Cleared Traditional

K102045 - DIMENSION VISA HBA1C, MODEL K3105A

K102045 is an FDA 510(k) clearance for DIMENSION VISA HBA1C, manufactured by Siemens Heatlhcare Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K102045 · Siemens Heatlhcare Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
208d
Days
Class 2
Risk

K102045 is an FDA 510(k) clearance for the DIMENSION VISA HBA1C, MODEL K3105A. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Siemens Heatlhcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on February 14, 2011 after a review of 208 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 Heatlhcare Diagnostics, Inc. devices

FDA 510(k) Submission Details - K102045

510(k) Number K102045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2010
Decision Date February 14, 2011
Days to Decision 208 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
120d slower than avg
Panel avg: 88d · This submission: 208d
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 171
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K102045.
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
K110934 · Siemens Healthcare Diagnostics · Aug 2011
DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
K110188 · Diazyme Laboratories · May 2011
DIMENSIONS HB1C KIT, MODEL DF105A
K102510 · Siemens Healthcare Diagnostics · May 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
S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023
K091711 · Alfa Wassermann Diagnostic Technologies, Inc. · Dec 2009