Cleared Traditional

K182744 - HemoTrol WB - Low

K182744 is the FDA 510(k) clearance for HemoTrol WB - Low by Eurotrol B.V.. It is a Class 2 Hematology device (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

Submission Details

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.

Device Classification

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 8
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
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
K003030 · Bio-Rad · Nov 2000
R&D HGB/GLC WHOLE BLOOD CONTROL
K993321 · R&D Systems, Inc. · Nov 1999