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

Ortho Clinical Diagnostics — Predicate Candidate Screening

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

75 daysmedian FDA review time

285 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K241534	VITROS Immunodiagnostic Products Syphilis Reagent Pack	Ortho Clinical Diagnostics	2024-08-28	90	0
K233581	VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack	Ortho Clinical Diagnostics	2024-05-08	183	0
K221197	VITROS Immunodiagnostic Products Intact PTH II Reagent Pack	Ortho Clinical Diagnostics	2023-09-05	498	0
K231517	VITROS Immunodiagnostic Products CEA Reagent Pack	Ortho Clinical Diagnostics	2023-08-23	90	0
K231525	VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack	Ortho Clinical Diagnostics	2023-08-09	75	0
K221355	VITROS Immuodiagnostic Products CA 125 II Reagent Pack	Ortho Clinical Diagnostics	2022-12-12	216	0
K213626	VITROS AFP	Ortho Clinical Diagnostics	2022-06-15	210	0
K212648	VITROS Immunodiagnostic Products CK-MB Reagent Pack	Ortho Clinical Diagnostics	2022-01-28	158	0
K201312	VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack	Ortho Clinical Diagnostics	2021-10-04	504	0
K200236	VITROS BRAHMS PCT Reagent Pack and Calibrators	Ortho Clinical Diagnostics	2020-02-25	26	0
K163433	VITROS Chemistry Products GLU Slides	Ortho Clinical Diagnostics	2017-09-18	285	0
K160712	VITROS Chemistry Products hsCRP Reagent	Ortho Clinical Diagnostics	2017-07-14	486	0
K171168	VITROS Immunodiagnostic Products Insulin Calibrators	Ortho Clinical Diagnostics	2017-05-16	25	0
K162020	VITROS Chemistry Products Cl- Slides	Ortho Clinical Diagnostics	2016-12-16	148	0
K152433	VITROS Chemistry Products CRP Slides; VITRO Chemistry Produc	Ortho Clinical Diagnostics	2015-09-24	28	2
K142595	VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibra	Ortho Clinical Diagnostics	2015-06-04	262	1
K101921	VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, V	Ortho-Clinical Diagnostics	2010-10-22	105	1
K083173	VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBR	Ortho-Clinical Diagnostics	2008-12-22	56	16
K063720	VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK	Ortho-Clinical Diagnostics	2007-04-09	115	0
K062165	VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; F	Ortho-Clinical Diagnostics	2007-01-05	161	0
K062838	VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRAT	Ortho-Clinical Diagnostics	2006-12-19	89	2
K060480	VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND C	Ortho-Clinical Diagnostics	2006-07-03	130	0
K052645	VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; V	Ortho-Clinical Diagnostics	2005-12-14	79	0
K042494	VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT	Ortho-Clinical Diagnostics	2004-10-19	35	0
K042303	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS	Ortho-Clinical Diagnostics	2004-09-27	33	0
K041764	THE VITROS 5,1 FS CHEMISTRY SYSTEM	Ortho-Clinical Diagnostics	2004-09-09	71	0
K033127	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS	Ortho-Clinical Diagnostics	2003-10-31	31	0
K031924	VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DH	Ortho-Clinical Diagnostics	2003-08-07	45	28
K024193	MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I	Ortho-Clinical Diagnostics	2003-02-21	63	0
K030067	VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS	Ortho-Clinical Diagnostics	2003-01-17	10	0
K022901	VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK A	Ortho-Clinical Diagnostics	2002-09-27	24	0
K020662	MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I	Ortho-Clinical Diagnostics	2002-04-12	42	0
K013899	VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1	Ortho-Clinical Diagnostics	2002-01-24	62	1
K013900	VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS	Ortho-Clinical Diagnostics	2001-12-21	28	0
K012561	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS	Ortho-Clinical Diagnostics	2001-08-29	21	0
K011463	VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS	Ortho-Clinical Diagnostics	2001-06-13	30	0
K001769	VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY P	Ortho-Clinical Diagnostics	2000-06-21	9	0
K993068	VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS	Ortho-Clinical Diagnostics	1999-10-04	21	1

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