510(k) · Cleared
Recalled · Class II · 2016G8 Automated HPLC Analyzer, Model HLC-723 G8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosoh Bioscience, Inc. · LCP Assay, Glycosylated Hemoglobin
Cleared on Sep 16, 2008 as substantially equivalent to K011434 (Tosoh Medics, Inc., 2001) after a 512-day review. Its family tree reaches back 2 generations to 1997. 4 later devices descend from it. It has been recalled once.
- Decided
- Sep 16, 2008
- Review
- 512 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972265 (1997). 4 later devices descend from it, 2 citing it directly.
- 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 deviceK071132 G8 Automated HPLC Analyzer, Model HLC-723 G8Tosoh Bioscience, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK122101 Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys…Sebia · 2012
- Descendant · 2 generations on · 1 of its ownK133344 Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls…Sebia · 2014
- Descendant · cites it directly · 0 of its ownK162822 ADAMS A1c HA-8180V, CALIBRATOR 80Arkray Factory, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK162281 CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)Sebia · 2017
Most influential descendants
Showing 4 of 4 · See all- K122101Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls…Sebia · 2012 · cites it directly2descendants
- K133344Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls, HBA1C Capillarys…Sebia · 2014 · 2 generations on1descendant
- K162822ADAMS A1c HA-8180V, CALIBRATOR 80Arkray Factory, Inc. · 2017 · cites it directly0descendants
- K162281CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)Sebia · 2017 · 2 generations on0descendants
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) | K071132 | G8 Automated HPLC Analyzer, Model HLC-723 G8 | Tosoh Bioscience, Inc. | 2008 | — |
| +1 | K122101 | Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C… | Sebia | 2012 | — |
| +2 | K133344 | Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls, HBA1C… | Sebia | 2014 | — |
| +1 | K162822 | ADAMS A1c HA-8180V, CALIBRATOR 80 | Arkray Factory, Inc. | 2017 | — |
| +2 | K162281 | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) | Sebia | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K011434 | G7 Automated HPLC Analyzer | 2001 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 7, 2016 | Class II | Z-1225-2017 | Software design | The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at the higher levels of HbA1c, e.g. 9%, but not at the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K122101 (Sebia, 2012) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K011434.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LCP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LCP
269in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCP
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCP
22in 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 G8 Automated Glycohemoglobin Analyzer HLC-723G8 is intended for INVITRO DIAGNOSTIC USE for the measurement of hemoglobin Al c (HbAl c) in whole blood specimens. Alc measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control.
The AlC Calibrator Set is a reference agent designed for calibrating Tosoh Automated Glycohemoglobin Analyzer HLC-723G8.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071132 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071132: G8 Automated HPLC Analyzer, Model HLC-723 G8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071132
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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