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

CFF — Predicate Candidate Screening

29 FDA 510(k) clearances under this product code; the 50 most recent screened below.

109 daysmedian FDA review time

294 days90th percentile

29clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K203184	HYDRASHIFT 2/4 isatuximab	Sebia	2021-11-12	381	0
K192095	CAPI 3 Immunotyping, Capillarys 3 Tera	Sebia	2019-11-01	88	0
K190851	HYDRASHIFT 2/4 daratumumab	Sebia	2019-05-02	30	0
K172195	HYDRASHIFT 2/4 daratumumab, daratumumab Control	Sebia	2018-01-11	174	0
K161928	CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL	Sebia	2016-12-21	160	0
K143483	MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-	Sebia	2015-01-08	31	0
K120169	INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT	Grifols USA, LLC	2012-08-24	218	0
K111369	THE HELENA V8 IMMUNODISPLACEMENT KIT	Helena Laboratories Uk, Ltd.	2012-06-26	407	0
K103757	IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTR	Grifols	2011-10-13	294	0
K082085	CAPILLARYS IMMUNOTYPING, MODEL 2100	Sebia	2009-04-17	268	0
K082388	MINICAP IMMUNOTYPING, MODEL: 2300	Sebia	2009-04-14	238	0
K061069	SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALEN	Helena Laboratories	2006-07-06	80	0
K033187	INTERLAB IMMUNOFIXATION TEST(S)	Interlab S.R.L.	2003-11-19	49	0
K033277	HYDRAGEL CSF ISOFOCUSING KITS	Morax	2003-11-04	25	0
K024162	SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389	Helena Laboratories	2003-02-19	64	0
K002799	PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER	Beckman Coulter, Inc.	2000-10-05	27	0
K993323	K-ASSAY IGM	Kamiya Biomedical Co.	1999-11-30	57	0
K993213	K-ASSAY IGA	Kamiya Biomedical Co.	1999-11-23	60	1
K990998	POLYSLIT IFE KIT	Helena Laboratories	1999-06-28	95	0
K981048	HYDRAGEL 6 CSF KIT	Morax	1998-10-07	201	0
K973040	SPIFE IFE-6	Helena Laboratories	1998-01-02	141	0
K960669	HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF,	Morax	1996-07-12	143	0
K933972	N-ASSAY TIA IGG	Crestat Diagnostics, Inc.	1994-03-22	221	0
K924769	IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC	The Binding Site, Ltd.	1993-02-23	153	0
K924767	IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC	The Binding Site, Ltd.	1993-02-23	153	0
K923658	REP IMMUNOFIX	Helena Laboratories	1992-11-02	102	0
K892424	REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178	Helena Laboratories	1989-06-09	60	0
K823884	PARAGON IMMUNOELECTROPHORESIS REAGENT	Beckman Instruments, Inc.	1983-03-07	70	0
K790667	CORNING PARAPROTEIN SCREENING	Corning Medical & Scientific	1979-07-24	109	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