Cleared Special

K063643 - MODIFICATION TO VARIANT II: HEMOGLOBIN ...

K063643 is the FDA 510(k) clearance for MODIFICATION TO VARIANT II: HEMOGLOBIN ... by Bio-Rad Laboratories Inc., Clinical Systems Divisi. It is a Class 2 Chemistry device (product code LCP) cleared through the Special 510(k) pathway after a 20-day FDA review.

K063643 · Bio-Rad Laboratories Inc., Clinical Systems Divisi · Chemistry device
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Dec 2006
Decision
20d
Days
Class 2
Risk

K063643 is an FDA 510(k) clearance for the MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PR.... Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Bio-Rad Laboratories Inc., Clinical Systems Divisi (Hercules, US). The FDA issued a Cleared decision on December 27, 2006 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - the FDA in vitro diagnostics and chemistry 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 Bio-Rad Laboratories Inc., Clinical Systems Divisi devices

Submission Details

510(k) Number K063643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2006
Decision Date December 27, 2006
Days to Decision 20 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
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 Chemistry devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 119
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K063643.
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K060650 · Ortho-Clinical Diagnostics, Inc. · Apr 2006
DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS
K053411 · Microgenics Corp. · Feb 2006