# The Binding Site Group, Ltd.

- Location (FDA's records): Birmingham, GB
- FDA decisions: 44 (2010–2025): 44 510(k) clearances
- Names in FDA's records: The Binding Site Group , Ltd. (43); The Binding Site Group (1)
- Product codes: CFN (14), DFH (4), DCN (3), DCF (3), DBA (2), DHR (2), DAE (2), PCN (2), PDE (2), OPX (2), DDG (1), CZW (1)
- 510(k) review time since 2016: median 70 days, against 28 for FDA's reviews in the same codes and years (4 of 9 faster)
- Predicates its devices cite: 20 (5 its own); citations of its devices by later devices: 5 (5 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- The Binding Site, Ltd.: 8 (https://510kreport.com/company/binding-site)
- Behring Diagnostics, Inc.: 3 (https://510kreport.com/company/behring-diagnostics)
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)
- Morax: 1 (https://510kreport.com/company/morax)

## Its most-cited devices
- K113823: Hevylite Human Igm Kappa and Hevylite Igm Lambda Kit (2013), cited by 1
- K160070: Rheumatoid Factor (RF) Kit for use on SPAPLUS (2016), cited by 1
- K120750: Human Igm CSF Kit (2013), cited by 1
- K191635: Optilite IgM Kit (2019), cited by 1
- K191985: Optilite IgA Kit (2019), cited by 1

## Recent decisions
- K250159: Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (Oct 17, 2025)
- K250549: Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit (May 23, 2025)
- K192116: Human IgA liquid reagent kit for Use on SPAPlus (Sep 4, 2019)
- K191985: Optilite IgA Kit (Aug 19, 2019)
- K191635: Optilite IgM Kit (Jul 15, 2019)
- K191465: Human IgM Kit for use on SPAPlus (Jun 27, 2019)
- K190686: Optilite IgM CSF Kit (May 28, 2019)
- K183151: Optilite IgA CSF Kit (Jan 23, 2019)

Source page: https://510kreport.com/company/binding-site-group