510(k) · Cleared
Recalled · Class II · 2018Automated Gylcohemoglobin Analyzer HLC-723G8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosoh Bioscience, Inc. · PDJ Hemoglobin A1c Test System
Cleared on Jan 23, 2014 as substantially equivalent to DEN130002 (Roche Diagnostics, 2013) after a 237-day review. Its family tree reaches back 1 generation to 2013. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 23, 2014
- Review
- 237 days
- Class
- Class II
- Product code
- PDJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN130002 (2013). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backDEN130002 Tina-Quant HBA1C Gen. 2 Test SystemRoche Diagnostics · 2013
- This deviceK131580 Automated Gylcohemoglobin Analyzer HLC-723G8Tosoh Bioscience, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK171861 CAPILLARYS Hb A1cSebia · 2018
- Descendant · cites it directly · 0 of its ownK171537 CAPI 3 Hb A1cSebia · 2017
- Descendant · cites it directly · 0 of its ownK162822 ADAMS A1c HA-8180V, CALIBRATOR 80Arkray Factory, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130002 | Tina-Quant HBA1C Gen. 2 Test System | Roche Diagnostics | 2013 | — |
| 0 (this device) | K131580 | Automated Gylcohemoglobin Analyzer HLC-723G8 | Tosoh Bioscience, Inc. | 2014 | — |
| +1 | K171861 | CAPILLARYS Hb A1c | Sebia | 2018 | — |
| +1 | K171537 | CAPI 3 Hb A1c | Sebia | 2017 | — |
| +1 | K162822 | ADAMS A1c HA-8180V, CALIBRATOR 80 | Arkray Factory, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 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 PDJ? 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 PDJ device
- #1 K252749 Medconn 8K Glycated Hemoglobin Test Systemscore 11.5 · 4 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 |
|---|---|---|---|
| * | DEN130002 | Tina-Quant HBA1C Gen. 2 Test System Our reading of the summary gave K121291, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130002, Tina-Quant HBA1C Gen. 2 Test System (Roche Diagnostics), granted May 23, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2013 |
| † | K071132 | G8 Automated HPLC Analyzer, Model HLC-723 G8 | 2008 |
| † | K072714 | Tina-Quant Hemoglobin A1C Gen.2 Test System | 2008 |
What descends from it? (3)
3 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 |
|---|---|---|---|---|
| Jul 13, 2018 | Class II | Z-3244-2018 | No Marketing Application | Analyzers were distributed with software which lacks a 510K |
| 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?
How does its category compare?
All PDJ devicesPDJ Hemoglobin A1c Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PDJ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDJ
203in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDJ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PDJ
42in 2025
MAUDE reports naming product code PDJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 9 |
| 2014 | 2 | — | 0 | 10 |
| 2015 | 4 | 234 | 0 | 2 |
| 2016 | 2 | — | 1 | 0 |
| 2017 | 3 | 173 | 0 | 1 |
| 2018 | 5 | 203 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 0 | — | 1 | 19 |
| 2023 | 0 | — | 0 | 16 |
| 2024 | 1 | — | 0 | 47 |
| 2025 | 2 | — | 0 | 42 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131580 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131580: Automated Gylcohemoglobin Analyzer HLC-723G8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131580
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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