# CJW: Bromcresol Purple Dye-Binding, Albumin

- Device class: 2; regulation: 21 CFR 862.1035; FDA's rule: 510(k) required
- FDA decisions: 18
- 510(k) review time 2021–2025: median 471 days (middle half 471–471)
- Recalls: 0 (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)
- 1985: 1
- 1986: 4
- 1991: 2
- 1998: 2
- 1999: 1
- 2000: 1
- 2002: 1
- 2013: 1
- 2019: 1
- 2022: 1

## Most-cited predicates
- K132664: Advia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin BCP Calibrator (2013), cited by 2
- K844426: Albumin BCP (1985), cited by 2
- K981814: ALBP (1998), cited by 1
- K842847: Wako Automated Reagents for Hitachi 705 (1984), cited by 1

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