510(k) · Cleared
Recalled · Class II · 2022ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) 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 Dec 4, 2017 as substantially equivalent to K130255 (Abbott Laboratories, 2014) after a 173-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 4, 2017
- Review
- 173 days
- Class
- Class II
- Product code
- PDJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K934070 (1994). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK171771 ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) AssaySiemens Healthcare Diagnostics, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK200256 ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssaySiemens Healthcare Diagnostics, Inc. · 2021 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K200256ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssaySiemens Healthcare Diagnostics, Inc. · 2021 · cites it directly0descendants
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) | K171771 | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2017 | — |
| +1 | K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2021 | 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 |
|---|---|---|
| 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? (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 4…of Predicate Trade Name ARCHITECT Hemoglobin A1C 510(k) Submitter Abbott Laboratories Diagnostics Division 510(k) Number K130255 Clearance Date February 28, 2014 4. Device Description The ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c_E) assa… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 9, 2022 | Class II | Z-0929-2022 | Device Design | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 8.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K200256 (Siemens Healthcare Diagnostics, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 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. 2017, 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 ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c_E) assay is an in vitro diagnostic assay for the quantitative determination of mmol/mol HbA1c (IFCC) and % HbA1c (DCCT/NGSP) in human anticoagulated venous whole blood and hemolysate for use on the ADVIA® Chemistry systems. Measurement of Hemoglobin A1c is used as an aid in the 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/K171771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171771: ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171771
Report an extraction error
Are you the manufacturer?
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