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

JHX — Predicate Candidate Screening

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

49 daysmedian FDA review time

168 days90th percentile

48clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K234005	Access CK-MB	Beckman Coulter, Inc.	2024-02-16	59	0
K212648	VITROS Immunodiagnostic Products CK-MB Reagent Pack	Ortho Clinical Diagnostics	2022-01-28	158	0
K163462	AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLE	Radiometer Medical Aps	2017-09-21	286	0
K120326	AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS	Radiometer Medical Aps	2012-11-21	293	0
K081360	PATHFAST CK-MB-II, PATHFAST MYO-II	Mitsubishi Kagaku Iatron	2009-08-17	459	0
K051650	STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB)	Dade Behring, Inc.	2005-09-08	79	9
K041596	ARCHITECT STAT CK-MB IMMUNOASSAY	Fisher Diagnostics	2004-07-21	37	0
K033747	RAMP CK-MB ASSAY	Response Biomedical Corp.	2004-05-17	168	0
K034055	IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I	Diagnostic Products Corp.	2004-01-21	22	1
K030012	CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM	Beckman Coulter, Inc.	2003-01-17	15	0
K022118	IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500	Diagnostic Products Corp.	2002-07-22	21	1
K013118	MODIFICATION TO ALPHA DX SYSTEM	First Medical, Inc.	2001-10-15	27	0
K004002	IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS);	Diagnostic Products Corp.	2001-02-14	50	2
K000716	ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER	Beckman Coulter, Inc.	2000-03-20	17	0
K994439	ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 3330	Beckman Coulter, Inc.	2000-01-14	22	0
K993068	VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS	Ortho-Clinical Diagnostics	1999-10-04	21	1
K991797	IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5	Diagnostic Products Corp.	1999-06-09	14	0
K984067	STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CK	Dade Behring, Inc.	1999-01-13	58	2
K981099	STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TE	Dade Behring, Inc.	1998-05-26	61	1
K980012	CREATINE KINASE REAGENT	Ac Biochemicals, Inc.	1998-02-25	54	0
K973126	TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAG	Biosite Incorporated	1997-10-06	47	0
K972782	DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY	Dade Intl., Inc.	1997-08-15	21	0
K962549	VIDAS CREATINE KINASE MB ASSAY 30-421	Biomerieux Vitek, Inc.	1996-08-30	63	0
K913380	MYDAS(TM)-MB2/MYDAS(TM)-MB	Intl. Immunoassay Laboratories, Inc.	1992-04-22	268	0
K913298	AIA-PACK CK-MB	Tosoh Corp.	1991-09-27	64	0
K911121	CIBA CORNING ACS CKMB IMMUNOASSAY	Ciba Corning Diagnostics Corp.	1991-04-03	22	0
K903441	MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS	Intl. Immunoassay Laboratories, Inc.	1990-11-06	98	0
K890543	IMPRES-MB REAGENT A AND REAGENT B	Intl. Immunoassay Laboratories, Inc.	1989-03-13	38	0
K881267	BIOTROL CK MONOEACTIF	Biotrol, USA, Inc.	1988-05-16	53	0
K881237	CREATINE KINASE (CK) REAGENT SET	Tech-Neal Scientific, Inc.	1988-04-28	37	0
K874144	TITAN GEL REP CPK-6 HV	Helena Laboratories	1987-11-23	41	0
K873399	TITAN GEL CPK REP SYSTEM	Helena Laboratories	1987-10-20	57	0
K873171	STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY	American Dade	1987-09-29	49	0
K870987	CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY	Ciba Corning Diagnostics Corp.	1987-05-26	76	0
K840549	CK-B RIA KIT	Diagnostic Systems Laboratories, Inc.	1984-05-07	89	0
K813573	CARDIOTRAC CORNING CK ISOENZYME SUBST	Corning Medical & Scientific	1982-01-18	27	0
K813087	ABURIA-CK RIA TEST KIT	Intl. Immunoassay Laboratories, Inc.	1981-12-17	45	0
K812759	NML CK-MB RIA	Nuclear Medical Laboratories, Inc.	1981-10-19	18	0
K802826	PARAGON ELECTRO. CREATINE KINASE TEST KI	Beckman Instruments, Inc.	1981-01-09	60	0
K801728	EMBRIA-CK	Intl. Immunoassay Laboratories, Inc.	1980-09-26	64	0
K801318	HELENA ULTRA SENSITIVE CPK REAGENT/DILUE	Helena Laboratories	1980-07-14	36	0
K800544	CORNING TRANSPHOR	Corning Medical & Scientific	1980-03-20	10	0
K792504	RIA-QUANT CK-MB TEST KIT	Mallinckrodt Critical Care	1980-01-16	43	0
K791582	CARDIO CK-B RIA KIT	Nuclear Medical Systems, Inc.	1979-11-15	92	0
K790294	BUFFER, CORNING MOPSO	Corning Medical & Scientific	1979-03-21	41	0
K771605	CREATINE KINASE ISOENZYME SUBSTRATE SET	Pfizer Pharmaceuticals	1977-09-15	24	0
K771324	3-(N-MORPHOLINS)-PROPANE SULFONIC ACID	Corning Medical & Scientific	1977-09-02	46	0
K760591	SIGMA PROCEDURE NO. 745 - EP.REAGENT SY	Sigma Chemical Co.	1976-10-29	52	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