Cleared Traditional

K970509 - INNOFLOUR CALIBRATOR REAGENT SET

K970509 is an FDA 510(k) clearance for INNOFLOUR CALIBRATOR REAGENT SET, manufactured by Oxis Intl., Inc.. The device is a Class 2 Toxicology device with product code DLJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K970509

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
Combination Product No
PCCP Authorized No
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.

DLJ Device Classification - Class 2, Special Controls

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 110
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K970509.
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K961726 · Roche Diagnostic Systems, Inc. · Jul 1996
STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION
K940048 · Solarcare Technologies Corp,Inc. · Mar 1996