Cleared Traditional

K934317 - CIDBA CORNING ACS CORTISOL IMMUNOASSAY

K934317 is an FDA 510(k) clearance for CIDBA CORNING ACS CORTISOL IMMUNOASSAY, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Chemistry device with product code JFT cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K934317 · Ciba Corning Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
254d
Days
Class 2
Risk

K934317 is an FDA 510(k) clearance for the CIDBA CORNING ACS CORTISOL IMMUNOASSAY. Classified as Fluorometric, Cortisol (product code JFT), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on May 13, 1994 after a review of 254 days - an extended review cycle.

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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K934317

510(k) Number K934317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1993
Decision Date May 13, 1994
Days to Decision 254 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 88d · This submission: 254d
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 18
Devices cleared under the same product code (JFT) and FDA review panel - the closest regulatory comparables to K934317.
ELECSYS CORTISOL TEST SYSTEM
K021218 · Roche Diagnostics Corp. · Sep 2002
ACS CORTISOL IMMUNOASSAY
K962559 · Ciba Corning Diagnostics Corp. · Nov 1996
AIA-PACK CORT ASSAY
K954591 · Tosoh Medics, Inc. · Dec 1995
VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT
K931031 · Biomerieux Vitek, Inc. · 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