510(k) Report

510(k) · Cleared

Cleared

Glycohemosure HBA1C Control

K032791510(k) TraditionalCleared Oct 30, 200352-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

Quantimetrix Corp. · GGM Control, Hemoglobin

Cleared on Oct 30, 2003 after a 52-day review. The FDA summary names its predicate without a number. 1 later device descends from it.

Decided
Oct 30, 2003
Review
52 days
Class
Class II
Product code
GGM
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared200020052010201520202025
  1. This deviceK032791 Glycohemosure HBA1C ControlQuantimetrix Corp. · 2003
  2. Descendant · cites it directly · 0 of its ownK043070 Liquid Stable HBA1C ControlCanterbury Scientific, Ltd. · 2004

Most influential descendants

Showing 1 of 1 · See all
  • K043070Liquid Stable HBA1C ControlCanterbury Scientific, Ltd. · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K032791Glycohemosure HBA1C ControlQuantimetrix Corp.2003—
+1K043070Liquid Stable HBA1C ControlCanterbury Scientific, Ltd.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
FIG. 1 — Lineage of K032791, 2003–2004Source: 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
*—Lyphochek Diabetes Control
Named without a submission number
—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K043070Liquid Stable HBA1C ControlCanterbury Scientific, Ltd.20040

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?

  • Of its descendants, K043070 (Canterbury Scientific, Ltd., 2004) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GGM devices

GGM Control, Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

The Quantimetrix GlycoHemosure is intended for the quality control of

laboratory procedures for the quantitation of HbAlc.

Indications for use as stated in the FDA summary.

More from Quantimetrix Corp.

38 FDA decisions under this applicant name. See the company

  • K142262Aution Check PlusQuantimetrix Corp. · 2015
  • K113177Complete D 25-OH Vitamin D ControlQuantimetrix Corp. · 2012
  • K103744Dropper A1C Diabetes ControlQuantimetrix Corp. · 2011
  • K062942Quantimetrix Nicosure Cotinine Urine ControlQuantimetrix Corp. · 2006
  • K062751Modification to Quantimetrix Cardiasure Cardiac MarkerQuantimetrix Corp. · 2006

Recent decisions in GGM

The GGM category page

  • K192842HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighEurotrol B.V. · 2019
  • 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

https://510kreport.com/device/K032791 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032791: Glycohemosure HBA1C Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032791

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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