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

JCM — Predicate Candidate Screening

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

75 daysmedian FDA review time

259 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K053031	EXTENDSURE HBFASC CONTROL	Cantebury Scientific , Ltd.	2005-12-07	41
K011389	HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)	Canterbury Health Laboratories	2001-06-21	45
K983704	MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE	Roche Diagnostic Systems, Inc.	1999-02-10	112
K942222	QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS	Isolab, Inc.	1995-01-20	259
K933086	AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328	Helena Laboratories	1994-10-31	495
K931234	HEMOCARD CONTROL HB-AA, AE, FAA, FAE	Isolab, Inc.	1993-05-11	62
K924173	HEMOCARD(TM) CONTROL	Isolab, Inc.	1992-12-01	104
K913427	SICKLE HEMOGLOBIN (HBA/S) CONTROL SET	Creative Laboratory Products, Inc.	1991-11-19	110
K911347	LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL	Bio-Rad	1991-06-10	75
K910431	HEMOCARD CONTROL	Isolab, Inc.	1991-03-11	38
K820787	HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL	Helena Laboratories	1982-04-08	16
K820037	SICKLE-CHECK	Diagnostic Technology, Inc.	1982-02-04	28

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