Cleared Traditional

K063306 - ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72

K063306 is an FDA 510(k) clearance for ACE HEMOGLOBIN A1C REAGENT, manufactured by Alfa Wassermann, Inc.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K063306 · Alfa Wassermann, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
167d
Days
Class 2
Risk

K063306 is an FDA 510(k) clearance for the ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S.... Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Alfa Wassermann, Inc. (West Caldwell, US). The FDA issued a Cleared decision on April 17, 2007 after a review of 167 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - the FDA in vitro diagnostics and chemistry 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Alfa Wassermann, Inc. devices

FDA 510(k) Submission Details - K063306

510(k) Number K063306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2006
Decision Date April 17, 2007
Days to Decision 167 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 88d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 174
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K063306.
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
K072714 · Roche Diagnostics Corp. · Apr 2008
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
VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
K063400 · Bio-Rad Laboratories, Inc. · Dec 2006
VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314
K060650 · Ortho-Clinical Diagnostics, Inc. · Apr 2006