De Novo · Granted
GrantedTina-Quant HBA1C Gen. 2 Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · PDJ Hemoglobin A1c Test System
Granted on May 23, 2013 as a new device type through De Novo after a 59-day review. 23 later devices descend from it.
- Decided
- May 23, 2013
- Review
- 59 days
- Class
- Class II
- Product code
- PDJ
- Recalls
- None
23 later devices descend from it, 7 citing it directly.
- This deviceDEN130002 Tina-Quant HBA1C Gen. 2 Test SystemRoche Diagnostics · 2013
- Descendant · cites it directly · 6 of its ownK142448 VARIANT II TURBO HbA1c Kit - 2.0Bio-Rad Laboratories, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK151321 D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK130255 Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C ControlsAbbott Laboratories · 2014 · Recalled
- Descendant · cites it directly · 3 of its ownK131580 Automated Gylcohemoglobin Analyzer HLC-723G8Tosoh Bioscience, Inc. · 2014 · Recalled
- Descendant · cites it directly · 2 of its ownK121610 Cobas C 501 Tina-Quant HBA1CDX Gen.3 AssayRoche Diagnostics Operations · 2013
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K142448VARIANT II TURBO HbA1c Kit - 2.0Bio-Rad Laboratories, Inc. · 2015 · cites it directly6descendants
- K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc. · 2015 · 2 generations on4descendants
- K130255Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C ControlsAbbott Laboratories · 2014 · cites it directly4descendants
- K131580Automated Gylcohemoglobin Analyzer HLC-723G8Tosoh Bioscience, Inc. · 2014 · cites it directly3descendants
- K121610Cobas C 501 Tina-Quant HBA1CDX Gen.3 AssayRoche Diagnostics Operations · 2013 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN130002 | Tina-Quant HBA1C Gen. 2 Test System | Roche Diagnostics | 2013 | — |
| +1 | K142448 | VARIANT II TURBO HbA1c Kit - 2.0 | Bio-Rad Laboratories, Inc. | 2015 | — |
| +2 | K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack | Bio-Rad Laboratories, Inc. | 2015 | — |
| +1 | K130255 | Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls | Abbott Laboratories | 2014 | 3 |
| +1 | K131580 | Automated Gylcohemoglobin Analyzer HLC-723G8 | Tosoh Bioscience, Inc. | 2014 | 2 |
| +1 | K121610 | Cobas C 501 Tina-Quant HBA1CDX Gen.3 Assay | Roche Diagnostics Operations | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (23)
See all 237 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142448 | VARIANT II TURBO HbA1c Kit - 2.0 | 2015 | 6 |
| K130255 | Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls | 2014 | 4 |
| K131580 | Automated Gylcohemoglobin Analyzer HLC-723G8 | 2014 | 3 |
| K121610 | Cobas C 501 Tina-Quant HBA1CDX Gen.3 Assay | 2013 | 2 |
| K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay | 2016 | 1 |
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3 | 2020 | 0 |
| K142595 | VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry… | 2015 | 0 |
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, K142448 (Bio-Rad Laboratories, Inc., 2015) has gone furthest, with 6 descendants of its own.
How does its category compare?
All PDJ devicesPDJ Hemoglobin A1c Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 | — |
https://510kreport.com/device/DEN130002 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN130002: Tina-Quant HBA1C Gen. 2 Test System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN130002
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026