Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CFN — Predicate Candidate Screening
61 FDA 510(k) clearances under this product code; the 50 most recent screened below.
71 daysmedian FDA review time
431 days90th percentile
61clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | Siemens Healthcare Diagnostics Products GmbH | 2023-12-13 | 28 | 0 |
| K221114 | Immunoglobulin G (IgG) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | 2023-08-02 | 474 | 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 |
| K162208 | DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent | Beckman Coulter, Inc. | 2017-01-09 | 157 | 0 |
| K150526 | Optilite IgG4 Kit | The Binding Site Group , Ltd. | 2015-05-30 | 89 | 0 |
| K142735 | The Optilite IgG3 kit | The Binding Site Group , Ltd. | 2014-12-21 | 89 | 0 |
| K130122 | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRAT | Beckman Coulter, Inc. | 2014-01-07 | 355 | 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 |
| K113823 | HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT | The Binding Site Group , Ltd. | 2013-03-27 | 456 | 0 |
| K103824 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS | The Binding Site | 2012-02-27 | 424 | 0 |
| K100588 | HUMAN IGA2 KIT FOR USE ON THE SPAPLUS | The Binding Site Group , Ltd. | 2010-08-16 | 167 | 0 |
| K082823 | HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS | The Binding Site Group , Ltd. | 2010-03-01 | 522 | 0 |
| K090920 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 9 | The Binding Site, Ltd. | 2009-12-30 | 273 | 1 |
| K090594 | DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA | Siemens Healthcare Diagnostics | 2009-04-29 | 55 | 0 |
| K083445 | N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N | Siemens Healthcare Diagnostics | 2009-03-24 | 123 | 2 |
| K082129 | HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER | The Binding Site, Ltd. | 2009-02-10 | 196 | 2 |
| K081827 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS | The Binding Site, Ltd. | 2008-12-19 | 175 | 0 |
| K081161 | DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION | Dade Behring, Inc. | 2008-07-28 | 95 | 0 |
| K073561 | DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRID | Dade Behring, Inc. | 2008-02-26 | 69 | 0 |
| K073489 | OLYMPUS IGA REAGENT | Olympus America, Inc. | 2008-02-11 | 61 | 1 |
| K073490 | OLYMPUS IGG REAGENT | Olympus America, Inc. | 2008-02-11 | 61 | 0 |
| K073487 | OLYMPUS IGM REAGENT | Olympus America, Inc. | 2008-02-11 | 61 | 1 |
| K072889 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLU | The Binding Site, Ltd. | 2008-02-01 | 114 | 0 |
| K061845 | DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CAL | Dade Behring, Inc. | 2006-08-24 | 56 | 0 |
| K061338 | DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY | Dade Behring, Inc. | 2006-07-06 | 52 | 0 |
| K042735 | N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) | Dade Behring, Inc. | 2005-02-15 | 137 | 0 |
| K042152 | BINDING SITE IGG SUBLCASS OLYMPUS KITS | The Binding Site | 2004-11-22 | 105 | 2 |
| K042475 | VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS | Ortho-Clinical Diagnostics, Inc. | 2004-11-10 | 58 | 0 |
| K032014 | N LATEX IGM | Dade Behring, Inc. | 2003-08-07 | 38 | 1 |
| K022083 | HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSE | The Binding Site, Ltd. | 2002-07-16 | 20 | 0 |
| K012292 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T | The Binding Site, Ltd. | 2001-08-31 | 42 | 0 |
| K012296 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T | The Binding Site, Ltd. | 2001-08-31 | 42 | 0 |
| K012295 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T | The Binding Site, Ltd. | 2001-08-20 | 31 | 2 |
| K012291 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T | The Binding Site, Ltd. | 2001-08-20 | 31 | 0 |
| K000701 | HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER | The Binding Site, Ltd. | 2000-04-27 | 57 | 0 |
| K993549 | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRAT | Beckman Coulter, Inc. | 2000-02-01 | 105 | 0 |
| K993547 | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRAT | Beckman Coulter, Inc. | 2000-02-01 | 105 | 1 |
| K993924 | WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN | Wako Chemicals USA, Inc. | 2000-01-14 | 57 | 0 |
| K981784 | IGM MININEPH ANTISERUM | The Binding Site, Ltd. | 1999-12-21 | 580 | 0 |
| K982100 | IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS | The Binding Site, Ltd. | 1999-12-20 | 553 | 1 |
| K981912 | HUMAN IGA SUBCLASS BNII COMBI KIT | The Binding Site, Ltd. | 1998-12-04 | 186 | 0 |
| K982382 | COBAS INTEGRA REAGENT CASSETTES | Roche Diagnostic Systems, Inc. | 1998-09-28 | 82 | 1 |
| K933971 | N-ASSAY TIA IGA | Crestat Diagnostics, Inc. | 1994-03-22 | 221 | 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