Cleared Traditional

K962559 - ACS CORTISOL IMMUNOASSAY

K962559 is an FDA 510(k) clearance for 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 127-day FDA review.

K962559 · Ciba Corning Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
127d
Days
Class 2
Risk

K962559 is an FDA 510(k) clearance for the ACS CORTISOL IMMUNOASSAY. Classified as Fluorometric, Cortisol (product code JFT), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (Irvine, US). The FDA issued a Cleared decision on November 5, 1996 after a review of 127 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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K962559

510(k) Number K962559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1996
Decision Date November 05, 1996
Days to Decision 127 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
39d slower than avg
Panel avg: 88d · This submission: 127d
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 K962559.
ARCHITECT CORTISOL ASSAY
K062204 · Seradyn, Inc. · Sep 2006
AXSYM CORTISOL ASSAY
K033731 · Fujirebio Diagnostics,Inc. · Feb 2004
ELECSYS CORTISOL TEST SYSTEM
K021218 · Roche Diagnostics Corp. · Sep 2002
AIA-PACK CORT ASSAY
K954591 · Tosoh Medics, Inc. · Dec 1995
CIDBA CORNING ACS CORTISOL IMMUNOASSAY
K934317 · Ciba Corning Diagnostics Corp. · May 1994
VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT
K931031 · Biomerieux Vitek, Inc. · Jul 1993