# GKA: Abnormal Hemoglobin Quantitation

- Device class: 2; regulation: 21 CFR 864.7415; FDA's rule: 510(k) required
- FDA decisions: 23
- 510(k) review time 2021–2025: median 338 days (middle half 305–627)
- Recalls: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2006: 2
- 2008: 1
- 2009: 1
- 2010: 1
- 2012: 2
- 2017: 1
- 2018: 1
- 2022: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- K051072: Bio-Rad Variant NBS Sickle Cell Program (2005), cited by 2
- K924813: Variant Sickle Cell Short Program (1993), cited by 2
- K112491: Sebia Capillarys Hemoglobin (E) with Capillarys 2 (2012), cited by 1
- K840011: Resolve-HB (1984), cited by 1
- K091283: Capillarys Neonat HB (PN 2006) (2010), cited by 1
- K112550: Capillarys Hemoglobin, Capillarys Flex Piercing System (2012), cited by 1
- K080911: Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and Variant NBS Workstation with (2008), cited by 1

Source page: https://510kreport.com/product-code/GKA
Data by year (CSV): https://510kreport.com/product-code/GKA.csv