# K192931: V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control - Pathway: 510(k) (Traditional) - Applicant: Helena Laboratories, Corp. - Decided: Apr 19, 2022 after 915 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: 1 generation back to K112491 (2012). 1 ancestor in all. No later device cites it as a predicate yet. 0 of 2 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K112491: Sebia Capillarys Hemoglobin (E) with Capillarys 2, Sebia (2012) Summary page 5. - (no number) Normal Hb A2 Control / Migration Control: named in the summary without a submission number - (no number) Hb AFSC Control: named in the summary without a submission number ## Indications for use The V8 Nexus Hemoglobin UltraScreen method is designed for the separation of normal hemoglobins (A, A2, and F) in human blood samples, and for the detection of major hemoglobins variants (S and C) by using a capillary zone electrophoresis (CZE) buffer with the V8 instrument. The V8 Nexus Hemoglobin UltraScreen test is indicated for use in patients 2 years of age and older. This test is designed for in-vitro diagnostic use only in conjunction with other laboratory and clinical findings. The V8 instrument is an automated analyzer which performs a complete hemoglobin profile for quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S and C. The assay is performed on the hemolysate of venous whole blood collected in tubes containing K2ZEDTA as the anticoagulant. The V8 AFSA2 Hemo Control (Cat. No. 1812) is to be used as a quantitative and/or qualitative control for the Hemoglobin UltraScreen on the V8 Capillary Electrophoresis (CE) system. Source page: https://510kreport.com/device/K192931 Methodology: https://510kreport.com/methodology