Cleared Traditional

K113437 - ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT

K113437 is an FDA 510(k) clearance for ACE HEMOGLOBIN ALC(HBALC) REAGENT, manufactured by Alfa Wassermann Diagnostic Technologies, Inc.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K113437 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry device
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Aug 2012
Decision
259d
Days
Class 2
Risk

K113437 is an FDA 510(k) clearance for the ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT.... Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on August 6, 2012 after a review of 259 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 Diagnostic Technologies, Inc. devices

FDA 510(k) Submission Details - K113437

510(k) Number K113437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2011
Decision Date August 06, 2012
Days to Decision 259 days
Submission Type Traditional
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
171d slower than avg
Panel avg: 88d · This submission: 259d
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 202
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K113437.
LABONACHECK A1C
K111128 · Ceragem International, Inc. · Sep 2012
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
K121492 · Beckman Coulter, Inc. · Sep 2012
HEMOCUE HBA1C 501
K121366 · Infopia Co, Ltd. · Sep 2012
EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL
K120497 · Medica Corp. · May 2012
TINA-QUANT HBA1C GEN.2
K110313 · Roche Diagnostics · Dec 2011
PREMIER HB9210 HBA1C ANALYZER
K112015 · Primus Corporation Dba Trinity Biotech · Nov 2011