510(k) · Cleared
ClearedHipro Glycosylated Hemoglobin (HbA1c) Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shijiazhuang Hipro Biotechnology Co., Ltd. · PDJ Hemoglobin A1c Test System
Cleared on Sep 12, 2024 as substantially equivalent to K151321 (Bio-Rad Laboratories, Inc., 2015) after an 892-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Sep 12, 2024
- Review
- 892 days
- Class
- Class II
- Product code
- PDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K926469 (1993). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK926469 Variant (TM) Hemoglobin a 1C ProgramBio-Rad · 1993
- 3 generations backK984268 Variant II Hemoglobin A1C ProgramBio-Rad · 1998 · Recalled
- 2 generations backK070452 Variant II Hemoglobin A1C Program with Models 270-2101NUBio-Rad Laboratories, Inc. · 2007 · Recalled
- 1 generation backK151321 D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc. · 2015
- This deviceK220999 Hipro Glycosylated Hemoglobin (HbA1c) Test SystemShijiazhuang Hipro Biotechnology Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K926469 | Variant (TM) Hemoglobin a 1C Program | Bio-Rad | 1993 | — |
| −3 | K984268 | Variant II Hemoglobin A1C Program | Bio-Rad | 1998 | 2 |
| −2 | K070452 | Variant II Hemoglobin A1C Program with Models 270-2101NU | Bio-Rad Laboratories, Inc. | 2007 | 1 |
| −1 | K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack | Bio-Rad Laboratories, Inc. | 2015 | — |
| 0 (this device) | K220999 | Hipro Glycosylated Hemoglobin (HbA1c) Test System | Shijiazhuang Hipro Biotechnology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K151321 | D-100 HbA1c, D-100 HbA1c Calibrator PackSummary page 6…: Hipro Glycosylated Hemoglobin (HbA1c) Test System 3. Legally Marketed Predicate Device Trade Name D-100™ HbA1c 510(k) Number K151321 Product Code PDJ, LCP Manufacturer Bio-Rad Laboratories, Inc. 4. Device Description The H… | 2015 |
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 31 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 3 other devices also cite its predicate K151321.
How does its category compare?
All PDJ devicesPDJ Hemoglobin A1c Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Hipro® Glycosylated Hemoglobin (HbAlc) Test System comprised of the Hipro Glycosylated hemoglobin (HbAlc) test kit and the HP-AFS/1 automatic immunoassay analyzer is 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. It is an in vitro diagnostics reagent system intended for quantitative determination of% hemoglobin Ale (DCCT/NGSP) in venous whole blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220999 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220999: Hipro Glycosylated Hemoglobin (HbA1c) Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220999
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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