# K050709: Resolve Hemoglobin Kit, JB-2 Staining System, Models FR-9120, FR-9400, FR-9360, FR-9367

- Pathway: 510(k) (Traditional)
- Applicant: Wallac OY
- Decided: Mar 8, 2006 after 355 days
- Product code: GKA (Abnormal Hemoglobin Quantitation)
- Device class: 2
- Regulation: 21 CFR 864.7415
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K924813 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924813: Variant Sickle Cell Short Program, Bio-Rad (1993) Summary page 1.
- K051072: Bio-Rad Variant NBS Sickle Cell Program, Bio-Rad Laboratories, Inc. (2005). Cleared while this submission was under review Summary page 1.

## Recalls of this device
- May 15, 2017 · Class II · Z-2685-2017: Potential for electric shock in the case of a failure to install the grommets, supplied with the system.

## Indications for use
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.

Source page: https://510kreport.com/device/K050709
Methodology: https://510kreport.com/methodology