Company · GB
The Binding Site Group , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2025. Name variants (Inc, Corp, punctuation) are merged.
44510(k) clearances (0 in 12 months)
29recalls (1 in 12 months)
25recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 25 |
| DFH | Kappa, Antigen, Antiserum, Control | 6 |
| DCN | System, Test, C-Reactive Protein | 5 |
| DEH | Lambda, Antigen, Antiserum, Control | 5 |
| DHR | System, Test, Rheumatoid Factor | 5 |
| DCF | Albumin, Antigen, Antiserum, Control | 3 |
| DAE | Complement C9, Antigen, Antiserum, Control | 2 |
| DBA | Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control | 2 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 2 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 2 |
| OPX | Immunoglobulin A Kappa Heavy & Light Chain Combined | 2 |
| PCN | Immunoglobulin G Kappa Heavy And Light Chain Combined | 2 |
| PDE | Immunoglobulin M Kappa Heavy And Light Chain Combined | 2 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 |
| DDB | Ceruloplasmin, Antigen, Antiserum, Control | 1 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 |
| DEB | Alpha-2-Macroglobulin, Antigen, Antiserum, Control | 1 |
| GRP | Antisera, All Types, H. Influenza | 1 |
| JZQ | Plates And Equipment, Radial Immunodiffusion | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 17, 2025 | K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser The Binding Site Group , Ltd., GB | SGG |
| May 23, 2025 | K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit The Binding Site Group , Ltd., GB | DFH |
| Sep 4, 2019 | K192116 | Human IgA liquid reagent kit for Use on SPAPlus The Binding Site Group , Ltd., GB | CFN |
| Aug 19, 2019 | K191985 | Optilite IgA Kit The Binding Site Group , Ltd., GB | CFN |
| Jul 15, 2019 | K191635 | Optilite IgM Kit The Binding Site Group , Ltd., GB | CFN |
| Jun 27, 2019 | K191465 | Human IgM Kit for use on SPAPlus The Binding Site Group , Ltd., GB | CFN |
| May 28, 2019 | K190686 | Optilite IgM CSF Kit The Binding Site Group , Ltd., GB | CFN |
| Jan 23, 2019 | K183151 | Optilite IgA CSF Kit The Binding Site Group , Ltd., GB | CFN |
| Oct 12, 2018 | K180099 | Optilite High Sensitivity C-Reactive Protein Kit The Binding Site Group , Ltd., GB | DCN |
| Aug 23, 2018 | K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit The Binding Site Group , Ltd., GB | DFH |
| Feb 28, 2018 | K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls The Binding Site Group , Ltd., GB | DCN |
| Feb 15, 2018 | K172613 | Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit The Binding Site Group , Ltd., GB | PCN |
| May 3, 2017 | K162263 | Optilite Rheumatoid Factor Kit The Binding Site Group , Ltd., GB | DHR |
| Apr 5, 2017 | K161982 | C-Reactive Protein Kit for use on SPAPLUS The Binding Site Group, GB | DCN |
| Dec 7, 2016 | K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUS The Binding Site Group , Ltd., GB | DHR |
| Oct 4, 2016 | K161854 | Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS The Binding Site Group , Ltd., GB | PCN |
| Aug 25, 2016 | K153560 | Optilite Low Level Albumin Kit The Binding Site Group , Ltd., GB | DCF |
| Jun 16, 2016 | K160819 | Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit The Binding Site Group , Ltd., GB | OPX |
| Dec 18, 2015 | K152389 | Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit The Binding Site Group , Ltd., GB | PDE |
| Nov 6, 2015 | K151759 | Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS The Binding Site Group , Ltd., GB | OPX |
| Aug 28, 2015 | K150412 | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator The Binding Site Group , Ltd., GB | DAE |
| Aug 26, 2015 | K150658 | Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit The Binding Site Group , Ltd., GB | DFH |
| May 30, 2015 | K150526 | Optilite IgG4 Kit The Binding Site Group , Ltd., GB | CFN |
| May 26, 2015 | K143118 | Human Microalbumin kit for use on SPAPLUS The Binding Site Group , Ltd., GB | DCF |
| Dec 21, 2014 | K142735 | The Optilite IgG3 kit The Binding Site Group , Ltd., GB | CFN |
| Aug 6, 2014 | K140686 | HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS The Binding Site Group , Ltd., GB | PDE |
| Jul 18, 2014 | K141100 | OPTILITE C1 INACTIVATOR KIT The Binding Site Group , Ltd., GB | DBA |
| Apr 16, 2014 | K140664 | HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS The Binding Site Group , Ltd., GB | DEB |
| Apr 16, 2014 | K140396 | FREELITE HUMAN LAMBDA FREE KIT The Binding Site Group , Ltd. | DEH |
| Jul 3, 2013 | K123256 | HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS The Binding Site Group , Ltd., GB | DEM |
| Jun 19, 2013 | K121045 | HUMAN ALBUMIN CSF KIT The Binding Site Group , Ltd., GB | DCF |
| Jun 3, 2013 | K122965 | HUMAN CAERULOPLASMIN KIT The Binding Site Group , Ltd., GB | DDB |
| May 30, 2013 | K120901 | HUMAN IGA CSF KIT FOR USE ON SPAPLUS The Binding Site Group , Ltd., GB | CFN |
| May 17, 2013 | K120750 | HUMAN IGM CSF KIT The Binding Site Group , Ltd., GB | CFN |
| May 17, 2013 | K120749 | HUMAN IGG CSF KIT The Binding Site Group , Ltd., GB | CFN |
| Apr 15, 2013 | K122304 | HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS The Binding Site Group , Ltd., GB | DBA |
| Apr 1, 2013 | K120056 | HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER The Binding Site Group , Ltd., GB | DFH |
| Mar 27, 2013 | K113823 | HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT The Binding Site Group , Ltd., GB | CFN |
| Feb 13, 2013 | K120236 | TRANSFERRIN KIT FOR USE ON THE SPAPLUS The Binding Site Group , Ltd., GB | DDG |
