Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

GTQ — Predicate Candidate Screening

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

63 daysmedian FDA review time

186 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K052645	VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; V	Ortho-Clinical Diagnostics	2005-12-14	79	0
K953437	OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT	Olympus America, Inc.	1995-10-20	91	0
K915742	TURBIQUANT ASL	Behring Diagnostics, Inc.	1993-06-28	553	0
K926236	BECKMAN ANTI-STREPTOLYSIN O KIT	Beckman Instruments, Inc.	1993-06-15	186	1
K924247	ACCUTEX ASO LATEX TEST	J.S. Medical Assoc.	1992-12-07	105	0
K922723	TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL	Simplicity Diagnostics, Inc.	1992-09-18	105	0
K915053	BECKMAN ANTISTREPTOLYSIN O, MODIFICATION	Beckman Instruments, Inc.	1992-03-19	140	0
K912150	BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT	Beckman Instruments, Inc.	1991-07-17	63	0
K904416	CROATEST (R) RHEUMATOID DIAGNOSTIC	Biotrax, Inc.	1991-06-24	270	0
K910885	QM300 CALIBRATOR G PACK	Kallestad Diag, A Div. of Erbamont, Inc.	1991-06-17	105	0
K910886	QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK	Kallestad Diag, A Div. of Erbamont, Inc.	1991-06-17	105	0
K910887	QM300 CONTROL G PACK	Kallestad Diag, A Div. of Erbamont, Inc.	1991-06-17	105	0
K910073	TARGET ASO TEST	Texas Immunology, Inc.	1991-05-21	132	0
K903854	RAPITEX(R) ASL NEW	Behring Diagnostics, Inc.	1991-01-28	160	0
K904311	RHEUMAGEN ASO T-CONTROL	Biokit USA, Inc.	1991-01-25	128	0
K901371	ASO-CUBE(TM)	Difco Laboratories, Inc.	1990-05-15	53	0
K894486	QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)	Biokit USA, Inc.	1989-10-24	98	0
K894780	IMMUNO/ASO	Immunostics Co., Inc.	1989-10-16	81	0
K890025	QUIK-DOT ANTISTREPTOLYSIN-O	Ampcor, Inc.	1989-01-31	27	0
K881209	ASO SLIDE TEST	Ncs Diagnostics, Inc.	1988-04-12	22	0
K862530	RAPID AS LATEX	Dilab, Inc.	1987-04-21	293	0
K854991	REUMAGEN ASL	Biokit USA, Inc.	1986-04-18	127	0
K854039	LASER ASO KIT	Behring Diagnostics, Inc.	1985-10-28	26	0
K853857	V-TREND ASO PLUS LATEX TEST	Texas Immunology, Inc.	1985-10-16	30	0
K853276	ASO SLIDE EIKEN	Syn-Kit, Inc.	1985-08-20	15	0
K852701	FISHER DIAGNOSTIC LATEST ASO TEST KIT	Allied Fisher Scientific	1985-07-19	23	0
K842839	SERIMM SURE ASO-CHEK CONTROL SERUM	Analytical Products, Inc.	1984-08-23	34	0
K842256	AS LATEX PLUS	Biokit USA, Inc.	1984-06-19	12	0
K831464	ASO-CHECK	Diagnostic Technology, Inc.	1983-06-16	41	0
K831363	TESTCORP ASO	Catheter Technology Corp.	1983-05-16	20	0
K820785	ASO SURE	Analytical Products, Inc.	1982-04-08	16	0
K820786	ASO SURE PLUS	Analytical Products, Inc.	1982-04-08	16	0
K812060	BI-ASO SLIDE TEST	Biologics Intl., Inc.	1981-08-13	23	0
K801177	ASO QUANTUM, ANTISTREPTOLYSIN O TEST	Sclavo, Inc.	1980-07-08	53	0
K800642	RAPI/TEX ASO STANDARD SERUM	Calbiochem-Behring Corp.	1980-04-24	31	0
K790831	ANTISTREPTOLYSIN (ASO) LATEX SLIDE TEST	Icl Scientific	1979-06-15	46	0
K760096	REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O	Gamma Biologicals, Inc.	1976-08-03	50	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