VITROS® Automation Solutions

Q: What is the product code of K160495?

The FDA product code is KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.

FDA 510(k) K160495 · Ortho-Clinical Diagnostics, Inc.

Substantially Equivalent

510(k) numberK160495

Submission

Device name: VITROS® Automation Solutions
Applicant: Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US
Received: February 22, 2016
Decision date: October 18, 2016
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1700
Specialty: Clinical Chemistry

Other 510(k)s with product code KLI

510(k)	Device	Applicant	Decision
K131515	Ace -Gt Reagent; Ace Lipase Ragent; Ace T4 ReagentKLI · Traditional	Alfa Wassermann	08/14/2013SE
K103484	GSP Neonatal Thyroxine (T4)KLI · Traditional	Wallac Oy, A Subsidiary of Perkinelmer, Inc.	04/22/2011SE
K082638	Advia Centaur System with Streamlab Analytical WorkcellKLI · Traditional	Siemens Healthcare Diagnostics, Inc.	02/26/2009SE
K030860	Accubind Neonatal T4 Microplate Eia, Model 2625-300KLI · Traditional	Monobind	08/22/2003SE
K023369	Access Total T4 AssayKLI · Traditional	Beckman Coulter, Inc.	12/09/2002SE
K001603	Reprobead T4 Enzyme Immunoassay Reagent Kit (Catalog# 105)KLI · Traditional	Repromedix Corp.	10/05/2000SE
K000600	Syva Emit 2000 Thyroxine Assay, CalibratorsKLI · Traditional	Syva Co., Dade Behring, Inc.	03/27/2000SE
K991432	Biocheck Total T4 Enzyme Immunoassay Test Kit, Model BC-1007KLI · Traditional	Biocheck, Inc.	06/02/1999SE
K982298	Opticoat T4 Eia KitKLI · Traditional	Biotecx Laboratories, Inc.	02/03/1999SE
K983440	Abbott Architect Total T4KLI · Traditional	Abbott Laboratories	11/25/1998SE

More from Abbott Laboratories

510(k)	Device	Decision
K252393	VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI · Traditional	10/29/2025SE
K241534	VITROS Immunodiagnostic Products Syphilis Reagent PackLIP · Traditional	08/28/2024SE
K233581	VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA · Traditional	05/08/2024SE
K221197	VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW · Traditional	09/05/2023SE
K231517	VITROS Immunodiagnostic Products CEA Reagent PackDHX · Traditional	08/23/2023SE
K231525	VITROS Immunodiagnostic Products CA 19-9TM Reagent PackNIG · Traditional	08/09/2023SE
K221355	VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK · Traditional	12/12/2022SE
K213626	Vitros AfpLOJ · Traditional	06/15/2022SE
K212648	VITROS Immunodiagnostic Products CK-MB Reagent PackJHX · Traditional	01/28/2022SE
K201312	VITROS Immunodiagnostic Products NT-proBNP II Reagent PackNBC · Traditional	10/04/2021SE

Questions and answers

When was VITROS® Automation Solutions cleared by the FDA?

VITROS® Automation Solutions (K160495) received a 510(k) decision of Substantially Equivalent on October 18, 2016, 239 days after the submission was received.

What is the product code of K160495?

The FDA product code is KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.