Cleared Traditional

K031902 - ONLINE TDM CARBAMAZEPINE

K031902 is the FDA 510(k) clearance for ONLINE TDM CARBAMAZEPINE by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code KLT) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K031902 · Roche Diagnostics Corp. · Toxicology device
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Sep 2003
Decision
89d
Days
Class 2
Risk

K031902 is an FDA 510(k) clearance for the ONLINE TDM CARBAMAZEPINE. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 17, 2003 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K031902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2003
Decision Date September 17, 2003
Days to Decision 89 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
2d slower than avg
Panel avg: 87d · This submission: 89d
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 37
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K031902.
ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS
K103627 · Abbott Laboratories · Oct 2011
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
SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL
K993987 · Syva Co. · Jan 2000