Cleared Traditional

K011648 - RANDOX CARBAMAZEPINE

K011648 is an FDA 510(k) clearance for RANDOX CARBAMAZEPINE, manufactured by Randox Laboratories, Ltd.. The device is a Class 2 Toxicology device with product code KLT cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K011648 · Randox Laboratories, Ltd. · Toxicology device
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Jan 2002
Decision
231d
Days
Class 2
Risk

K011648 is an FDA 510(k) clearance for the RANDOX CARBAMAZEPINE. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on January 15, 2002 after a review of 231 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 Randox Laboratories, Ltd. devices

FDA 510(k) Submission Details - K011648

510(k) Number K011648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2001
Decision Date January 15, 2002
Days to Decision 231 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 87d · This submission: 231d
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 51
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K011648.
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
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
IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6
K000007 · Diagnostic Products Corp. · Feb 2000