Cleared Traditional

ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS (K103627) - FDA 510(k) Clearance

Also marketed or referenced as:
ARCHITECT ICARBAMAZEPINE CALIBRATORS

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103627 · Abbott Laboratories · Toxicology device
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Oct 2011
Decision
305d
Days
Class 2
Risk

K103627 is an FDA 510(k) clearance for the ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 14, 2011 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Abbott Laboratories devices

Submission Details

510(k) Number K103627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2010
Decision Date October 14, 2011
Days to Decision 305 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
218d slower than avg
Panel avg: 87d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 33
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K103627.
ONLINE TDM CARBAMAZEPINE
K031902 · Roche Diagnostics Corp. · Sep 2003
RANDOX CARBAMAZEPINE
K011648 · Randox Laboratories, Ltd. · Jan 2002
IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6
K000007 · Diagnostic Products Corp. · Feb 2000
ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS
K993028 · Syva Co. · Jan 2000
SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL
K993987 · Syva Co. · Jan 2000
IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
K963673 · Beckman Instruments, Inc. · Feb 1997