Cleared Traditional

K011852 - DIMENSION HAIC ASSAY

K011852 is the FDA 510(k) clearance for DIMENSION HAIC ASSAY by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K011852 · Dade Behring, Inc. · Chemistry device
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Nov 2001
Decision
156d
Days
Class 2
Risk

K011852 is an FDA 510(k) clearance for the DIMENSION HAIC ASSAY, MODEL DF105. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on November 15, 2001 after a review of 156 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K011852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2001
Decision Date November 15, 2001
Days to Decision 156 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
68d slower than avg
Panel avg: 88d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 118
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K011852.
HEMOGLOBIN A1C REAGENT SET
K031539 · Pointe Scientific, Inc., · Aug 2003
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
K023763 · Randox Laboratories, Ltd. · Jan 2003
RANDOX HAEMOGLOBIN A1C
K021897 · Randox Laboratories, Ltd. · Nov 2002
INFINITY HBA KIT, MODELS 537-A, 537-B
K012410 · Sigma Diagnostics, Inc. · Oct 2001
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
K010748 · Beckman Coulter, Inc. · Jul 2001
VARIANT II TOTAL GHB
K003280 · Bio-Rad · Dec 2000