Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Binding Site Group , Ltd. — Predicate Candidate Screening
43 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
168 daysmedian FDA review time
431 days90th percentile
43clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT | The Binding Site Group , Ltd. | 2025-10-17 | 269 | 1 |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx | The Binding Site Group , Ltd. | 2025-05-23 | 87 | 0 |
| K192116 | Human IgA liquid reagent kit for Use on SPAPlus | The Binding Site Group , Ltd. | 2019-09-04 | 29 | 0 |
| K191985 | Optilite IgA Kit | The Binding Site Group , Ltd. | 2019-08-19 | 25 | 0 |
| K191635 | Optilite IgM Kit | The Binding Site Group , Ltd. | 2019-07-15 | 26 | 0 |
| K191465 | Human IgM Kit for use on SPAPlus | The Binding Site Group , Ltd. | 2019-06-27 | 24 | 0 |
| K190686 | Optilite IgM CSF Kit | The Binding Site Group , Ltd. | 2019-05-28 | 71 | 0 |
| K183151 | Optilite IgA CSF Kit | The Binding Site Group , Ltd. | 2019-01-23 | 70 | 0 |
| K180099 | Optilite High Sensitivity C-Reactive Protein Kit | The Binding Site Group , Ltd. | 2018-10-12 | 269 | 0 |
| K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx La | The Binding Site Group , Ltd. | 2018-08-23 | 260 | 0 |
| K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Prot | The Binding Site Group , Ltd. | 2018-02-28 | 161 | 1 |
| K172613 | Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambd | The Binding Site Group , Ltd. | 2018-02-15 | 168 | 0 |
| K162263 | Optilite Rheumatoid Factor Kit | The Binding Site Group , Ltd. | 2017-05-03 | 265 | 0 |
| K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUS | The Binding Site Group , Ltd. | 2016-12-07 | 329 | 0 |
| K161854 | Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylit | The Binding Site Group , Ltd. | 2016-10-04 | 90 | 0 |
| K153560 | Optilite Low Level Albumin Kit | The Binding Site Group , Ltd. | 2016-08-25 | 255 | 0 |
| K160819 | Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambd | The Binding Site Group , Ltd. | 2016-06-16 | 84 | 0 |
| K152389 | Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambd | The Binding Site Group , Ltd. | 2015-12-18 | 116 | 0 |
| K151759 | Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Hu | The Binding Site Group , Ltd. | 2015-11-06 | 130 | 0 |
| K150412 | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite C | The Binding Site Group , Ltd. | 2015-08-28 | 191 | 0 |
| K150658 | Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda F | The Binding Site Group , Ltd. | 2015-08-26 | 166 | 1 |
| K150526 | Optilite IgG4 Kit | The Binding Site Group , Ltd. | 2015-05-30 | 89 | 0 |
| K143118 | Human Microalbumin kit for use on SPAPLUS | The Binding Site Group , Ltd. | 2015-05-26 | 208 | 0 |
| K142735 | The Optilite IgG3 kit | The Binding Site Group , Ltd. | 2014-12-21 | 89 | 0 |
| K140686 | HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS | The Binding Site Group , Ltd. | 2014-08-06 | 140 | 0 |
| K141100 | OPTILITE C1 INACTIVATOR KIT | The Binding Site Group , Ltd. | 2014-07-18 | 80 | 0 |
| K140396 | FREELITE HUMAN LAMBDA FREE KIT | The Binding Site Group , Ltd. | 2014-04-16 | 57 | 0 |
| K140664 | HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS | The Binding Site Group , Ltd. | 2014-04-16 | 29 | 0 |
| K123256 | HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS | The Binding Site Group , Ltd. | 2013-07-03 | 258 | 0 |
| K121045 | HUMAN ALBUMIN CSF KIT | The Binding Site Group , Ltd. | 2013-06-19 | 439 | 0 |
| K122965 | HUMAN CAERULOPLASMIN KIT | The Binding Site Group , Ltd. | 2013-06-03 | 252 | 0 |
| K120901 | HUMAN IGA CSF KIT FOR USE ON SPAPLUS | The Binding Site Group , Ltd. | 2013-05-30 | 430 | 0 |
| K120749 | HUMAN IGG CSF KIT | The Binding Site Group , Ltd. | 2013-05-17 | 431 | 0 |
| K120750 | HUMAN IGM CSF KIT | The Binding Site Group , Ltd. | 2013-05-17 | 431 | 0 |
| K122304 | HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS | The Binding Site Group , Ltd. | 2013-04-15 | 257 | 0 |
| K120056 | HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALY | The Binding Site Group , Ltd. | 2013-04-01 | 448 | 0 |
| K113823 | HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT | The Binding Site Group , Ltd. | 2013-03-27 | 456 | 0 |
| K120236 | TRANSFERRIN KIT FOR USE ON THE SPAPLUS | The Binding Site Group , Ltd. | 2013-02-13 | 384 | 0 |
| K122066 | HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS | The Binding Site Group , Ltd. | 2012-08-30 | 45 | 0 |
| K113349 | HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 C | The Binding Site Group , Ltd. | 2012-07-11 | 240 | 0 |
| K100588 | HUMAN IGA2 KIT FOR USE ON THE SPAPLUS | The Binding Site Group , Ltd. | 2010-08-16 | 167 | 0 |
| K100179 | SPAPLUS | The Binding Site Group , Ltd. | 2010-08-13 | 204 | 0 |
| K082823 | HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS | The Binding Site Group , Ltd. | 2010-03-01 | 522 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda