Cleared Traditional

K931031 - VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT

K931031 is an FDA 510(k) clearance for VIDAS CORTISOL (CORT) ASSAY & SERUM FRE..., manufactured by Biomerieux Vitek, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K931031

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.

JFT Device Classification - Class 2, Special Controls

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.
AIA-PACK CORT ASSAY
K954591 · Tosoh Medics, Inc. · Dec 1995
CIDBA CORNING ACS CORTISOL IMMUNOASSAY
K934317 · Ciba Corning Diagnostics Corp. · May 1994
DELFIA CORTISOL KIT
K930732 · Wallac OY · Jul 1993
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