Cleared Traditional

STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO. (K895484) - FDA 510(k) Clearance

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

K895484 · Baxter Healthcare Corp · Toxicology device
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Oct 1989
Decision
23d
Days
Class 2
Risk

K895484 is an FDA 510(k) clearance for the STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.. Classified as Enzyme Immunoassay, Gentamicin (product code LCD), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on October 4, 1989 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3450 - 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K895484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1989
Decision Date October 04, 1989
Days to Decision 23 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 87d · This submission: 23d
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 Toxicology devices follow this clearance model.

Regulatory Peers - LCD Enzyme Immunoassay, Gentamicin

All 20
Devices cleared under the same product code (LCD) and FDA review panel - the closest regulatory comparables to K895484.
IL TEST GENTAMICIN CALIBRATORS
K943982 · Instrumentation Laboratory CO · Jan 1995
DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD
K904305 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1990
IL GENTAMICIN ASSAY SYSTEM
K903743 · Instrumentation Laboratory CO · Sep 1990
EMIT CONVENIENCE PACK: GENTAMICIN ASSAY
K874703 · Syva Co. · Dec 1987
EMIT QST GENTAMICIN ASSAY
K873855 · Syva Co. · Oct 1987
EMIT GENTAMICIN ASSAY
K873854 · Syva Co. · Oct 1987