Cleared Special

K063400 - VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0

K063400 is an FDA 510(k) clearance for VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, manufactured by Bio-Rad Laboratories, Inc.. The device is a Class 2 Chemistry device with product code LCP cleared through the Special 510(k) pathway after a 22-day FDA review.

K063400 · Bio-Rad Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
22d
Days
Class 2
Risk

K063400 is an FDA 510(k) clearance for the VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Hercules, US). The FDA issued a Cleared decision on December 1, 2006 after a review of 22 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. devices

FDA 510(k) Submission Details - K063400

510(k) Number K063400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2006
Decision Date December 01, 2006
Days to Decision 22 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

LCP Device Classification - Class 2, Special Controls

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 188
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K063400.
AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
K072686 · Axis-Shield Diagnostics, Ltd. · Mar 2008
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
K070452 · Bio-Rad Laboratories, Inc. · May 2007
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
K070734 · Diazyme Laboratories · Apr 2007
VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314
K060650 · Ortho-Clinical Diagnostics, Inc. · Apr 2006
DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS
K053411 · Microgenics Corp. · Feb 2006
D-10 HEMOGLOBIN A1C PROGRAM
K060001 · Bio-Rad Laboratories, Inc. · Jan 2006