510(k) · Cleared
ClearedDimension Hemoglobin A1c Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · PDJ Hemoglobin A1c Test System
Cleared on Jul 13, 2018 as substantially equivalent to K160571 (Roche Diagnostics Operations (Rdo), 2016) after a 203-day review. Its family tree reaches back 2 generations to 2013.
- Decided
- Jul 13, 2018
- Review
- 203 days
- Class
- Class II
- Product code
- PDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN130002 (2013). No later device cites it as a predicate yet.
- Root · 2 generations backDEN130002 Tina-Quant HBA1C Gen. 2 Test SystemRoche Diagnostics · 2013
- 1 generation backK160571 cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 AssayRoche Diagnostics Operations (Rdo) · 2016 · Recalled
- This deviceK173909 Dimension Hemoglobin A1c AssaySiemens Healthcare Diagnostics, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN130002 | Tina-Quant HBA1C Gen. 2 Test System | Roche Diagnostics | 2013 | — |
| −1 | K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay | Roche Diagnostics Operations (Rdo) | 2016 | 1 |
| 0 (this device) | K173909 | Dimension Hemoglobin A1c Assay | Siemens Healthcare Diagnostics, Inc. | 2018 | — |
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 |
|---|---|---|---|
| * | K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 AssaySummary page 4…Roche Diagnostics Operations (RDO) 510(k) Submitter Cobas C13 Tina-Quant HbA1cDx Gen.3 Assay 510(k) Number K160571 Clearance Date December 19, 2016 4. Device Description The Dimension® Hemoglobin A1C assay is an i… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All PDJ devicesPDJ Hemoglobin A1c Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Dimension® Hemoglobin A1c assay is an in vitro diagnostic assay for the quantitative determination of %HbA1c (DCCT/NGSP) and mmol/mol HbA1c (IFCC) in human anticoagulated venous whole blood for use on the Dimension® clinical chemistry system. Measurement of Hemoglobin A1c is used as an aid in diagnosis and monitoring of long-term blood glucose control in patients with diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173909 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173909: Dimension Hemoglobin A1c Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173909
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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