Cleared Traditional

K894517 - FPR AMIKACIN KIT

K894517 is an FDA 510(k) clearance for FPR AMIKACIN KIT, manufactured by Colony Laboratories, Inc.. The device is a Class 2 Toxicology device with product code KLQ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K894517 · Colony Laboratories, Inc. · Toxicology device
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Sep 1989
Decision
70d
Days
Class 2
Risk

K894517 is an FDA 510(k) clearance for the FPR AMIKACIN KIT. Classified as Radioimmunoassay, Amikacin (product code KLQ), Class II - Special Controls.

Submitted by Colony Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on September 28, 1989 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3035 - 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 Colony Laboratories, Inc. devices

FDA 510(k) Submission Details - K894517

510(k) Number K894517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date September 28, 1989
Days to Decision 70 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 87d · This submission: 70d
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 Toxicology devices follow this clearance model.

Regulatory Peers - KLQ Radioimmunoassay, Amikacin

All 16
Devices cleared under the same product code (KLQ) and FDA review panel - the closest regulatory comparables to K894517.
RANDOX AMIKACIN
K033884 · Randox Laboratories, Ltd. · Jun 2004
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