Cleared Special

HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS (K122066) - FDA 510(k) Clearance

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

K122066 · The Binding Site Group , Ltd. · Immunology device
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Aug 2012
Decision
45d
Days
Class 2
Risk

K122066 is an FDA 510(k) clearance for the HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on August 30, 2012 after a review of 45 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.

View all The Binding Site Group , Ltd. devices

Submission Details

510(k) Number K122066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2012
Decision Date August 30, 2012
Days to Decision 45 days
Submission Type Special
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 104d · This submission: 45d
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.