Cleared Traditional

RANDOX AMIKACIN (K033884) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 19
Devices cleared under the same product code (KLQ) and FDA review panel - the closest regulatory comparables to K033884.
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
EMIT-AMD AMIKACIN ASSAY
K822657 · Dade Behring, Inc. · Sep 1982
MACRO-VUE CARD TEST, AMIKACIN
K821771 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1982
COAT-A-COUNT AMIKACIN IRA
K820781 · Diagnostic Products Corp. · Apr 1982