Cleared Traditional

K160495 - VITROS Automation Solutions

K160495 is the FDA 510(k) clearance for VITROS Automation Solutions by Ortho-Clinical Diagnostics, Inc.. It is a Class 2 Chemistry device (product code KLI) cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K160495 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
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Oct 2016
Decision
239d
Days
Class 2
Risk

K160495 is an FDA 510(k) clearance for the VITROS® Automation Solutions. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on October 18, 2016 after a review of 239 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Ortho-Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K160495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2016
Decision Date October 18, 2016
Days to Decision 239 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 88d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 47
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K160495.
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
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K983440 · Abbott Laboratories · Nov 1998
DSL ACTIVE T4 EIA
K971269 · Diagnostic Systems Laboratories, Inc. · May 1997
SYNCHRON SYSTEMS THYROXINE REAGENT
K971203 · Beckman Instruments, Inc. · May 1997
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
K951321 · Bio-Rad · Aug 1995