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

Cala Diagnostics — Predicate Candidate Screening

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

57 daysmedian FDA review time

112 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K944247	CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL	Cala Diagnostics	1994-10-31	61
K944246	CARDIOCHEX CKMB MASS MEASUREMENT CONTROL	Cala Diagnostics	1994-10-31	61
K944243	CARDIOCHEX	Cala Diagnostics	1994-10-27	57
K930874	LD-1 CONTROL-LEVEL 1 & 2	Cala Diagnostics	1993-04-22	62
K930873	CKMB ISOENZYME CONTROL-LEVEL 1,2.3	Cala Diagnostics	1993-04-13	53
K930875	CKMB CONTROL - LEVEL 1,2,3	Cala Diagnostics	1993-04-13	53
K926015	CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3	Cala Diagnostics	1992-12-28	28
K915503	FIBRINOGEN FDP CONTROL	Cala Diagnostics	1992-01-30	52
K912827	SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3	Cala Diagnostics	1991-08-12	47
K912826	WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2	Cala Diagnostics	1991-07-26	30
K864456	CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3	Cala Diagnostics	1987-05-06	174
K850907	CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/	Cala Diagnostics	1985-06-25	112

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