Cleared Traditional

CIBA CORNING ACS ESTRADIOL-6 ASSAY (K954697) - FDA 510(k) Clearance

Class I Chemistry device.

K954697 · Ciba Corning Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
62d
Days
Class 1
Risk

K954697 is an FDA 510(k) clearance for the CIBA CORNING ACS ESTRADIOL-6 ASSAY. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Ciba Corning Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on December 13, 1995 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1260 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ciba Corning Diagnostics Corp. devices

Submission Details

510(k) Number K954697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1995
Decision Date December 13, 1995
Days to Decision 62 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
26d faster than avg
Panel avg: 88d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHP Radioimmunoassay, Estradiol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1260
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CHP Radioimmunoassay, Estradiol

All 17
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K954697.
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K973743 · Beckman Instruments, Inc. · Oct 1997
ELECSYS ESTRADIOL ASSAY
K965109 · Boehringer Mannheim Corp. · Feb 1997
AURAFLEX(R) ESTRADIOL
K946199 · Organon Teknika Corp. · Apr 1995
COAT-A-COUNT(R) ESTRADIOL-6
K943193 · Diagnostic Products Corp. · Feb 1995
IMMULITE ESTRADIOL
K932926 · Diagnostic Products Corp. · Jan 1994
CIBA CORNING ACS ESTRADIOL IMMUNOASSAY
K932715 · Ciba Corning Diagnostics Corp. · Dec 1993