510(k) · Cleared
Recalled · Class II · 2022Bio-Rad Variant NBS Sickle Cell Program
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · GKA Abnormal Hemoglobin Quantitation
Cleared on May 12, 2005 as substantially equivalent to K924813 (Bio-Rad, 1993) after a 16-day review. Its family tree reaches back 1 generation to 1993. 3 later devices descend from it. It has been recalled once.
- Decided
- May 12, 2005
- Review
- 16 days
- Class
- Class II
- Product code
- GKA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924813 (1993). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK924813 Variant Sickle Cell Short ProgramBio-Rad · 1993 · Recalled
- This deviceK051072 Bio-Rad Variant NBS Sickle Cell ProgramBio-Rad Laboratories, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK080911 Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 2008
- Descendant · 2 generations on · 0 of its ownK171664 Hemoglobin Variants System on Newborn Hemoglobin System with GDM and…Bio-Rad Laboratories, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK050709 Resolve Hemoglobin Kit, JB-2 Staining System, Models FR-9120…Wallac OY · 2006 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K080911Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 2008 · cites it directly1descendant
- K171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareBio-Rad Laboratories, Inc. · 2017 · 2 generations on0descendants
- K050709Resolve Hemoglobin Kit, JB-2 Staining System, Models FR-9120, FR-9400, FR-9360, FR-9367Wallac OY · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924813 | Variant Sickle Cell Short Program | Bio-Rad | 1993 | 1 |
| 0 (this device) | K051072 | Bio-Rad Variant NBS Sickle Cell Program | Bio-Rad Laboratories, Inc. | 2005 | — |
| +1 | K080911 | Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening… | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2008 | — |
| +2 | K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview… | Bio-Rad Laboratories, Inc. | 2017 | — |
| +1 | K050709 | Resolve Hemoglobin Kit, JB-2 Staining System, Models FR-9120, FR-9400… | Wallac OY | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2017 | 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 GKA? 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 GKA device
- #1 K232027 CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrumentscore 7.1 · 1 generation · 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 |
|---|---|---|---|
| * | K924813 | Variant Sickle Cell Short ProgramSummary page 2…n Name: Abnormal Hemoglobin Quantitation (21 CFR 864.7415) Applicant: Bio-Rad Laboratories, Inc. 510(k) Number: K924813 Indications for Use Statement and Intended Uses The Bio-Rad VARIANTnbs Sickle Cell Program is intended as a qualitative scre… | 1993 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 7, 2022 | Class II | Z-1208-2022 | Packaging process control | The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in VARIANT nbs Sickle Cell Progam Reorder Pack #250-3000. This CD-ROM software included in specific lots of… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GKA devicesGKA Abnormal Hemoglobin Quantitation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GKA
Too few GKA 510(k)s in any year since 2007 to give a median.
Recalls per year · GKA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKA
2in 2013
MAUDE reports naming product code GKA, 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 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 2 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 5 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 1 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Bio-Rad VARIANTnbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high performance liquid chromatography (HPLC).
The Bio-Rad VARIANTnbs Sickle Cell Program is intended for Professional Use Only. For In Vitro Diagnostic Use.
The Bio-Rad VARIANTnbs Sickle Cell Program is for use only with the Bio-Rad VARIANTnbs Newborn Screening System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051072 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051072: Bio-Rad Variant NBS Sickle Cell Program.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051072
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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