510(k) · Cleared

Cleared

Liquichek Diabetes Control, Level 1,2,3,4

K052838510(k) TraditionalCleared Nov 9, 200533-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

Bio-Rad · GGM Control, Hemoglobin

Cleared on Nov 9, 2005 as substantially equivalent to K862186 (Bio-Rad, 1986) after a 33-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.

Decided: Nov 9, 2005
Review: 33 days
Class: Class II
Product code: GGM
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K862186 (1986). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK862186 Lyphochek Glycated Hemoglobin/Whole Blood/Lev.I&IIBio-Rad · 1986
This deviceK052838 Liquichek Diabetes Control, Level 1,2,3,4Bio-Rad · 2005
Descendant · cites it directly · 0 of its ownK123798 Liquidchek Diabetes Control; Level 1, Level 2, Level 3, Trilevel…Bio-Rad Laboratories · 2013

Most influential descendants

Showing 1 of 1 · See all

K123798Liquidchek Diabetes Control; Level 1, Level 2, Level 3, Trilevel MinipakBio-Rad Laboratories · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K862186	Lyphochek Glycated Hemoglobin/Whole Blood/Lev.I&II	Bio-Rad	1986	—
0 (this device)	K052838	Liquichek Diabetes Control, Level 1,2,3,4	Bio-Rad	2005	—
+1	K123798	Liquidchek Diabetes Control; Level 1, Level 2, Level 3, Trilevel Minipak	Bio-Rad Laboratories	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K052838, 1986–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K862186	Lyphochek Glycated Hemoglobin/Whole Blood/Lev.I&II Summary page 1 …tantial Equivalence is Claimed Lyphochek Diabetes Control Bio-Rad Laboratories Irvine, California 92618 510 (k) Number: K862186 4.0 Description of Device This is a liquid product prepared from human whole blood containing preservatives…	Bio-Rad	1986	—

Also cleared against K862186: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K123798	Liquidchek Diabetes Control; Level 1, Level 2, Level 3, Trilevel Minipak	Bio-Rad Laboratories	2013	0

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?

Its one ancestor has no recall.
Of its descendants, K123798 (Bio-Rad Laboratories, 2013) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K862186.

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

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

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	1
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	2	1
2019	2	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

Liquichek Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052838 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052838: Liquichek Diabetes Control, Level 1,2,3,4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052838

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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