Cleared Traditional

K081895 - ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS

K081895 is an FDA 510(k) clearance for ADVIA CHEMISTRY HEMOGLOBIN A1C, manufactured by Siemens Medical Solutions Diagnostics. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K081895 · Siemens Medical Solutions Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
189d
Days
Class 2
Risk

K081895 is an FDA 510(k) clearance for the ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Siemens Medical Solutions Diagnostics (Tarrytown, US). The FDA issued a Cleared decision on January 8, 2009 after a review of 189 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 Siemens Medical Solutions Diagnostics devices

FDA 510(k) Submission Details - K081895

510(k) Number K081895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2008
Decision Date January 08, 2009
Days to Decision 189 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
101d slower than avg
Panel avg: 88d · This submission: 189d
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 209
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K081895.
S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023
K091711 · Alfa Wassermann Diagnostic Technologies, Inc. · Dec 2009
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
G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
K071132 · Tosoh Bioscience, Inc. · Sep 2008
DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
K080618 · Jas Diagnostics, Inc. · May 2008