510(k) Report

FDA applicant

The Binding Site, Ltd.

Santa Monica, CA125 decisions1988–202413 recalls

FDA records 125 decisions for The Binding Site, Ltd. (Santa Monica, CA) from 1988 to 2024: 125 510(k) clearances. Most are in product codes CFN (Method, Nephelometric, Immunoglobulins (G, A, M)) and DFH (Kappa, Antigen, Antiserum, Control). Its devices cite 2 predicates, 1 of them its own earlier devices. 13 recalls are linked to its devices.

FDA’s records also spell it “The Binding Site”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided The Binding Site, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 22008: 52009: 42010: 12012: 12013: 12014: 12024: 1
2007high 5 (2008) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2021

2009: 12012: 12014: 62016: 12018: 22021: 1
2007high 6 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — The Binding Site, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CFNMethod, Nephelometric, Immunoglobulins (G, A, M)15decisions
  • DFHKappa, Antigen, Antiserum, Control8decisions
  • DEHLambda, Antigen, Antiserum, Control7decisions
  • JZGSystem, Test, Beta-2-Microglobulin Immunological6decisions
  • MIDSystem, Test, Anticardiolipin Immunological5decisions
  • LLLExtractable Antinuclear Antibody, Antigen And Control5decisions

Also: MSV (4), CZJ (4), MOB (4), CFQ (4), DCK (3), MST (3).

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 26 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K031016Freelite Human Kappa and Lambda Free Kits for Use on the Dad Behring Nephelometer IIThe Binding Site, Ltd. · 20036cite it
  • K040009Freelite Human Kappa and Lambda KitsThe Binding Site, Ltd. · 20043cite it
  • K082129Human Igm Liquid Reagent Kit for Use on the Spaplus AnalyzerThe Binding Site, Ltd. · 20092cite it
  • K981029Bindazyme Anti-PR3 Enzyme Immunoassay KitThe Binding Site, Ltd. · 19982cite it
  • K103824Human Iga Liquid Reagent Kit for Use on Spa PlusThe Binding Site · 20122cite it
  • K981030Bindazyme Anti-Mpo Enzyme Immunoassay KitThe Binding Site, Ltd. · 19982cite it

What has FDA decided for it lately?

  • K231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitThe Binding Site, Ltd. · 2024
  • K140105Hevylite Human Iga Kappa Kit for Use on Siemens Bnii, Hevylite Human Iga Lambda Kit for Use on Siemens BniiThe Binding Site · 2014
  • K132555Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda KitThe Binding Site · 2013
  • K103824Human Iga Liquid Reagent Kit for Use on Spa PlusThe Binding Site · 2012
  • K100455Spaplus AnalyzerThe Binding Site · 2010
  • K090920Human Igg Subclass Liquid Reagent Kits (for Use on Hitachi 911/ 912/ 917 and Modular P)The Binding Site, Ltd. · 20091 recall
  • K092450Human Igd Kit for Use on SpaplusThe Binding Site · 2009
  • K083289Human Beta-2 Microglobulin KitThe Binding Site, Ltd. · 2009

All 115 as The Binding Site, Ltd. →All 10 as The Binding Site →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K070900FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie…May 20, 2021Class II
  • K082129Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction…Nov 6, 2018Class II
  • K082129Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction…Jul 25, 2018Class II
  • K062372Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S…Oct 28, 2016Class II
  • K042152Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code…Sep 11, 2014Class II
  • K090920Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex…Sep 11, 2014Class II

Other applicant names beginning “The”

FDA records each applicant name separately; these may or may not be the same firm.

The Binding Site Group, Ltd. 44