Cleared Traditional

INNOFLOUR CALIBRATOR REAGENT SET (K970509) - FDA 510(k) Clearance

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

K970509 · Oxis Intl., Inc. · Toxicology device
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May 1997
Decision
90d
Days
Class 2
Risk

K970509 is an FDA 510(k) clearance for the INNOFLOUR CALIBRATOR REAGENT SET. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Oxis Intl., Inc. (Portland, US). The FDA issued a Cleared decision on May 12, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Oxis Intl., Inc. devices

Submission Details

510(k) Number K970509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1997
Decision Date May 12, 1997
Days to Decision 90 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
3d slower than avg
Panel avg: 87d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLJ Calibrators, Drug Specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 - DLJ Calibrators, Drug Specific

All 122
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