# K171664: Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software

- Pathway: 510(k) (Special)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Sep 13, 2017 after 100 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: 3 generations back to K924813 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080911: Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and Variant NBS Workstation with, Bio-Rad Laboratories Inc., Clinical Systems Divisi (2008) Summary page 5.

## Indications for use
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).

Source page: https://510kreport.com/device/K171664
Methodology: https://510kreport.com/methodology