510(k) · Cleared
Recalled · Class II · 2022Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · PDJ Hemoglobin A1c Test System
Cleared on Feb 28, 2014 as substantially equivalent to DEN130002 (Roche Diagnostics, 2013) and 2 other predicates after a 392-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 28, 2014
- Review
- 392 days
- Class
- Class II
- Product code
- PDJ
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 2 generations to K934070 (1994). 4 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK934070 Tina-Quant Hemoglobin A1CBoehringer Mannheim Corp. · 1994
- 1 generation backK052101 C.F.a.S. (Calibrator for Automated Systems) HBA1CRoche Diagnostics · 2005
- This deviceK130255 Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C ControlsAbbott Laboratories · 2014
- Descendant · cites it directly · 1 of its ownK171771 ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) AssaySiemens Healthcare Diagnostics, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK200256 ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssaySiemens Healthcare Diagnostics, Inc. · 2021 · Recalled
- Descendant · cites it directly · 0 of its ownK173206 SEKURE HbA1c AssaySekisui Diagnostics P.E.I., Inc. · 2018
- Descendant · cites it directly · 0 of its ownK140654 Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c…Abbott Laboratories · 2015 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K171771ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) AssaySiemens Healthcare Diagnostics, Inc. · 2017 · cites it directly1descendant
- K200256ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssaySiemens Healthcare Diagnostics, Inc. · 2021 · 2 generations on0descendants
- K173206SEKURE HbA1c AssaySekisui Diagnostics P.E.I., Inc. · 2018 · cites it directly0descendants
- K140654Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c ControlsAbbott Laboratories · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934070 | Tina-Quant Hemoglobin A1C | Boehringer Mannheim Corp. | 1994 | — |
| −1 | K052101 | C.F.a.S. (Calibrator for Automated Systems) HBA1C | Roche Diagnostics | 2005 | — |
| 0 (this device) | K130255 | Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls | Abbott Laboratories | 2014 | — |
| +1 | K171771 | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2017 | 1 |
| +2 | K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2021 | 2 |
| +1 | K173206 | SEKURE HbA1c Assay | Sekisui Diagnostics P.E.I., Inc. | 2018 | — |
| +1 | K140654 | Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls | Abbott Laboratories | 2015 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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? (3)
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 |
| * | K052101 | C.F.a.S. (Calibrator for Automated Systems) HBA1CSummary page 2…. Predicate Device Reagents COBAS INTEGRA 800 Tina-quant HbAlcDx Gen.2 assay (k121291) Calibrators Roche C.f.a.s. (Calibrator for Automated Systems) HbAlc (k052101) Controls Roche PreciControl HbAlc norm and PreciControl HbAlc path (k103099) 4. Description of Device Reagents Th… | 2005 |
| * | K103099 | Precicontrol HBA1C Norm; Precicontrol HBA1C PathSummary page 2…(k121291) Calibrators Roche C.f.a.s. (Calibrator for Automated Systems) HbAlc (k052101) Controls Roche PreciControl HbAlc norm and PreciControl HbAlc path (k103099) 4. Description of Device Reagents The Hemoglobin A1 c Reagent Kit contains: Component Number of Bo… | 2010 |
What descends from it? (4)
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 |
|---|---|---|---|---|
| Jun 9, 2022 | Class II | Z-1455-2022 | Under Investigation by firm | There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay. |
| Jun 9, 2022 | Class II | Z-1454-2022 | Under Investigation by firm | There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay. |
| Apr 30, 2014 | Class II | Z-0135-2015 | Under Investigation by firm | HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot. If calibrator lot 45063UQ12 is used in the calibration of the HbA1c assay using values from an incorrect calibrator value sheet… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 10.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K171771 (Siemens Healthcare Diagnostics, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate DEN130002.
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 Hemoglobin A Ic assay is used in clinical laboratories for the quantitative in vitro measurement of percent hemoglobin Ale (NGSP) or HbAlc fraction mmol/mol (]FCC) in human whole blood and hemolysate on the ARCHITECT c 8000 System. Hemoglobin A Ic measurements are used as an aid in the diagnosis of diabetes mellitus, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose…
Read the full statement (128 words)
The Hemoglobin A Ic assay is used in clinical laboratories for the quantitative in vitro measurement of percent hemoglobin Ale (NGSP) or HbAlc fraction mmol/mol (]FCC) in human whole blood and hemolysate on the ARCHITECT c 8000 System.
Hemoglobin A Ic measurements are used as an aid in the diagnosis of diabetes mellitus, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.
The Hemoglobin Ale Calibrators are for use in the calibration of the Hemoglobin Ale assay on the ARCHITECT c 8000 System.
The Hemoglobin Ale Controls are used for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT c 8000 System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130255: Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130255
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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