510(k) · Cleared

Recalled · Class II · 2017

Resolve Hemoglobin Kit, JB-2 Staining System, Models FR-9120, FR-9400, FR-9360, FR-9367

K050709510(k) TraditionalCleared Mar 8, 2006355-day reviewClass II21 CFR 864.7415Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wallac OY · GKA Abnormal Hemoglobin Quantitation

Cleared on Mar 8, 2006 as substantially equivalent to K924813 (Bio-Rad, 1993) and 1 other predicate after a 355-day review. Its family tree reaches back 2 generations to 1993. It has been recalled once.

Decided: Mar 8, 2006
Review: 355 days
Class: Class II
Product code: GKA
Recalls: 1
Predicates: 2

Its longest line of descent runs back 2 generations to K924813 (1993). No later device cites it as a predicate yet.

By dateBy generation

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 deviceK050709 Resolve Hemoglobin Kit, JB-2 Staining System, Models FR-9120…Wallac OY · 2006

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)	K050709	Resolve Hemoglobin Kit, JB-2 Staining System, Models FR-9120, FR-9400…	Wallac OY	2006	—

FIG. 1 — Lineage of K050709, 1993–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K924813	Variant Sickle Cell Short Program Summary page 1 …Class IIper 21 CFR § 862.7415 Product Code: GKA Predicate Device: BioRad VARIANT Sickle Cell Short Program K924813 BioRad VARIANT nbs Sickle Cell Program K051072 Device Description:…	Bio-Rad	1993	1
*	K051072	Bio-Rad Variant NBS Sickle Cell Program Cleared while this submission was under review Summary page 1 …KA Predicate Device: BioRad VARIANT Sickle Cell Short Program K924813 BioRad VARIANT nbs Sickle Cell Program K051072 Device Description: The preparation and separation of hemoglobin is accomplished…	Bio-Rad Laboratories, Inc.	2005	1

Also cleared against K924813: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 15, 2017	Class II	Z-2685-2017	Device Design	Potential for electric shock in the case of a failure to install the grommets, supplied with the system.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 13 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.
1 other device also cites its predicate K924813.

How does its category compare?

All GKA devices

GKA Abnormal Hemoglobin Quantitation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GKA

1in 2024

2007high 2 (2012) · low 0 (2007)2026

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

2007high 5 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GKA

2in 2013

2007high 2 (2013) · low 0 (2007)2025

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 RESOLVE® Systems Hemoglobin kit is designed to

separate whole blood or cord blood samples for detection of

normal and variant hemoglobins by isoelectronic focusing.

The kit is designed to be run on a flat-bed electrofocusing

unit.

This assay is intended for use as an aid in the diagnosis of

neonatal and adult hemoglobinopathies.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050709 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050709: Resolve Hemoglobin Kit, JB-2 Staining System, Models FR-9120, FR-9400, FR-9360, FR-9367.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050709

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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