# JPD: Hemoglobin A2 Quantitation

- Device class: 2; regulation: 21 CFR 864.7400; FDA's rule: 510(k) required
- FDA decisions: 13
- Recalls: 3 (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)
- 1980: 1
- 1981: 2
- 1983: 1
- 1988: 1
- 1990: 1
- 1991: 1
- 1992: 3
- 1993: 1
- 1999: 1
- 2002: 1

## Most-cited predicates
- K991127: Variant II B-Thalassemia (1999), cited by 3
- K924122: Variant Beta-Thalassemia Short Program (1993), cited by 2
- K823870: Beta Thalquik Column #5341 (1983), cited by 1

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