510(k) · Cleared
Recalled · Class II · 2014Variant II B-Thalassemia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · JPD Hemoglobin A2 Quantitation
Cleared on Jun 10, 1999 as substantially equivalent to K924122 (Bio-Rad, 1993) after a 69-day review. Its family tree reaches back 1 generation to 1993. 5 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 10, 1999
- Review
- 69 days
- Class
- Class II
- Product code
- JPD
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924122 (1993). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK924122 Variant Beta-Thalassemia Short ProgramBio-Rad · 1993 · Recalled
- This deviceK991127 Variant II B-ThalassemiaBio-Rad · 1999
- Descendant · cites it directly · 1 of its ownK063643 Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 2006 · Recalled
- Descendant · cites it directly · 1 of its ownK041444 Bio-Rad D-10 Dual ProgramBio-Rad Laboratories, Inc. · 2004 · Recalled
- Descendant · cites it directly · 0 of its ownK222635 Premier Resolution SystemTrinity Biotech (Primus Corporation, Dba Trinity Biotech) · 2023
- Descendant · 2 generations on · 0 of its ownK130860 Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin…Bio-Rad Laboratories, Inc., Clinical Systems Divis · 2013
- Descendant · 2 generations on · 0 of its ownK060001 D-10 Hemoglobin A1C Program; D-10 Dual ProgramBio-Rad Laboratories, Inc. · 2006 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K063643Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 2006 · cites it directly1descendant
- K041444Bio-Rad D-10 Dual ProgramBio-Rad Laboratories, Inc. · 2004 · cites it directly1descendant
- K222635Premier Resolution SystemTrinity Biotech (Primus Corporation, Dba Trinity Biotech) · 2023 · cites it directly0descendants
- K130860Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM…Bio-Rad Laboratories, Inc., Clinical Systems Divis · 2013 · 2 generations on0descendants
- K060001D-10 Hemoglobin A1C Program; D-10 Dual ProgramBio-Rad Laboratories, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924122 | Variant Beta-Thalassemia Short Program | Bio-Rad | 1993 | 3 |
| 0 (this device) | K991127 | Variant II B-Thalassemia | Bio-Rad | 1999 | — |
| +1 | K063643 | Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short… | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2006 | 1 |
| +1 | K041444 | Bio-Rad D-10 Dual Program | Bio-Rad Laboratories, Inc. | 2004 | 2 |
| +1 | K222635 | Premier Resolution System | Trinity Biotech (Primus Corporation, Dba Trinity Biotech) | 2023 | — |
| +2 | K130860 | Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System… | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 2013 | — |
| +2 | K060001 | D-10 Hemoglobin A1C Program; D-10 Dual Program | Bio-Rad Laboratories, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2013 | 1 | 0 |
| 2023 | 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 JPD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K924122 | Variant Beta-Thalassemia Short ProgramSummary page 1…liet Carrara Regulatory Affairs/Quality Assurance Manager March 29, 1999 VARIANT™ II 3-thalassemia Class II, 81JPD Hemoglobin A, Quantitation VARIANT™ f3-thalassemia K924122 Bio-Rad Laboratories Hercules, CA 94547 The VARIANT™ II B-thalassemia Program is intended for the separation and area percent d… | 1993 |
What descends from it? (5)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2014 | Class II | Z-1537-2014 | Nonconforming Material/Component | There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used. |
| Sep 12, 2011 | Not classified | Z-0023-2012 | Process control | A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these… |
| Sep 12, 2011 | Not classified | Z-0025-2012 | Process control | A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these… |
| Sep 12, 2011 | Not classified | Z-0024-2012 | Process control | A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JPD devicesJPD Hemoglobin A2 Quantitation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JPD
FDA has decided no JPD device since 2007.
Median 510(k) review, days · JPD
Too few JPD 510(k)s in any year since 2007 to give a median.
Recalls per year · JPD
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPD
No MAUDE report names JPD since 2007.
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 | — | 2 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VARIANT™ II β-thalassemia Program is intended for the separation and area percent determinations of hemoglobins A2 and F and as an aid in the identification of abnormal hemoglobins in whole blood using ion-exchange high performance liquid chromatography (HPLC).
The VARIANT™ II β-thalassemia Program is intended for use only with the Bio-Rad VARIANT™ II Hemoglobin Testing System
For in vitro diagnostic use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991127: Variant II B-Thalassemia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991127
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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