Cleared Traditional

K911466 - INNOFLUOR VALPROIC ACID CALIBRATOR SET

K911466 is the FDA 510(k) clearance for INNOFLUOR VALPROIC ACID CALIBRATOR SET by Intl. Bioclinical, Inc.. It is a Class 2 Chemistry device (product code DLJ) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K911466 · Intl. Bioclinical, Inc. · Chemistry device
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May 1991
Decision
50d
Days
Class 2
Risk

K911466 is an FDA 510(k) clearance for the INNOFLUOR VALPROIC ACID CALIBRATOR SET. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Intl. Bioclinical, Inc. (Portland, US). The FDA issued a Cleared decision on May 23, 1991 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3200 - 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 Intl. Bioclinical, Inc. devices

Submission Details

510(k) Number K911466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1991
Decision Date May 23, 1991
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 88d · This submission: 50d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 94
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