The Binding Site Group Ltd.
BIRMINGHAM Birmingham, GB
The Binding Site Group Ltd. appears in FDA device records in BIRMINGHAM Birmingham, GB. FDA records list 44 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 29 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 44 510(k) clearances for The Binding Site Group Ltd. between 2010 and 2025. The busiest year on record is 2013, with 10. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 3 |
| 2012 | 2 |
| 2013 | 10 |
| 2014 | 5 |
| 2015 | 6 |
| 2016 | 4 |
| 2017 | 2 |
| 2018 | 4 |
| 2019 | 6 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | SGG | Substantially Equivalent | |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | DFH | Substantially Equivalent | |
| K192116 | Human IgA liquid reagent kit for Use on SPAPlus | CFN | Substantially Equivalent | |
| K191985 | Optilite IgA Kit | CFN | Substantially Equivalent | |
| K191635 | Optilite IgM Kit | CFN | Substantially Equivalent | |
| K191465 | Human IgM Kit for use on SPAPlus | CFN | Substantially Equivalent | |
| K190686 | Optilite IgM CSF Kit | CFN | Substantially Equivalent | |
| K183151 | Optilite IgA CSF Kit | CFN | Substantially Equivalent | |
| K180099 | Optilite High Sensitivity C-Reactive Protein Kit | DCN | Substantially Equivalent | |
| K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit | DFH | Substantially Equivalent | |
| K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls | DCN | Substantially Equivalent | |
| K172613 | Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit | PCN | Substantially Equivalent | |
| K162263 | Optilite Rheumatoid Factor Kit | DHR | Substantially Equivalent | |
| K161982 | C-Reactive Protein Kit for use on SPAPLUS | DCN | Substantially Equivalent | |
| K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUS | DHR | Substantially Equivalent | |
| K161854 | Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS | PCN | Substantially Equivalent | |
| K153560 | Optilite Low Level Albumin Kit | DCF | Substantially Equivalent | |
| K160819 | Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit | OPX | Substantially Equivalent | |
| K152389 | Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit | PDE | Substantially Equivalent | |
| K151759 | Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS | OPX | Substantially Equivalent | |
| K150412 | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator | DAE | Substantially Equivalent | |
| K150658 | Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit | DFH | Substantially Equivalent | |
| K150526 | Optilite IgG4 Kit | CFN | Substantially Equivalent | |
| K143118 | Human Microalbumin kit for use on SPAPLUS | DCF | Substantially Equivalent | |
| K142735 | The Optilite IgG3 kit | CFN | Substantially Equivalent | |
| K140686 | HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS | PDE | Substantially Equivalent | |
| K141100 | OPTILITE C1 INACTIVATOR KIT | DBA | Substantially Equivalent | |
| K140664 | HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS | DEB | Substantially Equivalent | |
| K140396 | FREELITE HUMAN LAMBDA FREE KIT | DEH | Substantially Equivalent | |
| K123256 | HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS | DEM | Substantially Equivalent | |
| K121045 | HUMAN ALBUMIN CSF KIT | DCF | Substantially Equivalent | |
| K122965 | HUMAN CAERULOPLASMIN KIT | DDB | Substantially Equivalent | |
| K120901 | HUMAN IGA CSF KIT FOR USE ON SPAPLUS | CFN | Substantially Equivalent | |
| K120750 | HUMAN IGM CSF KIT | CFN | Substantially Equivalent | |
| K120749 | HUMAN IGG CSF KIT | CFN | Substantially Equivalent | |
| K122304 | HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS | DBA | Substantially Equivalent | |
| K120056 | HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER | DFH | Substantially Equivalent | |
| K113823 | HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT | CFN | Substantially Equivalent | |
| K120236 | TRANSFERRIN KIT FOR USE ON THE SPAPLUS | DDG | Substantially Equivalent | |
| K122066 | HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS | JZG | Substantially Equivalent | |
| K113349 | HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO | DAE | Substantially Equivalent | |
| K100588 | HUMAN IGA2 KIT FOR USE ON THE SPAPLUS | CFN | Substantially Equivalent | |
| K100179 | SPAPLUS | CZW | Substantially Equivalent | |
| K082823 | HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS | CFN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9614373 | 3002808340 | The Binding Site Group Ltd. | 8 Calthorpe Road, BIRMINGHAM B15 1QT GB | 2026 | and 39 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DCFAlbumin, Antigen, Antiserum, Control
- LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- DEBAlpha-2-Macroglobulin, Antigen, Antiserum, Control
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- GRPAntisera, All Types, H. Influenza
- GOSAntiserum, Fluorescent, C. Diphtheriae
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- JBQAntithrombin Iii Quantitation
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- DDBCeruloplasmin, Antigen, Antiserum, Control
- DBAComplement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
- DAKComplement C1q, Antigen, Antiserum, Control
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- DAYComplement C5, Antigen, Antiserum, Control
- DAEComplement C9, Antigen, Antiserum, Control
- JRICuvette, Thermostated
- CEFElectrophoretic, Protein Fractionation
- PPMGeneral Purpose Reagent
- DADHaptoglobin, Antigen, Antiserum, Control
- OPYIgal Heavy & Light Chain Combined
- CZJIgd, Antigen, Antiserum, Control
- DGCIge, Antigen, Antiserum, Control
- OPXImmunoglobulin A Kappa Heavy & Light Chain Combined
- PCNImmunoglobulin G Kappa Heavy And Light Chain Combined
- PCOImmunoglobulin G Lambda Heavy And Light Chain Combined
- PDEImmunoglobulin M Kappa Heavy And Light Chain Combined
- PDFImmunoglobulin M Lambda Heavy And Light Chain Combined
- DFHKappa, Antigen, Antiserum, Control
- DEHLambda, Antigen, Antiserum, Control
- OTAMass Spectrometer For Clinical Multiplex Test Systems
- SGGMass Spectrometric, Immunoglobulins (G, A, M, D, E)
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- DDXPlasminogen, Antigen, Antiserum, Control
- JZQPlates And Equipment, Radial Immunodiffusion
- JZJPrealbumin, Antigen, Antiserum, Control
- MVUReagents, Specific, Analyte
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- DCNSystem, Test, C-Reactive Protein
- DHRSystem, Test, Rheumatoid Factor
- NDYTest, Cystatin C
- DFITotal Spinal-Fluid, Antigen, Antiserum, Control
