510(k) · Cleared
ClearedVariant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and Variant NBS Workstation with
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories Inc., Clinical Systems Divisi · GKA Abnormal Hemoglobin Quantitation
Cleared on May 2, 2008 as substantially equivalent to K051072 (Bio-Rad Laboratories, Inc., 2005) after a 30-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- May 2, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- GKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924813 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK924813 Variant Sickle Cell Short ProgramBio-Rad · 1993 · Recalled
- 1 generation backK051072 Bio-Rad Variant NBS Sickle Cell ProgramBio-Rad Laboratories, Inc. · 2005 · Recalled
- This deviceK080911 Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 2008
- Descendant · cites it directly · 0 of its ownK171664 Hemoglobin Variants System on Newborn Hemoglobin System with GDM and…Bio-Rad Laboratories, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareBio-Rad Laboratories, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924813 | Variant Sickle Cell Short Program | Bio-Rad | 1993 | 1 |
| −1 | K051072 | Bio-Rad Variant NBS Sickle Cell Program | Bio-Rad Laboratories, Inc. | 2005 | 1 |
| 0 (this device) | K080911 | Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening… | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2008 | — |
| +1 | K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview… | Bio-Rad Laboratories, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K051072 | Bio-Rad Variant NBS Sickle Cell ProgramSummary page 1…nagement (GDM) 3.0 Software Classification Name: Assay, Abnormal Hemoglobin, GKA Predicate Device(s): VARIANT T Mnbs Sickle Cell Program, Bio-Rad Laboratories, Inc., K051072 ·Intended Use: The Bio-Rad VARIANTTMnbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software | 2017 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K171664 (Bio-Rad Laboratories, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K051072.
How does its category compare?
All GKA devicesGKA Abnormal Hemoglobin Quantitation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 VARIANTTMnbs 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 VARIANTTMnbs Sickle Cell Program is intended for Professional Use Only. For In Vitro Diagnostic Use.
The Bio-Rad VARIANT TM nbs Sickle Cell Program is for use only with the Bio-Rad VARIANTTMnbs Newborn Screening System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080911: Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and Variant NBS Workstation with.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080911
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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