# DFH: Kappa, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5550; FDA's rule: 510(k) required
- FDA decisions: 63
- 510(k) review time 2021–2025: median 266 days (middle half 212–500)
- Recalls: 1 (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)
- 2013: 1
- 2015: 1
- 2016: 1
- 2017: 1
- 2018: 3
- 2019: 1
- 2021: 2
- 2022: 4
- 2024: 2
- 2025: 2

## Most-cited predicates
- K040009: Freelite Human Kappa and Lambda Kits (2004), cited by 3
- K171742: N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 (2017), cited by 2
- K964260: Immage Immunochemistry System Kappa Light Chain (Kap) Reagent Immage Immunochemistry System Lamda Light Chain (Lam) Reag (1997), cited by 2
- K182098: N Latex FLC kappa assay, N Latex FLC lambda assay (2018), cited by 2
- K042939: Capillary's Immunotyping (PN 2100) (2005), cited by 1
- K070900: Freelite Human Kappa and Lambda Free Diagnostic Test Kits for Use on the Roche Cobas Integra 400/400 Plus Analyzer Kit (2007), cited by 1
- K902484: Beckman Kappa Light Chain Reagent (Add'l Claims) (1990), cited by 1
- K884597: Beckman Lambda Light Chain Reagent (1988), cited by 1
- K884276: Beckman Kappa Light Chain Reagent (1988), cited by 1
- K211648: Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay (2022), cited by 1

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