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

The Binding Site, Ltd. — Predicate Candidate Screening

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

112 daysmedian FDA review time

345 days90th percentile

115clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K231290	Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lamb	The Binding Site, Ltd.	2024-01-24	265	0
K090920	HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 9	The Binding Site, Ltd.	2009-12-30	273	1
K083289	HUMAN BETA-2 MICROGLOBULIN KIT	The Binding Site, Ltd.	2009-05-06	180	0
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
K081674	BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME H	The Binding Site, Ltd.	2008-10-15	120	0
K080384	HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER	The Binding Site, Ltd.	2008-06-06	114	0
K072889	HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLU	The Binding Site, Ltd.	2008-02-01	114	0
K070900	FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FO	The Binding Site, Ltd.	2007-11-30	242	0
K062372	FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPA	The Binding Site, Ltd.	2007-06-21	311	2
K062183	FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KI	The Binding Site, Ltd.	2006-11-21	113	0
K051299	IGD DIAGNOSTIC TEST KITS	The Binding Site, Ltd.	2005-11-23	189	0
K051915	FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAY	The Binding Site, Ltd.	2005-09-06	53	0
K040009	FREELITE HUMAN KAPPA AND LAMBDA KITS	The Binding Site, Ltd.	2004-03-11	69	0
K033811	FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLY	The Binding Site, Ltd.	2004-01-30	52	0
K032240	BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZ	The Binding Site, Ltd.	2003-09-29	70	0
K031563	BINDAZYME CLQ CIC EIA KIT	The Binding Site, Ltd.	2003-09-10	114	1
K031016	FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD	The Binding Site, Ltd.	2003-07-15	106	0
K030238	BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT	The Binding Site, Ltd.	2003-03-24	60	0
K023131	FREELITE HUMAN LAMBDA FREE KIT	The Binding Site, Ltd.	2003-01-21	134	0
K023009	FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON T	The Binding Site, Ltd.	2003-01-21	134	0
K014270	MININEPH HUMAN B2-MICROGLOBULIN KIT	The Binding Site, Ltd.	2002-08-15	231	0
K022083	HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSE	The Binding Site, Ltd.	2002-07-16	20	0
K021081	HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACH	The Binding Site, Ltd.	2002-06-17	75	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
K011663	MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTR	The Binding Site, Ltd.	2001-07-30	62	0
K011662	MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTR	The Binding Site, Ltd.	2001-07-30	62	0
K010440	FREELITE LAMBDA FREE KIT	The Binding Site, Ltd.	2001-04-26	72	0
K010441	FREELITE KAPPA FREE KIT	The Binding Site, Ltd.	2001-04-26	72	0
K010146	ENA EIA KIT RANGE	The Binding Site, Ltd.	2001-03-01	43	0
K010147	ENA EIA KIT	The Binding Site, Ltd.	2001-03-01	43	0
K010148	ENA SCREEN EIA KIT	The Binding Site, Ltd.	2001-02-23	37	0
K004019	ANA EIA DIAGNOSTIC TEST KIT	The Binding Site, Ltd.	2001-02-15	50	0
K003669	KAPPA IMMAGE FREELITE KIT	The Binding Site, Ltd.	2001-02-01	65	0
K003671	LAMBDA IMMAGE FREELITE KIT	The Binding Site, Ltd.	2001-02-01	65	0
K002563	SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRAD	The Binding Site, Ltd.	2000-10-26	70	0
K002564	SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE	The Binding Site, Ltd.	2000-10-26	70	0
K002560	SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT	The Binding Site, Ltd.	2000-10-26	70	0
K002561	SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT	The Binding Site, Ltd.	2000-10-26	70	0
K001127	ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY	The Binding Site, Ltd.	2000-08-30	149	0
K001636	C-REACTIVE PROTEIN ANTISERUM KIT	The Binding Site, Ltd.	2000-08-24	86	0
K001556	HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY	The Binding Site, Ltd.	2000-08-21	95	0
K991802	BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT	The Binding Site, Ltd.	2000-05-05	345	0
K991801	BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT	The Binding Site, Ltd.	2000-05-05	345	0
K991803	BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.	The Binding Site, Ltd.	2000-05-05	345	0
K991804	BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.	The Binding Site, Ltd.	2000-05-05	345	0
K000701	HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER	The Binding Site, Ltd.	2000-04-27	57	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