510(k) · Cleared
Recalled · Class II · 2022Hemoglobin A1c Assay, 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 May 22, 2015 as substantially equivalent to K130255 (Abbott Laboratories, 2014) after a 434-day review. Its family tree reaches back 3 generations to 1994. It has been recalled 2 times.
- Decided
- May 22, 2015
- Review
- 434 days
- Class
- Class II
- Product code
- PDJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K934070 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK934070 Tina-Quant Hemoglobin A1CBoehringer Mannheim Corp. · 1994
- 2 generations backK052101 C.F.a.S. (Calibrator for Automated Systems) HBA1CRoche Diagnostics · 2005
- 1 generation backK130255 Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C ControlsAbbott Laboratories · 2014 · Recalled
- This deviceK140654 Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c…Abbott Laboratories · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934070 | Tina-Quant Hemoglobin A1C | Boehringer Mannheim Corp. | 1994 | — |
| −2 | K052101 | C.F.a.S. (Calibrator for Automated Systems) HBA1C | Roche Diagnostics | 2005 | — |
| −1 | K130255 | Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls | Abbott Laboratories | 2014 | 3 |
| 0 (this device) | K140654 | Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls | Abbott Laboratories | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K130255 | Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C ControlsSummary page 5…ication: Class II Product Code: JJX Panel Classification: Clinical Chemistry 3. Predicate Device ARCHITECT Hemoglobin A1c Reagents, Calibrators, and Controls (k130255) Note: The candidate device consists of the same reagents as the predicate device, and utilizes the same calibrators and c… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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-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. |
| May 22, 2019 | Class II | Z-1688-2020 | Under Investigation by firm | Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 8.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K130255.
How does its category compare?
All PDJ devicesPDJ Hemoglobin A1c Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 A1c assay is used in clinical laboratories for the quantitative in vitro measurement of percent hemoglobin A1c (NGSP) or HbA1c fraction mmol/mol (IFCC) in human whole blood and hemolysate on the ARCHITECT c 4000 System. Hemoglobin A1c 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 (131 words)
The Hemoglobin A1c assay is used in clinical laboratories for the quantitative in vitro measurement of percent hemoglobin A1c (NGSP) or HbA1c fraction mmol/mol (IFCC) in human whole blood and hemolysate on the ARCHITECT c 4000 System.
Hemoglobin A1c 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 A1c Calibrators are for use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 4000 System.
The Hemoglobin A1c Controls are used for the estimation of test precision and the detection of systematic analytical deviations of the Hemoglobin A1c assay on the ARCHITECT c 4000 System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140654: Hemoglobin A1c Assay, 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/K140654
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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