Cleared Special

K080916 - CAPILLARYS URINE

K080916 is an FDA 510(k) clearance for CAPILLARYS URINE, manufactured by Sebia. The device is a Class 2 Immunology device with product code JKM cleared through the Special 510(k) pathway after a 90-day FDA review.

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.

FDA 510(k) Submission Details - K080916

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 105d · This submission: 90d
Pathway characteristics
Modification to existing cleared device.

JKM Device Classification - Class 2, Special Controls

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.

K080916 · CAPILLARYS URINE
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