Cleared Traditional

K123518 - ABBOTT CARBAMAZEPINE ASSAY

K123518 is an FDA 510(k) clearance for ABBOTT CARBAMAZEPINE ASSAY, manufactured by Microgenics Corporation. The device is a Class 2 Toxicology device with product code KLT cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K123518 · Microgenics Corporation · Toxicology device
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Jun 2013
Decision
203d
Days
Class 2
Risk

K123518 is an FDA 510(k) clearance for the ABBOTT CARBAMAZEPINE ASSAY. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Microgenics Corporation (Fremont Blvd., US). The FDA issued a Cleared decision on June 5, 2013 after a review of 203 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3645 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Microgenics Corporation devices

FDA 510(k) Submission Details - K123518

510(k) Number K123518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2012
Decision Date June 05, 2013
Days to Decision 203 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 87d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLT Device Classification - Class 2, Special Controls

Product Code KLT Enzyme Immunoassay, Carbamazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3645
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 Toxicology devices follow this clearance model.

Regulatory Peers - KLT Enzyme Immunoassay, Carbamazepine

All 47
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K123518.
ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS
K103627 · Abbott Laboratories · Oct 2011
ADVIA IMS CARBAMAZEPINE METHOD
K042808 · Bayer Healthcare, LLC · Feb 2005
ONLINE TDM CARBAMAZEPINE
K031902 · Roche Diagnostics Corp. · Sep 2003
RANDOX CARBAMAZEPINE
K011648 · Randox Laboratories, Ltd. · Jan 2002
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
K000903 · Bayer Corp. · May 2000
IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6
K000007 · Diagnostic Products Corp. · Feb 2000