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

DEB — Predicate Candidate Screening

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

31 daysmedian FDA review time

147 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K140664	HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS	The Binding Site Group , Ltd.	2014-04-16	29
K081249	DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSI	Dade Behring, Inc.	2008-07-21	80
K053073	N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN	Dade Behring, Inc.	2006-03-28	147
K974564	IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT	Beckman Instruments, Inc.	1998-02-17	74
K914389	ALPHA-2 MACROGLOBULIN TEST RID KIT	The Binding Site, Ltd.	1991-12-20	80
K896483	QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK	Kallestad Diag, A Div. of Erbamont, Inc.	1989-12-01	18
K850683	72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2	Kent Laboratories, Inc.	1985-11-27	279
K851282	RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI	Cooper Biomedical, Inc.	1985-05-24	53
K850603	SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN	Applications Lab	1985-03-05	18
K812493	IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO	Dako Corp.	1981-09-23	23
K791340	HUMAN ALPHA2 MACROGLOBULIN	Beckman Instruments, Inc.	1979-08-16	31
K772246	ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY	Kallestad Laboratories, Inc.	1977-12-22	13
K771780	LAS-R TM	Hyland Therapeutic Div., Travenol Laboratories	1977-10-04	11

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