510(k) clearance for the HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED). 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 May 14, 2002 after a review of 46 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 K021022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2002
Decision Date May 14, 2002
Days to Decision 46 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
67d faster than avg
Panel avg: 113d · This submission: 46d
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 46
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K021022.
CONTROL PLASMA LMW HEPARIN
K030965 · Instrumentation Laboratory CO · Jun 2003
LIQUICHEK D-DIMER CONTROL, MODEL 356, 357
K030182 · Bio-Rad · Feb 2003
HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
K021024 · Instrumentation Laboratory CO · May 2002
HEMOSIL NORMAL CONTROL (ASSAYED)
K021023 · Instrumentation Laboratory CO · May 2002
LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783
K012722 · Bio-Rad · Sep 2001
CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
K992829 · Medical Analysis Systems, Inc. · Nov 1999