510(k) · Cleared
ClearedD-100 HbA1c, D-100 HbA1c Calibrator Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · PDJ Hemoglobin A1c Test System
Cleared on Dec 9, 2015 as substantially equivalent to K142448 (Bio-Rad Laboratories, Inc., 2015) and 1 other predicate after a 205-day review. Its family tree reaches back 3 generations to 1993. 4 later devices descend from it.
- Decided
- Dec 9, 2015
- Review
- 205 days
- Class
- Class II
- Product code
- PDJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K926469 (1993). 5 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK926469 Variant (TM) Hemoglobin a 1C ProgramBio-Rad · 1993
- 2 generations backK984268 Variant II Hemoglobin A1C ProgramBio-Rad · 1998 · Recalled
- 1 generation backK070452 Variant II Hemoglobin A1C Program with Models 270-2101NUBio-Rad Laboratories, Inc. · 2007 · Recalled
- This deviceK151321 D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK252749 Medconn 8K Glycated Hemoglobin Test SystemShanghai Medconn Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK242911 Medconn Glycated Hemoglobin Test systemShanghai Medconn Medical Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK220999 Hipro Glycosylated Hemoglobin (HbA1c) Test SystemShijiazhuang Hipro Biotechnology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK182651 HbA1c AdvancedBeckman Coulter Ireland, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K252749Medconn 8K Glycated Hemoglobin Test SystemShanghai Medconn Medical Technology Co., Ltd. · 2026 · cites it directly0descendants
- K242911Medconn Glycated Hemoglobin Test systemShanghai Medconn Medical Technology Co., Ltd. · 2025 · cites it directly0descendants
- K220999Hipro Glycosylated Hemoglobin (HbA1c) Test SystemShijiazhuang Hipro Biotechnology Co., Ltd. · 2024 · cites it directly0descendants
- K182651HbA1c AdvancedBeckman Coulter Ireland, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K926469 | Variant (TM) Hemoglobin a 1C Program | Bio-Rad | 1993 | — |
| −2 | K984268 | Variant II Hemoglobin A1C Program | Bio-Rad | 1998 | 2 |
| −1 | K070452 | Variant II Hemoglobin A1C Program with Models 270-2101NU | Bio-Rad Laboratories, Inc. | 2007 | 1 |
| 0 (this device) | K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack | Bio-Rad Laboratories, Inc. | 2015 | — |
| +1 | K252749 | Medconn 8K Glycated Hemoglobin Test System | Shanghai Medconn Medical Technology Co., Ltd. | 2026 | — |
| +1 | K242911 | Medconn Glycated Hemoglobin Test system | Shanghai Medconn Medical Technology Co., Ltd. | 2025 | — |
| +1 | K220999 | Hipro Glycosylated Hemoglobin (HbA1c) Test System | Shijiazhuang Hipro Biotechnology Co., Ltd. | 2024 | — |
| +1 | K182651 | HbA1c Advanced | Beckman Coulter Ireland, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K142448 | VARIANT II TURBO HbA1c Kit - 2.0Summary page 4…Predicate Device Name 510(k) Number VARIANT II TURBO HbA1c Kit -2.0 K142448 VARIANT II Hemoglobin A1c Calibrators K070452 510(k) Summary 5. Description of the Devi… | 2015 |
| * | K070452 | Variant II Hemoglobin A1C Program with Models 270-2101NUSummary page 4…510(k) Number VARIANT II TURBO HbA1c Kit -2.0 K142448 VARIANT II Hemoglobin A1c Calibrators K070452 510(k) Summary 5. Description of the Device: The Bio-Rad D-100™ HbA1c utilizes principles of ion… | 2007 |
What descends from it? (4)
4 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)
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 22 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K252749 (Shanghai Medconn Medical Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K142448.
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 D-100™ HbA1c test is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood using ion-exchange high-performance liquid chromatography (HPLC) on the D-100 Hemoglobin Testing System. Hemoglobin A1c measurements are used as an aid in 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 (114 words)
The D-100™ HbA1c test is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood using ion-exchange high-performance liquid chromatography (HPLC) on the D-100 Hemoglobin Testing System.
Hemoglobin A1c measurements are used as an aid in 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 D-100™ HbA1c test is intended for Professional Use Only.
Calibrators:
The D-100™ HbA1c Calibrator Pack is for the calibration of the D-100 Hemoglobin Testing System used for the quantitative determination of hemoglobin A1c(HbA1c) in human whole blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151321: D-100 HbA1c, D-100 HbA1c Calibrator Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151321
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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