Cleared Traditional

K832445 - STRATUS GENTAMICIN FLUOROMETRIC ENZYM

K832445 is the FDA 510(k) clearance for STRATUS GENTAMICIN FLUOROMETRIC ENZYM by American Dade. It is a Class 2 Chemistry device (product code LCD) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K832445 · American Dade · Chemistry device
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Aug 1983
Decision
37d
Days
Class 2
Risk

K832445 is an FDA 510(k) clearance for the STRATUS GENTAMICIN FLUOROMETRIC ENZYM. Classified as Enzyme Immunoassay, Gentamicin (product code LCD), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on August 31, 1983 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3450 - 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: 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 American Dade devices

Submission Details

510(k) Number K832445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1983
Decision Date August 31, 1983
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 88d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCD Enzyme Immunoassay, Gentamicin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3450
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 - LCD Enzyme Immunoassay, Gentamicin

All 30
Devices cleared under the same product code (LCD) and FDA review panel - the closest regulatory comparables to K832445.
DETERMINATION OF GENTAMICIN
K860045 · Clinical Data, Inc. · Jan 1986
ACA GENTAMICIN TEST PACK
K852672 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1985
DU PONT GENTAMICIN ASSAY REAGENTS
K850060 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1985
EMIT AMD GENTAMICIN ASSAY
K832056 · Syva Co. · Aug 1983
EMIT QST TOBRAMYCIN ASSAY
K831416 · Syva Co. · Jun 1983
EMIT QST GENTAMICIN ASSAY
K831304 · Syva Co. · Jun 1983