Cleared Traditional

VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT (K931031) - FDA 510(k) Clearance

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

K931031 · Biomerieux Vitek, Inc. · Chemistry device
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Jul 1993
Decision
148d
Days
Class 2
Risk

K931031 is an FDA 510(k) clearance for the VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT. Classified as Fluorometric, Cortisol (product code JFT), Class II - Special Controls.

Submitted by Biomerieux Vitek, Inc. (Rockland, US). The FDA issued a Cleared decision on July 27, 1993 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1205 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomerieux Vitek, Inc. devices

Submission Details

510(k) Number K931031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1993
Decision Date July 27, 1993
Days to Decision 148 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 88d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFT Fluorometric, Cortisol
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1205
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 - JFT Fluorometric, Cortisol

All 19
Devices cleared under the same product code (JFT) and FDA review panel - the closest regulatory comparables to K931031.
Elecsys Cortisol III
K242505 · Roche Diagnostics · Jul 2025
ADVIA Centaur Cortisol (COR)
K192788 · Siemens Healthcare Diagnostics, Inc. · Nov 2019
ELECSYS CORTISOL TEST SYSTEM
K021218 · Roche Diagnostics Corp. · Sep 2002
CORTISOL TEST SYSTEM
K895421 · Baxter Healthcare Corp · Dec 1989
TDX CORTISOL
K854419 · Abbott Laboratories · Nov 1985
TDX CORTISOL
K852927 · Abbott Laboratories · Aug 1985