Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

The Binding Site — Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

144 daysmedian FDA review time
424 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K140105HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLIThe Binding Site2014-03-18620
K132555HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KThe Binding Site2013-12-201280
K103824HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUSThe Binding Site2012-02-274240
K100455SPAPLUS ANALYZERThe Binding Site2010-09-031980
K092450HUMAN IGD KIT FOR USE ON SPAPLUSThe Binding Site2009-12-281400
K072166CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZERThe Binding Site2008-01-241710
K042579BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KITThe Binding Site2005-07-283090
K042152BINDING SITE IGG SUBLCASS OLYMPUS KITSThe Binding Site2004-11-221052
K041891MININEPH HUMAN RHEUMATOID FACTOR KITThe Binding Site2004-11-051160
K040466BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIAThe Binding Site2004-07-161440

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