# K080911: Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and Variant NBS Workstation with

- Pathway: 510(k) (Special)
- Applicant: Bio-Rad Laboratories Inc., Clinical Systems Divisi
- Decided: May 2, 2008 after 30 days
- Product code: GKA (Abnormal Hemoglobin Quantitation)
- Device class: 2
- Regulation: 21 CFR 864.7415
- Recalls of this device: none
- 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.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051072: Bio-Rad Variant NBS Sickle Cell Program, Bio-Rad Laboratories, Inc. (2005) Summary page 1.

## Most influential descendants
- K171664: Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software (2017), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K080911
Methodology: https://510kreport.com/methodology