Cleared Traditional

VITROS AFP

K213626 · Ortho-Clinical Diagnostics · Immunology
Jun 2022
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K213626 is an FDA 510(k) clearance for the VITROS AFP, a Kit, Test,alpha-fetoprotein For Testicular Cancer (Class II — Special Controls, product code LOJ), submitted by Ortho-Clinical Diagnostics (Pencoed, GB). The FDA issued a Cleared decision on June 15, 2022, 210 days after receiving the submission on November 17, 2021. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K213626 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2021
Decision Date June 15, 2022
Days to Decision 210 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LOJ — Kit, Test,alpha-fetoprotein For Testicular Cancer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

Similar Devices — LOJ Kit, Test,alpha-fetoprotein For Testicular Cancer

All 16
Elecsys AFP
K220176 · Roche Diagnostics · Sep 2022
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
K090236 · Siemens Healthcare Diagnostics · Apr 2009
OLYMPUS AFP - ALPHA-FETOPROTEIN
K081709 · Olympus Life Science Research Europa GmbH (Europa) · Mar 2009
VIDAS AFP ASSAY
K080017 · bioMerieux, Inc. · Sep 2008
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
K071597 · Dade Behring, Inc. · Jun 2008
ST AIA-PACK AFP ENZYME IMMUNOASSAY
K023894 · Tosoh Medics, Inc. · Dec 2002