| Aug 30, 2012 | K122066 | HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS The Binding Site Group , Ltd., GB | JZG |
| Jul 11, 2012 | K113349 | HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO The Binding Site Group , Ltd., GB | DAE |
| Aug 16, 2010 | K100588 | HUMAN IGA2 KIT FOR USE ON THE SPAPLUS The Binding Site Group , Ltd. | CFN |
| Aug 13, 2010 | K100179 | SPAPLUS The Binding Site Group , Ltd. | CZW |
| Mar 1, 2010 | K082823 | HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS The Binding Site Group , Ltd. | CFN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2026 | The Binding Site Group, Ltd. Brand Name: EXENT Analyser
Product Name: EXENT Analyser
Model/Catalog Number: IE800.A
Software Version: 1.0.20
Product Description: The EXENT Analyser is an automated analyser intended for the qualita Open, Classified |
OTA | K250159 |
| Oct 15, 2021 | The Binding Site Group, Ltd. Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S
Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S Terminated |
DEH | K140396 |
| May 20, 2021 | The Binding Site Group, Ltd. FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096 Terminated |
DFH | K070900 |
| Nov 18, 2020 | The Binding Site Group, Ltd. Optilite Freelite Mx Kappa Free Kit
REF LK016.M.OPT.A Terminated |
DFH | K173732 |
| Apr 9, 2020 | The Binding Site Group, Ltd. The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to mea Terminated |
JJE | None listed |
| Mar 31, 2020 | The Binding Site Group, Ltd. C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456, Terminated |
DCN | K161982 |
| Dec 12, 2019 | The Binding Site Group, Ltd. Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum usin Terminated |
DCN | K172868 |
| Nov 6, 2019 | The Binding Site Group, Ltd. Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319 Terminated |
DHR | K160070 |
| Oct 7, 2019 | The Binding Site Group, Ltd. Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components) Terminated |
DHR | K162263 |
| Jul 29, 2019 | The Binding Site Group, Ltd. OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565 Terminated |
CFN | K191465 K191635 |
| Dec 13, 2018 | The Binding Site Group, Ltd. Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S
The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on st Terminated |
CFN | K082129 |
| Nov 17, 2018 | The Binding Site Group, Ltd. Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S
The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on st Terminated |
CFN | K082129 |
| Aug 12, 2018 | The Binding Site Group, Ltd. VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specifi Terminated |
GRP | None listed |
| Mar 9, 2018 | The Binding Site Group, Ltd. Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K.
The Optilite Beta-2-Microglobulin (2M) Urine Terminated |
JZG | K122066 |
| Jan 4, 2018 | The Binding Site Group, Ltd. Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A
Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement Terminated |
DHR | K160070 |
| Aug 23, 2017 | The Binding Site Group, Ltd. Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK.
Product is designed for the quantitative Terminated |
DEM | K123256 |
| Jan 23, 2017 | The Binding Site Group, Ltd. MininephThl Human lgG4 Kit
Product Code: ZK009.LR
This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of th Terminated |
CFN | K982100 |
| Jan 23, 2017 | The Binding Site Group, Ltd. Human lgG Subclass Liquid Reagent Kits for use on the
Siemens BN"IJ Analyser
Product Code: NK001.T
This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in Terminated |
CFN | K012295 |
| Jan 23, 2017 | The Binding Site Group, Ltd. Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser
Product Code: NK009.T
This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in s Terminated |
CFN | K012295 |
| Jan 23, 2017 | The Binding Site Group, Ltd. Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 and Hitachi Modular P
Product Code LK009.H/LK001.H
This kit i Terminated |
CFN | K090920 |
| Jan 23, 2017 | The Binding Site Group, Ltd. Human lgG4 Subclass Liquid Reagent Kits For use on the
Roche Cobas"6000
This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU se Terminated |
CFN | None listed |
| Jan 23, 2017 | The Binding Site Group, Ltd. Human lgG4 Subclass kit for use on the Beckman Coulter AU"
series
This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaure Terminated |
CFN | K042152 |
| Jan 23, 2017 | The Binding Site Group, Ltd. Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser
Product Code LK009.IM
This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckma Terminated |
CFN | K042152 |
| Jan 19, 2017 | The Binding Site Group, Ltd. Freelite Human Lambda Free Kit for use on SPAPLUS
Product Code: LK018.S, LK018.10S
Freelite aids the detection and monitoring of Multiple Myeloma and related diseases Terminated |
DEH | K062372 |
| Jan 19, 2017 | The Binding Site Group, Ltd. Human Lambda Free SPAPlus Kit
Product Code: LK018.S
Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases. Terminated |
DEH | K062372 |
| Jan 19, 2017 | The Binding Site Group, Ltd. Digital RID Plate Reader and Software
Product Code: AD400 Terminated |
JZQ | None listed |
| Jan 18, 2017 | The Binding Site Group, Ltd. Optilite Freelite Lambda Free Kit
Product Code: LK018.OPT, LK018.OPT.A
Protein testing kit. Terminated |
DEH | K150658 |
| Dec 23, 2016 | The Binding Site Group, Ltd. Optilite IgG4 Kit
Product Code: LK009.OPT.A Terminated |
CFN | K150526 |
| May 13, 2015 | The Binding Site Group, Ltd. Optilite Analyser, Product Code: IE700
Product Usage:
The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that m Terminated |
JJE | K110035 |