510(k) Report

510(k) · Cleared

Cleared

A1C 2.2 Plus - Automated Glycohemoglobin Analyzer

K972265510(k) TraditionalCleared Sep 25, 1997100-day reviewClass II21 CFR 864.7470

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 25, 1997 after a 100-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 15 later devices descend from it.

Decided
Sep 25, 1997
Review
100 days
Class
Class II
Product code
LCP
Recalls
None
Predicates
0

15 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared2001: 1 descendant cleared2008: 2 descendants cleared2009: 1 descendant cleared2010: 1 descendant cleared2006: 1 descendant cleared2015: 1 descendant cleared2012: 2 descendants cleared2017: 2 descendants cleared2011: 1 descendant cleared2014: 1 descendant cleared1995200020052010201520202025
  1. This deviceK972265 A1C 2.2 Plus - Automated Glycohemoglobin AnalyzerTosoh Medics, Inc. · 1997
  2. Descendant · cites it directly · 11 of its ownK011434 G7 Automated HPLC AnalyzerTosoh Medics, Inc. · 2001 · Recalled
  3. Descendant · 2 generations on · 4 of its ownK071132 G8 Automated HPLC Analyzer, Model HLC-723 G8Tosoh Bioscience, Inc. · 2008 · Recalled
  4. Descendant · cites it directly · 4 of its ownK041764 The Vitros 5,1 FS Chemistry SystemOrtho-Clinical Diagnostics · 2004
  5. Descendant · 3 generations on · 2 of its ownK122101 Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys…Sebia · 2012
  6. Descendant · 4 generations on · 1 of its ownK133344 Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls…Sebia · 2014

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2001: 12004: 22006: 12008: 22009: 12010: 12011: 12012: 22014: 12015: 12017: 2
2001high 2 (2004) · low 0 (2002)2026

Most influential descendants

Showing 5 of 15 · See all
  • K011434G7 Automated HPLC AnalyzerTosoh Medics, Inc. · 2001 · cites it directly11descendants
  • K071132G8 Automated HPLC Analyzer, Model HLC-723 G8Tosoh Bioscience, Inc. · 2008 · 2 generations on4descendants
  • K041764The Vitros 5,1 FS Chemistry SystemOrtho-Clinical Diagnostics · 2004 · cites it directly4descendants
  • K122101Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls…Sebia · 2012 · 3 generations on2descendants
  • K133344Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls, HBA1C Capillarys…Sebia · 2014 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K972265A1C 2.2 Plus - Automated Glycohemoglobin AnalyzerTosoh Medics, Inc.1997—
+1K011434G7 Automated HPLC AnalyzerTosoh Medics, Inc.20012
+2K071132G8 Automated HPLC Analyzer, Model HLC-723 G8Tosoh Bioscience, Inc.20081
+1K041764The Vitros 5,1 FS Chemistry SystemOrtho-Clinical Diagnostics2004—
+3K122101Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C…Sebia2012—
+4K133344Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls, HBA1C…Sebia2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200420
200610
200820
200910
201010
201110
201220
201410
201510
201720
FIG. 1 — Lineage of K972265, 1997–2017Source: 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 510(k) statement (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. #1 K221326 Nova Allegro HbA1c Assay, Nova Allegro Analyzerscore 9.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K011434G7 Automated HPLC AnalyzerTosoh Medics, Inc.200111
K041764The Vitros 5,1 FS Chemistry SystemOrtho-Clinical Diagnostics20044

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, K011434 (Tosoh Medics, Inc., 2001) has gone furthest, with 11 descendants of its own.

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

2007: 72008: 52009: 62010: 22011: 102012: 92013: 22014: 82015: 32016: 22017: 52018: 22019: 42020: 12023: 22024: 1
2007high 10 (2011) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LCP

269in 2019

2007: 133 days median2008: 206 days median2009: 158 days median2011: 176 days median2012: 143 days median2014: 127 days median2015: 239 days median2017: 218 days median2019: 269 days median
2007high 269 (2019) · low 127 (2014)2026

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

Recalls per year · LCP

1in 2025

2007: 12008: 32009: 62010: 52011: 512013: 42014: 22015: 22016: 62017: 12018: 12022: 12024: 12025: 1
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

2007: 52008: 112009: 152010: 42011: 272012: 512013: 1932014: 1822015: 642016: 292017: 1492018: 1,9112019: 1142020: 132021: 72022: 82023: 272024: 392025: 22
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007713315
20085206311
20096158615
20102—54
2011101765127
20129143051
20132—4193
201481272182
20153239264
20162—629
201752181149
20182—11,911
201942690114
20201—013
20210—07
20220—18
20232—027
20241—139
20250—122
20260—0—

What is it indicated for?

The A1c 2.2 Plus Automated Glycohemoglobin 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 read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Tosoh Medics, Inc.

41 FDA decisions under this applicant name. See the company

  • K023893ST Aia-Pack Cea Enzyme ImmunoassayTosoh Medics, Inc. · 20021 recall
  • K023894ST Aia-Pack Afp Enzyme ImmunoassayTosoh Medics, Inc. · 20021 recall
  • K023091ST Aia-Pack Testosterone AssayTosoh Medics, Inc. · 20023 recalls
  • K023891ST Aia-Pack CA 125 Enzyme ImmunoassayTosoh Medics, Inc. · 2002
  • K020489G7 Automated HPLC Analyzer, Beta-Thalassemia ModeTosoh Medics, Inc. · 20022 recalls

Recent decisions in LCP

The LCP category page

  • K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2024
  • K231465Q-Pad Test SystemQurasense · 2023
  • K214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS · 2023
  • K192987Aina HbA1c Monitoring System 2Jana Care, Inc. · 2020
  • K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd. · 2019

https://510kreport.com/device/K972265 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972265: A1C 2.2 Plus - Automated Glycohemoglobin Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972265

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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