Cleared Traditional

K042808 - ADVIA IMS CARBAMAZEPINE METHOD

K042808 is an FDA 510(k) clearance for ADVIA IMS CARBAMAZEPINE METHOD, manufactured by Bayer Healthcare, LLC. The device is a Class 2 Chemistry device with product code KLT cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K042808 · Bayer Healthcare, LLC · Chemistry device
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Feb 2005
Decision
119d
Days
Class 2
Risk

K042808 is an FDA 510(k) clearance for the ADVIA IMS CARBAMAZEPINE METHOD. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Bayer Healthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on February 8, 2005 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3645 - 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 Bayer Healthcare, LLC devices

FDA 510(k) Submission Details - K042808

510(k) Number K042808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2004
Decision Date February 08, 2005
Days to Decision 119 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
31d slower than avg
Panel avg: 88d · This submission: 119d
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 Chemistry devices follow this clearance model.

Regulatory Peers - KLT Enzyme Immunoassay, Carbamazepine

All 50
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K042808.
ABBOTT CARBAMAZEPINE ASSAY
K123518 · Microgenics Corporation · Jun 2013
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
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
K010814 · Syva Co., Dade Behring, Inc. · Apr 2001
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
K000903 · Bayer Corp. · May 2000