Cleared Traditional

K182744 - HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High

K182744 is an FDA 510(k) clearance for HemoTrol WB - Low, manufactured by Eurotrol B.V.. The device is a Class 2 Hematology device with product code GGM cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K182744 · Eurotrol B.V. · Hematology device
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Feb 2019
Decision
126d
Days
Class 2
Risk

K182744 is an FDA 510(k) clearance for the HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High. Classified as Control, Hemoglobin (product code GGM), Class II - Special Controls.

Submitted by Eurotrol B.V. (Ede, NL). The FDA issued a Cleared decision on February 1, 2019 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Eurotrol B.V. devices

FDA 510(k) Submission Details - K182744

510(k) Number K182744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2018
Decision Date February 01, 2019
Days to Decision 126 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
13d slower than avg
Panel avg: 113d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGM Device Classification - Class 2, Special Controls

Product Code GGM Control, Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - GGM Control, Hemoglobin

All 13
Devices cleared under the same product code (GGM) and FDA review panel - the closest regulatory comparables to K182744.
HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
K192842 · Eurotrol B.V. · Nov 2019
LYPHOCHEK DIABETES CONTROL
K070546 · Bio-Rad Laboratories · Apr 2007
R&D SICKLE QC CONTROL
K070334 · R&D Systems, Inc. · Mar 2007
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
K052838 · Bio-Rad · Nov 2005
GLYCOHEMOSURE HBA1C CONTROL
K032791 · Quantimetrix Corp. · Oct 2003
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
K003030 · Bio-Rad · Nov 2000