# K051072: Bio-Rad Variant NBS Sickle Cell Program

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: May 12, 2005 after 16 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: 1 generation back to K924813 (1993). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 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 2.

## Most influential descendants
- K080911: Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and Variant NBS Workstation with (2008), 1 descendant of its own
- K171664: Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software (2017), 0 descendants of its own
- K050709: Resolve Hemoglobin Kit, JB-2 Staining System, Models FR-9120, FR-9400, FR-9360, FR-9367 (2006), 0 descendants of its own

## Recalls of this device
- Apr 7, 2022 · Class II · Z-1208-2022: 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 sof

## Indications for use
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.

Source page: https://510kreport.com/device/K051072
Methodology: https://510kreport.com/methodology