Cleared Traditional

K070486 - CAPILLARYS URINE (PN 2012)

K070486 is an FDA 510(k) clearance for CAPILLARYS URINE (PN 2012), manufactured by Sebia, Inc.. The device is a Class 2 Immunology device with product code JKM cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K070486 · Sebia, Inc. · Immunology device
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Dec 2007
Decision
304d
Days
Class 2
Risk

K070486 is an FDA 510(k) clearance for the CAPILLARYS URINE (PN 2012). Classified as Immunochemical, Bence-jones Protein (product code JKM), Class II - Special Controls.

Submitted by Sebia, Inc. (Norcross, US). The FDA issued a Cleared decision on December 21, 2007 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5150 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sebia, Inc. devices

FDA 510(k) Submission Details - K070486

510(k) Number K070486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2007
Decision Date December 21, 2007
Days to Decision 304 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
199d slower than avg
Panel avg: 105d · This submission: 304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.