Cleared Traditional

K033884 - RANDOX AMIKACIN

K033884 is an FDA 510(k) clearance for RANDOX AMIKACIN, manufactured by Randox Laboratories, Ltd.. The device is a Class 2 Chemistry device with product code KLQ cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K033884 · Randox Laboratories, Ltd. · Chemistry device
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Jun 2004
Decision
177d
Days
Class 2
Risk

K033884 is an FDA 510(k) clearance for the RANDOX AMIKACIN. Classified as Radioimmunoassay, Amikacin (product code KLQ), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on June 9, 2004 after a review of 177 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3035 - 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 Randox Laboratories, Ltd. devices

FDA 510(k) Submission Details - K033884

510(k) Number K033884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2003
Decision Date June 09, 2004
Days to Decision 177 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 88d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLQ Device Classification - Class 2, Special Controls

Product Code KLQ Radioimmunoassay, Amikacin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3035
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 - KLQ Radioimmunoassay, Amikacin

All 15
Devices cleared under the same product code (KLQ) and FDA review panel - the closest regulatory comparables to K033884.
QMS AMIKACIN REAGENTS
K052815 · Seradyn, Inc. · Nov 2005
INNOFLUOR AMIKACIN ASSAY SYSTEM
K955570 · Oxis Intl., Inc. · Feb 1996
INNOFLUOR (TM) AMIKACIN REAGENT SET
K903100 · Innotron of Oregon, Inc. · Aug 1990
COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR
K852317 · Roche Diagnostic Systems, Inc. · Jun 1985
AMIKACIN ANALYTICAL TEST PACK ACA
K843211 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1984
EMIT QST AMIKACIN ASSAY
K840193 · Syva Co. · Mar 1984