Cleared Traditional

K931031 - VIDAS CORTISOL (CORT) ASSAY & SERUM FRE...

K931031 is the FDA 510(k) clearance for VIDAS CORTISOL (CORT) ASSAY & SERUM FRE... by Biomerieux Vitek, Inc.. It is a Class 2 Chemistry device (product code JFT) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K931031 · Biomerieux Vitek, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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 17
Devices cleared under the same product code (JFT) and FDA review panel - the closest regulatory comparables to K931031.
ACS CORTISOL IMMUNOASSAY
K962559 · Ciba Corning Diagnostics Corp. · Nov 1996
AIA-PACK CORT ASSAY
K954591 · Tosoh Medics, Inc. · Dec 1995
CIDBA CORNING ACS CORTISOL IMMUNOASSAY
K934317 · Ciba Corning Diagnostics Corp. · May 1994
ACCESS(R) CORTISOL REAGENTS
K926322 · Bio-Rad Laboratories, Inc. · May 1993
NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR
K900010 · Kallestad Diag, A Div. of Erbamont, Inc. · Apr 1990
CORTISOL TEST SYSTEM
K895421 · Baxter Healthcare Corp · Dec 1989