- DDGTransferrin, Antigen, Antiserum, Control
Recall records
Showing 25 of 29| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2362-2026 | 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 qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays. | It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include false or missed detection of M-protein (false positive); and falsely elevated or decreased M-protein concentration. | Class II | Open, Classified | |
| Z-0274-2022 | 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 | Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer. | Class II | Terminated | |
| Z-2030-2021 | 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 | The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values. | Class II | Terminated | |
| Z-0943-2021 | Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A | Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values. | Class II | Terminated | |
| Z-2071-2020 | 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 measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. | A software issue that may affect the analyzer's result accuracy. | Class II | Terminated | |
| Z-1500-2020 | Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319 | It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing. | Class II | Terminated | |
| Z-2110-2020 | Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components) | Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum. This could result in reporting abnormal (false positive) results, which may lead to unnecessary additional serological testing and a delay in treatment. | Class II | Terminated | |
| Z-1327-2020 | OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565 | There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed. | Class II | Terminated | |
| Z-1619-2020 | C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456, | A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected | Class II | Terminated | |
| Z-0671-2020 | 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 using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser. The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent. | Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits | Class II | Terminated | |
| Z-0604-2019 | 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 stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format. | Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges. | Class II | Terminated | |
| Z-1469-2020 | 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 specific IgG antibodies against Haemophilus influenzae type b (Hib) capsular polysaccharide, present in human serum. Sufficient materials are supplied to allow a maximum of 41 samples to be tested in duplicate, with a calibration curve and two controls. | A deterioration of performance was identified with influenza type B Enzyme Immunoassay Kits with findings of a positive bias with kit controls. Patient sample results may be affected with falsely elevated results incorrectly indicating a protective level of anti-Hib antibody in the assessment of immunodeficiency. | Class II | Terminated | |
| Z-0477-2019 | 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 stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format. | After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one day after running the assay calibration curve. Samples have been shown to be similarly affected. | Class II | Terminated | |
| Z-1301-2018 | 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 kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. This test should be used in conjunction with other laboratory and clinical findings. | The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use. | Class II | Terminated | |
| Z-0553-2018 | 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 of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings | The low and high controls for the product are returning results above the assigned values. | Class II | Terminated | |
| Z-0002-2018 | 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 in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. The measurement of Alpha-1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, Alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings. | The high control for the kit is recovering low and may be out of range for assigned values. | Class II | Terminated | |
| Z-1089-2017 | Optilite IgG4 Kit Product Code: LK009.OPT.A | A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert | Class III | Terminated | |
| Z-1053-2017 | 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 | A change in the calibration curve causing an increase in false prozone flags. | Class II | Terminated | |
| Z-1043-2017 | Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit. | Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to this batch will see results >114mg/L giving lower results and conversely when switching to the next batch results will be seen to shift upwards. | Class II | Terminated | |
| Z-1018-2017 | 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 may be adaptable to the analyzer depending on the reagent used. The Indiko Glucose (H-K) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemnia, and of pancreatic islet cell carcinoma. | Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position. | Class II | Terminated | |
| Z-1073-2017 | 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 these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents | Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results. | Class II | Terminated | |
| Z-1072-2017 | 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 serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents | Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results. | Class II | Terminated | |
| Z-1071-2017 | 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 serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents | Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results. | Class II | Terminated | |
| Z-1070-2017 | 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 is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents | Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results. | Class II | Terminated | |
| Z-1069-2017 | 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 series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents Product Code LK009.CB | Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets The Binding Site Group Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain