Cleared Special

K161297 - Beta-2-Microglobulin (FDA 510(k) Clearance)

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

K161297 · Beckman Coulter Ireland, Inc. · Immunology device
Jun 2016
Decision
29d
Days
Class 2
Risk

K161297 is an FDA 510(k) clearance for the Beta-2-Microglobulin. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Beckman Coulter Ireland, Inc. (Co. Clare, IE). The FDA issued a Cleared decision on June 7, 2016 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5630 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K161297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2016
Decision Date June 07, 2016
Days to Decision 29 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
248d faster than avg
Panel avg: 277d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JZG System, Test, Beta-2-microglobulin Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5630
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 Immunology devices follow this clearance model.