510(k) · Cleared
Recalled · Class II · 2026ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_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 Jul 2, 2021 as substantially equivalent to K171771 (Siemens Healthcare Diagnostics, Inc., 2017) after a 515-day review. Its family tree reaches back 4 generations to 1994. It has been recalled 2 times.
- Decided
- Jul 2, 2021
- Review
- 515 days
- Class
- Class II
- Product code
- PDJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K934070 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK934070 Tina-Quant Hemoglobin A1CBoehringer Mannheim Corp. · 1994
- 3 generations backK052101 C.F.a.S. (Calibrator for Automated Systems) HBA1CRoche Diagnostics · 2005
- 2 generations backK130255 Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C ControlsAbbott Laboratories · 2014 · Recalled
- 1 generation backK171771 ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) AssaySiemens Healthcare Diagnostics, Inc. · 2017 · Recalled
- This deviceK200256 ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssaySiemens Healthcare Diagnostics, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K934070 | Tina-Quant Hemoglobin A1C | Boehringer Mannheim Corp. | 1994 | — |
| −3 | K052101 | C.F.a.S. (Calibrator for Automated Systems) HBA1C | Roche Diagnostics | 2005 | — |
| −2 | K130255 | Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls | Abbott Laboratories | 2014 | 3 |
| −1 | K171771 | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2017 | 1 |
| 0 (this device) | K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2021 | — |
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 |
|---|---|---|---|
| * | K171771 | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) AssaySummary page 6…hich Equivalence is Claimed The predicate device for this Special 510(k) submission is the ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c_E) assay cleared under K171771 on December 4, 2017. The classification information is as follows. Trade Name Common/Usual Name… | 2017 |
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 8, 2026 | Class II | Z-2703-2026 | Under Investigation by firm | The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results. |
| Feb 23, 2026 | Class II | Z-1657-2026 | Process control | A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 8.5 years on median.
- 2 of the 6 ancestors have 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. 2021, 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 AIc (AlcE) assay is an in vitro diagnostic assay for the
quantitative determination of mmol/mol HbAlc (IFCC) and % HbAlc (DCCT/NGSP) in human anticoagulated
venous whole blood and hemolysate for use on the ADVIA@ Chemistry Systems. Measurement of Hemoglobin Alc
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/K200256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200256: ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_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/K200256
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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