510(k) Report

510(k) · Cleared

Cleared

HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High

K192842510(k) TraditionalCleared Nov 15, 201943-day reviewClass II21 CFR 864.8625

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Eurotrol B.V. · GGM Control, Hemoglobin

Cleared on Nov 15, 2019 as substantially equivalent to K182744 (Eurotrol B.V., 2019) after a 43-day review. Its family tree reaches back 2 generations to 1996.

Decided
Nov 15, 2019
Review
43 days
Class
Class II
Product code
GGM
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K964052 (1996). No later device cites it as a predicate yet.

K964052 · Hemocue Hemotrol · Direct Solutions · 1996 · recalledK182744 · HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High · Eurotrol B.V. · 2019199520002005201020152020
K182744 · HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High · Eurotrol B.V. · 2019K964052 · Hemocue Hemotrol · Direct Solutions · 1996 · recalled0
  1. Root · 2 generations backK964052 Hemocue HemotrolDirect Solutions · 1996 · Recalled
  2. 1 generation backK182744 HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighEurotrol B.V. · 2019
  3. This deviceK192842 HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighEurotrol B.V. · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K964052Hemocue HemotrolDirect Solutions19962
−1K182744HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighEurotrol B.V.2019—
0 (this device)K192842HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighEurotrol B.V.2019—
FIG. 1 — Lineage of K192842, 1996–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GGM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K182744HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
Summary page 4
…GGM – control, Hemoglobin HemoTrol® Duo High AN01624A03 Predicate Device Eurotrol HemoTrol® WB 510(k) number: K182744 Device Description HemoTrol® Duo is an assayed hemoglobin quality control material intended for professional use in the verifi…
Eurotrol B.V.2019—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 22.2 years on median.
  • 1 of the 2 ancestors has a recall of any class.

How does its category compare?

All GGM devices

GGM Control, Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · GGM

2in 2019

2007: 22019: 2
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GGM

Too few GGM 510(k)s in any year since 2007 to give a median.

Recalls per year · GGM

2in 2018

2018: 2
2007high 2 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GGM

1in 2018

2014: 12018: 1
2007high 1 (2014) · low 0 (2007)2025

MAUDE reports naming product code GGM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—01
20150—00
20160—00
20170—00
20180—21
20192—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

HemoTrol® Duo is an assayed quality control material for professional use to verify the performance characteristics of

the HemoCue® Hb 301 and the HemoCue® Hb 801 System. HemoTrol® Duo is intended for the quantitative

determination of hemoglobin.

Indications for use as stated in the FDA summary.

More from Eurotrol B.V.

7 FDA decisions under this applicant name. See the company

  • K182744HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighEurotrol B.V. · 2019
  • K152553CueSee HypoxicEurotrol B.V. · 2016
  • K131595Eurotrol Gas-Ise HCT QC and Eurotrol Gas-Ise HCT LVMEurotrol B.V. · 2013
  • K121467Eurotrol Hematocrit ControlEurotrol B.V. · 2013
  • K121468Eurotrol Gas-Ise MetabolitesEurotrol B.V. · 2012

Recent decisions in GGM

The GGM category page

  • K182744HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighEurotrol B.V. · 2019
  • K070546Lyphochek Diabetes ControlBio-Rad Laboratories · 2007
  • K070334R&D Sickle QC ControlR&D Systems, Inc. · 2007
  • K052838Liquichek Diabetes Control, Level 1,2,3,4Bio-Rad · 2005
  • K032791Glycohemosure HBA1C ControlQuantimetrix Corp. · 2003

https://510kreport.com/device/K192842 · printed Nov 6, 2026

Cite this page

510(k) Report. “K192842: HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192842

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026