510(k) · Cleared
ClearedVARIANT II TURBO HbA1c Kit - 2.0
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 Mar 24, 2015 as substantially equivalent to DEN130002 (Roche Diagnostics, 2013) after a 203-day review. Its family tree reaches back 1 generation to 2013. 6 later devices descend from it.
- Decided
- Mar 24, 2015
- Review
- 203 days
- Class
- Class II
- Product code
- PDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN130002 (2013). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN130002 Tina-Quant HBA1C Gen. 2 Test SystemRoche Diagnostics · 2013
- This deviceK142448 VARIANT II TURBO HbA1c Kit - 2.0Bio-Rad Laboratories, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK151321 D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK252749 Medconn 8K Glycated Hemoglobin Test SystemShanghai Medconn Medical Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK242911 Medconn Glycated Hemoglobin Test systemShanghai Medconn Medical Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK220999 Hipro Glycosylated Hemoglobin (HbA1c) Test SystemShijiazhuang Hipro Biotechnology Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK182651 HbA1c AdvancedBeckman Coulter Ireland, Inc. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc. · 2015 · cites it directly4descendants
- K252749Medconn 8K Glycated Hemoglobin Test SystemShanghai Medconn Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K242911Medconn Glycated Hemoglobin Test systemShanghai Medconn Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K220999Hipro Glycosylated Hemoglobin (HbA1c) Test SystemShijiazhuang Hipro Biotechnology Co., Ltd. · 2024 · 2 generations on0descendants
- K182651HbA1c AdvancedBeckman Coulter Ireland, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130002 | Tina-Quant HBA1C Gen. 2 Test System | Roche Diagnostics | 2013 | — |
| 0 (this device) | K142448 | VARIANT II TURBO HbA1c Kit - 2.0 | Bio-Rad Laboratories, Inc. | 2015 | — |
| +1 | K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack | Bio-Rad Laboratories, Inc. | 2015 | — |
| +2 | K252749 | Medconn 8K Glycated Hemoglobin Test System | Shanghai Medconn Medical Technology Co., Ltd. | 2026 | — |
| +2 | K242911 | Medconn Glycated Hemoglobin Test system | Shanghai Medconn Medical Technology Co., Ltd. | 2025 | — |
| +2 | K220999 | Hipro Glycosylated Hemoglobin (HbA1c) Test System | Shijiazhuang Hipro Biotechnology Co., Ltd. | 2024 | — |
| +2 | K182651 | HbA1c Advanced | Beckman Coulter Ireland, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | DEN130002 | Tina-Quant HBA1C Gen. 2 Test System Our reading of the summary gave K121291, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130002, Tina-Quant HBA1C Gen. 2 Test System (Roche Diagnostics), granted May 23, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2013 |
What descends from it? (6)
2 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?
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 VARIANT™ II TURBO HbA1c Kit- 2.0 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 VARIANT II TURBO Hemoglobin Testing System and VARIANT II TURBO Link Hemoglobin Testing System. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.…
Read the full statement (114 words)
The VARIANT™ II TURBO HbA1c Kit- 2.0 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 VARIANT II TURBO Hemoglobin Testing System and VARIANT II TURBO Link Hemoglobin Testing System.
This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
The VARIANT II TURBO HbA1c Kit- 2.0 is intended for Professional Use Only.
The Hemoglobin Capillary Collection System (HCCS) is intended for the collection of human whole blood for the percent determination of hemoglobin A1c using Bio-Rad HPLC methods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142448: VARIANT II TURBO HbA1c Kit - 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142448
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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