Cleared Traditional

K151578 - Carbamazepine Gen 4

K151578 is the FDA 510(k) clearance for Carbamazepine Gen 4 by Roche Diagnostics Operations (Rdo). It is a Class 2 Toxicology device (product code KLT) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K151578 · Roche Diagnostics Operations (Rdo) · Toxicology device
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Oct 2015
Decision
133d
Days
Class 2
Risk

K151578 is an FDA 510(k) clearance for the Carbamazepine Gen 4. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on October 22, 2015 after a review of 133 days - within the typical 510(k) review window.

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 Roche Diagnostics Operations (Rdo) devices

Submission Details

510(k) Number K151578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2015
Decision Date October 22, 2015
Days to Decision 133 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
46d slower than avg
Panel avg: 87d · This submission: 133d
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 38
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K151578.
ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS
K103627 · Abbott Laboratories · Oct 2011
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
ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS
K993028 · Syva Co. · Jan 2000