Cleared Traditional

INNOFLUOR GENTAMICIN ASSAY SYSTEM (K972331) - FDA 510(k) Clearance

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

K972331 · Oxis Intl., Inc. · Toxicology device
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Aug 1997
Decision
39d
Days
Class 2
Risk

K972331 is an FDA 510(k) clearance for the INNOFLUOR GENTAMICIN ASSAY SYSTEM. Classified as Fluorescence Polarization Immunoassay, Phenobarbital (product code LGQ), Class II - Special Controls.

Submitted by Oxis Intl., Inc. (Portland, US). The FDA issued a Cleared decision on August 1, 1997 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3660 - 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 Oxis Intl., Inc. devices

Submission Details

510(k) Number K972331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1997
Decision Date August 01, 1997
Days to Decision 39 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 87d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGQ Fluorescence Polarization Immunoassay, Phenobarbital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3660
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 - LGQ Fluorescence Polarization Immunoassay, Phenobarbital

All 11
Devices cleared under the same product code (LGQ) and FDA review panel - the closest regulatory comparables to K972331.
AXSYM PHENOBARBITAL
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TDX BARBITURATES
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COBAS REAGENTS PHENOBARBITAL & PHENOBAR
K843825 · Roche Diagnostic Systems, Inc. · Feb 1985