510(k) · Cleared

Recalled · Class II · 2018

ST Aia Pack HBA1C

K100304510(k) TraditionalCleared Aug 27, 2010205-day reviewClass II21 CFR 864.7470Recalls 4

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

Tosoh Bioscience, Inc. · LCP Assay, Glycosylated Hemoglobin

Cleared on Aug 27, 2010 as substantially equivalent to K011434 (Tosoh Medics, Inc., 2001) after a 205-day review. Its family tree reaches back 2 generations to 1997. It has been recalled 4 times.

Decided: Aug 27, 2010
Review: 205 days
Class: Class II
Product code: LCP
Recalls: 4
Predicates: 1

Its longest line of descent runs back 2 generations to K972265 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK972265 A1C 2.2 Plus - Automated Glycohemoglobin AnalyzerTosoh Medics, Inc. · 1997
1 generation backK011434 G7 Automated HPLC AnalyzerTosoh Medics, Inc. · 2001 · Recalled
This deviceK100304 ST Aia Pack HBA1CTosoh Bioscience, Inc. · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K972265	A1C 2.2 Plus - Automated Glycohemoglobin Analyzer	Tosoh Medics, Inc.	1997	—
−1	K011434	G7 Automated HPLC Analyzer	Tosoh Medics, Inc.	2001	2
0 (this device)	K100304	ST Aia Pack HBA1C	Tosoh Bioscience, Inc.	2010	—

FIG. 1 — Lineage of K100304, 1997–2010Source: 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
*	K011434	G7 Automated HPLC Analyzer Summary page 2 …tion Name: Class 11 LCP 21 CFR 864.7470 Glycosylated Hemoglobin Assay Predicate Device: K01 1434 Tosoh Automated Glycohemoglobin Analyzer HLC-723G7…	Tosoh Medics, Inc.	2001	2

Also cleared against K011434: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 6, 2018	Class II	Z-2745-2018	Software design	HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers should exercise caution when reviewing chromatograms and ensure that Flag 43 is enabled on their device to avoid reporting invalid…
Mar 5, 2018	Class II	Z-1810-2018	Nonconforming Material/Component	The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
Mar 5, 2018	Class II	Z-1812-2018	Nonconforming Material/Component	The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
Mar 5, 2018	Class II	Z-1809-2018	Nonconforming Material/Component	The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 8.9 years on median.
1 of the 2 ancestors has a recall of any class.
4 other devices also cite its predicate K011434.

How does its category compare?

All LCP devices

LCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

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?

ST AlA-PACK HbAlc is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement for percent concentration of Hemoglobin A1c (HbAlc) in EDTA whole blood on Tosoh AlA System Analyzer. HbAlc measurement is used in the management and treatment of diabetes. The ST AlA-PACK HbAlc CALIBRATOR SET is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of ST AlA-PACK HbAlc Assay. The AlA-PACK HbAlc CONTROL SET is intended for IN VITRO…

Read the full statement (120 words)

The ST AlA-PACK HbAlc CALIBRATOR SET is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of ST AlA-PACK HbAlc Assay.

The AlA-PACK HbAlc CONTROL SET is intended for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AlA-PACK HbAlc Assay.

The ST AlA-PACK HbAlc PRETREATMENT SOLUTION is intended for IN VITRO DIAGNOSTIC USE ONLY for the pretreatment of the patient samples or AlA-PACK HbAlc CONTROL SET for the ST AlA-PACK HbA1lc assay.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100304 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100304: ST Aia Pack HBA1C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100304

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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