Cleared Special

K113610 - ANA-SCREEN WITH MDSS (FDA 510(k) Clearance)

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

K113610 · Bio-Rad Laboratories · Immunology device
Jul 2012
Decision
216d
Days
Class 2
Risk

K113610 is an FDA 510(k) clearance for the ANA-SCREEN WITH MDSS. Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on July 9, 2012 after a review of 216 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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.

Submission Details

510(k) Number K113610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2011
Decision Date July 09, 2012
Days to Decision 216 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 277d · This submission: 216d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LKJ Antinuclear Antibody, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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.