Cleared Special

CAPILLARYS URINE (K080916) - FDA 510(k) Clearance

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

K080916 · Sebia · Immunology device
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Jul 2008
Decision
90d
Days
Class 2
Risk

K080916 is an FDA 510(k) clearance for the CAPILLARYS URINE. Classified as Immunochemical, Bence-jones Protein (product code JKM), Class II - Special Controls.

Submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on July 1, 2008 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5150 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sebia devices

Submission Details

510(k) Number K080916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2008
Decision Date July 01, 2008
Days to Decision 90 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
14d faster than avg
Panel avg: 104d · This submission: 90d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JKM Immunochemical, Bence-jones Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5150
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.