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510(k) K160495

VITROS® Automation Solutions by Ortho-Clinical Diagnostics, Inc. — Product Code KLI

K160495 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS® Automation Solutions". The FDA issued a decision of Substantially Equivalent on October 18, 2016. The device falls under product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2016
Date Received
February 22, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Device Class
Class II
Regulation Number
862.1700
Review Panel
CH
Submission Type

Other clearances by Ortho-Clinical Diagnostics, Inc.

  • K252393 — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (October 29, 2025)
  • DEN210040 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immu (May 5, 2023)
  • DEN210038 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immuno (May 5, 2023)
  • K210858 — VITROS Chemistry Products PHBR Slides (August 13, 2021)
  • K191316 — VITROS XT Chemistry Products ALB-TP Slides (June 7, 2019)
  • K190807 — VITROS XT Chemistry Products TBIL-ALKP Slides (April 26, 2019)
  • K190520 — VITROS XT Chemistry Products GLU-Ca Slides (April 3, 2019)
  • K190490 — VITROS XT Chemistry Products TRIG-CHOL Slides (March 27, 2019)
  • K190326 — VITROS XT Chemistry Products UREA-CREA Slides (March 14, 2019)
  • K182072 — VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITR (October 30, 2018)

Other clearances for product code KLI

  • K131515 — ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT (August 14, 2013)
  • K103484 — GSP NEONATAL THYROXINE (T4) (April 22, 2011)
  • K082638 — ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL (February 26, 2009)
  • K030860 — ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 (August 22, 2003)
  • K023369 — ACCESS TOTAL T4 ASSAY (December 9, 2002)
  • K001603 — REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) (October 5, 2000)
  • K000600 — SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS (March 27, 2000)
  • K991432 — BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 (June 2, 1999)
  • K982298 — OPTICOAT T4 EIA KIT (February 3, 1999)
  • K983440 — ABBOTT ARCHITECT TOTAL T4 (November 25, 1998)

FDA data resources