Cleared Traditional

K011852 - DIMENSION HAIC ASSAY, MODEL DF105

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

K011852 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K011852

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.

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 189
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K011852.
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
K023763 · Randox Laboratories, Ltd. · Jan 2003
RANDOX HAEMOGLOBIN A1C
K021897 · Randox Laboratories, Ltd. · Nov 2002
POLYMEDCO HBA1C TEST
K020532 · Polymedco, Inc. · Apr 2002
INFINITY HBA KIT, MODELS 537-A, 537-B
K012410 · Sigma Diagnostics, Inc. · Oct 2001
G7 AUTOMATED HPLC ANALYZER
K011434 · Tosoh Medics, Inc. · Sep 2001
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
K010748 · Beckman Coulter, Inc. · Jul 2001