Cleared Traditional

K091711 - S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023

K091711 is an FDA 510(k) clearance for S- TEST HEMOGLOBIN ALC (HBA1C), 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 184-day FDA review.

K091711 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry device
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Dec 2009
Decision
184d
Days
Class 2
Risk

K091711 is an FDA 510(k) clearance for the S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023. 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 December 11, 2009 after a review of 184 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 - K091711

510(k) Number K091711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2009
Decision Date December 11, 2009
Days to Decision 184 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
96d slower than avg
Panel avg: 88d · This submission: 184d
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 K091711.
AFINION ANALYZER
K110056 · Axis-Shield Poc AS · Feb 2011
ST AIA PACK HBA1C
K100304 · Tosoh Bioscience, Inc. · Aug 2010
CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023
K082275 · Infopia Co, Ltd. · Jan 2010
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
K090699 · Bio-Rad Laboratories, Inc. · Jul 2009
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
K090413 · Bayer Healthcare, LLC · May 2009
ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
K073309 · Horiba Abx · Oct 2008