Cleared Abbreviated

K163078 - DC-UIBC-CAL (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K163078 · Sekisui Diagnostics P.E.I., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
35d
Days
Class 2
Risk

K163078 is an FDA 510(k) clearance for the DC-UIBC-CAL. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Sekisui Diagnostics P.E.I., Inc. (Charlottetown,, CA). The FDA issued a Cleared decision on December 8, 2016 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sekisui Diagnostics P.E.I., Inc. devices

Submission Details

510(k) Number K163078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2016
Decision Date December 08, 2016
Days to Decision 35 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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.