510(k) · Cleared

Recalled · Class III · 2015

G7 Automated HPLC Analyzer

K011434510(k) TraditionalCleared Sep 18, 2001131-day reviewClass II21 CFR 864.7470Recalls 2

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

Tosoh Medics, Inc. · LCP Assay, Glycosylated Hemoglobin

Cleared on Sep 18, 2001 as substantially equivalent to K972265 (Tosoh Medics, Inc., 1997) after a 131-day review. Its family tree reaches back 1 generation to 1997. 11 later devices descend from it. It has been recalled 2 times.

Decided: Sep 18, 2001
Review: 131 days
Class: Class II
Product code: LCP
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K972265 (1997). 11 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK972265 A1C 2.2 Plus - Automated Glycohemoglobin AnalyzerTosoh Medics, Inc. · 1997
This deviceK011434 G7 Automated HPLC AnalyzerTosoh Medics, Inc. · 2001
Descendant · cites it directly · 4 of its ownK071132 G8 Automated HPLC Analyzer, Model HLC-723 G8Tosoh Bioscience, Inc. · 2008 · Recalled
Descendant · 2 generations on · 2 of its ownK122101 Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys…Sebia · 2012
Descendant · 3 generations on · 1 of its ownK133344 Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls…Sebia · 2014
Descendant · cites it directly · 1 of its ownK081895 Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C CalibratorsSiemens Medical Solutions Diagnostics · 2009 · Recalled
Descendant · cites it directly · 1 of its ownK072686 Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C ControlsAxis-Shield Diagnostics, Ltd. · 2008

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2004high 2 (2008) · low 0 (2005)2026

Most influential descendants

Showing 5 of 11 · See all

K071132G8 Automated HPLC Analyzer, Model HLC-723 G8Tosoh Bioscience, Inc. · 2008 · cites it directly4descendants
K122101Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls…Sebia · 2012 · 2 generations on2descendants
K133344Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls, HBA1C Capillarys…Sebia · 2014 · 3 generations on1descendant
K081895Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C CalibratorsSiemens Medical Solutions Diagnostics · 2009 · cites it directly1descendant
K072686Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C ControlsAxis-Shield Diagnostics, Ltd. · 2008 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K972265	A1C 2.2 Plus - Automated Glycohemoglobin Analyzer	Tosoh Medics, Inc.	1997	—
0 (this device)	K011434	G7 Automated HPLC Analyzer	Tosoh Medics, Inc.	2001	—
+1	K071132	G8 Automated HPLC Analyzer, Model HLC-723 G8	Tosoh Bioscience, Inc.	2008	1
+2	K122101	Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C…	Sebia	2012	—
+3	K133344	Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls, HBA1C…	Sebia	2014	—
+1	K081895	Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C Calibrators	Siemens Medical Solutions Diagnostics	2009	2
+1	K072686	Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C Controls	Axis-Shield Diagnostics, Ltd.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2008	2	0
2009	1	0
2010	1	0
2011	1	0
2012	2	0
2014	1	0
2017	2	0

FIG. 1 — Lineage of K011434, 1997–2017Source: 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 LCP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LCP device

#1 K221326 Nova Allegro HbA1c Assay, Nova Allegro Analyzerscore 9.6 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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
*	K972265	A1C 2.2 Plus - Automated Glycohemoglobin Analyzer Summary page 1 …bin Analyzer Tosoh Medics, Inc. South San Francisco, CA K972265 DeviceDescription: The G7 AutomatedHPLC Analyzer: HbAlc Variant Mode isan automatedHigh…	Tosoh Medics, Inc.	1997	—

Also cleared against K972265: 1 other device →

What descends from it? (11)

See all 11

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K071132	G8 Automated HPLC Analyzer, Model HLC-723 G8	Tosoh Bioscience, Inc.	2008	4
K081895	Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C Calibrators	Siemens Medical Solutions Diagnostics	2009	1
K072686	Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C Controls	Axis-Shield Diagnostics, Ltd.	2008	1
K100304	ST Aia Pack HBA1C	Tosoh Bioscience, Inc.	2010	0
K033674	Multigent Hemoglobin A1C (Reagents), HB A1C Calibrators and HB A1C Controls	Seradyn, Inc.	2004	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 10, 2015	Class III	Z-2066-2015	Error in labeling	The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015. The correct expiration date is October 2014.
Aug 18, 2010	Class III	Z-1075-2013	Component change control	The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages in whole blood. The firm received…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K071132 (Tosoh Bioscience, Inc., 2008) has gone furthest, with 4 descendants of its own.
1 other device also cites its predicate K972265.

How does its category compare?

All LCP devices

LCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LCP

1in 2024

2007high 10 (2011) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LCP

269in 2019

2007high 269 (2019) · low 127 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LCP

1in 2025

2007high 51 (2011) · low 0 (2012)2026

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

Adverse event reports per year · LCP

22in 2025

2007high 1,911 (2018) · low 4 (2010)2025

MAUDE reports naming product code LCP, 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	7	133	1	5
2008	5	206	3	11
2009	6	158	6	15
2010	2	—	5	4
2011	10	176	51	27
2012	9	143	0	51
2013	2	—	4	193
2014	8	127	2	182
2015	3	239	2	64
2016	2	—	6	29
2017	5	218	1	149
2018	2	—	1	1,911
2019	4	269	0	114
2020	1	—	0	13
2021	0	—	0	7
2022	0	—	1	8
2023	2	—	0	27
2024	1	—	1	39
2025	0	—	1	22
2026	0	—	0	—

What is it indicated for?

The G7 Automated HPLC Analyzer is a high pressure liquid chromatography

system intended for IN VITRO DIAGNOSTIC USE ONLY. Glycosylated

hemoglobin measurements obtained by this device are used in the management

and treatment of diabetes.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K011434 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011434: G7 Automated HPLC Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011434

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026