510(k) · Cleared
ClearedHemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
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 Sep 13, 2017 as substantially equivalent to K080911 (Bio-Rad Laboratories Inc., Clinical Systems Divisi, 2008) after a 100-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Sep 13, 2017
- Review
- 100 days
- Class
- Class II
- Product code
- GKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K924813 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK924813 Variant Sickle Cell Short ProgramBio-Rad · 1993 · Recalled
- 2 generations backK051072 Bio-Rad Variant NBS Sickle Cell ProgramBio-Rad Laboratories, Inc. · 2005 · Recalled
- 1 generation backK080911 Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 2008
- This deviceK171664 Hemoglobin Variants System on Newborn Hemoglobin System with GDM and…Bio-Rad Laboratories, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924813 | Variant Sickle Cell Short Program | Bio-Rad | 1993 | 1 |
| −2 | K051072 | Bio-Rad Variant NBS Sickle Cell Program | Bio-Rad Laboratories, Inc. | 2005 | 1 |
| −1 | K080911 | Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening… | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2008 | — |
| 0 (this device) | K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview… | Bio-Rad Laboratories, Inc. | 2017 | — |
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 |
|---|---|---|---|
| * | K080911 | Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and…Summary page 5…cate Device Name 510(k) Number TM Bio-Rad VARIANT nbs Sickle Cell Program K080911 002-22 5. Description of the Instrument: The instrument, New… | 2008 |
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 24 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
How does its category compare?
All GKA devicesGKA Abnormal Hemoglobin Quantitation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Hemoglobin Variants System is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E
in eluDtes of neonatal blood collected on filter paper by high-performance liquid chromatography (HPLC).
The Hemoglobin Variants System is intended for Professional Use Only. For in vitro diagnostic use.
The Hemoglobin Variants System is for use only with the Newborn Hemoglobin System (NHS).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171664: Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171664
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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